Herpes zoster from ZOSTER (ZOSTAVAX) 2008
Vaccine Manufacturer:MERCK & CO. INC.
Vaccine Code:VARZOS
Vaccine Type:VARICELLA-ZOSTER VACCINE
Vaccine Name:ZOSTER (ZOSTAVAX)
Year Reported:2008
Symptom Reported:Herpes zoster
ZOSTER (ZOSTAVAX) Side Effects Report #301386
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/31/2007. Male patient, 67.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an adult male who on an unspecified date was vaccinated with a dose of zoster vaccine live (Oka/Merck). A few days later the patient developed shingles on the head. The patient had never had shingles before. It was unspecified if medical attention was sought. The outcome was not reported. No product quality complaint was involved. Follow-up information received indicates that the physician is interested in the VZV identification program. Follow-up information indicates that the patient is a 67-year-old male with allergies to atorvastatin calcium (Lipitor) and ezetimibe (+) simvastatin (MSD) and has a past history to childhood chickenpox, colon polyp, depression, high lipids and hypertension. On 16-Nov-2007 he received a ~unit,~ his first dose of zoster vaccine live (Oka/Merck) (lot #658361/090U) in the left arm. On 18-Nov-2007, the patient developed a herpetiform rash with approximately 30 lesions on the back of the skull, face, dermatome II and V and had pain. He had a maximum temperature of 98.6. It was reported that there was no recent exposure to chickenpox. The outcome was reported as not recovered. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the OKA/Merck vaccine VZV strain. The sample lesion was collected on 27-Nov-2007. The sample was taken from a crusted vesicle from the scalp. Additional follow-up information was received. The PCR results for the sample from a crusted vesicular lesion from the scalp site identified the presence of WT VZV. Additional follow-up information from the reporting physician indicated that the 67 year old white male developed the onset of herpetiform rash on the forehead, back of head and the face on the morning of 19-Nov-2007 (also reported as 18-Nov-2007). There was no illness at the ti" "Chickenpox, Hypertension, Lipids NOS high, Colonic Polyp, Depression, Hypersensitivity.""body temp, 98.6; VZV strain, 11/27/07, VZV wild type strain" . During the same period patient was treated with "aspirin, Lexapro, Zetia, Pravachol, Altace". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #301424
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/27/2007. Female patient, 68.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Rash on left upper arm, some pain. Went to the doctor 12/14/07 and was diagnosed as having shingles. Was put on Famciclovir for 7 days." NoneSjogrens syndromeShingles-Herpes zoster . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #301965
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/31/2007. Male patient, 79.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Pt reports he had Zostavax at hospital Nov 07. Presents to this clinic 12-29-07 - reports started noticing shingles 2 or 3 weeks ago - confirmed by doctor - active shingles noted. . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #302513
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 01/11/2008. Male patient, 61.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Severe Headache the day following vaccine administation which lasted several days. Severe case of Shingles starting December 1, 2007 which is just now starting to fade. Patient has had Shingles in the past 2-3 times yearly for the last 10 years. However, he states he has never been treated with antiviral medication." States was getting over a case of Shingles at time of vaccination."Diabetes, Elevated Cholesterol; Allergies to Prednisone and Celebrex" . During the same period patient was treated with Medformin 1000mg BID for Diabetes Crestor 10mg da. for Cholesterol Nenapril 2.5 mg for Kidneys Numerous supplements. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #302626
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 01/11/2008. Female patient, 66.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Varicella Zostr (L) U.E. None"Allergies: PCN, Sulfa, Codeine" . During the same period patient was treated with Xalatan eye drops .005%; magriu; Vit C; Ca+ and Vit D; glucoscondrotiny; Vit K; Estradiol .5; Betimol 1% Eye. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #303062
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 01/21/2008. Female patient, 61.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Vaccine administered 12/28/2007. seen in Urgent Care clinic 1/05/2008 with facial rash, viral culture obtained verifying Herpes Zoster infection." None"HTN, Hyperlipidemia"Zoster culture positive 1/07/2008 . During the same period patient was treated with "Cozaar, Zetia, Atenolol, Levothroid". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #303200
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 01/16/2008. Female patient, 68.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "See accompanying form with course of events following Pneumovax injection. In addition, patient reports 12/17/07 a spot on her back, not painful, looked like an insect bite, difficulty sleeping. Later that day, c/o extreme pain under R shoulder blade which later spread to under R breast. She had MRI scheduled with physician appointment. On 12/18/07, seen by Dr. who diagnosed shingles, prescribed Valtrex. Valtrex helped to improve sx. She says that she has since recovered to about 90% with those sx. She reports having a mild-moderate case of chickenpox as a child, approximately 8-9 yrs. of age. She says that 4 other family members had chickenpox at same time. She denies ever having shingles before." Pain in L arm as described"Nerve damage to L knee, also reports Tylenol ~stops kidneys~""None, but MRI was done on 12/18/07 for other reasons" . During the same period patient was treated with Kenalog (cortisone) 20 mg injection to L knee on 12/4/07. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #303559
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 01/24/2008. Male patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a health care worker concerning a 65 (also reported as 66) year old male patient who on 10-JAN-2008 was vaccinated with Zostavax (Oka/Merck) (dose, frequency, route not specified). On 14-JAN-2008, the patient was seen in the ER and was admitted for a cardiac condition but he has full blown shingles. The patient was not admitted because of the Zostavax (Oka/Merck). The patient's date of birth is 21-FEB-1942. The called is interested in the VZV analysis by PCR. There was no product complaint. On 14-JAN-2008, the physician was contacted for follow up and offered the VZVIP. The physician reported that the patient had a history of MS and was on interferon intermittently. He also had a splenectomy in the past. He explained that the patient was vaccinated ~last week~ with Zostavax (Oka/Merck) by his primary care physician. The patient developed shingles on 13-JAN-2008 and had a rash, right thoracic area, T-8. He explained that the patient was doing fine with his herpes zoster. The patient also had CAD and had a stent placed previously. He explained that the patient started to have chest pain so he was hospitalized to evaluate further. The VZVIP was discussed with the physician and he indicated he would look at the packet of information. On 15-JAN-2008, additional information was received from a physician. The physician reported that the patient had a medical history of multiple sclerosis for the last 15 years. It was reported that the patient's daughter came down with shingles on 05-JAN-2008 on her face, not in her eye. The patient broke out with shingles rash on intercostal nerves on 14-JAN-2008. On 15-JAN-2008, patient developed chest pain and went to the hospital and was admitted. The patient underwent cardiac catheterization and it was normal. On 16-JAN-2008, a call was received from another physician regarding the patient. He reported that the patient was now home from the hospital. The physician indicated he was interested in the VZVIP. On 18-JAN-2008, the" Multiple sclerosis; Coronary artery diseaseSplenectomy; Stent placementcardiac catheterization 01/15/08 - normal . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #303623
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 01/22/2008. Male patient, 77.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Received call from attending physician of patient. Dr. says his patient has vaccine related rash & believes it is shingles which became apparent within 48 hours after receiving the vaccine. I called the manufacturer requesting more info regarding Zostavax. Medical dept (Merck) says they are willing to test sample from rash to see if the rash is related to vaccination. This info. was relayed to patient's doctor & other for user. None specifiedBlood pressure (high) hx according to patient. . During the same period patient was treated with Routines: nadolol; Vasotec; Norvasc; Crestor; ASA 81 mg.. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #303639
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 01/25/2008. Female patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "76 yo female with onset pain left back and arm 4 days ago followed by redness and blisters. Pain is 8/10 constant with new blisters arising. No systemic symptoms, no HX of Immunosuppression. Had Zoster vaccine 4/10/2007. No relief with Tylenol. Exam: Skin with grouped vesicles on erythematous base in linear distribution over left upper back, medial upper arm and left upper chest; right upper back with unassociated linear crusts attributed to scratch trauma by patient. Face and hands clear. Herpes Zoster (Shingles)." HTN; HLP; OA; Trigger FingerNone . During the same period patient was treated with "ASA, HCTZ, Simvastatin, Candesartan, Dexamethasone, Meloxicam, Trimethoprim". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #304029
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 01/30/2008. Female patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning his 72 year old wife, with high cholesterol, and an allergy to codeine, who approximately six months ago (approx. July 2007), was vaccinated with ZOSTAVAX. Concomitant therapy included CRESTOR. On 23-Dec-2007, the patient developed a shingles rash that presented on her jaw, face, ear, and scalp. On 26-Dec-2007, she presented to the hospital with a chief complaint of pain and was hospitalized. Treatment included unspecified intravenous pain medications, and intravenous acyclovir. She was discharged after two nights in the hospital. The reporter indicated that the rash had cleared (date unspecified, but the patient was still experiencing significant pain. A product quality complaint was not reported. Additional information has been requested." Cholesterol high; Drug hypersensitivityUnknown . During the same period patient was treated with CRESTOR. Patient was hospitalized Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #304468
ZOSTER (ZOSTAVAX) vaccine side effect was reported . Male patient, 68.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient began having symptoms of shingles on 1/28/08. He had a rash under shoulder blades and pain associated with rash. Patient under treatment. . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #304531
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/07/2008. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Lesions on upper right arm, under arm, and on breast and pain across the back. Vaccine was given on 1-23-08 about 2pm. Complete case of zoster by 7pm. Called the dr on the 25th he said take benadryl. On the 1st still in pain. Went to the dr and he diagnosed as such. Gave me Famvir. Today is the 7th of Feb and still in pain." nonenone . During the same period patient was treated with diovan. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #304572
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/08/2008. Male patient, 61.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Pt had active case of Herpes Zoster when he received the Zostavax vaccine. It appears that the active case worsened following administration of the Zostavax vaccine Shingles"Allergies: NKA; PMH: HTN, hyperlipidemia, osteoarthritis, obesity" . During the same period patient was treated with NONE. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #304635
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/08/2008. Female patient, 69.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Patient was given the Zostavax in the right tricep on 1/28/08 and on 1/29/08, she woke with approx 50 shingles-like lesions on her right buttocks. Patient was seen by a physician on 1/29/08 who confirmed non-injection site like zoster-like rash." N/A"Allergy to erythromycin, penicillin." . During the same period patient was treated with N/A. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #304639
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/08/2008. Female patient, 78.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, 2-8-08 Pt called health dept and stated she has been diagnosed with shingles. Pt placed on Tylenol with codeine and acyclovir 800 mg one 5x day x7 days. NoneNone . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #304715
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/11/2008. Female patient, 76.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "outbreak of shingles involving ophthalmic division CN5, 1st symptom occurred 48 hours after immunization, mild burning, HA. Rash started 2/7/08, 6 days after immun. Rx acyclovir on 2/11/08" None"hypertension, CAD, OA"None . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #304729
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/11/2008. Male patient, 82.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "- Rash after Zoster vaccine administer (Mild Herpes Zoster, left abdomen)" . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #305171
ZOSTER (ZOSTAVAX) vaccine side effect was reported . Female patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Received shingles shot 01-07-08. Shingles broke out 01-30-08. . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #305172
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/13/2008. Female patient, 73.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Shingles (clinical) 2 days after shingles vaccine with typical rash R thorax. None . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #305218
ZOSTER (ZOSTAVAX) vaccine side effect was reported . Female patient, 61.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "To Whom it May Concern: I am writing to notify you of my experience concerning the Zostavax vaccine. During a routine physical, I was offered the vaccine because I am over 60. Because I have been plagued with herpes since childhood, I felt it would be a good idea to receive it, which I did on December 28th. On January 12th, I had been feeling very tired and began having pain in my ribcage and lower back. On January 16th I broke out in shingles. I went in to my doctor and was given a prescription for acyclovir. I also received the actual information sheet from the pharmaceutical company which stated that a recipient should not be around newborns, pregnant women or immunocompromised persons. I am an RN in an Intensive Care Nursery and had been working post-vaccine. This cause quite a bit of distress in the ICN and also the Infectious Disease Department...and, of course, to me. I also spent my holidays with a person who has leukemia, my grandchildren, one of whom was too young to have received the chickenpox vaccine. On January 18th one of my grandsons had chickenpox although no other students in his school had them. I, of course, was not able to return to work until the 6 weeks period ended. I strongly feel the information regarding avoiding newborns, pregnant women and immunocompromised people should be included on the office handout from CDC. My doctor is going to give prospective recipients both sheets in the future. I requested that she also notify you of my situation just to further legitimize these facts." Herpes . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #305358
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/21/2008. Female patient, 84.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Pt's left eye began twitching 2 weeks ago. It was dry but not painful. Pt denies any other symptoms. Her doctor diagnosed her with shingles of the eye based on examination and symptomology and gave pt a prescription for anti-viral eye drops. nonenoneN/A . During the same period patient was treated with "Triamterene/HCTZ, Altace". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #305489
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/21/2008. Male patient, 84.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer concerning her 85 year old husband with a history of myocardial infarction and no allergies who in February 2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). In February 2007, 3 weeks after vaccination the patient developed a headache then began to develop numbness and paralysis of the right side of his face. The patient was diagnosed with Bell's Palsy and then diagnosed with RAMSAY-HUNT Syndrome. The patient lost the hearing in his right ear. Multiple unspecified diagnostic laboratory tests were undertaken. It was reported that various MRI's and CT scans were also undertaken. Unspecified medical attention was sought. At the time of report the patient had not recovered. A product quality complaint was not involved. Upon internal review, lost the hearing in right ear was determined to be an other important medical event. This was one of several reports received from the same source. Follow-up information has been received from a physician concerning an 85 year old male with a history of myocardial infarction who on 12-FEB-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# 656608/0032U). In approximately March 2007 about 1 month after vaccination, the patient developed shingles in his ear. The patient also had BELL's PALSY and was droopy on the right and developed RAMSAY HUNT syndrome. The physician thought the patient was treated with prednisone and acyclovir. It was also reported that the patient's wife developed BELLS's PALSY (WAES# 0802USA02705). Subsequently, the patient recovered was noted to be ~done fine.~ The patient was enrolled in a program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine VZV strain. Additional information has been requested. 5/9/08 Received CT & MRI reports only. 5/13/08 Reviewed PCP medical records of 2/12/2007-1/24/208. FINAL PCP DX: BELL's PALSY, right; RAMSAY HUNT syndrome; post viral symptoms. On" "Myocardial infarction PMH: HTN, hypothyroidism, hyperlipidemia, recurrent gallstones s/p cholecystectomy, CAD, CABG, prostate cancer, DJD, PAD w/claudication, asymptomatic aortic stenosis. Allergies: codein, morphine & ASA."magnetic resonance 02/07 Results not provided; computed axial 02/07 Results not provided; diagnostic laboratory 02/07 Results not provided LABS: MRI brain 3/30/2007 w/ischemic changes. CT brain/head on 3/21/2007 revealed generalized cere . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #305516
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/22/2008. Female patient, 68.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient developed shingles after receiving a Zostavax. Treated with antivirals & received cervical nerve block for pain. NoneHypertension; hyperlipidemia; DII controlledPositive Tzanck stain . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #305550
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/22/2008. Male patient, 82.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an 82 year old male with hypertension, high cholesterol and a childhood history of chickenpox who on 14-JAN-2008 was vaccinated into the left arm with a ~single dose~ of ZOSTAVAX (lot# 658210/1079U). On 21-JAN-2008 the patient developed vesicles at ~L C/2 C2~, also reported as shingles on his left shoulder, upper arm and neck. It was noted that a rash did not occur at the injection site or elsewhere within 42 days of the vaccination. The patient was treated with acyclovir and lidocaine (LIDODERM). It was reported that the vesicles remained for ten (plus) days. The patients symptoms included generalized aching with pain ~in the region~. It was noted that the patient had not had any recent exposure to chickenpox or herpes zoster. A direct fluorescent antibody was not done, nor was a specimen collected for VZV identification. Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. At the time of reporting it was noted that the patient had partially recovered, with pain and neuralgia persisting, along with severe hyperesthesia. The event of shingles was considered to be disabling by the reporter given that ~the patient is in pain~. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. Additional information has been requested." Hypertension; Cholesterol highChickenpoxNone . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #305736
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/26/2008. Female patient, 77.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Shingles the day after Zostavax given - Dense Left Chest & Breast, and Less Dense Left Back" NoneHTNNone . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #305793
ZOSTER (ZOSTAVAX) vaccine side effect was reported . Female patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "On 2/14/08 she developed erythematous plaques and patches on her left upper arm and left side of neck. Within 2 days, multiple vesicles within these areas consistent with herpes zoster. She came into our clinic on 2/19/08 for evaluation. Treated with 7 day course of Valacyclovir." Asthma exacerbation on inhaled steroidsPolymyalgia rheumatica on low dose; oral prednisone (2mg daily); coronary artery disease; hypertension; osteoporosis; hyperlipidemia; asthma; history of colon CA in 2000.None . During the same period patient was treated with Advair 500/50 1 puff BID; Prednisone 2mg daily; plus many others.. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #306182
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/29/2008. Male patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient experienced outbreak of Shingles/Herpes Zoster 6 weeks after receiving Zostavax in V1 distribution nonehyperlipidemia . During the same period patient was treated with "Vytorin, Aspirin, glucosamine". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #306214
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/22/2008. Female patient, 80.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Started 2 days after the immunization with rash/itching - persistent. Later (after couple months) developed tingling/pain both intermittent. By Nov. 8, 2007 developed swelling of same arm (2 cm > circumference than opposite are), increased sensitivity to light touch. 3/14/08 Spoke w/reporter who stated patient experienced shingles type rash at injection site. Tx w/ topical cream. Rash now resolved but arm remains swollen & extremely sensitive to touch or clothing. Tx symptomatically w/pain meds. MD expects complete recovery in time." NoneCodeine; Vicodin; IVP dye; lipids; constipation; nasal polyps; anxiety.None done other than Venous Doppler negative for clot. . During the same period patient was treated with Lipitor; Restoril; Xanax; Nasonex; Miralax; Lactulose; Zyrtec.. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #306257
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/27/2008. Male patient, 73.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Came down with shingles - 30 days hospital turned into heart attack - 30 more days hospital body rash all over - still under treatment 7 months now. Very painful and bleeding. 3/21/08-records received for DOS 8/17-8/19/07-DC DX: herpetic shingles on left lower leg and also on bilateral thighs. Possible allergic reaction to the patient taking herpes zoster vaccine. C/O chest pain and rash. Vaccine administered 2 weeks ago. Burning sensation along chest and lower left leg. Did not feel well and generalized weakness. Presented to ER with burning chest pain, rash all over chest. C/O itchiness and redness." NONENONE 3/21/08-records received- PMH: Coronary artery disease. Hypertension. Hyperlipidemia and status post PCI 13 years ago."BLOOD POISONED 3/21/08-records received-Blood culture negative, wound culture negative. Urine culture negative. Troponin negative." . Patient was hospitalized Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #306284
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/28/2008. Female patient, 67.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "See attached; ~Patient~ received the shingles vaccination on January 7, 2008. Sometime, the following week, she began to experience a tingling sensation beginning with the upper right portion of her face. Over the next week, the tingling and slight lack of feeling to the entire right half of her face, the right side of her tongue and the right side of her bottom lip. The feeling was similar to a novacaine shot which has almost worn off. She also had a mild headache which lasted about three days. Her face hot to her but it wasn't hot to the touch. The only visible symptom was a slight redness which appeared on her right cheek. A week to 10 days later, she called the Hospital. After describing her symptoms, she was told that the symptoms couldn't be caused by or related to the vaccination. The Center called Dr.'s internist. He gave her the name of a neurologist that he strongly suggested she see for a neurological exam as soon. After a series neurological tests and brain and neck MRI's and MRA's, Dr. concluded that ~patient~ has a mild case of shingles. Dr. prescribed Neutrontin. As of this date most of the symptoms remain." NoneSlightly elevated blood pressure and allergies to mold and ragweedMRI Brain; MRA Brain; MRA Neck . During the same period patient was treated with Premarin; Diovan. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #306498
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/05/2008. Female patient, 83.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Vacinated on 2/20/08. Sore rt. side 2/22; 5 red spots under rt. arm on 2/23. Pain deep in body beginning 2/24 and extensive rash. Diagnosed with Shingles on 2/26/08. Started medications on 2/26: Gabapentin, Prednisone, Acyclovir. Rash from center of chest to under rt arm; also on back." None."Allergic to penicillins, sulfonamides" . During the same period patient was treated with Fosamax; Lipitor. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #306528
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/05/2008. Female patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Pt developed shingles of her ophthalmic branch on the right side on 3/3/08. NoneNoneN/A . During the same period patient was treated with Zoloft; Lipitor. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #306881
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/11/2008. Female patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Patient reports redness and pain at injection site on her arm within the first 24hr of vaccination which resolved by 72hrs. She developed a rash on her L buttock and down the back of her L thigh starting 48hrs after vaccination- 3/2/08. She was examined in the office on 3/5/08 and found to have nl L arm, but classic Varicella zoster rash in a L S1 distribution. Was started on therapy with Vancyclovir that day. Culture swab of a blister was obtained." URI/sinusitis on 2/22sulfa drugs - unkn past reaction; Actonel for osteopenia caused muscle soreness.Vsv rapid culture positive for presence of varicella zoster virus reported by Quest diagnositc of Seattle. . During the same period patient was treated with Zithromax on 2/27/08 Aspirin 81mg daily. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #306985
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/07/2008. Male patient, 69.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Dx: severe brachial plexopathy due to shingles. 12/10/07 came in with pain left neck - shoulder, hypersensitive skin, 3 small vesicles/erythema rash (L) neck. Pain and paresthesias progressed - LUE - neuropathy (L) brachial plexus with sensory and motor involvement. Slowly improving with phys therapy, gabapentin, analgesics. 4/4/08 Reviewed clinic records of 5/2007-3/2008. FINAL DX: severe left brachial plexopathy, likely secondary to herpes zoster infection, improving. Records reveal patient experienced good general health on 8/24/07. Neck, hip & back pain 11-12/07 x 5 days & felt to be shingles. Developed numbness, tingling, burning, shooting pain in shoulder, upper back, down left arm from neck. Pain interferred w/sleep & was sleeping in chair. Also has numbness left arm/hand & decreased ROM. No improvement w/meds. Dx w/sensory & motor neuropathy of LUE. MRI & referred to neuro. Neuro exam revealed left arm weakness w/significantly diminished strength in biceps, deltoid & grip. Left arm muscle atrophy noted. Referred to PT & started neurontin. Improved as of last note 3/11/08. Follow-up: Continues with some muscle weakness b/t shoulder girdle mild paresthesia. No pain. Has been able to D/C NEURONTON." None"DM Type II, HTN, CAD, Prostate CA in remission; Hyperlipidemia; NKA PMH: hypercholesterolemia, CABG, Morton's neuroma right foot, allergic rhinitis"MRI C-spine - no evidence cervical radiculopathy; Nerve conduction studies; Neurology consult LABS: MRI c & t-spine abnormal w/disc protrusion & mild effacement of the cervical cord on left. EMG/NCS . During the same period patient was treated with Ecotrin; Glyburide; Diovan/HCT; Crestor; Metformin; Singulair. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #307036
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/13/2008. Female patient, 77.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient developed shingles 2 weeks after receiving vaccine. Mild cold symptoms; AfebrileHypertension; Hyperthyroidism; Aortic Stenosis; Hypercholesterolanemia; S/P Endometrial cancer.None . During the same period patient was treated with CA Poten; Crestor; Hydrochlorthiozide; Synthroid; Vitamins; Calcium; Omega 3. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #307755
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/21/2008. Female patient, 87.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Approx one week after vaccination, pt developed shingles on left upper quadrant of abdomen" NoneOsteoarthritis No known drug allergies . During the same period patient was treated with esomeprazole 40mg po daily. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #307898
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/21/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 60 year old female licensed visiting nurse with a history of a cold in January 2008 and chickenpox (otherwise reported to be a normal healthy person with no recent stress or immunosuppression) who on unspecified dates administered Zostavax (Oka/Merck) to many patients. The patient never received Zostavax (Oka/Merck). It was noted that the patient has administered the vaccine to at least 10 patients in the last month. Subsequently the patient developed shingles. Due to her symptoms she has been home from work. The shingles has affected the left side of the patient's face and eye. The patient was seen by a physician. The patient was placed on ZOVIRAX, prednisone and VICODIN. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. The patient considered her events to be disabling." Cold; ChickenpoxNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #308160
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/24/2008. Female patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Pt reports having a full blown case of shingles but stated she had never had chicken pox. Pt was treated by family physicians starting on 1/7/08 with Valtrex 1mg, Prednisone 20mg and Lortab." N/ACodeine allergy . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #308674
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/29/2008. Male patient, 73.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Joint Pain - Celestine shot and pain pills 1/7/08. Hospital - 1/28/08-1/31/08 with instructions to take 20 mg Prednisone. 2/21/08 Decrease Prednisone to 15 mg. 3/15/08 - Emergency Room visit and then transferred. Herpes breakout - mouth, lips, heavy rash breakout face, neck, chest, arms and hands, joint pain returned. Inflammation of pericardium and chest pain during hospitalization. Blood pressure dropped, blood became extremely thin and required a vitamin K injection. Since discharge from hospital, at times extreme pain in chest with shortness of breath at all times. Joint pain greatly improved with 40mg daily of Prednisone. Cardiologist placed on two additional medications due to pump function decrease and heart beating too fast. Required hospitalization on 2 occasions: 1/28-1/31/08 and 3/15-19/08. Permanent disability: Undetermined, still unable to perform as prior to vaccine. Physical abilities prior to vaccine equaled some 15-20 years his junior. 4/4/08-records received for DOS 1/28-1/31/08-DC DX: Chronic atrial fibrillation. Joint Pain/Inflammatory polyarthritis. Hypertension. Presented with lower extremity swelling. Week after receiving herpes zoster vaccine began to have diffuse arthralgias in knees, shoulders, hands and elbows which persisted and accompanied by lower extremity swelling for the last two weeks. Worsening fatigue over the same interval. 4/9/08-records received for DOS 2/21/08-Follow up visit after hospitalization, continues to improve after steroid therapy. Rash on face, chest and arms. Assessment: Inflammatory polyarthritis, stable." None"Hypertension - atrial fib 4/4/08-records received-PMH: chronic atrial fibrillation. Cardioversions. Cervical disc disease, degenerative joint disease, melanoma, valvular heart disease consisteing of mild MR, hypertension, chronic Coumadin therapy. 4/9/08-records received-Osteoarthritis pre-existing.""Natural immune system damaged, symptoms of Herpes, Lupus. Inflammation of pericardium. 4/4/08-records received-EKG: atrial fibrillation. Cardiac enzymes negative. 4/9/08-records received-ANA 1:1280." . During the same period patient was treated with Topral; Coumadin; Vitamins. Patient was hospitalized Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #308693
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/27/2008. Male patient, 61.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Patient presents to clinic 1/24/08 with active lesions on his abdomen. Zostavax inj was given to patient on 1/10/08. Zostavax was ordered for this patient who is on an immunosuppressant, Etanercept to treat his rheumatoid arthritis. Valacyclovir 1000mg TID x 7 days was ordered by provider in clinic to treat active herpes zoster." Active rheumatoid arthritis being treated with Etanercept. . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #308759
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 04/02/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Pt. noticed rash on L arm, initially blistery, pruritic, stinging. Two other areas on L arm have developed. Characteristic pattern of shingles, lesions appear to stay in L dermatome, possible C6. Lesions are crusted over and don't require treatment: over 10 days from onset. Follow up in 2 weeks." No"Allergic to ACE inhibitors, BETA Adrenergic blockers, CELEBREX caps.; Allergic rhintis; Hx of anemia; Benign breast neoplasm; Hx cholecystectomy; Eczematoid Dermatitis; Fibromyalgia; Hypertension; Osteoporosis" . During the same period patient was treated with "Aspirin, Calcium, ELIDEL cream, FOSAMAX, HYZAAR". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #308824
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 04/02/2008. Male patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "information has been received from a physician concerning a 70 year old male consumer with a cardiac history who on 19-MAR-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included ~routine medicines.~ Subsequently, on 26-MAR-2008 the patient developed chest pain in the left nipple area. The patient was taken to the emergency room since he had a cardiac history. It was unspecified if lab studies were performed. The patient also had a rash on his left chest and back area and was diagnosed with shingles. The patient was hospitalized overnight. At the time of the report the patient still had shingles. The status of his chest pain was unknown. There was no product quality complaint involved. Additional information has been requested." Cardiac disorderUnknown . During the same period patient was treated with therapy unspecified. Patient was hospitalized Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #308876
ZOSTER (ZOSTAVAX) vaccine side effect was reported . Female patient, 76.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Vesicular rash (L) arm and leg that burned and resembled zoster rash. . During the same period patient was treated with "Calcium & Vitamin D, Sig: as directed; SINGULAIR 10 mg tablet; 1 tab (s) orally once a day (in the evening); ALBUTEROL 90 mcg/inh aerosol with adapter, Sig: 2 puff (s) inhaled QID prn; CLARINEX 5 mg tablet, Sig: 1 tab (s) orally once a day;". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309083
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 04/07/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a male consumer with hypertension, hyperlipidemia and allergies to ~medications for hypertension and hyperlipidemia~ who on 18-MAR-2008 was vaccinated with Zostavax (Oka/Merck) (lot # 659324/1835U). On 19-MAR-2008 the patient went to the ER for back pain. He was diagnosed in the ER with a urinary tract infection and was given CIPRO. The patient developed shingles on his right back and flank. The rash was erythematous blisters with burning that began on 26-MAR-2008. It was also noted that the patient was seen in the office. At the time of the report the patient has not recovered. There was no product quality complaint involved. The reporter considered the patient's events to be other important medical events since he was seen in the ER and office. Additional information has been requested." Hypertension; Hyperlipidaemia; Drug hypersensitivityUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309364
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 04/11/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "4/1/08 had slight headache day of vac. 4/2/08 felt well, 4/3/08 awoke w/ red eye and irritation around eye. Appt w/ PCP (Maxwell) DX sinus infection-- was given antibiotic oral and oint for eye. 4/6/08 symptoms worse--went to ER w/ DX shingles. ER MD gave Rx Valtrex. 4/7/08 appt w/ ophthamologist eye OK, but Rx Valtrex. 4/10/08 SX much better, no PHN" none . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309365
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 04/11/2008. Male patient, 79.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "States he received the Zostavax vaccine at the Medicine Shoppe in Clarion, PA on 3/25/08. States he had shingles when he was vaccinated and ~should have never received the vaccine~. Had an outbreak of shingles on the right chest and right back. Outbreak is improving now, and patient now has an order for gabapentin to help with the pain. Also received acyclovir 800 mg q4h following the immunization. Patient denied having any other immunizations in the month prior to receiving Zostavax." Shingles (as described above)"COPD, HTN, hypothyroidism, hyperlipidemia, BPH, erectile dysfunction, premature atrial contractions"N/A . During the same period patient was treated with "loratadine 10 mg daily, levothyroxine 0.1 mg daily, vardenafil 10 mg prn, flunisolide nasal 2 sprays bid, combivent inhaler 2 puffs tid, simvastatin 40 mg qhs, terazosin 4 mg qhs". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309370
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 04/11/2008. Male patient, 79.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Zosavax 0.65 mg SC given on 4/4/08. 24 hours later, painful red rash and vesicles on R face, scalp and eye consistent with zoster opthalmicus. In other words, he developed shingles one day after shingles vaccine given. No contraindications for vaccine." "discussion of mild PSA elevation = 9.3, COPD (stable)""See 18. hypothyroid, diet controlled DM (AIC = 6.3), history of rheumatoid arthritis (but no steroids)""PSA = 9.3 (8/07) --> 11.74 (4/08), HBAIC = 6.3 (4/08), sugar 134, creat 1.2 (4/08) [was 1.4 on 8/07]" . During the same period patient was treated with "levoxyl, ASA". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309382
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 04/13/2008. Male patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Rec'd Zostavax at 1330 3/19/2008. Thirty hours later(20 March 2000 hours) noticed intense itching left anterior/lateral abdominal wall at approx T10 level, and twelve associated raised welts which then blurred together by 0800 3/21/2008. Associated painful burning. No associated fever, no local reaction at injection site. Presumed to be zoster. Called internist and obtained a script via telephone for Valtrex 1.0 Gram to be taken three times a day for 7 days, and began taking 3/21/2008 at 1400 hours. Saw Dr. at outpatient facility on 3/24/2008 and he confirmed zoster and documented it in the medical record. Used topical calamine lotion from day 3 through 12 while active blisters noted. As of this date the pain and itching have subsided and the ~rash~ is fading. I believe the vaccine precipitated the zoster I have experienced." nonetuss ornade/quininevisual exam by physician who confirmed diagnosis of zoster. . During the same period patient was treated with "rabeprazole,lovastatin". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309468
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 05/01/2008. Female patient, 74.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "10/27/07 Got shingles vaccine to prevent getting them. March 6, 2008 had to go to the doctor ~medical center~ for shingles again. The doctor gave me a prescription for Valtrex 500 mg. I had to pay $200 for the shingle vaccine - my insurance would not cover this. Should I get a booster shot or is there any help for me with this problem (shingles)?" None10/29/07-Got shingles vaccine; 3/10/08-Broke out with shingles on my back where I have had them three times. Had to go to Medical Center. Dr. gave me VARTREX. . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309471
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 04/14/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Herpes Zoster eruption on (R) flank. Started on 4-12-08. Had Zostavax on 4-10-2008 NoneBiaxin causes a rash . During the same period patient was treated with Verapamil; HCTZ; Prilosec; Razadyne. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309532
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 04/15/2008. Male patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "DEVELOPED RASH WITH POSTULES WITH NUMBNESS AND MINIMAL PAIN, ON RT THIGH AND RT BUTTOCKS AREA INTO THE GROIN AREA. STARTED THE AM OF 4/3/08. DX BY DERMATOLOGY AT THE HOSPITAL ON 4/12/08 AS SHINGLES." NONENONENONE . During the same period patient was treated with "FELODIPINE, LINSONOPRIL, HCTH, IRON, OMEGA 3 FISH OIL CAPS.". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309603
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 04/15/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient developed zoster rash 9 days after receiving vaccine NONECoronary artery disease; arthritis; osteoporosis; autoimmune hepatitis . During the same period patient was treated with Lutein; Zetia 10mg; KClo meq; Pravachol 80mg 1 day; ASA 81 mg 1 day. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309636
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/27/2008. Female patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Client reports, ~I got the shingles from my shingles shot~. Client reports getting Zoster shot on 2/11/08 and having blisters appear (2) by her (L) eye then (1) in her (L) eye. Client reports pain being so severe that she can't wear her glasses." None"Patient takes Estrace 2mg, takes for hormone therapy. (Allergy to Statia)."Unknown . During the same period patient was treated with Takes Estrace 2mg. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309693
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX and developed shingles. A product quality complaint was not reported. Additional information was not available. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309694
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 73.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 73 year old female consumer with a degenerative disc and allergies to LEVAQUIN, OXYCONTIN, and ~Otrast~ and ~Otram~ and a history of chicken pox who on 12-NOV-2007 who received a single dose series injection in the left arm of ZOSTAVAX (lot# ~1088U~.) Concomitant therapy included MOBIC, triamterene, aspirin, alendronate sodium (MSD), DYAZIDE, and Valium. On 18-NOV-2007, she developed a few red spots on the back of her neck. She reported that the day (19-NOV-2007); there were a few more spots. On 21-NOV-2007, she was seen by her physician who diagnosed her with shingles. At the time of this report, the consumer reported that she was recovering. A product quality complaint was no reported. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. Follow up information from a physician reported that six days (18-NOV-2007) post vaccination, she developed classic herpes zoster in the left C5-C6 dermatone area. He described the lesions as herpetic vesicles numbering 12-15 lesions. Current patient status was not reported. Follow up information reported that the varicella zoster vaccine identification specimens were obtained on 18-NOV-2007, and 27-NOV-2007 from a vesicle from an unspecified site. The PCR results for the specimen from the vesicle identified the presence of WT. Additional information has been requested." Intervertebral disc degeneration; Drug hypersensitivity; Allergic reaction to antibioticsChickenpoxVZV strain 11/18/07 VZV; VZV strain 11/27/07 . During the same period patient was treated with FOSAMAX; aspirin; VALIUM; DYAZIDE; MOBIC; triamterene. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309695
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a pharmacist concerning an immunizing pharmacist that developed shingles. A product quality complaint was not reported. Further information was not available. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309700
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a medical assistant concerning a 70-year-old male with no known allergies, who on 07-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On 12-NOV-2007 the patient developed shingles. He had blisters on his right chest area. The patient sought medical attention at the office. The outcome was reported as recovering, as some blisters are still present. It is reported that the physician is interested in the VZV Analysis by PCR. No product quality complaint was involved. Follow up information has been received from the physician who indicated that the patient was vaccinated in the upper right arm with a subcutaneous dose of 0.65 milliliters of ZOSTAVAX (Oka/Merck) (lot # unknown). The patient has had no history of chickenpox, or a recent exposure to chickenpox. On 04-Nov-2007, the patient was exposed to shingles. On 13-Nov-2007, previously reported as 12-Novc-2007, the patient developed a rash that spread on the right chest wall. There were no other systemic symptoms. The physician stated that he was not sure if the patient would be willing to come back to the office for a specimen for the VZVIP program. He reported that the patient was very upset that he developed shingles. On approximately 27-Nov-2007, the physician spoke with the patient who said that his vesicles were recovering and starting to scab over but still had some pain. Additional information has been requested." Nonebody temp 98.9 F . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309703
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 66.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 66 year old 120 lb. 64.5 in. white retired female with no allergies and no pertinent medical history who on 20-NOV-2007 at 14:30 hours received a subcutaneous single dose in the right deltoid of ZOSTAVAX (lot# 656395/0290U, or lot# 0657766/0620U). Concomitant therapy included venlafaxine hydrochloride (EFFEXOR). It was reported that one day after the vaccination (21-NOV-2007); she developed itchy, red splotches, and deep aching under her right breast extending around to the right mid back. The patient called the physicians office and was advised to take diphenhydramine (BENADRYL). On 23-OCT-2007, she was examined in the office by the physician who diagnosed her with Herpes Zoster. The Herpes Zoster reportedly affected the T7 to T8 dermatone area. Treatment included administration of kertolac (TORADOL) 60 mg. intramuscular in the office. She was written prescriptions for kertolac (TORADOL), 10 mg tablets, one tablet twice a day, oxycodone (+) actaminophen (PEROCET). She was also prescribed methylprednisolone, hydrocodone, and valacyclovir (VALTREX). The patient was last seen by the physician on 12-DEC-2007, and current patient status was reported as unknown by the physician. A product quality complaint was not reported. Additional information has been requested." NoneUnknown . During the same period patient was treated with Effexor. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309705
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an approximately 75 year old male who on 18-DEC-2006 received a single dose injection of Zostavax (Oka/Merck). There were no concomitant vaccinations. It was reported that after he had received the vaccination, he developed on 07-DEC-2007, a severe case of shingles. It was reported that he sought unspecified medical attention. Current patient status was not reported. It was reported that the patient had picked up the vaccine from a pharmacy and transported it himself to the physician's office. Follow up information indicated that patient developed shingles in December 2007. The reporter felt that the patient did not get immunity from the vaccine and was not an adverse reaction. Current patient status was not reported. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309716
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 73.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer concerning her 73-year-old husband who had no medical history or allergies who on 06-NOV-2007 was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included LIPITOR. On 23-NOV-2007, the patient developed blisters in his mouth, a low-grade fever, was lethargic and developed some lesions on his gums. On 24-NOV-2007, the lesions had spread to the back of his tongue and the inside of his cheek. All of the lesions were noted to be on one side of his mouth except for on the upper part of his tongue which had lesions on both sides. The patient was experienced severe pain, burning, soreness and hoarseness. On 26-NOV-2007, the patient was examined by a physician who was not sure what was causing the patient's symptoms. He was prescribed VALTREX. On 27-NOV-2007, the patient was examined by a Periodonist who diagnosed him with shingles. On 28-NOV-2007, the patient was examined by an ENT physician who diagnosed him with stomatitis. No laboratory/diagnostic tests were performed. As of 28-NOV-2007, the patient was still taking VALTREX and for the first time since onset had some improvement. The patient was noted to be recovering. Additional information has been requested." NoneNone . During the same period patient was treated with LIPITOR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309719
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 60 year old female with codeine, ASA and morphine allergy who on 20-NOV-2007 at 10:30 AM was vaccinated with a first 0.6 ml dose of ZOSTAVAX (Lot # 658397/1820U). On 21-NOV-2007 the patient developed blistering around injection site which did spread along dermatome. On 27-NOV-2007 the physician diagnosed it as mild to moderate case of shingles. Additional information has been received from the physician who stated that the patient on 21-NOV-2007 in morning developed zoster like eruption starting at injection site. It was reported that the eruption occurred within 24 hours of vaccination. On an unspecified date the patient recovered. No further information is expected." Drug hypersensitivityUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309741
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 76.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a nurse practitioner concerning a 77-year-old female who on 21-DEC-2006 was vaccinated subcutaneous with a single dose of ZOSTAVAX. On 19-NOV-2007 the patient developed a mild case of shingles on one side of her body. On 26-NOV-2007 the patient developed another mild case of shingles on the opposite side of her body. The patient was treated with famciclovir (FAMVIR) antiviral medication. The patient sought unspecified medical attention. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309742
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a couple that came into the office and one of them in 2007 (a few months ago) was vaccinated with a dose of Zostavax (Oka/Merck) and one did not, ~afterwards the couple kissed in the mouth~ and the next day the spouse that did not receive the vaccine presented with shingles on their face. The patient sought unspecified medical attention. At the time of the report the patient's status was unknown. A product quality complaint was not involved. A product quality complaint was not involved. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309745
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a patient who was vaccinated with a dose of ZOSTAVAX (lot# not available) and subsequently developed shingles ~6 months after receiving the vaccine.~ It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. The patient was enrolled in a program to identify if VZV is present and if it is present to identify if it is associated with wild-type (WT) VZV strain or with the Oka/Merck vaccine VZV strain. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309748
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 89.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from an 89 year old male with no pertinent medical history or drug allergies who on approximately 19-OCT-2007 ~6 weeks ago,~ was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck) (no lot# provided) by the physician while he had shingles. There was no concomitant medication. The shingles went away but after 4 days on approximately 23-OCT-2007 the shingles ~came back.~ The patient sought unspecified medical attention. No labs or diagnostic studies were performed. The patient was not recovered at the time of this report. There was no product quality complaint. Follow-up information from a physician indicated that the 89 year old retired male who on 02-NOV-2007 at 11:00 was vaccinated SC with a 0.5 ml dose of Zostavax (Oka/Merck) (lot# 658395/0966U) in the right arm. The patient stated that he had shingles on the ~down deep inside of his body at the time of vaccination.~ Follow-up with the physician never had an actual diagnosis of shingles at any time. A screening form also indicated that there was no illness at the time of vaccination or contraindications to therapy. Additional follow-up information from a physician indicated that the patient did not receive Zostavax (Oka/Merck) (lot# 658395/0966U) during a shingles episode and that the patient never had shingles. The physician does not have any additional information. No further information is available. This is in follow-up to report(s) previously submitted on 3/26/2008. Follow-up information received from the consumer stating that the physician prescribed him codeine for his pain-which had not helped. No further information is available." NoneUnknown . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309752
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a pharmacist concerning a female with no pertinent medical history or drug allergies who on 14-NOV-2007 was vaccinated SC with one dose of Zostavax (Oka/Merck) (lot# 658839/1411U). There was no concomitant medication. On 23-NOV-2007 the patient developed shingles. The patient was seen by the physician for medical attention. No labs or diagnostic studies were performed. The patient was treated with acyclovir. The patient was recovering. There was no prodcut quality complaint. NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309754
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 75 year old male with an aspirin allergy and adverse drug reaction to blood thinners who on 26-NOV-2007 was vaccinated with a single dose of Zostavax (Oka/Merck). Concomitant drug therapy included a small dose of losartan potassium (MSD), COUMADIN, FLOMAX, vitamin D (unspecified), calcium (unspecified) and supplements. On 30-NOV-2007 the patient was diagnosed with shingles. The patient sought unspecified medical attention. Lab diagnostic studies included a skin test. The patient was not recovered at the time of this report. There was no product quality complaint. Additional information has been requested." Drug hypersensitivity; Adverse drug reaction"diagnostic laboratory, 11/30/07, skin test" . During the same period patient was treated with (therapy unspecified); calcium (unspecified); COZAAR; FLOMAX (TAMSULOSIN; vitamin D (unspecified); COUMADIN. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309761
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 59 or 60 year old female who in approximately November 2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). ~Nine days after vaccination, in November 2007~, the physician confirmed that the patient had shingles. Shingles were present around the torso on one side. Unspecified medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309765
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female who on 05-NOV-2007 was vaccinated with a dose of Zostavax (Oka/Merck). The physician reported that on 12-NOV-2007, the patient presented to the office with shingles and pain. The patient was informed she had a ~bad case~ of shingles and was placed on prednisone. At the time of this report, the patient's shingles persisted as she remained uncomfortable. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309770
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer concerning her 75 to 80 year old male friend who on an unspecified date, received a one time subcutaneous dose of 0.65ml ZOSTAVAX (OKA/Merck). The consumer stated that ~even though he was vaccinated~, within the last six months (approx.July 2007), the patient developed shingles. Current patient status was not reported. A product quality complaint was not reported. Follow up information provided no additional information. Additional information is not expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309771
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a consumer concerning her 71-year-old male husband who on 29-NOV-2007 was vaccinated in the left arm with a dose of Zostavax (Oka/Merck). On 02-DEC-2007 (three days post vaccination) the patient experienced tingling in his right arm. Approximately two more days later the patient developed blisters on his right arm which were diagnosed as shingles. The patient sought unspecified medical attention. At the time of the report the patient's status was unknown. A product quality complaint was not involved. No further information is available. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309775
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 92.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a health professional concerning a 92 year old female with arthritis, glaucoma, macular degeneration and allergies to chocolate and ~DAMRON~ and hypertension and a history of hysterectomy who on 01-NOV-2007 was vaccinated with ZOSTAVAX (Lot # 658604/1088U) at 10:20 am first dose. Concomitant medication included aspirin, amlodipine besylate (+) benazepril hydrochloride (LOTREL) esomeprazole magnesium (NEXIUM) and montelukast sodium (MSD). On 12 NOV-2007 the patient was seen by the physician for a watery draining left eye. It was reported that the patient had macular degeneration and extremely poor vision at which time she was diagnosed with a bacterial infection and prescribed erythromycin opthalmic ointment. The patient used this ointment for a few days and then she developed facial pain and a rash. The patient contacted the office and they presumed it was a reaction to the erythromycin and she was told to stop it. The patient had pain so she went to the emergency department. The patient reported that she had macular degeneration and could only see a shadow and movement. The patient had left sided facial pain forehead. Vital signs were temperature 96, BP 164/62, pulse 108, respiratory rate 17 and pulse oximetry 98%. The emergency room summary noted that the patient had a vesicular rash on her forehead and around the eye. Corneal staining was negative. The clinical impression was herpes zoster without current evidence of hutchinsons sign. The patient had a vesicle broken and the fluid sent for smear. The patient was managed as an outpatient with acyclovir 800mg five times a day and PERCOCET one q 4-5 hours prn pain. The patient recovered. Additional information is not expected." Macular degeneration; Hypertension; Hypersensitivity; Glaucoma; ArthritisHysterectomyBlood pressure 11/16/07 164/6 (value); Diagnostic laboratory 11/16/07 tzanck stain; Body temperature 11/16/07 96 (value); Total heartbeat count 11/16/07 108 (value); Respiratory rate 11/16/07 17 (value); Pulse oximetry 11/16/07 98% (value). . During the same period patient was treated with LOTREL; Aspirin; NEXIUM; SINGULAIR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309776
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 96.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 96 year old female who on 15-NOV-2007 was vaccinated with a 0.65 ml subcutaneous dose of Zostavax (Oka/Merck). Concomitant therapy included KLONOPIN and LEXAPRO. ~About 13 days later~, on 27-NOV-2007, the patient experienced a severe case of shingles around the eyes. No product quality complaint was involved. No other information was provided. Additional information has been requested." NoneUnknown . During the same period patient was treated with KLONOPIN; LEXAPRO. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309781
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 59.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 59 year old female with hypertension, hypercholesterolaemia, and allergies to penicillin and aspirin who on 27-NOV-2007 was vaccinated SC with a single dose of Zostavax (Oka/Merck). Concomitant therapy included LIPITOR and AVAPRO. On 05-DEC-2007 the patient experienced onset of a painful, pruritic rash on her left mid-thoracic region which extended to the left mid-back. The patient was examined in the office on 07-DEC-2007 and was diagnosed with suspected herpes zoster. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested." Hypertension; Hypercholesterolaemia; Penicillin allergy; Drug hypersensitivityNone . During the same period patient was treated with LIPITOR; AVAPRO. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309787
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse concerning a 60-year-old female who on 04-DEC-2007 was vaccinated with one dose of Zostavax (Oka/Merck). On 16-FEB-2008 ~last Saturday~ the patient returned to the clinic with a rash on her palms and upper left arm. The nurse said it was shingles. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309791
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a female who on an unspecified date was vaccinated with ZOSTAVAX. Subsequently the patient broke out in ~shingles like pox~ post vaccination. The reporter is not interested in VZV Analysis by PCR. The patients ~symptoms~ resolved. At the time of reporting the patient was ~okay~. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309792
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 80.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning an approximate 70-year-old female who in approximately February 2008, was vaccinated with a dose of Zostavax (Oka/Merck). In approximately February 2008, it was reported the patient was on vacation and experienced a rash 10 days after vaccination and called the doctors office to let them known about it. The rash was over her entire body and the patient was going to follow-up with a doctor where she was vacationing. At the time of the report the patient's status was unknown. Additional information has been requested. 06/24/2008 This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a registered nurse concerning an 80 year-old female with no known allergies who on 30-OCT-2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 658602/1080U). Concomitant therapy included an unspecified influenza vaccine ~within the last 4 weeks~. On 07-NOV-2007, the patient was on vacation and broke out in a rash on 04-NOV-2007 (also reported as 10 days after vaccination) and called the doctors office to let them know about it. The rash was over her entire body but especially on her face and arms. The patient stated that ~it looks like chicken pox before it blisters to heads~ and ~I have shingles~. She did not complain of pain or itching. She stated that she felt fine. The patient was going to follow-up with a doctor where she was vacationing the next day. At the time of the report the patient's status was unknown. In follow up the registered nurse indicated that they were unable to follow up with the patient because she did not answer her telephone on vacation for the next 3 days and her other telephone number was disconnected. Additional information is not expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309814
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 78.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a 78 year old female with peripheral neuropathy and a medical history of an ~outbreak of herpes zoster~ and no known allergies who in August 2007, was vaccinated with ZOSTAVAX. Concomitant therapy included carbamazepine and baclofen. The pharmacist reported the patient ~developed a self-diagnosed case of shingles~ in December 2007. The patient's shingles persisted. Follow-up information received from the LPN indicating that the patient ~got shingles again on 04-Nov-2007~. The patient also has a history of trigeminal neuralgia. No further information is expected." Neuropathy peripheral; Trigeminal neuralgiaHerpes zosterUnknown . During the same period patient was treated with Baclofen; Carbamazepine. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309816
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse concerning a female nurse with a history of shingles in the past and herpes simplex who after giving multiple vaccinations of ZOSTAVAX on 14-FEB-2008 developed shingles. There was no concomitant medication. It was reported that the nurse noticed a rash on 18-FEB-2008 and also had a cold sore on her lips. The nurse wore gloves when administering the vaccinations but not when it was being reconstituted. The nurse is taking acyclovir. Subsequently, the patient recovered from shingles and cold sore on lips. Additional information has been requested." Shingles; Herpes simplexNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309818
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 22.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a health professional concerning a 22 year old female employee, with no history of shingles, who worked in a small area where close to 1000 doses of Zostavax (Oka/Merck) was administered to patients since August 2006. It was confirmed that the patient was not vaccinated with Zostavax (Oka/Merck). Subsequently the patient was diagnosed with shingles by her physician and treated. No product quality complaint was involved. No other information was provided. Follow-up information from a health professional indicated that the patient had either recovered completely or was recovering. All lesions were either gone or almost completely dried up. This is one of several reports from the same source. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309821
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a male with no allergies and a history of recurrent shingles who in April 2007, was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck). Since being vaccinated, in 2007, the patient developed two outbreaks of shingles on the same hip. At the time of this report, 11-DEC-2007, the patient is currently recovering from his second outbreak since his vaccination. The area is about 2 inches in diameter. It was unspecified if medical attention was sought and no laboratory or diagnostic tests were performed. No product quality complaint was involved. Additional information has been requested." ShinglesNone . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309827
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 50.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received concerning a male in his 50's with a history of colon cancer who was vaccinated with ZOSTAVAX. Subsequently ~7-8 days after receiving ZOSTAVAX,~ the patient developed shingles. The patient sought unspecified medical attention. The patient's shingles persisted. Additional information has been requested." Colon cancerUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309831
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning a male patient who was vaccinated with ZOSTAVAX. The physician reported that she vaccinated the patient and three weeks after the vaccination the patient presented with a severe case of shingles. The case was severe but the pain was limited. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309832
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a consumer concerning their sister's friend who on an unspecified date was vaccinated with Zostavax (Oka/Merck). Subsequently the patient developed shingles. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309835
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a patient who, on an unspecified date, was vaccinated with a dose of ZOSTAVAX. Subsequently the patient experienced herpes zoster at the injection site following the dermatome. Medical attention was sought through a phone call. The outcome is unknown. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309837
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 40.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a health professional concerning a 40 year old female employee, with no history of shingles, who worked in a small area where close to 1000 doses of Zostavax (Oka/Merck) was administered to patients since August 2006. It was confirmed that the patient was not vaccinated with Zostavax (Oka/Merck). Subsequently the patient was diagnosed with shingles by her physician and treated. No product quality complaint was involved. No other information was provided. This is one of several reports from the same source. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309838
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a health professional concerning a female employee in her 60's, with no history of shingles, who worked in a small area where close to 1000 doses of Zostavax (Oka/Merck) was administered to patients since August 2006. It was confirmed that the patient was not vaccinated with Zostavax (Oka/Merck). Subsequently the patient was diagnosed with shingles by her physician and treated. No product quality complaint was involved. No other information was provided. Follow-up information indicated that the patient had a VZV PCR test and no VZV DNA was amplified. This is one of several reports from the same source. Additional information has been requested." Unknown"VZV strain, 12/13/07, no VZV DNA amplified" . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309839
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a health professional concerning a female employee in her late 30's or early 40's, with chronic Epstein-Barr virus (EBV) and recurrent herpes simplex outbreaks, who worked in a small area where close to 1000 doses of Zostavax (Oka/Merck) was administered to patients since August 2006. It was confirmed that the patient was not vaccinated with Zostavax (Oka/Merck). Subsequently the patient was diagnosed with shingles by her physician and treated. It was noted that the patient had blisters and scabs and was currently experiencing her second episode of shingles since November 2007, which started on 11-DEC-2007. No product quality complaint was involved. No other information was provided. Follow-up information from a health professional indicated that the patient has had 3 cases of shingles since November 2007. The shingles was diagnosed by a nurse practitioner in a nearby urgent care facility. Subsequently the patient had either recovered or was recovering. All lesions were either gone or almost completely dried up. VZV PCR results showed that all four samples were either inadequate or negative. This is one of several reports from the same source." Epstein-Barr virus infection; Herpes simplex"VZV strain, sample 1-4, inadequate, negative, inadequate" . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309843
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 84.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a patient who was vaccinated with Zostavax .65 mL injection (Oka/Merck). Subsequently, 48 hours after receiving on 06-DEC-2007 the vaccine the patient developed a mild case of shingles. The patient sought unspecified medical attention. Further information has been received regarding this 84 year old retired male who was vaccinated on 03-DEC-2007 with Zostavax (Oka/Merck) ( Lot # 658602/1080U) sc in the right arm. The physician reported that on 06-DEC-2007 the patient developed shingles involving the left C2-3 dermatome. Culture was positive for varicella zoster detected by immunofluorescent monoclonal antibody. The physician did not report the outcome of the patients experience. Additional information has been requested." Unknown"viral culture, 12/06/07, +, varicella zoster monoclonal antibody" . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309844
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 87.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an 88 year old male with a history of atrial fibrillation, coronary artery disease, hyperlipidaemia and no drug reactions/allergies, who on 15-OCT-2007 was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified), ~topral~ (therapy unspecified), COUMADIN, ALTACE, LIPITOR, FLOMAX, OCUVITE and aspirin 81 once daily. On 11-DEC-2007 the patient developed zoster. On 14-DEC-2007 a specimen was obtained. On 17-DEC-2007 the specimen was sent to the laboratory. The adverse experience was herpes zoster. The zoster was described as unilateral, T10 distribution on the right side. The patient complained of itching for the first two days followed by pain. The patient was treated for a mild respiratory viral infection on the day of vaccination, which was treated with NASACORT. The physician was not interested in the VZV Analysis by PCR at the time. On 17-DEC-2007 the physician stated that he was interested in VZV analysis by PCR and that he collected a specimen on 14-DEC-2007 that he would like to submit. The VZV DNA was amplified. The B-globulin DNA was amplified. The VZV strain identification showed wild-type. The interpretation was adequate specimen, wild strain. No other information to report. There were no lab diagnostic studies performed. Unspecified medical attention was sought. The patient contacted the physician. The outcome was reported as not recovered. The was no product quality complaint. Follow-up information received from the physician indicated that the patient had severe shingles. He did not have a recent exposure to chickenpox or shingles. The source of specimen was lesion type, vesicle. No other information was available. Additional follow-up information indicated that on the morning of 06-FEB-2008, the wife of the patient left another message for the doctor requesting a call back explaining that she wanted more information about the strain and someone to contact her. S" Respiratory tract infection viralAtrial fibrillation; Coronary artery disease; Hyperlipidaemia"diagnostic laboratory, specimen was lesion type, vesicle" . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309845
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse practitioner concerning a 66 year old female with a history of chickenpox, AODM, HTN, HLP, and insomnia and drug reactions/allergies to NKDA, who on 26-JUN-2007 was vaccinated SC in the left side with a 0.64 mL dose of ZOSTAVAX (lot number: 657764/0584U). On 16-OCT-2007 the patient developed a shingles rash after receiving the vaccine. She experienced intense burning in the right thoracic area. There was an impression post herpetic neuralgia T7 dermatome. The patient's maximum temperature was 97.8 and pain was 9. There was no presence of rash. There was no recent exposure to chickenpox or shingles. There was no photo taken. The patient was being treated with pregabalin (LYRICA), lidocaine (LIDODERM PATCH) and unspecified steroids. The patient had not fully recovered at the time. No further information was provided. There was no product quality complaint. Additional information has been requested." Hypertension; Insomnia; ChickenpoxBody temperature 97.8 . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309848
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer concerning her female employee who on an unspecified date was vaccinated with a dose of ZOSTAVAX (manufacturer not specified). On an unknown date it was reported the patient developed a case of shingles even though she was vaccinated against it. At the time of the report the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested. 02/17/2010 Information has been received from a Phyiscia Assistant concerning a female cleaning lady with unknown vaccination history. The patient cleans the house of a woman who was vaccinated with a dose of ZOSTAVAX on 13-DEC-2008 and subsequently developed a rash. To this woman's knowledge the patient was not vaccinated with ZOSTAVAX. Subsequently, the patient developed shingles. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309916
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered pharmacist concerning a female who's husband was vaccinated with a dose of ZOSTAVAX (Oka/Merck) on 20-NOV-2007. On an unspecified date the patient subsequently developed shingles. The patient sought medical attention via her physician. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a registered pharmacist concerning a female (235 lbs., 69 in.) physician who's 66 year old husband was vaccinated with a dose of ZOSTAVAX (Merck) subcutaneous (lot 658395/0966U) on 20-NOV-2007 at 13:00. On 27-NOV-2007, one week later, the patient developed shingles. The patient sought medical attention via her physician and subsequently recovered. A product quality complaint was not involved. Additional information is not expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309919
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 70 year old female consumer with a history of shingles in 1988 and 2002 and no known allergies who in approximately June 2007, was vaccinated IM with a dose of ZOSTAVAX. There was no concomitant medication. ~One and a half weeks ago~, on approximately 08-DEC-2007 the patient developed shingles. The patient indicated that the case she has now is not as bad as her previous cases. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. No further information is available." ShinglesNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309922
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, child 8.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer concerning her 8 year old grandson, with no pertinent medical history, concurrent conditions or drug reactions/allergies, who on 04-DEC-2007 was sitting in the waiting room of his grandparents' physician's office while they were vaccinated with ZOSTAVAX. The consumer reported that on approximately 11-DEC-2007, the boy felt very tired, complained about abdominal pain, had a lack of appetite, and developed a rash on his left side by the ribs that was painful but not itchy. The patient was seen by his pediatrician who diagnosed shingles. The patient's shingles persisted. Additional information was received from the administering physician who noted that the grandmother was a 67 year old white retired female who was vaccinated on 04-DEC-2007 with ZOSTAVAX subcutaneously. According to the grandmother, her grandson had chickenpox at a young age. No further information available. Follow up information was received from the physician who reported that the patient was diagnosed with shingles on 18 DEC 2007, and that the patient had had natural chickenpox at four months of age. It was further noted that there was no information available regarding ~zoster vaccine live exposure~. No further information is expected." ChickenpoxUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309923
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received concerning a female in her 60's who was vaccinated with ZOSTAVAX. Subsequently the patient developed shingles. It was unspecified if the patient sought medical attention. Additional information is not expected. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309925
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 66.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 66 year old male with drug hypersensitivity to chloroquine (diploplia) and a history of chickenpox at ten years of age, who on 12-NOV-2007 (also reported as 11-DEC-2007) was vaccinated into the left arm with 0.5 ml ZOSTAVAX (Lot # 658604/1088U). Concomitant vaccinations included a 0.5 ml. dose of VARIVAX, and MMR II. Concomitant therapy included ramipril (ALTACE), 2.5 mg daily, and cyanocobalanin (+) folic acid (+) pyridoxine hydrochloride (FOLBEE). On 15-NOV-2007 (also reported as day three), the patient developed a fine vesicular rash that was wide spread described as a shingles rash. The patient was reported to have felt poorly (fatigue, achy), and experienced discomfort from the rash, including pain and itching. Dermatone was T 12 and extremities. It was also noted that the patient's wife was vaccinated with ZOSTAVAX on the same day, but had no reaction. The patient had been exposed to his granddaughter on 11 NOV 2007, one day prior to being vaccinated. The granddaughter, who though not diagnosed at that time, was subsequently diagnosed with chickenpox. Neither a direct fluorescent antibody nor specimens were obtained. At the time of reporting it was noted that the rash was resistant with scaring, and the patient had not yet recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. This is a consolidation of two reports concerning the same patient. Additional information has been requested." ChickenpoxUnknown . During the same period patient was treated with FOLBEE; ALTACE. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309926
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a patient who, on an unspecified date, was vaccinated with a dose of ZOSTAVAX. Subsequently the patient experienced herpes zoster at the thoracic area and followed a dermatome. Medical attention was sought through a phone call. The outcome is unknown. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309927
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 41.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial and follow up information has been received from a physician concerning a 42 year old white female with fibromyalgia, sjogren's syndrome and systemic lupus erythematosus who on approximately 12-DEC-2007 was vaccinated into the right deltoid with a first dose of ZOSTAVAX (Lot ~14114~). Concomitant therapy included hydroxychloroquineS04 (PLAQUENIL), alprazolam (XANAX), duloxetine hydrochloride (CYMBALTA), acetaminophen/hydrocodone bitartrate (LORTAB), pramipexole dihydrochloride (MIRAPEX) and ~xanaflex~. Subsequently the patient developed a shingles outbreak after being given ZOSTAVAX. The patient had contacted the physician and sought medical attention. The physician also noted ~questionable neurontin and hydrocodone reactions~. The patient was reported to be recovered on 21 DEC 2007. It was noted that the patient had not yet returned to the clinic despite repeated requests. There was no product quality complaint. No further information is expected." Fibromyalgia; Sjogren's syndrome; Systemic lupus erythematosus; Drug hypersensitivityUnknown . During the same period patient was treated with [Therapy unspecified]; LORTAB; XANAX; CYMBALTA; PLAQUENIL; MIRAPEX. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309928
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a female with a history of shingles who was vaccinated with a dose of ZOSTAVAX. On an unspecified date the patient developed shingles. At the time of the report the patient's status was unknown. A product quality complaint was not involved. No further information is available. ShinglesUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309930
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a male who was vaccinated with a dose of ZOSTAVAX. On approximately 01-DEC-2007 ~4-6 weeks after vaccination~, the patient developed a mild case of shingles. Unspecified medical attention was sought. No additional information was provided. There was no product quality complaint. Additional information is expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309935
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 58.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist and a 58 year old female with penicillin allergy and ~recurrent shingles for thirty seven years~ who on 18-JUN-2007 was vaccinated with Zostavax (Oka/Merck). Concomitant therapy unspecified by patient who stated ~I take lots of medication~. The patient reported that within a month after receiving the vaccine (approx) 18-JUL-2007 she developed shingles. Unspecified medical attention was sought. The patient reported that just a week ago (12-DEC-2007) she developed shingles. A product quality complaint was not reported. Additional information has been requested." Penicillin allergy; ShinglesUnknown . During the same period patient was treated with [therapy unspecified]. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309936
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 67.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a health professional concerning a 67 year old male with no known allergies or medical history who on 30-NOV-2007, was vaccinated with a 0.65 ml subcutaneous dose of Zostavax (Oka/Merck) (lot# /658867/1413U). There was no concomitant medication. On 14-DEC-2007, the patient was seen by a physician. It was reported that the patient developed a mild case of shingles beginning on 11-DEC-2007, and presented with five lesions with pain and discomfort on his right rib cage. The patient was prescribed VALTREX, one gram every 8 hours for 7 days. On 20-DEC-2007, the patient via phone reported to the nurse that he had been taking 2 ibuprofens (strength unspecified) with meals for pain. As of this report, the patient was reported to have been recovering. A product quality complaint was not reported. Additional information has been requested." NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309938
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 64 year old male with no pertinent medical history, drug reactions or allergies who on 05-FEB-2008 was vaccinated with 0.65 ml of ZOSTAVAX. There was no concomitant medication. Ten days post vaccination, on approximately 15-FEB-2008, the patient developed shingles. At the time of reporting the patient had not yet recovered. Unspecified medical attention was sought. There was no product quality complaint. No further information was provided. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. Additional information is not expected. This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a physician concerning a 64 year old male with no pertinent medical history, drug reactions or allergies who on 05-FEB-2008 was vaccinated with0.65 ml of ZOSTAVAX (Merck). There was no concomitant medication. Two days post vaccination, on approximately 15-FEB-2008, the patient developed shingles. At the time of reporting the patient had not yet recovered. Unspecified medical attention was sought. There was no product quality complaint. No further information was provided. The patient was enroled in teh VZVIP program, the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to indetify if VZV is present and if it is present and if it is present to identify if it is associated with the wild-type VZV strain or with the the Merck vaccine VZV strain. Follow up information was received from the consumer who reported that he still had shingles and that neither LYRICA nor VALTREX helped get rid of his shingles pain. The consumer also reported that his wife was vaccinated on 05-FEB-2008 with ZOSTAVAX (Merck), and has had itchiness and a burn" NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309940
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning a male who, on an unspecified date, was vaccinated with 0.65 ml of ZOSTAVAX. It was reported that the patient developed shingles (date unspecified) after receiving ZOSTAVAX. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a physician concerning a 70 year old male with no pertinent medical history, drug reactions, or allergies who in 2007 was vaccinated with a first dose, into the right deltoid, with a 0.65 ml of ZOSTAVAX (Merck) (lot # 652966/0722F). There was no illness at the time of vaccination. It was reported that in February 2008 the patient developed Herpes Zoster (date unspecified). Unspecified medical attention was sought. At the time of reporting the patient was recovered (date unspecified). There was no product quality complaint. Additional information is not expected." Unknown; NoneUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309941
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a male who was vaccinated with a dose of ZOSTAVAX. On approximately 01-DEC-2007 ~4-6 weeks after vaccination~, the patient developed a mild case of shingles. Unspecified medical attention was sought. No additional information was provided. There was no product quality complaint. Additional information is expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309944
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 80.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an ~over 80-year-old female who ~a few months ago,~ approximately January 2008, was vaccinated with a first dose of of Zostavax (Oka/Merck). No lot number was provided. On 19-FEB-2008 the patient ~developed shingles~. A ~shingles-type rash was located on her forehead, above her eye, and also near her hairline on one side.~ Unspecified medical attention was sought. The outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309945
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 74.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a certified medical assistant (C.M.A.) concerning a 74-year-old male with a history of childhood chickenpox who on 12-DEC-2007 was vaccinated subsequently with a 0.65 ml dose of Zostavax (Oka/Merck). There was no concomitant medication. On 09-FEB-2008 the patient developed herpes zoster lesions on left side of face. The patient was seen at a physician's office and a viral culture of the lesions was performed and was positive for varicella zoster virus. This event was reported to be non-serious. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information was received from a physician on 21-FEB-2008. The 74-year-old male patient was vaccinated on 18-DEC-2007 [previously reported as 12-DEC-2007]. It was reported that no rash occurred at the site of the injection site or elsewhere within 42 days of the vaccination 18-FEB-2008 (previously reported as 09-FEB-2008). A herpes zoster vesicular eruption with distribution of the first division of the trigeminal, approximately 60 days following Zostavax (Oka/Merck) vaccination. The eruption was described as a VI dermatome classic eruption on the trunk and the patient's pain on a scale of 0-10 was rated as a 1. A giant cell culture was pending at the time of this report, no direct flourescent antibody was done and no specimen was collected for PCR. It was reported that the patient recovered. Additional information has been requested." Chickenpoxviral culture 02/09/08 Lesions-Positive for Varicella Zoster Virus . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309946
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a consumer concerning a friend who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck). Subsequently the patient developed a case of shingles. It was unspecified if medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. No further information is available. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309948
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a registered nurse concerning a patient who was vaccinated with Zostavax (Oka/Merck). It was reported that the patient developed shingles after receiving Zostavax (Oka/Merck). It is unknown if medical attention was sought. There was no product quality complaint. This is one of several reports received from the same source. The nurse mentioned that some of the cases were reported to VAERS. Additional information is not expected. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309958
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 61.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 61 year old male with an unspecified cardiac disorder and diabetes who on 09-JAN-2008 was vaccinated with a ~single dose~ of Zostavax (Oka/Merck) (Lot # ~1131U~), site of administration unspecified. It was reported that on 15 JAN 2008 the patient developed herpes zoster, with dermatome C2-3 involvement. Vesicular lesions were present on the patient's head and neck. It was also reported that on 15 JAN 2008 the patient developed a shingles like rash on the forehead. On a pain scale of one to ten, the patient's pain was assessed at three. The patient ~was given some topical cream and acyclovir~. Unspecified medical attention was sought. There was no product quality complaint. A direct fluorescent antibody was not collected. It was reported that the specimen for the VZV identification program was obtained from a vesicular area (site unspecified). At the time of reporting the patient had recovered (date unspecified). Additional information has been requested." Cardiac disorder; DiabetesNone . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309959
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 88.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from an 88 year old female with shingles, post herpetic neuralgia, osteoporosis and no known allergies who in July 2007, was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included EVISTA. The patient's physician told her to get the vaccine to help with her burning and itching. The caller stated that she has shingles on her left side on her back around to under her bust. She stated the itchiness and burning has gotten worse in the last couple of days. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested." Shingles; Post herpetic neuralgia; OsteoporosisUnknown . During the same period patient was treated with EVISTA. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309968
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from an office manager concerning a female in her early sixties who on an unspecified date was vaccinated SQ with 1 vial of ZOSTAVAX. Subsequently 2-3 weeks later the patient developed shingles. It was unspecified if medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309970
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a female consumer concerning herself and her husband, both ~in their sixties~, who on 18-OCT-2007 were vaccinated with Zostavax (Oka/Merck). On 17-JAN-2008 the female consumer reported she developed symptoms of shingles. At the time of reporting the female consumer stated she was~ taking VALTREX and pain medication, battling the virus~. It was also noted that her husband showed no symptoms at the time of reporting. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309972
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 90.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse practitioner (NP) concerning an approximately 90 year old female with hypertension, dementia and osteoporosis who in December 2007, was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included NORVASC and ATENOL. In December 2007, the patient developed shingles on her leg, ~somewhere around L2 or L3~ after receiving a single dose of Zostavax (Oka/Merck). The NP reported that she has not seen the patient since December, and therefore the patient's present status is unknown. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested." Hypertension; Dementia; OsteoporosisUnknown . During the same period patient was treated with NORVASC; ATENOL. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309973
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 81.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an 84 year old female who in 2007 was vaccinated with a dose of ZOSTAVAX. On 11-FEB-2008 the patient developed a severe case of shingles on thoracic area that traveled around her back. Visual diagnosis was done. Unspecified medical attention was sought. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. Follow up information has been received from a physician concerning an 82 year old female with penicillina and TAMIFLU allergies who on 12-JUN-2007 was vaccinated intramuscularly with ZOSTAVAX (Oka/Merck). There was no illness at the time of vaccination. On 6 FEB 2008 the patient dveleoped a rash. On 11-FEB-2008 the patient was seen in the office at which time there was a rash present in the middle o f the back and left breast area, accompanied by pain in back. On FEB 2008 the patient was see again in the office, at which time the skin had sacrred/scabbed with no open lesions. At the time of reporting the patient was recovered. No diagnostic or lab testing was performed. Additional information is not expected." Penicillin allergy; drug hypersensitivityUnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309980
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 47.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 47-year-old female with a history of screws and rods in her back and spinal fusion surgery who on 14-JAN-2008 was vaccinated with her first dose of ZOSTAVAX (lot # 658210/1079U). On 11-FEB-2008 the patient broke out with a case of shingles. She reported that she had at least 25 cases of shingles or more previously which all started after her third back/spine fusion surgery. The patient reported that her shingles are on the left side of her face, exterior of her lips, inside her mouth, throat, glands, in her sinus cavity and they look like clusters of blisters. She also stated she has pain in her eyes. The patient did not seek medical attention. On an unspecified date the patient had a ~sculpt done of her sinus cavity and a culture~. At the time of the report the patient's status was not recovered. Additional information has been requested." Spinal fusion surgery"Nasal culture - sculpt done of her sinus cavity, culture." . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309982
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 59.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning a 59-year-old male who on 04-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck). On approximately 11-FEB-2008 the patient developed shingles. Unspecified medical attention was sought. The outcome was not reported. No product quality complaint was involved. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309984
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 62 year old male consumer with no known allergies or pertinent medical history who on 28-JAN-2008 was vaccinated IM with a 0.65 ml first dose of Zostavax (Oka/Merck). There was no concomitant medication. On 31-JAN-2008 the patient developed a case of shingles. Medical attention was not sought, there were no lab studies performed. There was no product quality complaint involved. No further information was provided. Additional information has been requested." NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309989
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 59.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician regarding a 59 year old female whose husband was vaccinated on 19 JAN 2008 with a 0.65 ml of ZOSTAVAX (Lot # ~0179U~), and about one week later, on approximately 26 JAN 2008, she developed painful, dermatomal vesicular eruptions of the right buttock and right inguinal area. The patient was evaluated in the office and determined to have varicella zoster. The patient was on the following medications at the time of the event: thyroid (ARMOUR THYROID TABLETS), exetimibe (ZETIA) and HCTZ/triamterene (MAXIDE). The patient denied any drug reactions, allergies and stated ~she does not have a problem with her immune system~. No lab diagnostic studies were performed. There was no product quality complaint. At the time of reporting it was not noted if the patient had recovered, but it was reported that ~the patient was no longer being treated for this experience~. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. Additional information is not expected." UnknownNone . During the same period patient was treated with ZETIA; MAXIDE; ARMOUR THYROID TABLETS. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309992
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer, with an allergy to ~phenergan~ and no pertinent medical history, who was recently exposed to her husband who was vaccinated on 27-Jan-2008 with a dose of ZOSTAVAX (Oka/Merck). The consumer is currently taking alendronate sodium (MSD). In the ~middle of January~, also reported as ~a couple of weeks~ after her husband was vaccinated, the patient recognized symptoms of shingles. She sought medical attention at the dermatologist who told her that she had a mild case of shingles on her left buttock. The patient reported that ~it feels like a cactus thorn in my left buttock when I lean back and sit.~ There were no laboratory or diagnostic studies performed. The outcome was reported as recovering. No product quality complaint was involved. Additional information is not expected." HypersensitivityNone . During the same period patient was treated with FOSAMAX. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #309999
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 77.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer who knew of a 77-year-old female who was vaccinated on an unspecified date with a dose of ZOSTAVAX (product circular# 9815604). Subsequently, on an unknown date, the patient developed shingles. No additional information about the patient was available. No product quality complaint was involved. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310001
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist and physician's office concerning a 70 year old male with no history of cancer, leukemia or HIV and a history of chickenpox, and unknown shingles history who on 14-JAN-2008 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck) (lot# 658397/1820U) in the right arm. The patient had no prednisone or immunosuppressive products noted. On 21-JAN-2008 the patient developed shingles. On 29-JAN-2008 the patient contacted the pharmacist to inform him that he was diagnosed with shingles located on his arm. The pharmacist contacted the physician's office to confirm the shingles diagnosis, which was located on the patient's abdomen, not the arm. The outcome was unknown. There was no product quality complaint. Additional information has been requested." ChickenpoxUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310003
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 82.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from an 82 year old male with hepatitis c, no drug reactions or allergies and a history of 3 prior cases of shingles, a broken back twice, a rash on and off in the groin area, constipation while on therapy with codeine and DARVOCET and winter itch who on 16-NOV-2007 was vaccinated with ZOSTAVAX (Oka/Merck). Concomitant therapy included VALTREX and amlodipine besylate. The patient reported that approximately two months after he received ZOSTAVAX (Oka/Merck), on approximately 28-JAN-2008, he was diagnosed with shingles. At the time of reporting the patient had not yet recovered. There were no lab diagnostic studies performed. unspecified attention was sought. There was no product quality complaint. Additional information has been requested." Hepatitis CShingles; Back injury; Rash; Constipation; Winter itchNone . During the same period patient was treated with amlodipine besylate; VALTREX. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310006
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female ~in her mid to late 60's~ who on an unspecified date was vaccinated with a ~single dose~ of zoster vaccine live (Oka/Merk). ~Within the last few weeks~ prior to reporting, in approximately January 2008, the patient developed a severe varicella rash which was cultured and positively identified as shingles. At the time of reporting the patient was recovering. Unspecified medical attention was sought. There was no product quality complaint." Unknowndiagnostic laboratory posit - culture for shingles . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310010
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a licensed practical nurse concerning a 65 year old female who on 28-JAN-2008 was vaccinated with ZOSTAVAX (Oka/Merck). On an unspecified date the patient developed a rash at the injection site where she was vaccinated with vaccinated with ZOSTAVAX (Oka/Merck). It was also noted that the patient had shingles on her arm. Unspecified medical attention was sought. At the time of reporting the patient had not yet recovered. There was no product quality complaint. Additional information has been requested. unknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310024
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a female who on 17-JAN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# not available). On ~25-JAN-2008 the patient experienced diagnosed with shingles. ~The patient sought unspecified medical attention. The outcome was unknown. There was no product quality complaint. Follow-up information from the reporting pharmacist concerning a 72 year old female who on 17-JAN-2008 at 11:18 was vaccinated with her first dose of ZOSTAVAX (Oka/Merck) (lot# 658838/1412U) in the left deltoid. On 19-JAN-2008 the developed a reaction that worsened on 20-JAN-2008. The patient went to the physician and was diagnosed with shingles on 21-JAN-2008. The patient was treated with VALREX. The outcome was unknown. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310026
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a pharmacist concerning an elderly female who was vaccinated with a dose of Zostavax (Oka/Merck). It was reported that the patient developed 2 bouts of shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/26/2008. Additional information has been received which indicated that neither the patient nor the doctor wish to follow up. No further information is expected. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310029
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 70-year-old female who in August 2006, was vaccinated subcutaneous with a 0.5 ml dose of Zostavax (Oka/Merck). There was no concomitant medication. On 29-JAN-2008 the patient developed shingles on the back of her skull. The patient sought unspecified medical attention. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested." Impaired fasting glucose; Convulsion disorder; Penicillin allergy; Drug hypersensitivity; Coronary artery diseaseStent placementUnknown . During the same period patient was treated with Aspirin; ATENOLOL; LIPITOR; ZETIA; DILANTIN. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310032
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning an 82 year old female who was vaccinated with a dose of ZOSTAVAX. Subsequently the patient developed shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/26/2008. Initial and follow up information has been received from a pharmacist concerning a 72 year old female (also reported as 82) with microscopic colitis who in the AM of 19-NOV-2003 was vaccinated into the left deltoid with a first dose of 0.5 ml of ZOSTAVAX (Merck) (lot# 658082/0744U). On 24 JAN 2008 the patient developed acute shingles, with vesicles at the left neck, shoulder and C4 dermatome, greater than 20 lesions. The patient experienced pain on a scale of 1 to 10, at a level of 9 to 10. Other systemic symptoms reported included neck pain. There was no illness at the time of vaccination. There was no recent exposure to chickenpox or herpes zoster. No lab diagnostic studies were performed, and no specimen was collected for PCR. Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patients outcome as unknown, the patient left the state shortly after onset. Additional information is not expected." Colitis microscopicUnknown"Unknown; body temp, 97.9" . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310035
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning a female who was vaccinated with a dose of Zostavax (Oka/Merck). Subsequently the patient experienced broke out in shingles. It was reported that the patient worked at the clinic. On an unspecified date the patient recovered. Unspecified medical attention was sought. A product quality was not involved. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310044
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a female who on an unspecified date was vaccinated with ZOSTAVAX. Subsequently the patient broke out in ~shingles like pox~ on her forehead and stomach post vaccination. The reporter is not interested in VZV Analysis by PCR. The patient's ~symptoms~ resolved. At the time of reporting the patient was ~okay~. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310045
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female ~in her later 70's~ who in January 2008, was vaccinated with 0.65 ml ~one dose~ of ZOSTAVAX. Two weeks post vaccination, in approximately January 2008, the patient developed a ~mild case of shingles~ on opposite arm and not on the arm of the injection. The physician noted that the patient did not have any pain, nor did they have a history of shingles. Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patient was recovered (date unspecified). Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310046
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 77.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 77 year old male who on 16-JAN-2008 was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included VASOTEC, nadolol and NORVASC. The physician reported that ~the patient had shingles after he was given Zostavax (Oka/Merck)~. Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patient's status was unknown. Additional information has been requested." UnknownUnknown . During the same period patient was treated with NORVASC; VASOTEC; nadolol. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310122
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse (RN) concerning a patient who was vaccinated with a dose of ZOSTAVAX that was stored at a freezer range above the recommended range. The RN reported that the patient subsequently developed a shingles-like rash. The patient was seen in a physician's office and the rash was cultured (results not provided). No other symptoms or treatment was reported. At the time of this report, the outcome was unknown. This is one of several reports from the same source. Additional information has been requested." UnknownDiagnostic laboratory - rash culture . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310123
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse (RN) concerning a female patient with no history of chickenpox who was vaccinated with a dose of ZOSTAVAX. The RN reported that the patient developed shingles on her face. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. The RN noted that the vaccine was stored properly. This is one of several reports from the same source. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310131
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a female consumer with a history of shingles twice, who on 24-JUL-2007 was vaccinated with a dose of ZOSTAVAX. On approximately 24-OCT-2007, the patient developed shingles. The consumer reported that ~I had the disease twice, so I contacted two doctors to get their advise as to whether I should or should not get the vaccine. The answers from both were a definite yes, no question. Just three months later, I developed the disease, and now 11 weeks later, I am still suffering~. It was unspecified if medical attention was sought. Follow-up information has been received in which the consumer provided the address of her physician. Additional information has been requested." ShinglesUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310132
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a 63 year old female with asthma, elevated cholesterol and an aspirin allergy who on approximately 03-DEC-2007 (~6 weeks ago~) was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant drug therapy included ezetimibe (+) simvastatin (MSD), PREMARIN, TOPAMAX and an unspecified tranquilizer. On 10-JAN-2008 the patient was diagnosed with shingles, located on the left side of her face in the temple area. The patient sought medical attention through a physician's office visit. No labs or diagnostic studies were performed. The patient was not recovered at the time of this report. There was no product quality complaint. Additional information has been requested." Asthma; Cholesterol levels raised; Drug hypersensitivityNone . During the same period patient was treated with (therapy unspecified); PREMARIN; VYTORIN; TOPAMAX. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310133
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a healthcare professional concerning a 71-year-old male, with a history of chickenpox, who on 04-JAN-2008 was vaccinated subcutaneous in the right deltoid with his first 0.65 ml dose of ZOSTAVAX (Merck) (lot # 658867/1413U). There was no recent exposure to chickenpox or herpes zoster. On approximately 10-JAN-2008, 6 days post vaccination, the patient developed shingles on the left side (ribs). The patient sought unspecified medical attention. On 25-JAN-2008 the patient recovered. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/26/2008. The event was considered non serious. Further information is not expected." ChickenpoxUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310135
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 64 year old female with blood pressure high cholesterol high who on 12-DEC-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included LIPITOR, AVAPRO, CARDIZEM CD and aspirin. On approximately 11-JAN-2008 (~3-4 days ago~) the patient developed shingles rash that was mild that was mild confined to one finger of one hand. The shingles was painless and did not bring any discomfort. The patient described Valtrex 1 gr twice daily for 7 days. The patient is recovering and the rash is scabbing. Follow-up information received from the Herpes Zoster Questionnaire on 16-Jan-2008 indicating that the patient was vaccinated with ZOSTAVAX (Oka/Merck) (lot#658361/1090U). A rash did occur with an onset of approximately 09-Jan-2008 isolated to the one finger with 4 or 5 zoster like lesions. The patient had no fever and was experiencing pain rated as a ~3~ on a scale of 1 to 10. No other systemic symptoms reported. The patient had not yet recovered, still has lesions. Patient has a history of chickenpox in her childhood. No recent exposure to chicken pox or herpes zoster. Follow-up information was received from the VZV identification program indicating that the sample of the lesion was collected on 16-Jan-2008 and sent to the laboratory on 21-Jan-2008 and the source of the specimen was a ~scab~, did not mention the site. The specimens arrived at the laboratory on 24-Jan-2008. Results: Was VZV DNA amplified - No. Was B-globin DNA amplified - No. Interpretation: Inadequate specimen - No strain ID. Results reported on 04-Feb-2008. Follow-up information was received from the VZV identification program indicating that the sample was ran twice and the result was still ~inadequate~. No further information is expected." Blood pressure high; Cholesterol highChickenpox"VZV strain 01/24/08 - INADEQUATE SPECIMEN, no strain identified." . During the same period patient was treated with aspirin; LIPITOR; CARDIZEM CD; AVAPRO. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310136
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 74.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 74 year old female with no pertinent medical history, drug reactions or allergies who ~11 months ago~ in approximately February 2007, was vaccinated subcutaneously with 0.65 ml of ZOSTAVAX. Concomitant therapy included alendronate sodium. In approximately October 2007, the patient developed shingles. The patient reports being seen by her doctor for the ~breakthrough~ and was given antibiotics. At the time of reporting the patient was recovering. There was no product quality complaint. There were no lab diagnostic studies performed. At the time of reporting the patient's status was recovering. Additional information has been requested." NoneNone . During the same period patient was treated with FOSAMAX. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310184
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 92.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 92 year old female who in ~October 2007~, was vaccinated with Zostavax (Oka/Merck). Within the ~past week~ in approximately Jan 2008, and approximately three months after receiving Zostavax (Oka/Merck), the patient developed shingles. Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patient's status was unknown. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310190
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a 64 year old male patient with hyperlipidaemia, hypertension, asthma, eczema and coronary artery disease who on 10-DEC-2007 was vaccinated with a dose of ZOSTAVAX (dose and frequency unknown). On 14-DEC-2007, the patient experienced a shingles like rash on the upper right hand quadrant of his torso and was seen by his physician. The patient's outcome was unknown. There was no quality complaint. Additional information has been requested." Hyperlipidaemia; Hypertension; Asthma; Eczema; Coronary artery disease . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310191
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer concerning a female in her 60's who in December 2007, was vaccinated with Zostavax (Oka/Merck) 0.65 mL. Three days later, the patient developed shingles. The patient sought unspecified medical attention. The patient's shingles persisted. There was no product quality complaint. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310192
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 87.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a pharmacist concerning an 87 year old female who on 07-DEC-2007 was vaccinated with ZOSTAVAX. On 18-DEC-2007 the patient developed shingles. The patient's shingles persisted. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310201
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning an approximately 70 year old male with a history of psoriasis who on 26-DEC-2007 was vaccinated with a dose of Zostavax (Oka/Merck). On 27-DEC-2007 the patient went into the office and was diagnosed with abdominal zoster. No further adverse event information. Unspecified medical attention was sought through the physician. There was no product quality complaint. Additional information has been requested. PsoriasisUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310202
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Male patient, 84.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial and follow-up information has been received from a licensed practical nurse and physician concerning an 84 year old male with hypercholesterolaemia and penicillin allergy who on 02-NOV-2007 was vaccinated SC with a single dose of ZOSTAVAX. Concomitant drug therapy included simvastatin tablets. On 21-DEC-2007 the patient developed a red, raised rash on his right cheek of face as confirmed by nurse. On 28-DEC-2007 the physician examined the patient and diagnosed possible herpes zoster. No labs or diagnostic studies were performed. Details of the treatment plan were unknown. The patient was not recovered at the time of this report. There was no product quality complaint. Additional information has been requested." Hypercholesterolaemia; Penicillin allergyNone . During the same period patient was treated with ZOCOR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310211
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from an office manager concerning a 65-year-old female with allergic reaction to tetracycline, codeine, morphine, naprosyn and fentanyl, who on 02-MAY-2007 was vaccinated subcutaneously with a ~single dose vial~ of ZOSTAVAX (lot # 656395/0290U). Concomitant therapy included CRESTOR, estrogens (unspecified) and ~lipid medication~ (therapy unspecified). On an unspecified date the patient developed ~shingles pain~ at her abdomen. The patient sought medical attention via an office visit with a physician. No diagnostic labs were performed. At the time of the report the patient's status was recovering. A product quality complaint was not involved. Additional information has been requested." Allergic reaction to antibiotics; Drug hypersensitivityNone . During the same period patient was treated with therapy unspecified; estrogens (unspecified); CRESTOR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310220
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 70 year old female with no pertinent medical history, drug reaction or allergies who on 03-JAN-2008 was vaccinated with Zostavax (Oka/Merck). The reporting physician noted that the vaccine was administered at the pharmacy, and therefore he did not have access to the lot number and route of administration. There was no concomitant medication. On 05-JAN-2008 the patient developed shingles. The shingles rash followed the right thoracic dermatome. The patient was prescribed prednisone and VALTREX. At the time of reporting the patient had not yet recovered. There was no product quality complaint. There were no lab diagnostic studies performed. Additional information has been requested." NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310230
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a Registered Nurse concerning a nurse who on an unspecified date developed shingles after administering Zostavax (Oka/Merck). At the time of the report the patinet's status was unknown. It was unspecified if medical attention was sought. There is no product quality complaint involved, no additional information was provided. Additional information requested. This is one of several reports from the same source." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310232
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/26/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female with no pertinent medical history or drug allergies who on 30-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 658602/1080U) in the right deltoid (unspecified route). There was no concomitant medication. On that same day within 4 hours of vaccination, the patient developed initial symptoms of itching of the right breast and numbness followed by a rash over her right shoulder and right breast. On 31-JAN-2008 the patient developed shingles. The patient was seen by the physician for medical attention. Lab diagnostic studies performed included a ~VZV IgG~ test. The patient was treated with FAMVIR. The patient was noted to be uncomfortable and was not recovered at the time of this report. There was no product quality complaint. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of CBER and was released by the regulatory agency. Additional information has been requested." None"CSF VZV IgG Ab, 01/30?/08" . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310070
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 04/11/2008. Male patient, 79.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Patient did not receive this vaccine from our medical center, but did receive treatment for the adverse event from our facility. Patient states he received the ZOSTAVAX vaccine on 3/25/08. States he had shingles when he was vaccinated and should have never received the vaccine. Had an outbreak of shingles on the right chest and right back. Outbreak is improving now, and patient now has an order for gabapentin to help with the pain. Also received acyclovir 800 mg q4h following the immunization for treatment of the shingles. Patient denied having any other immunizations in the month prior to receiving ZOSTAVAX." "PMH includes-COPD, HTN, hypothyroidism, hyperlipidemia, BPH, erectile dysfunction, premature atrial contractions."N/A . During the same period patient was treated with Acyclovir; Gabapentin; Loratadine; Levothyroxine; Vardenafil; Flunisolide nasal; Combivent inhaler; Simvastatin; Terazosin. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #310517
ZOSTER (ZOSTAVAX) vaccine side effect was reported . Female patient, 74.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Pain L side of scalp & eye area, rash & redness of L eye. Shingles +. Treatment Valtrex 1 gm 1 >/= 1. Dr (ophthalmology) exam - no evidence of ophthalmic involvement." NONEHTN/hypothyroidism/COPD . During the same period patient was treated with "Diovan HCT 320/12.5, Synthroid .088 mg". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #311038
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 04/19/2008. Female patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Mild case of shingles. Initial itching - appearance like bug bites at 6 spots on lower right abdomen and waist. Itching stopped. Spots opened. Blisters. Redness at site. Raw and painful. Redness expanded. Pain stopped one week later. Eruptions drying up. Redness leaving. NoneNo . During the same period patient was treated with "atenolol 25 mg, levothyroxine 112 HCG, Prilosec OTC 20 mg". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #311056
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 04/28/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Developed shingles 1 week after shingles vaccine; shingles in T12 distribution, left side" no"anxiety, allergies, hypothyroidism, menopausal""No labwork performed, clinical exam only" . During the same period patient was treated with "Activella, lunesta, levothroid". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #311400
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 05/01/2008. Female patient, 66.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Patient developed typical zoster rash on 4/21 (4 days after receiving Zostavax). This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a consumer concerning his wife, a 66 year old female with no pertinent medical history, drug reactions or allergies who on 16-Apr-2008 was vaccinated with a ~single dose~ of ZOSTAVAD (Merck). Concomitant therapy included FOSAMAX and XALATAN, also reported as ~not under any medicatin on a continuous basis~. On 20-Apr-2008 the patient developed shingles, with progessively severe pain. The patient was prescribed anti retroviral therapy with famcicivoir to be taken over one week. There were no lab diagnostic studies performed. There was no product quality complaint. At the time of reporting the patient had not yet recovered. Follow-up information received 12-May 2009 via medical records: On 16-Apr-2008 the patient was vaccinated intramuscular with a dose of roster vaccine live (Merck). The patient's medical history consisted of oteropenia (12-Mar-2004), eczema (12-Mar-2004) internal haemorrhoids (12-Mar-2004), borderline glaucoma (12-Mar-2004), irritable colon (12-Mar-2004), flat feet (12-Mar-2004), derangement minscus NEC (12-Mar-2004), malignant neoplasm uterus NOS (12-Mar-2004), symtosatic female cilmacteric (24-Feb-2004, and a history of vaginitis atrophic (24-Feb-2004) and a hysterectomy.The patient's concomitant medications were updated to include the following: MSD, XALATAN, MSD, ANUSOL HC and CITRACAL + D. On 16-Apr-2008 the patient contacted her physician with complaints of ~pain in the side~ and a ~rash under breast~. On 21-Apr-2008 the paitent was seen by her physician and assessed for diabetes, hypertension, cadiovasular disease, unintentional weight loss/gain, difficulty chewing and/or swollowing (no findings). The patient described the rash as itching and burning on her right side (thoracic at bra line). The physical examination revealed classic lesions of vesicle in linear pattern (general impression herpes zoster post v" None"osteopenia, IBS, knee pain"None . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #311649
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 05/05/2008. Female patient, 61.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Pt acquired shingles after vaccinated. Treated with Zovirax. Noh/o breast cancer . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #311698
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 04/30/2008. Male patient, 67.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Developed herpes zoster opthalmicus and several herpetiform lesions on posterior chest bilaterally. 5/13/08 Reviewed PCP medical records which consisted of vax record & hospital d/c summary. Hospitalized from 4/27-4/30/2008. FINAL HOSPITAL DX: left periorbital pain secondary to herpes zoster ophthalmicus. Records reveal patient experienced URI s/s approx 3 wks prior to admit. S/S persisted & intensified. Tx w/antibiotics for presumed sinusitis. Developed left periorbital edema, mild erythema & increased facial pain w/low grade fever. Tx w/IV antibiotics for presumed orbital cellulitis. On day of admission, developed chest lesions then developed forehead lesions. Tx w/antiviral & ophthal consult done. 5/23/08 Reviewed additional hospital records of 4/27-4/30/2008: H&P & labs." None"coronary artery disease, elevated lipids, HTN, is not immunocompromised or on steroids etc. PMH: allergic rhinitis; DJD; renal stones 2005; CAD w/stents; s/p rotator cuff repair; right CTS repair.""CT scan (_) for sinusitis; (+) for pre-septal orbital edema LABS: Blood c/s neg. Sed rate 6, WBC 8,000, segs 73%, lymphs 10%, monos 15%. Sodium 133, potassium 2.9. LFTs WNL. CT scan of sinuses revealed uncomplicated left periorbital" . During the same period patient was treated with Lipitor; Prilosec; Fosamax; ASA. Patient was hospitalized Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #311791
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 05/06/2008. Female patient, 83.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse practitioner concerning an 83 year old female consumer who on 14-FEB-2008 was vaccinated SQ with a 0.65ml of ZOSTAVAX. Concomitant therapy included acyclovir (ZOVIRAX) and clorazepate dipotassium. Subsequently, on 20-FEB-2008, the patient developed shingles. Unspecified medical attention was sought. It was unspecified if lab studies were performed. It was reported that the patient was treated for shingles (treatment regimen not reported) and made a full recovery. It was also reported that the patient went on vacation and when she returned from vacation she developed pneumonia and died on 12-APR-2008. There was no product quality complaint involved. The cause of death was pneumonia. The nurse practitioner considered the event to be disabling. Additional information has been requested." UnknownUnknown . During the same period patient was treated with ZOVIRAX; Clorazepate dipotassium. Patient was hospitalized Patient died on 2//08/04/1.
ZOSTER (ZOSTAVAX) Side Effects Report #311908
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 05/08/2008. Female patient, 81.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient developed rash. Went to Dr. After examination Dr. told patient she had shingles . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #312011
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 05/10/2008. Female patient, 82.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Two days after receiving vaccine, patient developed shingles. Patient has painful, disseminated rash on back and stomach in traditional shingles pattern. Rash has continued to spread for 5 days without treatment. Pt treated with acyclovir 800mg po daily x 10 days." noneisolated systolic hypertension . During the same period patient was treated with none. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #312212
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 05/06/2008. Female patient, 77.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Shingles-rash and blisters, still have pain. Treatment- Valtrex, Gabapentin, Oxycodone" NoneNone . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #312298
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 05/08/2008. Female patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Normal mammogram in 3/07. During physical in 4/07 was given Zostavax-shingles vaccine. Days later developed symptoms on chest. Was told it was shingles-from the vaccine. Did not improve and was biopsied. Diagnosed as Inflammatory Breast Cancer. 5/16/08 Death certificate states COD as metastatic inflammatory breast cancer. 5/16/08 Reviewed PCP medical records of 4/19/07-7/10/2007 which reveal patient experienced good health on 4/19/07 w/a normal breast exam. Returned on 6/15/07 with rash on right breast x 2-3 weeks. Vesicular rash in T8 dermatome that was crusting over but had been pruritic & tender. Dx w/shingles. Returned 7/10/07 because rash was not healing. Exam at that time revealed a keloid type rash over the anterior chest & right breast into the axilla. A biopsy was done & started on antibiotic for surrounding erythema. NONE-deemed healthy at physical"blood pressure, cholesterol PMH: HTN, hypercholesterolemia, leg cramps, acid reflux. Seborrheic keratosis removed 10/2005."LABS: mammogram of 3/23/2007 neg. Pap smear 2006 neg . During the same period patient was treated with "blood pressure, cholesterol". Patient died on 8//07/12/1.
ZOSTER (ZOSTAVAX) Side Effects Report #312349
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 05/14/2008. Male patient, 80.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician, concerning an 80 year old male patient (a retired plumber), who on 18-FEB-2008 was vaccinated in the right deltoid with a dose of Zostavax (Oka/Merck) (lot # invalid). There was no illness at the time of vaccination. On 29-FEB-2008 the patient developed pneumonia, bilateral with hypoxemia, and varicella zoster right facial. A chest x-ray confirmed bibasilar pneumonia, and the patient was hospitalized for 7 days (details not provided). Subsequently, the patient recovered from the events (duration and date not specified). The physician considered one or more of the events to be immediately life-threatening. Additional information has been requested." Unknownchest X-ray 02/29/08 - bibasilar pneumonia . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #313216
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 05/26/2008. Male patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "A rash and bumps begin to break out on forehead and scalp on 5-18-2008. It continued to move to my right eyebrow, nose and eyelid with no loss of vision. It was spreading and very painful. On 5-25-2008 I went to Urgent Care. I was seen by a P.A.. His diagnosis was Herpes Zoster/Shingles. I received prescriptions for Valtrex, Neurontin and Vicoprofen. I am to take the Valtrex for 10 days. The Neurontin/1 per day for one week then increase to 2 pills per day. The Vicoprofen every 6 hours for pain." None"Depression, high cholestrol, seasonal allergies"None. . During the same period patient was treated with "Prozac 40 mg, Cardura 4 mg, Allegra 180 mg, Zocor 20 mg, aspirin 81 mg, Omega 3 Fish Oil 1000 mg, Centrum Silver.". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #313815
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 02/13/2008. Male patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Client was diagnosed, by his PCP, with shingles one week post receipt of ZOSTAVAX. (Client contacted health dept 1/26/08 via email; then unavailable until 2/13/08 for further contact)." nonenoneNONE; Diagnosis by physician (PCP) observation . During the same period patient was treated with "LIPITOR, ACTOS, lisinopril". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #314105
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 05/29/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Left leg broke out with shingles. On 5/27/2008 patient ran a temperature/rash to left leg appeared.None . During the same period patient was treated with none. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #314116
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 05/29/2008. Female patient, 78.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, 4/15/08 Recieved Zostavax vaccine. 24 days later developed scattered lesions. A few on arm and a few on legs. She felt it was related to her gluten intolerence. Her PCP started her on Topicort. On 5/14/08 she developed 2 areas of lesions right above her RUQ. They gradually spread along the right side to her back. She went to the ED on 5/27/08. She was diagnosed as having Shingles. She was prescribed Valtrex and given Oxycodone for pain. As of my interview today the lesions are scabbed and no new outbreaks occuring. She has postherpetic neuralgia. Rated a 10 on a pain scale. NoneCeliac Sprue . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #314570
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/02/2008. Female patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, pt developed a shingles/herpetic like rash over elbow on same side where vaccine was given about a month after vaccine was given (painful) resolved on its own but now has recurred (about 6 months later) noneHTN . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #314771
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/03/2008. Female patient, 84.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, PATIENT REPORTS THAT SHE HAD A SINGLE SHINGLE COME UP ON LEFT SIDE OF FOREHEAD. SHE SAW TWO DOCTORS WHO HAVE CALLED IT A SHINGLE. THIS WAS REPORTED TO ME ON 5/19/2008. . During the same period patient was treated with DILUENT LOT 3114U EXP 3/10. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #314772
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/03/2008. Male patient, 83.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, PATIENT REPORTS THAT HE HAS HAD A ITCHY SINGLE SHINGLE APPEAR ON HIS ABDOMEN. HE SAW THE DR WHO CONFIRMED IT WAS A SHINGLE. THIS WAS REPORTED TO ME 5-19-2008. . During the same period patient was treated with DILUENT LOT 3114U EXP 3/10. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #315204
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 05/30/2008. Female patient, 69.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Patient developed 3~ red circle around injection site. On 5/29 was diagnosed with shingles infection" Sulfa Allergy . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #315988
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/10/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a female consumer with a history of shingles who was vaccinated on an unspecified date with ZOSTAVAX (Oka/Merck) (Dose, route and Lot # not reported). The consumer reported that on an unspecified date ~I got the shingles through the nerve in my left arm down to my fingers with all the symptoms, of course, the blisters, pain and swelling~. ~My doctor told me later that the shot had live cultures in it and that most patients get shingles from it~. The consumer reported that this was the third time that she had shingles. At the time of the event, the outcome was unknown. Upon internal review, shingles was considered to be disabling." ShinglesUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #316042
ZOSTER (ZOSTAVAX) vaccine side effect was reported . NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Zosters rash. Nonetetanus allergy -> swelling . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #316155
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/12/2008. Female patient, 69.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 71 year old female with hypertension, hypothyroidism and no drug allergies who on 09-JAN-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant drug therapy included unspecified thyroid replacement therapy and unspecified medication for hypertension. On 22-MAY-2008 the patient was diagnosed with shingles. The patient sought medical attention through a physician office visit. No labs or diagnostic studies were performed. The patient was treated with ZOVIRAX, prednisone and an unspecified pain medication. The patient was noted to be recovering at the time of this report. There was no product quality complaint. No other information was available at this time. Shingles was also considered to be disabling (related to pain) by the physician. Additional information has been requested." Hypertension; hypothyroidism; thyroid hormone replacement therapyNone . During the same period patient was treated with [therapy unspecified]. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #316163
ZOSTER (ZOSTAVAX) vaccine side effect was reported . Female patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Shingles vaccine 5/15/08; Erythematous vesicles started 6/2-6/3/08; 6/3/08 - Increasing lesions - Admission to hospital ~varicella like rash~ 6/20/08-records received for DOS 6/3-6/6/08-DC DX:Disseminated herpes zoster. Treated with acyclovir. C/O progressive deveoping generalized rash. Chills" NKDA 6/20/08-records received-PMH: lymphoma currently in remission. Allergies to sulfa and aspartame. Recent sinus infection."6/20/08-records received-WBC 2.9, neutrophil % 25, lymphocytes %62. Blood culture no growth." . Patient was hospitalized Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #316166
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/10/2008. Female patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Patient received Zostavax 2 1/2 weeks ago. She developed right sided head pain 2 weeks ago, right facial pain and sensitivity 1 week ago and rash on face 3 days ago consistent with a clinical case of Zoster -shingles- involving the trigeminal nerve 1st and second branch. No eye involvement thus far. 7/15/08 Reviewed PCP medical records of 5/12-6/9/08. FINAL DX: Facial shingles w/trigeminal nerve involvement Records reveal patient w/left ear drainage & pain on 5/12 & tx w/topical & oral antibiotics. RTC 6/9 with shooting pain right scalp x 2 wks which had progressively gotten worse. Facial rash x 2-3 days w/burning sensation. Exam revealed erythematous papules & vesicles on right face w/ulcerations, hemorrhagic crusts, increased touch sensitivity over face & right scalp. Tx w/antibiotics & pain meds. Follow-up: The patient developed clinical zoster a few days after receiving the vaccine. The rash cleared after 3 weeks, but pain persisted despite Acyclovir and gabapentin initially. Gabapentin ongoing for about 6 more weeks. She had recurrence of similar pain mildly 6 months later which resolved after about 1 week without Rx. Today feels well." "Non smoker. Patient had chicken pox in her youth. History of NAFLD - non-alcoholic fatty infiltration of the liver - mild. Allergic to codeine, sulfa. PMH: chronic left OM w/mastoid cavity s/p perforation" . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #316209
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/09/2008. Female patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Red rash on R great toe with hives. No scabbing, sore throat and cold symptoms at same time, Nerve pain. Ibuprophen and ABSORBINE Jr. Healed in 2-2 1/2 wks. (Pt thinks shingles)." None did not see med provider . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #316387
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/17/2008. NA patient, 78.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient received Zostavax on 6/9/08 and called on 6/13/08 and had outbreak of shingles. nonenonenone . During the same period patient was treated with "vitaeyes, actonel, effexor". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #316437
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/17/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Pt received inj. on 5/23/08. Broke out in rash on 6/6/08. Saw MD on 6/16/08 and confirmed shingle breakout. None . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #316454
ZOSTER (ZOSTAVAX) vaccine side effect was reported . Female patient, 68.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "The pt rec'd ZOSTAVAX 0.65 ml SQ x1 on 5/12/08, developed disseminated zoster and visited MD on 5/14/08." "NKDA, angina, HTN" . During the same period patient was treated with "ASA, CARDIZEM, COZAAR, diazide, PRILOSEC". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #316614
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/16/2008. Male patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Got shingles vac. 10/2007. Came on heavy case of shingles 01/2008. Am still on drugs for P.H.N as of 6/16/08. Have tried acupuncture, have been referred to chronic pain clinic w/in system now on LYRICA-no more B rates." None . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #316956
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/23/2008. Female patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "PATIENT BROKE OUT WITH SHINGLES LESIONS ON HANDS, ARMS, LEGS." . During the same period patient was treated with PRENISONE 3MG DAILY. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #317587
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/22/2008. Male patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Shingles . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #317745
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/27/2008. Female patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "The patient recieved Zostavax on 6/2/08 and presented to the Emergency Department on 6/4/08 complaining of pain. Upon examination, erythematous vesicular lesions were noticed. She was diagnosed with herpes zoster and discharge with Valtrex and Lidoderm patch. She followed up with her primary care physician, who gave her pain medications. As of 6/23/08, the pain is still present." Abdominal painAllergy to iodine and sulfa drugs . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #317758
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/27/2008. Female patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "6/26/08 Swollen (softball sized) inflamed area near injection site with rash. Red inflamed rash on left and right arm, clustered on left thigh, some going up to groin area, left side hairline. Some appeared pustule like. Dr. prescribed Cephalexin and Cortaid topical. 6/27/08 Patient returned to pharmacy with increased redness and spreading of rash to other sites, the right eyelid, waistline,groin with some that appeared pustule like. Injection site swelling had improved but pain, rash, redness had spread all over body. Patient was distraught over the outcome of the vaccine and expressed this to the pharmacist on duty. Pharmacist on duty told patient to return immediately to her primary care doctor for treatment. Also, we spoke with the Zostavax (merck) rep. for our area and informed her of the incident and she will be contacting physician's office. This is in follow-up to report (s) previously submitted on 9/26/2008. Information has been received from a pharmacist concerning a 63 year old femlae who on 23-Jun-2008 was vaccinated subcutamously with a .65 ml dose of roster vaccine live (oka/Merck) (Lot # 659411/0293X). There were no concomitant medications reported. The pharmicist staed that a patient developed hives after receiveing roster vaccine live (Oka/Merck) (Lot # 659411/0293Y). The patient received the vaccine on 23-Jun-2008, and she came back to the pharmacy on 26-Jun-2008 with hives. The hives radiated to legs and waist. There were also some hives on her chest and one small blister on her eye lid. On 28-Jun-2008 she came back to the pharmacy and filled MEDROL dose pack. The patient told the pharmacist that she was referred to a dermatologist. Medical attention was sought, the pharmacist saw the patient. There were no product quality complaint. Follow up information was received concerning a 63 year old female patient with no medical history, no known allergies, who on 23-Jun-2008 at 4:30 pm was vaccinated with a first dose of ZOSTER vaccine live (Oka/Merck) (Lot # 659411/0293X) subcutaneously on the left" NoneNoneUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #317766
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/28/2008. Female patient, 69.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient had a local reaction to Zostavax vaccination recieved on 06/18/08. Administered into left arm. Swelling occured. Two days later patient described back pain (6/20/08). Blistery rash developed on 06/23/08. Patient saw physician to verify diagnosis of shingles NoUnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #317862
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/27/2008. Female patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 75 year old female with a history of lymphoma who in May 2008, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot no. route and site of administration were not reported). On 03-JUN-2008 the patient experienced shingles and was hospitalized. However, the reason and length of hospitalization was unspecified. The patient sought unspecified medical attention. Additional information has been requested." LymphomaUnknown . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #317941
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/30/2008. Female patient, 87.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Pt experienced a case of shingles beginning on 6/05/08. ER MD Rx'd on 6-9-08 Prednisone - PCP Rx'd Gabapentin on 6-13-08. None . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #318055
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/01/2008. Female patient, 81.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, infected with Shingles virus . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #318146
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/02/2008. Female patient, 78.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, received zostavax on 6/6/08. Two weeks later developed shingles R thigh nononone . During the same period patient was treated with "cozaar,atenolol,lipitor,ranitadine". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #318928
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 68.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 67 year old male who in 30-Jan-2008, was vaccinated with a dose of ZOSTAVAX. On 30-JAN-2008 the patient complained of pain and was referred to an urologist who determined that the patent experienced shingles. The patient received ZOSTAVAX at a facility. The reporting physician was not the treating physician. Subsequently, the patient recovered from shingles on an unknown date. Unspecified medical treatment was sought. No product quality complaint. Additional information has been requested. This is in follow-up to report(s) perviously submitted on 6/24/2008. Follow-up information has been received from a physician concerning a 68 year old white retired male who on 23-JAN-2008 was vaccinated intramuscularly with a dose of ZOSTAVAX (lot # 658867/1413U). Concomitant therapy included pneumococcal 23v polysaccharide vaccine (MSU). On 29-JAN-2008, the patient developed herpes zoster. Subsequently, the patient recovered from herpes zoster. Additional information is not expected" UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #318929
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 74.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 74 year old male who on 18-MAR-2008 was vaccinated with a dose of ZOSTAVAX SQ in the left arm (lot# 659762/1874U). Concomitant therapy included CELEBREX, warfarin, lisinopril and metoprolol. On 19-MAR-2008 the patient experienced shingles on the trunk above the belly but below the chest. Patient had no itching or pain but only had a rash. Regarding medical treatment the patient only spoke to the pharmacist. No product quality complaint. Additional information has been requested." UnknownUnknown . During the same period patient was treated with CELEBREX; VYTORIN; Lisinopril; Metoprolol; Warfarin. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319123
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer concerning her 71 year old sister with no known allergies, high blood pressure and diabetes who in September or October 2007, was vaccinated with a single dose of series of zoster vaccine live (Oka/Merck). Subsequently, around 14-MAR-2008 the patient started to break out in shingles and had a lot of pain. Medical attention was sought. The patient's back hurt so she went to a chiropractor who stated she had red dots on her back." Unknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319124
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 64 year old female who in approximately January 2008, was vaccinated SC with a dose of zoster vaccine live (Oka/Merck). Two months later, in approximately March 2008, the patient developed zoster opthalmicus. Unspecified medical attention was sought. The patient's zoster opthalmicus persisted. A product complaint was not involved. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319125
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a pharmacist concerning a female patient with no history of chickenpox who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently the patient developed shingles. A product quality complaint was not involved. No further information is available. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319127
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a Registered Nurse concerning a patient who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck) and subsequently developed shingles. At the time of the report the patient's status was unknown. It was unspecified if medical attention was sought. There was no product quality complaint involved, no additional information was provided. Additional information requested. This is one of several reports from the same source." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319132
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse practitioner concerning a 71 year old female with high blood pressure, hypercholesterolaemia and hypersensitivity to codeine who on 15-NOV-2007 was vaccinated subcutaneously with ~one dose~ of zoster vaccine live (Oka/Merck) (lot # 658604/1088U). Concomitant therapy included TOPROL XL TABLETS, PLAVIX, DETROL LA, VALIUM, AMBIEN AND ADVAIR. On 22-FEB-2008, the patient developed discomfort on or around her ear and face, followed by a rash the next day. The patient was diagnosed with herpes zoster on 25 FEB 2008. A VZV titer was performed (on an unspecified date) the results of which were not reported. At the time of reporting the patient had not yet recovered. The NP was not interested in getting a VZV analysis. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested." Blood pressure high; Hypercholesterolaemia; Drug hypersensitivitydiagnostic laboratory - VZV titer . During the same period patient was treated with PLAVIX; VALIUM; ADVAIR; TOPROL XL TABLETS; DETROL LA; AMBIEN. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319135
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 86.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an 86 year old female consumer with no pertinent medical history who on an unspecified date was vaccinated with 1 dose of zoster vaccine live (Oka/Merck). Concomitant therapy included alendronate sodium (MSD) and VALTREX. Subsequently, on 17-SEP-2007 the patient developed a rash on ~her lower buttocks.~ Medical attention was sought in the emergency room. On an unspecified date the patient recovered. There was no product quality complaint involved. Follow-up information has been received from a health professional concerning this 86 year old female with osteoporosis, increased lipids, sulfonamide and CIPRO allergies and a history of a motor vehicle accident, cerebrovascular accident, RAYNAUDS and diverticulosis who on 28-AUG-2007 was vaccinated SQ in the left arm with a first dose of zoster vaccine live (Oka/Merck) (lot # 658085/0882U). The patient was recovering from a rib fracture due to a motor vehicle accident at the time of vaccination. Additional concomitant therapy included minerals (unspecified) (+) CENTRUM SILVER, LIPITOR, aspirin and folic acid. Subsequently, on 17-SEP-2007 at 2:45 PM the patient had a painful rash on her left buttocks and leg. The patient was diagnosed with shingles. The patient was given VALTREX 1 gm three times a day X 1 week and VICODIN as needed for pain. On 26-Sep-2007, the patient had an office visit and was improved (recovered). Additional information is not expected." Rib fracture; Osteoporosis; lipids increased; Sulfonamide allergy; Allergic reaction to antibioticsMotor vehicle accident; Cerebrovascular accident; RAYNAUDS; DiverticulosisUnknown . During the same period patient was treated with FOSAMAX; aspirin; LIPITOR; folic acid; CENTRUM SILVER. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319144
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse concerning an approximately 70 year old male consumer who in approximately December 2007, was vaccinated with zoster vaccine live (Oka/Merck). On 25-MAR-2008 or 26-MAR-2008 the patient had a full case of zoster. Medical attention was sought in the office. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319151
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 61.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning a 61 year old female who on 24-OCT-2007 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included Metformin, glipizide (GLUCOTROL XL), hydrochlorothiazide, diltiazem HCL, propranolol Hcl, aspirin, lorazepam (ATIVAN), omega-3 marine triglycerides, vitamins (unspecified), albuterol, acetaminophen/hydrocodone bitartrate (LORTAB), hyoscyamineSO4, lovastatin, lisinopril, rabeprazole sodium (ACTPHEX), nitrofurantoin, fluconazole (DIPLUCAN), fluoxitene, naproxen (NAPROSYN) and nystatin (MYCOSTATIN). On 22-FEB-2008 the patient developed herpes zoster. Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patient's status was unknown." UnknownUnknown . During the same period patient was treated with "(therapy unspecified), lortab, albuterol, aspirin, diltiazem hydrochloride, diflucan, glucotrol xl, hydrochlorothiazide, hyoscyamine sulfate,lisinopril, ativan, lovastatin, metformin, naprosyn, nitrofurantoin, mycostatin, omega-3 marine tri". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319152
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a registered nurse concerning a female patient who was exposed to her grandmother who on 08-FEB-2008 was vaccinated SQ in the right arm with 0.65mL of zoster vaccine live (Oka/Merck) (lot # 659325/1823U). Medical attention was sought on 24-MAR-2008 in the clinic. The patient had shingles. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that the patient was treated with acyclovir 400mg. The patient's outcome was not reported. Follow-up information indicated no new information. Additional information is not expected. This is one of several reports from the same source. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319156
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 69.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a Nurse Practitioner and a 70 year old male with no known allergies and an ~unremarkable~ medical history who on 02-NOV-2007 was vaccinated SQ in the right arm with 0.65mL first dose of zoster vaccine live (Oka/Merck) (Lot # 658395/0966U). There was no concomitant therapy. On 04-FEB-2008, the patient went to the doctor's office for a pruritic and painful rash on his back that started on 02-FEB-2008. The patient was seen by the physician and diagnosed with shingles, described as vesicular lesions on his back. The patient was treated with VALTREX. On 14-FEB-2008, the patient called the office complaining of pain (post herpetic neuralgia) so he was started on LYRICA 75mg bid. There were no lab studies performed. The patient recovered on 29-FEB-2008. There was no product quality complaint involved. Additional information is not expected." NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319158
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a Licensed Practical Nurse concerning a 64-year-old female with hypertension, hyperlipidaemia, scoliosis, rhinitis allergic, osteoporosis, gastrooesophageal reflux disease, mitral valve prolapse, depression, left carotid bruit, and penicillin, MACROBID and BACTRIM allergies who on 18-MAR-2008 was vaccinated subcutaneously in the right deltoid with a 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot# 659759/1873U). Concomitant therapy included hydrochlorothiazide (manufacturer unknown), atenolol, NEXIUM, LIPITOR, ZYRTEC, OMACOR and NASACORT. On 20-MAR-2008, the patient experienced a shingles like rash on the patient's left shoulder. Medical attention was sought at the physician's office. There were no laboratory or diagnostic tests performed. The outcome was reported as not recovered. No product quality complaint was involved. Follow-up has been received from the L.P.N. concerning a patient with a history of chickenpox at the age of 7 who was vaccinated with a 0.6 mL (previously reported as 0.65 mL) dose of zoster vaccine live (Oka/Merck). It was reported that a rash had not occur at the site of injection or elsewhere within 42 days of the vaccination. Date of Herpes Zoster was reported as 20-Mar-2008. The patient rated the pain a 5-6 on a scale of 0-10 (10 being the most). Other symptoms included itching. There was no recent exposure to chickenpox. A direct fluorescent antibody was not done. Follow-up has been received from the L.P.N. and physician who indicated that additional concomitant therapy included cyclobenzaprine hydrochloride (MSD). On 20-Mar-2008, the patient developed a rash on the chest area above the left breast and shoulder. The patient's maximum temperature was 98 degrees. There was no recent history of exposure to chickenpox or shingles. On an unspecified date the patient recovered. The patient was enrolled in the Varicella Zoster Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT)" Hypertension; Hyperlipidaemia; Scoliosis; Rhinitis allergic; Osteoporosis; Gastrooesophageal reflux disease; Hypersensitivity; MChickenpoxbody temp 98 degree - maximum temperature; VZV strain 03/26/08 - VZV WILD TYPE STRAIN . During the same period patient was treated with atenolol; LIPITOR; ZYRTEC; FLEXERIL; NEXIUM; HYDRO-DIURIL; OMACOR; NASACORT. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319161
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an ~over 70 years old~ female who was vaccinated on an unspecified date with zoster vaccine live (Oka/Merck) at the pharmacy. Subsequently, 10 to 12 days later the patient developed shingles. Unspecified medical attention was sought in the Emergency Room. The patient was not admitted. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319167
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a Nurse Practitioner concerning a female who on an unspecified date was vaccinated with a 0.65ml dose of zoster vaccine live (Oka/Merck). Subsequently the patient developed shingles. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319168
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 85.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from an 85 year old male consumer with no known allergies and a history of shingles and kidney infection who on 03-JAN-2008 was vaccinated with a first dose of zoster vaccine live (Oka/Merck) in the arm. The patient was on unspecified concomitant therapy. ~14 days post vaccination~, on 17-Jan-2008, the patient developed shingles. Unspecified medical attention was sought and the patient was treated with medication (specifics were not known) from his Physician. The patient also noted ~constant misery.~ There were no lab studies performed. On an unspecified date the patient recovered. There was no product quality complaint involved. Additional information has been requested." "Shingles, Kidney infection"None . During the same period patient was treated with (therapy unspecified). Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319170
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 67.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial and follow-up information has been received from a Certified Medical Assistant concerning a 67 year old female with no known drug allergies or pertinent medical history, who on 20-FEB-2008 was vaccinated IM (also reported as SQ) in the left deltoid with a 0.65mL dose of zoster vaccine live (Oka/Merck) (lot # 659324/1835U). Subsequently, a few days after vaccination on 23-FEB-2008 or the 26-FEB-2008 the patient developed a vesicular rash and pain following dermatome distribution at the right scapular area. Unspecified medical attention was sought in the office. There were no lab studies performed. The patient was diagnosed with shingles, with lesions on her right shoulder, chest, and back. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested." NoneNone . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319180
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 84.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning an 85 year old female with hypertension, osteoporosis and no known drug reactions or allergies who on 23-MAR-2007 was vaccinated subcutaneously with 0.65 mL of zoster vaccine live (Oka/Merck) (Lot # 656607/0163U). Concomitant therapy included hydrochlorothiazide, losartan potassium (MSD), CRESTOR, amlodipine besylate, aspirin and omeprazole. On 28-FEB-2008, the patient sought medical treatment for left hip pain that was described as a mild eruption of a shingles rash at the L1 dermatome. The patient was prescribed FAMVIR, VICODIN, and LYRICA. At the time of the reporting the patient had not yet recovered. The physician was not interested in VZV Analysis by PCR. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested." Hypertension; OsteoporosisNone . During the same period patient was treated with amlodipine besylate; aspirin; hydrochlorothiazide; COZAAR; omeprazole; CRESTOR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319183
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 62 year old female consumer with no known allergies, cholesterol and hypertension who on 25-FEB-2008 was vaccinated with 0.65ml of zoster vaccine live (Oka/Merck). Concomitant therapy included atorvastatin calcium (LIPITOR) and bisoprolol fumarate/HCTZ (ZIAC). On the same day that she was administered zoster vaccine live (Oka/Merck), 25-FEB-2008 the patient developed shingles. On 01-MAR-2008 patient reported she started taking famciclovir (FAMVIR) and experienced a headache. Unspecified medical attention was sought. There were no lab studies performed. The patient's outcome was not reported. There was no product quality complaint involved. Additional information has been requested." "Cholesterol, Hypertension"None . During the same period patient was treated with "LIPITOR, ZIAC". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319193
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning a 75 year old female consumer who on 13-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 25-MAR-2008 the patient called the office and reported blisters on her trunk. The nurse diagnosed the blisters as shingles from the patient's description over the phone. The patient was referred to her physician. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that the patient was not tested because she recovered on an unspecified date. Additional information has been requested. This is one of several reports from the same source." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319195
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 67.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 68 year old female consumer with no known allergies who on 07-AUG-2007 was vaccinated SQ with a dose of zoster vaccine live (Oka/Merck). On 24-MAR-2008, the patient developed shingles. The patient had rashes on her back, side of her head, and on her neck. She also complained of pain on the head and neck. On an unspecified date the patient was seen by the physician. It was unspecified if lab studies were performed. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the physician's office concerning a 68 year old consumer with no known allergies who on 07-AUG-2007 was vaccinated with zoster vaccine live (Oka/Merck) indicated there was no illness at the time of vaccination, and the patient did not have any lab studies performed. The patient's outcome was not reported. Follow-up information has been received from a physician concerning this 68 year old female consumer with no known allergies or pertinent medical history who on 07-AUG-2007 was vaccinated IM right side (also reported as SQ) with a first dose of zoster vaccine live (Oka/Merck) (lot # ~07334'). There was no illness at the time of vaccination. On 29-MAR-2008 the patient was diagnosed with shingles. There were no lab studies performed. At the time of the report the patient's status was reported as recovered. (The patient does not have pain, but still has marks). It was noted that the patient did not have a rash at the site of injection or elsewhere within 42 days of the vaccination. The patient did developed lesions at the C3 location. The patient also developed pain (rated 4 on a scale of 0 to 10). It was also note that there was no recent exposure to chickenpox or herpes zoster. It was unspecified if the patient had a history of chickenpox. Additional information is not expected." None . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319202
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a registered nurse concerning a female patient who was exposed to her grandmother who on 08-FEB-2008 was vaccinated SQ in the right arm with 0.65mL of zoster vaccine live (Oka/Merck) (lot # 659325/1823U). Medical attention was sought on 24-MAR-2008 in the clinic. The patient had shingles. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that the patient was treated with acyclovir 400mg. The patient's outcome was not reported. Additional information is not expected. This is one of several reports from the same source. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319205
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 83.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 83 year old female consumer with a penicillin allergy and a history of shingles ~several years ago, and they reoccur every so often,~ who about two months ago on approximately 05-JAN-2008 was vaccinated with single dose of series of zoster vaccine live (Oka/Merck). Concomitant therapy included blood pressure medication and NEXIUM. Subsequently, after receiving zoster vaccine live (Oka/Merck) her shingles reoccurred and have gotten worse. The patient reported that the shingles reoccurred on her upper back, between her shoulder blades and on her bottom, and she stated her shingles are really itchy and they sting. In addition, she stated after receiving zoster vaccine live (Oka/Merck) she has been losing her hair and also some hair from her eyebrows. Unspecified medical attention was sought, there were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow up information from the registered nurse indicated she had no additional information to provide for this case because the patient had not yet contacted or returned to their office since the vaccine was administered. Follow-up information from the patient indicated ~she still had shingles and her hair was still falling out.~ Follow-up information from the registered nurse indicated no further information is available. No additional information is available." Penicillin allergyShinglesNone . During the same period patient was treated with blood pressure medication (therapy unspecified); NEXIUM. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319206
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 80.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an 80 year old female consumer who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed a zoster rash over her entire body 2 weeks after vaccination. Medical attention was sought in the office with a specialist. It was unspecified if lab studies were performed. The specialist diagnosed the rash as zoster. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319207
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer concerning a friends' friend who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed shingles. There was no product quality complaint involved. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319208
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse who reported one case involving a household contact of a person vaccinated with zoster vaccine live (Oka/Merck) who developed shingles. She confirmed that the vaccinee in this case did not develop a rash or shingles. She did not have any other details about the household contact, including whether they had a history of chickenpox. The possibility of PCR for this case was discussed, but the nurse explained that she learned of this case several weeks ago and thought that the household contact might have recovered. The VZVIP program and specimen collection was discussed. It is unknown if medical attention was sought. There was no product quality complaint. This is one of several reports received from the same source. The nurse mentioned that some of the cases were reported to VAERS. Additional information is not expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319209
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a registered nurse concerning a patient who was vaccinated with zoster vaccine live (Oka/Merck). It was reported that the patient developed shingles after receiving zoster vaccine live (Oka/Merck). It is unknown if medical attention was sought. There was no product quality complaint. This is one of several reports received from the same source. The nurse mentioned that some of the cases were reported to VAERS. Additional information is not expected. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319211
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 84.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from an 84 year old male consumer with no known allergies, a history of chickenpox and mumps who on approximately 20-FEB-2008 was vaccinated SQ with 0.65mL of zoster vaccine live (Oka/Merck) once. Concomitant therapy included primidone, isosorbide, benazepril HCL, LIPITOR, omeprazole (MDS), PAXIL and alprazolam. On approximately 21-FEB-2008 the day after he was vaccinated he developed shingles. Medical attention was sought and he was prescribed a topical cream, ~halobetasol proportionate cream.05 (glades).~ There were no lab studies performed. The patient stated when he applied the cream to his rash it would go away and reappear on a different part of his body. This happened each time he applied the cream to the rash whit it appeared. The patient also stated that he purchased the vaccine a week before it was administered and stored it in his freezer until it was administered. At the time of the report the patient's status was unknown. The patient stated he thinks that it is all gone, but there might be some on his back. There was no product quality complaint involved. Follow-up information from the physician's office indicated that patient was last seen in their office on 20-NOV-2007. The physician's office indicated they did not buy or administer the vaccine to the patient. Follow-up information from the patient indicated he has another ~bout of shingles.~ He reported he has lesions on his back, abdomen, and both of his elbows. He indicated he has not notified his physician thus far about this latest event. Additional information is not expected." Chickenpox; MumpsNone . During the same period patient was treated with alprazolam; LIPITOR; benazepril hydrochloride; isosorbide; nifedipine; PRILOSEC; PAXIL; primidone. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319212
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 68.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial and follow-up information has been received from a physician concerning a 69 year old male consumer with no known allergies and a history of childhood chickenpox who on 22-FEB-2007 was vaccinated in the left upper arm with a single dose of zoster vaccine live (Oka/Merck) (lot # 656413/1477F). Concomitant therapy included allopurinol, simvastatin (MSD), HYTRIN, NORVASC, TOPROL XL TABLETS) and furosemide. Subsequently, on 28-FEB-2008 the patient developed a ~severe case of zoster~ and experienced pain. Unspecified medical attention was sought. At the time of the report the patient was no recovered. There was no product quality complaint involved. New information from the physician indicated he would be collecting a specimen for VZVIP on 10-Mar-2008. At the time of the report update, the patient's status was reported as uncomfortable and the patient was started on on FAMVIR at the time he was diagnosed with shingles. Follow-up information from the physician indicated that there was no rash at the site of injection or elsewhere within 42 days of vaccination. The patient's pain was reported as 8 on a scale of 0 to 10 and the patient's maximum temperature was reported as 100 degrees F. There was no recent exposure to chickenpox or herpes zoster. The patient developed 8 clusters of vesicular lesions up to 3.5 cm in diameter on the right T12 location. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. The sample of the lesion was collected on 10-MAR-2008 and sent to the laboratory on 10-MAR-2008. The sample was taken from a crusted lesion. The PCR results for the specimen from a crusted lesion identified the presence of WT VZV. Follow-up information from the physician indicated that the patient recovered on an unspecified date. Additional information is not expected." ChickenpoxVZV strain 03/10/08 - VZV WILD TYPE STRAIN; body temp 100 F . During the same period patient was treated with allopurinol; NORVASC; furosemide; TOPROL XL TABLETS; ZOCOR; HYTRIN. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319218
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 66.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "This is in follow-up to report (s) previously submitted on 6/24/2008. Information has been received from a physician concerning a 66 year old female consumer who on an unspecified date was vaccinated with ZOSTAVAX (Oka/Merck). Subsequently, the patient developed shingles four months after the vaccine was given. Medical attention was sought, the patient spoke to the physician. It was unspecified if lab studies were performed. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source. Follow-up information has been received from this 66 year old female patient with no pertinent medical history or drug reactions, who reported that she received the vaccination sometime in November 2007. Concomitant therapy included LIPITOR. Subsequently, the patient broke out with shingles ~about 6 months later, around 01-APR-2008~. the patient reported she developed shingles on her left groin, and her whole left hip became numb. The patient also reported that she had a lot of pain from the shingles. Medical attention was sought. The patient stated that once she saw the shingles she went to her physician right way. There were no lab studies performed. At the time of the report the patient was recovered. The patient reported that the pain only lasted about three weeks and that the shingles have gone away at this point in time. Additional information has been requested. This is one of several reports from the same source." UnknownNone . During the same period patient was treated with LIPITOR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319220
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 76.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 76 year old female consumer who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed shingles within six months after the vaccine was given. Unspecified medical attention was sought and it was unspecified if lab studies were performed. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319232
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 68.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Initial and follow-up information has been received from a pharmacist concerning a 67 year old female who on 06-NOV-2007 was vaccinated in the right upper arm with a 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot # 658398/1087U). ON 29-FEB-2008 (also reported as 03-MAR-2008 or 04-MAR-2008) the patient developed a shingles rash from her neck to the top of head on the left side only. It was reported that a rash did not occur at the injection site or elsewhere within 42 days of vaccination. Unspecified medical attention was sought. On an unspecified date the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information is not expected. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319237
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 80.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial information has been received from a consumer concerning her 80 year old mother with diabetes (type unspecified) and a history of shingles in 2006 who on 23-AUG-2007 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included insulin and VICODIN. On 09-MAR-2008, medical attention was sought in the hospital emergency room where the patient was diagnosed with shingles, there were no lab studies performed. The patient's daughter stated her mother was treated with VALTREX and discharged. The patient's daughter also stated that her mother had a severe case of shingles in 2006, that was located on the other side of her body from this current outbreak of shingles. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information was received from the physician's office concerning an 80 year old consumer with diabetes (type unspecified), penicillin and BACTRIM allergies. On 23-AUG-2007, the patient was vaccinated SQ in the right deltoid with a single dose of zoster vaccine live (Oka/Merck) (lot # 656858/0356U). Additional concomitant therapy included PREVACID, aspirin, metformin, folic acid, losartan potassium (MSD), AMBIEN, and PLAVIX. Approximately seven months after vaccination, on 12-MAR-2008 (also reported as 09-Mar-2008 and 13-MAR-2008) the patient's left arm had an extensive red inflamed rash, with intermittent white blisters and numerous lesions, also reported as recurrent shingles on her left arm. It was unknown if the patient had a history of chickenpox or herpes zoster. The patient's pain was rated 6-7 on a scale of 0 (least) to 10 (most). The patient's maximum temperature was reported as 98.4. On 21-MAR-2008 the patient recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) strain or with The OKA/Merck vaccine strain. The sample of a lesion was collected on 13-MAR-2008 and sent to" Diabetes; Penicillin allergy; Allergic reaction to antibioticsShingles"body temp 03/12/08 98.4; VZV strain 13/13/08 Negative - INADEQUATE SPECIMEN, no strain identified" . During the same period patient was treated with VICODIN; aspirin; PLAVIX; folic acid; insulin; PREVACID; COZAAR; metformin; AMBIEN. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319238
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from an office manager concerning a 65 year old female consumer with no known allergies or pertinent medical history who on 19-DEC-2007 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant vaccination and therapy included influenza virus vaccine (unspecified) and tetanus toxoid. Subsequently, 2 weeks after vaccination on 02-JAN-2008 the patient developed shingles. The lesions were on her left buttocks. Medical attention was sought, the patient called the physician. There were no lab studies performed. At the time of the report the patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/24/2008. Medical attention was sought, the patient called the physician on 02-APR-2008. There was no product quality complaint involved. Additional information is not expected." NoneNone . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319244
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 61.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning a 61 year old female consumer with type 2 diabetes mellitus, sulfonamide and shellfish allergies who developed shingles in a cervical dermatome distribution on 08-APR-2008 after being exposed to her mother who was vaccinated with zoster vaccine live (Oka/Merck) on 05-APR-2008. Concomitant therapy included LEXAPRO, quinapril HCl, GLUCOPHAGE, sitagliptin phosphate (MSD) and potassium acetate. It was noted that the first lesion erupted on 08-APR-2008. On 12-APR-2008 the patient sought medical attention at an immediate care facility because of neck pain and a second vesicular lesion. There were no lab studies performed. The patient was treated with VALTREX, and given a prescription of hydrocodone bitartrate for pain. The patient was referred by the immediate care physician to her primary care provider for follow-up. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow up information was from the physcian who thought shingles was a reactivation of a latent disease and there was no relationship between patient's symptoms and relative's vaccination and she also thought that it was not significant. No further information is expected." Sulfonamide allergy; Shellfish allergy; Type 2 diabetes mellitusNone . During the same period patient was treated with LEXAPRO; GLUCOPHAGE; potassium acetate; quinapril hydrochloride; JANUVIA. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319247
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "This is in follow-up to report (s) previously submitted on 6/24/2008. Information has been received from a physician concerning a female patient who is absolutely certain that she had chickenpox as child and has never previously had shingles who exactly 3 weeks ago on 21-MAR-2008 was vaccinated with ZOSTAVAX (Oka/Merck). On 11-APR-2008 the patient was seen by the physician and appeared to have shingles in the left ophthalmic nerve distribution. Her symptoms included burning on the skin, with rash onset 5-6 hours later, low grade fever, and myalgias. It was noted that this seemed classic, as well as the rash and distribution. It was also noted that the patient had a severe injection site reaction with swelling, erythema, warmth, and bruising for 3 days. At the time of the report the patient's status concerning the shingles was unknown. Additional information has been requested. Follow up information was received from a health professional concerning the patient's reaction was not due to ZOSTAVAX (Oka/Merck), but it was dur to a dermatological treatment the patient was receiving at that time. Follow up information was received from a physician concerning the patient had facial celulitis, not zoster outbreak. The facial celulitis was not related to shingles vaccine, turned out to be coincidental timing was unfortunate." ChickenpoxUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319248
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 62 female consumer with no known allergies and a history of shingles who in November 2007, was vaccinated with 0.65mL of zoster vaccine live (Oka/Merck). Concomitant therapy included AGGRENOX, NEURONTIN, hydroxyzine hydrochloride, CRESTOR and ALTACE. Subsequently, in ~late November 2007~ on approximately 26-NOV-2007, the patient developed shingles after receiving the vaccine. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested." ShinglesNone . During the same period patient was treated with AGGRENOX; NEURONTIN; hydroxyzine hydrochloride; ALTACE; CRESTOR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319254
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 81.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial and follow up information has been received from a physician and an 81 year old male consumer with no known allergies and with a history of atrial fibrillation and severe balance issues (for 2 years and most recent episode approximately 21-FEB-2008) who on 27-FEB-2008 (also reported as 28-FEB-2008) was vaccinated with 0.65mL of zoster vaccine live (Oka/Merck). Concomitant therapy included COUMADIN and simvastatin (manufacturer unknown). Subsequently, on 13-MAR-2008 the patient developed a blister rash on his anterior left thigh. On 14-MAR-2008 he presented to the physician's office. Upon exam the patient had shingles on left leg. He was treated with VALTREX 1 gram every 8 hours X 7 days. Patient reported that on 12-MAR-2008 he ~was walking and it was hard to straighten out, he drifted backward.~ EMS was called, vital signs were ok and there were no speech problems. ~Carotids-no bruits, ROMBERG-negative, movement within normal limits and tandem walking was ok.~ Impression was imbalance. An MRI and MRA of the head were planned. As of 18-APR-2008 the patient was recovered from the shingles. There was no product quality complaint involved. Additional information is not expected." Atrial fibrillation; balance disorderblood pressure 03/14/08 122/6; body temp 03/14/08 97.9 degree . During the same period patient was treated with ZOCOR; COUMADIN. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319258
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 74.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a 74 year old male consumer who on 21-JAN-2008 was vaccinated SQ with 0.65mL of zoster vaccine live (Oka/Merck) (lot # 659325/1823U). Subsequently, on an unspecified date the patient developed shingles after receiving the vaccination. Medical attention was sought in the office. It was unspecified if lab studies were performed. The patient was treated with unspecified antiviral medication. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information indicated no new information. Additional information has been requested. This is one of several reports from the same source." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319262
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a male consumer who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck), approximately one week later he developed shingles. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information indicated no new information. Additional information is not expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319265
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a medical assistant and a physician who ~last year~ in 2007 vaccinated himself with zoster vaccine live (Oka/Merck). Subsequently, in 2008 he came down with a case of shingles. The physician stated he was without a rash, but has experienced post herpetic neuralgia. Medical attention was sought with another physician who diagnosed him with a case of herpes zoster. The physician had numerous ultrasounds and a MRI which were negative for anything. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information form the physician indicated that there were no side effects experienced. Additional information is not expected. This is one of several reports from the same source." Unknownmagnetic resonance - negative results; ultrasound - negative results . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319268
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician and a pharmacist concerning a 63 year old female consumer with no known drug allergies, diabetes, hypertension, Gastrooesophageal reflux disease and hyperlipidaemia who on 07-MAR-2008 was vaccinated SQ in the left deltoid with 0.65mL (also reported as 0.5mL) of zoster vaccine live (Oka/Merck) (lot # ~01429U~). Concomitant therapy included PREVACID, AVAPRO, TOPROL XL TABLETS, ezetimibe (MSD), alendronate sodium (MSD), CRESTOR, ACTONEL, metformin, flaxseed, fish oil and aspirin. Subsequently, on 11-MAR-2008 the patient had shingles symptoms. She had a shingles-like rash with no vesicles. There are 3 patches which were red and raised on her left, mid-lower back near T-11. It was also reported as ~the patient developed shingles.~ Medical attention was sought in the office. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/MERCK vaccine strain. Follow-up information indicated that the patient developed 3 lesions along the T12 dermatome. The patient also developed pain (rated 3 on a scale of 0 to 10). It was also noted that there was no recent exposure to chickenpox or herpes zoster. The sample of the lesion was collected and sent to the laboratory on 13-MAR-2008. The sample was taken from a lesion along the T12 dermatome location. The PCR results for the specimen taken from a lesion along the T12 dermatome location was an ADEQUATE SPECIMEN and identified the presence of WT VZV. Additional information has been requested." Diabetes; Hyperlipidaemia; Hypertension; Gastrooesophageal reflux diseaseVZV strain 03/13/0/08 - VZV WILD TYPE STRAIN . During the same period patient was treated with FOSAMAX; aspirin; ZETIA; flaxseed; AVAPRO; PREVACID; metformin; TOPROL XL TABLETS; omega-3 marine triglycerides; ACTONEL; CRESTOR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319278
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 68.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a licensed practical nurse concerning a 68 year old female with no pertinent medical history, drug reactions or allergies who on 14-JAN-2008 was vaccinated subcutaneously with 0.65 mL of zoster vaccine live (Oka/Merck) (Lot # 659403/1825U). There was no concomitant medication. On 28-FEB-2008, the patient broke out in shingles. On 17-MAR-2008, the patient contacted the nurse and reported that she had shingles blisters on her face. The patient was seen by a dermatologist and was being treated with an antiviral. The nurse was not interested in VZV ID program. At the time of reporting the patient's present status was unknown. There was no product quality complaint. There were no lab diagnostic studies performed. Additional information has been requested." UnknownNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319279
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse practitioner concerning a patient who on an unknown date in December 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). On 13-MAR-2008, the patient was seen by the nurse practitioner for a very mild case of shingles. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319285
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 73.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 73 year old male who on 12-OCT-2007 was vaccinated subcutaneously with 065 mL of zoster vaccine live (Oka/Merck). Concomitant therapy included digoxin and ~an Ace inhibitor.~ It was reported that ~within twenty-four hours of the vaccination,~ approximately 13-OCT-2007, the patient developed a rash from his lower back to his left knee. The patient reported that his doctor diagnosed the rash as shingles. At the time of reporting the rash was gone, but his leg was still ~touch sensitive.~ Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. Additional information has been requested." NoneNone . During the same period patient was treated with (therapy unspecified); digoxin. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319288
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 71 year old male who on 01-FEB-2008 was vaccinated SC with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included ARICEPT, LEXAPRO, FLOMAX and digoxin. Seven to ten days after vaccination, on approximately 08-FEB-2008 the patient developed shingles. The patient was advised to and did visit a dermatologist. There were no lab studies performed. Subsequently, the patient recovered after visiting the dermatologist. There was no product quality complaint involved. No further information was provided. Additional information has been requested." UnknownNone . During the same period patient was treated with digoxin; AIRCEPT; LEXAPRO; FLOMAX. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319293
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 57.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 57 year old female consumer with a history of shingles who in October 2007, was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 13-MAR-2008 the patient presented with a shingles outbreak. Medical attention was sought, the patient contacted the physician. At the time of the report the patient had not recovered. There was no product quality complaint involved. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow-up information has been received from the physician's office concerning this 57 year old female consumer with DARVON, DEMEROL, penicillin, erythromycin and aspirin allergies and a history of shingles and chickenpox (at age 10) who on 01-NOV-2007 (also reported in October 2007) was vaccinated in the left arm with 0.65ml of ZOSTAVAX (Merck) (lot # 657766/0620U). There was no concomitant medication. There was no rash at the site of injection or elsewhere within 42 days of vaccination. Subsequently, on 28-APR-2008 the patient developed pain, rated 7 on a scale of 0 to 10. It was reported that the patient developed pruritis and felt hot (her body temperature was not measured). On 29-APR-2008 (also reported as 13-MAR-2008) the patient developed a painful, pruritic papular rash on her back. The papular lesions developed on the right side of the L3 vertebral area. It was reported that there was no recent exposure to chickenpox or herpes zoster. At the time of report the patient's status was unknown. The patient was currently on VALTREX. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. The sample of the lesions was collected on 10-APR-2008, and sent to the laboratory on 01-MAY-2008. The sample was taken from a papular lesion. The PCR results for the specimen from the papular lesion was an inadequate swab - capillary tube- negative. F" Drug hypersensitivity; Penicillin allergy; Allergic reaction to antibioticsShingles; Chickenpox"VZV strain, 04/30/08, INADE, capillary tube - negative; VZV strain, 04/30/08, NO, ADEQUATE SPECIMEN" . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319295
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a Nurse Practitioner concerning a female consumer who approximately a year ago in approximately March 2007 was vaccinated SQ with 0.65 mL of zoster vaccine live (Oka/Merck). Subsequently, within the last month (approximately February 2008) the patient developed shingles. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. There were no lab studies performed. There was no product quality complaint involved. Additional information has been requested." UnknownNone . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319297
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from an office manager concerning a 63 year old male consumer who in July 2007, was vaccinated SQ with a single dose vial of zoster vaccine live (Oka/Merck). Subsequently, in August 2007 the patient developed shingles. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. No further information was provided. There was no product quality complaint involved. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319316
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning his wife who is a nurse who ~last year~ in 2007 vaccinated herself with zoster vaccine live (Oka/Merck). Subsequently, in 2008 she came down with a case of shingles. The physician stated she had a rash , but no post herpetic neuralgia. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the physician indicated no adverse effects were experienced. Additional information is not expected. This is one of several reports from the same source." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319319
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female consumer who on an unspecified date was vaccinated with two doses of zoster vaccine live (Oka/Merck). The physician reported the patient received her two doses of zoster vaccine live (Oka/Merck). Subsequently, after receiving two doses of zoster vaccine live (Oka/Merck) she was diagnosed with shingles on 10-MAR-2008. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319324
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 68.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 68 year old female with penicillin and meperidine hydrochloride (DEMEROL) allergies and a history of shingles and embolus leg who ~five-six months ago~ in approximately October 2007, was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included esomeprazole magnesium (NEXIUM), simvastatin (MSD) and ezetimibe (MSD). On 07-FEB-2008 the patient was diagnosed with shingles. It was noted that the patient had the rash and the pain but the blisters never appeared. Unspecified medical attention was sought, there were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. 09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Additional information received from someone in the physician's office indicated that this 68 year old female was vaccinated in the left deltoid with a 0.5 ml first dose of ZOSTAVAX (Oka/Merck) (lot # 657766/0620U) on 22-SEP-2007. Subsequently the patient presented to the ER for flank pain. The patient thought that she was coming down with shingles but that diagnosis was never made. On an unspecified date the patient recovered. Additional information is not expected." "Penicillin allergy, Drug hypersensitivity""Shingles, Embolus leg"Unknown . During the same period patient was treated with "NEXIUM, ZETIA, ZOCOR". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319325
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female who was vaccinated with zoster vaccine live (Oka/Merck) on approximately 15-FEB-2008. On approximately 07-MAR-2008, the patient developed shingles. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319343
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a male consumer who on an unspecified date was vaccinated with a dose of 0.65 mL of zoster vaccine live (Oka/Merck). Subsequently, the patient developed a mild outbreak of shingles. The patient was seen by the physician, it was unspecified if lab studies were performed. The patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319345
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female who in approximately August 2007, about 8 months ago was vaccinated with her first dose of zoster vaccine live (Oka/Merck). On approximately 02-MAR-2008 about 4 weeks ago, the patient was diagnosed with shingles. The patient sought unspecified medical attention. The outcome was unknown. No further information was provided. There was no product quality complaint. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319350
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 69.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a 69 year old male consumer who in November 2007, was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, sometime after receiving the vaccination the patient developed shingles on an unspecified date. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319353
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. NA patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an approximately 72 year old consumer with a history of having chickenpox twice, who on an unspecified date was vaccinated SQ with 0.65ml of zoster vaccine live (Oka/Merck). Subsequently a year after receiving the vaccination the patient developed a mild case of shingles. Medical attention was sought in the office. It was unspecified if lab studies were performed. At the time of the report the patient's status was unknown. There was no product complaint involved. Additional information has been requested." ChickenpoxUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319354
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 62 year old female consumer with no known allergies or pertinent medical history who on 31-MAR-2008 was vaccinated SQ with zoster vaccine live (Oka/Merck). There was no concomitant medication. Subsequently, on 02-APR-2008 the patient developed shingles. The patient had approximately ten lesions on her right forehead. The patient was seen by the the physician. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. The patient's sister also had an adverse experience after vaccination with zoster vaccine live (Oka/Merck) (WAES # 0804USA05038)." NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319355
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 54.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 54 year old female consumer with diabetes and rheumatoid arthritis who on 07-FEB-2008 was vaccinated IM with 0.65 mL of zoster vaccine live (Oka/Merck). On 10-APR-2008, the patient was seen in the physician's office with a rash on T3 dermatome. It was unspecified if lab studies were performed. The patient was diagnosed with shingles. The patient was treated with VALTREX 1000 mg three times a day for 10 days. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information from the physician indicated that the patient also had neuritis. At the time the report the patient had not recovered. Additional information has been requested." Diabetes; Rheumatoid arthritisUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319416
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 67.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning a 68 year old female patient who on 03-OCT-2007 was vaccinated subcutaneous into the upper left arm with a .65 ml dose of zoster vaccine live (Oka/Merck) (lot # 658212/0887U). On 11-APR-2008 the patient broke out in shingles. The patient went to an instant care clinic on 14-APR-2008 and then to physician's office on 15-APR-2008 and both healthcare professionals confirmed diagnosis of shingles. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319417
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a consumer concerning his wife who on 16-APR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On an unspecified date the patient developed shingles. The patient's diagnosis was confirmed by a physician and the patient was treated with anti-viral medication. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. No further information is available. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319428
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a male who on an unknown date was vaccinated with a 0.65 mL dose of zoster vaccine live (Oka/Merck). On an unspecified date, one day post vaccination, the patient developed shingles. The patient was seen by physician. At the time of the report the patient's status was recovering. A product quality complaint was not involved. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319429
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 54.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 54-year-old male with an allergy to VICODIN, hypertension and a history of shingles who on 24-APR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included PREVACID, LIPITOR, WELLBURTIN, lisinopril (manufacturer unknown), atenolol (manufacturer unknown) and ~clonosopine.~ On 25-APR-2008, the patient developed shingles markings in his pubic hair area 1 1/2 inches in length and about 1/2 inches wide. The consumer was convinced he had shingles because he has experienced shingles several times prior to receiving the vaccine. The patient did not seek medical attention. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. No further information is available." Drug hypersensitivity; HypertensionShinglesNone . During the same period patient was treated with (therapy unspecified); atenolol; LIPITOR; WELLBUTRIN; PREVACID; lisinopril. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319437
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 76.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "This is in follow-up to report (s) previously submitted on 6/24/2008. Information has been received from a 76 year old female with a penicillin allergy who on 21-MAR-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # and dose were not provided). On 21-APR-2008, the patient was diagnosed with shingles when she visited her physician's office. The patient mentioned that she never had shingles prior to receiving ZOSTAVAX (Oka/Merck). The patient reported that she developed rashes and pain on her trunk. The consumer was seen by a medical doctor on 21-Apr-2008. No further information is available. Information has been received from a physician concerning a 76 year old female with a penicillin and KEFLEX allergy who on 21-MAR-2007 was vaccinated with ZOSTAVAX (Oka/Merck) subcutaneously in the right deltoid (Lot # 565607/01E3U). On 21-APR-2008 the patient developed rashes and pain on her trunk. On" Penicillin allergyUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319440
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female consumer who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed shingles. At the time of the report the patient's status was unknown. No further information is available. The patient's also had an adverse experience after vaccination with zoster vaccine live (Oka/Merck) (WAES # 0804USA03492)." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319442
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a male patient who in approximately April 2007 was vaccinated with zoster vaccine live (Oka/Merck) (Dose, route, and lot number were not reported). On an unspecified date soon after vaccination, the patient developed a mild shingles-like rash. The physician reported that the patient did not experience post herpetic neuralgia. Subsequently, the patient recovered from the shingles like rash. Further information was requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319446
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 82.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an 82 year old female who ~about 2 months ago~, in approximately February 2008, was vaccinated with zoster vaccine live (Oka/Merck). There was no illness reported at the time of vaccination. On 24-APR-2008, the patient developed facial pain. Over the next few days, the patient developed shingles on her eyelid and the side of her face and sought medical treatment at the physician's office. No laboratory/diagnostic tests were performed. She was being treated with Neurontin and Percocet. As of 29-APR-200, the patient was recovering from shingles on her eyelid and the side of her face. Additional information has been requested." UnknownNone . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319449
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse practitioner concerning a 60-year-old female with a history of herpes zoster and no known drug allergies who on 15-AUG-2007 was vaccinated subcutaneously with a dose of 0.65 mL of zoster vaccine live (Oka/Merck) (656395/0290U). On 22-AUG-2007, seven days post vaccination, the patient developed shingles. There were lesions under her left breast, and on her buttocks. Medical attention was sought at the office. No treatment was given. There were no laboratory tests or diagnostic procedures. The outcome was reported as improving, ~the patient is better, but the lesions remain.~ No product quality complaint was involved. The nurse practitioner is interested in the VZV program. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/24/2008. No additional information is available." Herpes zosterNone . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319450
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 82.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an 82 year old female who on 26-SEP-2007 was vaccinated with zoster vaccine live (Oka/Merck) (lot# 658207/0883U). Concomitant therapy included CRESTOR and vitamins (unspecified). On 27-APR-2008, the patient experienced back pain and went to an emergency room (ER). On 28-APR-2008, the patient was seen in a doctor's office and diagnosed with shingles. The patient was place on treatment therapy PERCOCET and VALTREX. As of 29-APR-2008, the patient's shingles persisted. Follow-up information from the patient indicated that she had a dry rash which cleared up with the use of VALTREX. It was noted that the patient's current symptoms included redness and pain. It was also noted that the patient takes oxycodone (unspecified manufacturer) and ibuprofen (unspecified manufacturer). The patient reported that the pain caused nausea and weakness; therefore, she cannot eat and has lost weight. It was noted that the pain intensifies at certain times. The patient stated she does not want to become addicted to medication so she tries to avoid taking pain medication whenever possible. At the time of the report the patient's status was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow-up information from the nurse indicated that as of 04-JUN-2008 the patient was still having Post-Herpetic Neuralgia (PHN) and had not called since. The patient was having issues with pain and was switched from PERCOCET to DARVOCET. The nurse explained that the patient did not have blisters or vesicles as her shingles presentation and the patient stated that she ~knew the vaccine was not 100% effective~. Additional information has been requested." UnknownUnknown . During the same period patient was treated with CRESTOR; vitamins (unspecified). Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319451
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 72 year old female consumer with high blood pressure ~(medication controlled),~ penicillin and TYLENOL allergies who on 18-APR-2008 was vaccinated SQ in the left arm with zoster vaccine live (Oka/Merck). Concomitant therapy included ZOCOR, EFFEXOR and verapamil. Subsequently, on 26-APR-2008 the patient developed back pain. On 29-APR-2008 medical attention was sought in the office. There were no lab studies performed. The patient was diagnosed with shingles. The patient was prescribed VALTREX for treatment of the shingles. No other symptoms or treatment reported. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested." Blood pressure high; Penicillin allergy; Drug hypersensitivityNone . During the same period patient was treated with ZOCOR; EFFEXOR; verapamil. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319452
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a female with a history of shingles who in February 2008, was vaccinated SC with a 0.65 mL dose of zoster vaccine live (Oka/Merck). The patient presented with shingles two weeks after the vaccine was given. The pharmacist stated that the patient still had a lesion on her back. The patient stated to the pharmacist that the shingles were not ~as bad~ as they had been in the past for her. The patient's shingles persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/24/2008. The patient's shingles resolved. Additional information is not expected." ShinglesUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319453
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse concerning a patient (demographics unknown) who on 11-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck). On 28-APR-2008, the patient developed shingles. At the time of the report, the patient's shingles persisted. Unspecified medical attention was sought. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319456
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 77.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse concerning an approximately 74 year old male consumer with no known allergies, high cholesterol and a history of ~arterial flutter corrected with ablation~ who on 09-APR-2008 was vaccinated SQ with a first dose of zoster vaccine live (Oka/Merck) (lot # 659762/1874U). Concomitant therapy included CARDIZEM CD, ezetimibe (MSD), FLOMAX, saw palmetto, aspirin, niacin, SYNTHROID, simvastatin (MSD), PAXIL, folic acid and RISPERDAL. Subsequently, the patient developed a tender area on his scalp. On 22-APR-2008 or 23-APR-2008 the patient was seen by a dermatologist and a culture of the area was performed. The results can back as shingles. At the time of the report this patient was recovering. There was no product quality complaint involved. Follow-up information indicated no new information. Follow-up information from the registered nurse indicated no new information. Additional information is not expected." Cholesterol highAtrial flutter; Cardiac ablationdiagnostic procedure 04/22/08 shingles - Test=culture . During the same period patient was treated with aspirin; CARDIZEM CD; ZETIA; folic acid; SYNTHROID; niacin; PAXIL; RISPERDAL; saw palmetto; ZOCOR; FLOMAX. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319499
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician and the husband of a 70 year old female with no allergies, blood pressure increased, a history of chickenpox as a child and hysterectomy on 11-APR-2008 was vaccinated with 0.5 cc zoster vaccine live (Oka/Merck) in the left shoulder. Concomitant therapy included unspecified high blood pressure medication, LIPITOR, amlodipine, and ALLEGRA. On 14-APR-2007, the patient experienced severe pains in her head. Lumps and spots developed on the left side of her head. On 17-APR-2008, the patient was seen by the physician. Blister formations were noted on the left head. She was diagnosed with shingles/herpes zoster in the occipital division of the 5th nerve on left side of the head with a 3-4 out of 10 level of pain and malaise. The number of lesions were not counted by the physician. It was noted she had no recent exposure to chickenpox. No fluorescent antibody or PCR was collected. Subsequently, the patient recovered. The reporting physician advised that the hospital pharmacy who dispensed the zoster vaccine be contacted for the vaccine's lot#. The hospital pharmacy provided lot # of 658861/1822U. However, the hospital pharmacy was unable to verify that this (lot#) was what the patient received, as the physician was responsible for lot # documentation. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow up information was received from the physician concerning a 70 year old female with no known allergies and a history of chicken pox as a child, who on 11-APR-2008, in the morning, was vaccinated with a second dose of ZOSTAVAX (Merck) subcutaneously in the left shoulder. Concomitant medications included LIPITOR, NORVASC, ALLEGRA and LOXOL. On 17-APR-2008, the patient experienced a rash. Distribution of Herpes zoster lesions were found in the occipital division of V cranial nerve (left). At the time of reporting the patient had recovered. There was no recent exposure to chicken pox. There was no illness at the t" Blood pressure increasedChickenpox; HysterectomyUnknown . During the same period patient was treated with (therapy unspecified); amlodipine besylate; LIPITOR; ALLEGRA; LOZOL. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319572
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 83.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an ~over 80~ year old female consumer who on an unspecified date was vaccinated with a single dose vial of 0.65 mL of zoster vaccine live (Oka/Merck). It was not noted whether or not the patient had a history of shingles prior to the vaccination. Subsequently, about a month after receiving the vaccine the patient developed a rash. It was noted that upon visual examination by the physician that the patient developed a mild case of shingles. There was no pain associated with it. The patient was treated with VALTREX. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested." Unknownphysical examination- Visual examination . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319573
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 74.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a certified medical assistant concerning an approximately 75 year old female consumer who on 06-JUL-2007 was vaccinated with 0.65mL of zoster vaccine live (Oka/Merck) (lot # 657765/0585U). Concomitant therapy included ALLEGRA, aspirin, FLONASE, and METROGEL. It was reported that in April 2008, the patient felt a shocking and burning pain under her left breast. The pain continued and developed into shingles lesions within two weeks. Unspecified medical attention was sought and it was unspecified if lab studies were performed. The patient was treated with NEURONTIN. At the time of the report the patient was recovering. There was no product quality complaint involved. Follow-up information has been received from the physician concerning this 75 year old female consumer with no known allergies and a history of chickenpox years ago who on 06-JUL-2007 was vaccinated in the left arm with 0.65 mL of zoster vaccine live (Oka/Merck) (lot # 657765/0585U). Concomitant therapy included ALLEGRA, aspirin, FLONASE, and minocycline. Subsequently, on 08-MAY-2008 the patient developed left sided chest pain and clusters of vesicles on the left side of her chest and back. The patient did not developed a rash at the site of injection or elsewhere within 42 days of vaccination. The patient's temperature was 98.3. It was noted that there was no recent exposure to chickenpox or herpes zoster. The physician also reported that the patient's treatment was changed from NEURONTIN to LYRICA. The patient recovered on an unspecified date. Additional information is not expected." Chickenpoxbody temp 98.3 . During the same period patient was treated with aspirin; ALLEGRA; FLONASE. METROGEL; minocycline. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319580
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse practitioner concerning a 71-year-old female with hypertension, hyperthyroidism, Hyperlipidaemia, migraine and an allergy to pneumococcal vaccine polyvalent (MSD) (WAES # 0806USA00185) and naproxen (ALEVE) who on 02-APR-2008 was vaccinated subcutaneous in the left arm with 0.65 ml dose of zoster vaccine live (Oka/Merck) (lot # 659267/1836U). On 07-APR-2008 the patient developed shingles. The patient had pain and broke out in painful shingles on the left side, T1 dermatome. The patient was seen at her physician's office the same day and was prescribed valacyclovir (VALTREX) and lidocaine transdermal (LIDODERM). At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested." "Hypertension, hyperthyroidism, Hyperlipidaemia, Migraine, Drug hypersensitivity"Unknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319584
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a female who in March 2008, was vaccinated with zoster vaccine live (Oka/Merck) (lot# 659268/1430U). Concomitant therapy included amitriptyline hydrochloride (MSD) and rosuvastatin calcium (CRESTOR). In April 2008, the patient developed shingles. As of 08-MAY-2008, the patient was recovering. Additional information has been requested." UnknownUnknown . During the same period patient was treated with "ELAVIL, CRESTOR". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319586
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 67.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a physician concerning a 67 year old male with no known drug reactions/allergies and no pertinent medical history (including no history of chickenpox) who was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included aspirin and NIRVAN. ~One month ago~, in 15-APR-2008, the patient developed a mild shingles outbreak. Additional systemic symptoms included fatigue. The patient also experienced pain rated 8 on a scale of 0 (least) to 10 (most). The patient was seen by a physician. He was treated with LYRICA. It was noted that the patient had no recent exposure to chickenpox or herpes zoster. Subsequently, the patient recovered from mild shingles outbreak. The product quality complaint unit was not involved. Additional information is not expected." NoneNone . During the same period patient was treated with Unknown; aspirin; NIRVAN. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319589
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 82.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse at a physician's office concerning a female who was vaccinated with a single dose of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced shingles. The patient's shingles persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Initial information has been received from a nurse at the physician's office and follow up information was received from the physician concerning an 83 year old female with allergic to SEPTRA who on 02-APR-2007 was vaccinated in her upper arm with the first dose of ZOSTAVAX (Merck). On 15-OCT-2007, the patient was vaccinated with a dose of influenza virus vaccine (unspecified) (manufacturer unknown). There was no illness at time of vaccination. On 21-APR-2009 the patient developed a herpes zoster outbreak on the left lower thoracic dermatome. Subsequently, on 06-JUN-2008 the patient recovered from herpes zoster outbreak. A doctor visit was required. Additional information is not expected." Sulfonamide allergyUnknownUnknown; None . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319592
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a male patient with a history of chilhood chickenpox and no recent history of exposure to chickenpox of herpes zoster,who was vaccinated with the first dose of zoster vaccine live (Oka/Merck) at a local pharmacy 6 months ago, in approximately November 2007. In May 2008, the patient came into the physician's office with a mild case of shingles. There were 3-4 clusters papulovesicular lesions mostly distributed on the right chest (T3-4). The patient rated his pain at 1 on scale of 0 (least) to 10 (most). There were no other systemic symptoms. Subsequently the patient recovered. No fluorescent antibody or specimen were collected. No product quality complaint was involved. Additional information is not expected." Medical history: VaricellaUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319593
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 82.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a individual concerning his wife an 83 year old female patient with ~heart problems~ and allergies to ~some types of anesthesia,~ and a history of cataract operation and ~artery circulation surgery~ who in the end of December 2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included unspecified ~heart medication.~ On approximately 05-MAY-2008, the patient ~broke out with shingles,~ which were ~mild and located on her chest between her breast and her waist.~ Unspecified medical attention was sought. Subsequently, the patient recovered from the shingles. No product quality complaint was involved. Additional information has been requested." Cardiovascular event prophylaxis; Drug hypersensitivity; Cardiac disorderCataract operation; Arterial operation NOSNone . During the same period patient was treated with (therapy unspecified). Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319599
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a patient who in the fall of 2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). ~Very recently,~ in approximately May 2008, the patient experienced shingles. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319611
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated with a first dose of zoster vaccine live (Oka/Merck). Subsequently, the patient came down with a case of shingles. Unspecified medical attention was sought. The patient's outcome was not provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319614
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female consumer who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed shingles. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319616
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated with a first dose of zoster vaccine live (Oka/Merck). Subsequently, the patient came down with a case of shingles. Unspecified medical attention was sought. The patient's outcome was no provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319619
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 71-year-old female consumer with a history of breast cancer with radiation about 8 years ago and ~previously in her 50's had developed the shingles and eventually had recovered~ who in April 2007, was vaccinated with a ~single dose series~ of zoster vaccine live (Oka/Merck). Concomitant therapy included vitamins (unspecified) and ~abalide.~ On 18-FEB-2008, the patient noticed that she started to have pain in her right shoulder. The consumer reported that later on that night she noticed she had developed the shingles again which were located on her right side on the upper body around her breast area and her upper back. The consumer reported that her shingles did not have any puss sores, but she had pain. She did see a physician who gave her medication to treat the shingles. There were no laboratory tests performed. The consumer reported that the shingles have faded, but she still can see some of the lesions, and that her pain that she had associated with the shingles first went away in the front and then around 02-Apr-2008, the pain on her back had gone away. No product quality complaint was involved. Additional information has been requested." Breast cancer; Radiotherapy; ShinglesNone . During the same period patient was treated with (therapy unspecified); vitamins (unspecified). Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #320182
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning a 64-year-old male, with no pertinent medical history or allergies, who on 27-SEP-2007 was vaccinated subcutaneous with a ~single dose~ of zoster vaccine live (Oka/Merck) (lot # 658081/0743U). Concomitant vaccine included a dose of influenza virus vaccine (unspecified). On 31-MAR-2008 the patient developed shingles. The rash appeared on the patient's hip and buttocks and because of the pain and tenderness around the rash he has a hard time walking. The patient was seen by the physician. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested." NoneNone . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #320189
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 87.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from an office manager concerning an 87 year old female consumer with degenerative joint disease, hypertension and drug allergies to ACTONEL, alendroanate sodium, MIACALCIN and glucosamine who on 07-FEB-2008 was vaccinated with a single series of zoster vaccine live (Oka/Merck) (lot # 659326/1824U). Concomitant therapy included ~some different medications.~ The office manager reported the patient received the vaccination and then three weeks later on approximately 28-FEB-2008 the patient broke out in a mild case of shingles, which were not painful. The patient had red spots that were located on her back and ~flack~ area. It was noted that the patient did not tell the physician until she came in for her routine check up on 03-APR-2008. There were no lab studies performed. At the time of the report the patient still had some spots on her body, but she was recovering. There was no product quality complaint involved, Additional information has been requested. The patient also had an adverse experience after being placed on therapy with alendroanate sodium (WAES # 0804USA02780)." "Degenerative joint disease, Drug hypersensitivity, Hypertension"None . During the same period patient was treated with (therapy unspecified). Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #320191
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient, 82.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer concerning her 82 year old husband with no known allergies, diabetes, hypertension, osteoporosis and depression and a history of cerebrovascular accident who on 13-JUN-2007 was vaccinated SQ with a first dose series of 0.65 mL of zoster vaccine live (Oka/Merck). Concomitant therapy included lisinopril, diltiazem HCl, simvastatin, terazosin, hydrochloride, alendronate sodium (MSD), NOVOLIN, NOVOLOG and citalopram hydrobromide. On 27-MAR-2008, the patient developed shingles. The patient's shingles have improved, but he has not completely recovered. She also stated she had concerns as to how the vaccine was stored at the pharmacy where her husband received the vaccine. However, her specific storage concerns were not reported. Unspecified medical attention was sought. There were no lab studies performed. There was no product quality complaint involved. Additional information has been requested." Diabetes; Hypertension; Osteoporosis; DepressionCerebrovascular accidentNone . During the same period patient was treated with FOSAMAX; citalopram hydrobromide; diltiazem hydrochloride; NOVOLOG; NOVOLIN; lisinopril; simvastatin; terazosin hydrochloride. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #320193
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed shingles. At the time of the report the patient's status was unknown. Additional information has been requested. This is one of several reports from the same source." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319023
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/10/2008. Male patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, 1 week after receiving shingles vaccine I came down with shingles and still have them after 3 weeks. (Right thigh area). NoneNone"Sharp pains, blisters" . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319341
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse practitioner concerning a male consumer who on an unspecified date was vaccinated with a first dose of 0.65ml ZOSTAVAX. Subsequently, four days after being vaccinated the patient developed shingles. The patient was seen by the nurse practitioner, it was unspecified if lab studies were performed. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319510
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/16/2008. Female patient, 67.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient received shingles vaccine on 10/25/07. On approximately 04/22/08 identified recurrence of shingles rash. On 4/24/08 patient went to private physician for treatment of herpes rash - Famciclovir - herpes rash subsided 1st week of June. This is in follow-up to report (s) previously submitted on 9/24/2008. The patient recovered from shingles. The patient sought medica attention. The reporter did not express interest in the VZV analysis by PCR. No further information is available. nonehypertension; shinglesnone . During the same period patient was treated with Accuprel; HCTZ Daily. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319600
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 60 year old female with high cholesterol, asthma and a sulfa allergy. The patient reported that she experienced chickenpox as an adult and the virus stays moment in her left ear. At the end of January or beginning of February 2008, the patient was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included atorvastatin calcium (LIPITOR) and levothyroxine Na (SYNTHROID). The patient reported on 22-MAY-2008 that she currently had shingles on her torso. The patient's shingles persisted. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a 60 year old female with high cholesterol, asthma and a sulfa allergy. The patient reported that she experienced chickenpox as an adult and the virus stays dorment in her left ear. At the end of January or beginning of February 2008. The patient was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included LIPITOR and SYNTHROID. The patient reported on 22-MAY-2008 that she currently had shingles on her torso. The patient's shingles persisted. The patient sought unspecified medical attention. Additional information has been requested." Cholesterol high; Asthma; Sulfonamide allergyChickenpoxNone . During the same period patient was treated with LIPITOR; SYNTHROID. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319827
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/18/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a registered nurse concerning a male who was vaccinated with a dose of ZOSTAVAX. On an unspecified date the patient developed shingles along the sciatic region. At the time of the report the patient was debilitated with pain. The patient's shingles persisted. The reporter considered shingles to be disabling. No further information is available. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #319929
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/21/2008. Female patient, 81.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient received Zostavax vaccine at approximately 10:30 am on 7/18/08. Administered in L upper arm. That evening at 7pm began to have Right back patient. By next morning pain increase and later in day developed rash beneath Right breast. Following day this rash spread toward back. On 7/21/08 patient diagnosed with Herpes Zoster of right T 8-9 dermatome. None"No know allergies;Problem list: hypertension, congestive heart failure, atrial fibrillation, psoriatic arthritis, asthma, spinal stenosis, anxiety"none . During the same period patient was treated with "furosemide, enalapril, Coumadin, gabapentin, metoprolol, Prilosec, potassium chloride, lexapro , Advair, Darvocet, magnesium oxide". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #320117
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/21/2008. Male patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "62 y/o white male with shingles like skin eruption some 4-5 days after the receipt of ZOSTAVAX. Rash, focal, pain." None"07/07/2008 Esophagitis, reflux (Active)."Possible skin culture: results unknown. . During the same period patient was treated with Nexium; Motrin. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #320121
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/29/2008. Female patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Pt rec'd ZOSTAVAX July 15 and on July 16 had headache. Then developed zoster on (L) left side of face Neuropathywas taking cell cyst (immunosuppressive)None . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #320148
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/22/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient received zostavax on 7/9/08. Patient developed a itchy area left side of abdomen 2 days after injection. Then a vesicle red rash appeared 2 days later. The rash is painful when scratched. Patient came into clinic 7/22/08 and a diagnosis of shingles was made. None"HTN, postmenopausal, arthritis" . During the same period patient was treated with "Diovan HCT 160/12.5mg, Ribron eye drops, omega 3 fish oil, Multivitamin, calcium with Vit d, red yeast rye, triple flex, aleve prn, flonase, vagifem 25mcg". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #320165
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/22/2008. Male patient, 76.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, 7/16 received ZOSTAVAX. 7/21 broke out in rash-classic shingles appearance ((L) T.O dermatome) elected against antiviral Rx None . During the same period patient was treated with aspirin. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #320520
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/25/2008. Female patient, 89.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Patient developed shingles (physician-diagnosed) six days after receiving shingles vaccine, ZOSTAVAX. Lesions are on her right side (chest and back). She has burning pain on her right side." None"Hypertension, cardiovascular disease, osteoarthritis, osteopenia" . During the same period patient was treated with "Hypertension (several), ZOCOR, ULTRAM, TYLENOL, fish oil, multi-vitamin". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #320564
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/25/2008. Female patient, 84.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from an investigator concerning an 84 year old white female patient with anaemia, coronary artery disease, chronic obstructive pulmonary disease, gastrooesophageal reflux disease, hypertension, hypothyroidism and lipid disorder and a history of polymyalgia rheumatica who entered a study. On 26-JUN-2008 the patient was vaccinated SC with a first dose of ZOSTAVAX. Concomitant therapy included MICARDIS HCT, LEVOXYL, ezetimibe, iron (unspecified), VISION FORMULA tablets, stool softener (unspecified). calcium carbonate, ADVAIR, NEXIUM and SPIRIVA. On 11-JUL-2008 the patient began having facial and eye pain. The patient saw an ophthalmologist on 14-JUL-2008 and was started on TOBRADEX. The facial swelling and eye pain worsened. The patient was admitted to the hospital on 14-JUL-2008. Left facial shingles with corneal involvement was treated with IV acyclovir and hydromorphone in the hospital. The patient's left facial shingles with corneal involvement persisted. The reporting investigator felt that the adverse event was related to the study therapy. The record for this patient was unblinded on 23-JUL-2008. The patient was treated with ZOSTAVAX. Additional information ahs been requested." Anaemia; Coronary pulmonary artery disease; Chronic obstructive pulmonary disease; Gastrooesophageal reflux disease; HypertensioPolymyalgia rheumaticaUnknown . During the same period patient was treated with [therapy unspecified]; calcium carbonate; NEXIUM; ZETIA; ADVAIR; gastrointestinal preparations; MICARDIS HCT; iron (unspecified); LEVOXYL; SPIRIVA. Patient was hospitalized Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #320785
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/29/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Shingles outbreak. Vesicular/macular rash (L) chest, axilla, back - burning pain." Sinus infection"NKDA; HTN, Lipids; Rosacea;"None . During the same period patient was treated with Aspirin; Lipitor; Diovan; HCTZ. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #320870
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/30/2008. Female patient, 77.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, PATIENT DEVELOPED RASH AND AFTER SEEING HER PRIMARY CARE PHYSICIAN SHE WAS DIAGNOSED WITH SHINGLES. PATIENT INDICATED NO ILLNESS AT TIME OF VACCINATION.PATIENT INDICATED NO KNOWN ALLERGIES AT TIME OF VACCINATION. . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #321032
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/31/2008. Female patient, 84.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning an 85 year old female with no known allergies, who on 18-MAR-2008 was vaccinated subcutaneously with ~1 vial ~ of ZOSTAVAX. There was no concomitant medication. In April 2008 and again in May or June 2008, the patient developed shingles after receiving ZOSTAVAX. The patient saw the physician. No lab diagnostic studies were performed. At the time of reporting, the patient had recovered from the AEs (date not specified by the reporter). There was no product quality complaint. Follow up information was received from the physician concerning a 88 year old female with no medical history, no known allergies who was vaccinated with ZOSTAVAX. There was no concomitant medication. The patient experienced herpes zoster twice since the immunization. On 10-JUL-2008, the patient recovered. There was no illness at the time of vaccination. No laboratory/diagnostic tests were performed. The reporting physician felt that the patient's herpes zoster was serious as an other important medical event. No further information is available." NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #321033
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/31/2008. Female patient, 43.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 44 year old white female, weight 209lb, height 54 inches, with hypothyroidism and lipid disorder and no known drug allergies and a history of chicken pox in childhood and chronic recurring bouts of shingles who on the morning of 25-MAY-2007 was vaccinated with the first dose of ZOSTAVAX subcutaneously in the left arm. Concomitant therapy included VALTREX. In February, 2008, therapy with VALTREX stopped. (Also reported VALTREX used through 31-AUG-2007). On 15-May-2008, the patient developed shingles on her back and trunk, chills and myalgia. The patient rated her pain a 7 on a scale of 0 (least) to 10 (most). The shingles lasted for 7 days. The maximum temperature was 99.2F. The patient restarted VALTREX. Subsequently the patient recovered. The patient sought unspecified medical attention. The reporting physician considered the recurrent shingles to be an other important medical event. Additional information has been requested." Hypothyroidism; Lipids abnormalShingles"Body temperature, 05/??/08, 99.2 F" . During the same period patient was treated with VALTREX. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #321034
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 07/31/2008. Female patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse and follow-up information was received from a physician concerning the nurse's 76 year old mother who on 25-JUN-2007 was vaccinated with one dose of ZOSTAVAX (Oka/Merck) (lot no. 656413/1477F). Concomitant therapy included PREMPRO and SYNTHROID. On 09-JUN-2008 the patient first experienced severe pain in her right leg which was followed by a shingles rash on her right side within twenty four hours. The rash has resolved but the patient has ~splotches~ where the rash was and was experiencing numbness in her lower right leg. The physician reported in follow up that ~the patient did not have an adverse event. She had a breakthrough case of shingles in the sciatic distribution and post herpetic neuralgia~. At the time of this report, the patient was not recovered. The patient was seen by the physician to seek unspecified medical attention. The physician considered a breakthrough case of shingles, numbness in the lower right leg and post herpetic neuralgia to be other important medical events. Additional information is not expected." UnknownUnknown . During the same period patient was treated with PREMPRO; SYNTHROID. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #321256
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 08/04/2008. Male patient, 61.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Shingles 72 hours after administration of ZOSTAVAX. DiabetesDiabetes . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #321390
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 08/01/2008. Female patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "7/13/08 Reports ~sore head~ on 7/15/08. Taken by ambulance for ~facial twisting~ remained hospitalized 7/15 - 7/18. Biopsy taken - results pending and treated for shingles per client.8/11/08-records received for DOS 7/17-7/18/08-Seen for C/O right scalp discomfort beginning 1-2 days prior, neuritic in quality and sam distribution as previous bout of herpes zoster several years ago. Received vaccine 7 days prior to admission. DC DX: Altered level of consciousness, resolved. Scalp lesions with neuritic pain." None noted8/11/08-records received-PMH:stroke 4/08. History of CVA. Rheumatoid arthritis. Chronic kidney disease. GERD.Biopsy - pending results 8/11/08-records received-EEG normal. . During the same period patient was treated with Propanolol 20mg BID; ASA 325mg qd; Prilosec 40mg qd. Patient was hospitalized Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #321536
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 08/15/2008. Female patient, 67.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, I'm in good health with no underlying problems other than osteoarthritis. Developed case of shingles. None of the typical symptoms that usually precede this disease. Only very severe sciatic pain the day before-Had 19 blistes-Took VALTREX=effective blisters lasted 7-10 days NoneArthritis; MVP; allergic to tetanus toxoidNone-sust visual confirmation of typical shingles blisters . During the same period patient was treated with EVISTA; FOSAMAX; VIT D otc. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #321549
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 08/07/2008. Female patient, 81.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient developed a rash on upper arm of the arm that was injected. Dr said it resembled a slight case of shingles. No major problems reported. n/a . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #321692
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 08/09/2008. Female patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, received shingles vaccine and then developed the actual shingles disease. . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #321787
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 08/11/2008. Female patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Rash on bottom - 3 large red round areas & several small pimply marks. The area is uncomfortable - it is hard to lay down or sit. MD diagnosed as shingles. None . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #321929
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 08/12/2008. Female patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Pt received ZOSTAVAX vaccine on 3-4-08. Pt came into office on 8-11-08 with rash painful, erythematous, vesicular eruptions. This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a licensed practical nurse concerning a 63 year old female with arthritis, bronchitis, blood pressure high, cardiac disorder, sinusitis, hay fever, bad knee, penicillin allergy, codeine allergy, drug hypersensitivity and sulfonamide allergy and a history of measles, mumps, chickenpox, infectious mononucleosis, hives, cancer, back discomfort, anaemia, ulcer, haemorrhoids, bladder infection and hernia who on 04-MAR-2008 was vaccinated subcutaneously into the left deltoid with a 0.65 ml dose of ZOSTAVAX (Merck) (lot no. 659759/1873U). Concomitant therapy included alendronate sodium, ZANTAC, INDERAL, nortriptyline, cabbage palm, ZYRTEC, WELLBUTRIN XL, DIOVAN HCT, fluticasone furoate, metformin, KLOR-CON, DYAZIDE, simvastatin (manufacturer unknown), metoprolol, diltiazem HCL, CECLOR, diltiazem HCL, doxycycline, NITROLINGUAL and ~other medications~. On 07-AUG-2007 the patient was diagnosed with shingles. The patient had rash on upper left leg which was painful and blistering redness. The patient had no other symptoms. The patient was treated with TYLENOL. On 11-AUG-2008 the patient was in office with draining lesions located on left upper thigh. The physical examination was done. Blood pressure was 108/64. Pulse was 66. Respiratory rate was 18. Body temperature was 97.1 F. There was no abnormal discovery with the patient. The patient was well health and well nourish. Heart was regular rate and rhythm. Lungs were clear to auscultation and no wheeze. There were multiple patches of painful, erythematous; vesicular erythema within the L2 dermatome of the left leg. It was diagnosed that the rash was probably shingles infection. The patient was treated with VALTREX 1000 mg, three times per day for 7 days; triamcinolone cream 1%, VICODIN, 1-2 tablets, four times per day as needed for pain. The patien" F/U labs; Arthritis; Sinusitis; Drug hypersensitivity; Unspecified disorder of knee joint; Sulfonamide allergy; Penicillin aller"Codeine, PCN, Vicodin, Relafin, Sulfa, Advair; MEDICAL HISTORY: Measles; Mumps; Chickenpox; Infectious mononucleosis; Back disorder; Hives; Anaemia; Haemorrhoids; Bladder infection; Hernia; Ulcer; Cancer""physical examination, 08/11/08, no abnormal discovery, well health, well nourish; blood pressure, 08/11/08, 108/6; physical examination, 08/11/08, lungs: clear to auscultation, no wheeze; physical examination, 08/11/08, heart: regular rate" . During the same period patient was treated with "(therapy unspecified); FOSAMAX; WELLBUTRIN XL; cabbage palm; CECLOR; ZYRTEC, 10 mg; diltiazem hydrochloride; doxycycline; fluticasone furoate; DYAZIDE; DIOVAN HCT; metformin; metoprolol; NITROLINGUAL; nortriptyline; KLOR-CON; INDERAL; ZANTA". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #321980
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 08/12/2008. Female patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 64 or 65 year old female with diabetes who on 16-MAY-2008 at 16:00 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) at the pharmacy. There was no illness at time of vaccination. The patient broke out in shingles six hours later. In the morning on 12-JUN-2008, VALTREX was used. On 16-JUN-2008 an unspecified exam was done and no result provided. Subsequently, the patient recovered from shingles. The patient called the physician. Shingles were considered to be an other important medical event by the reporter. Additional information is not expected." DiabetesUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #322560
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 08/18/2008. Male patient, 83.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an 83 year old immunocompromised male with Waldenstrom's macroglobulinaemia who was exposed to his wife who on 07-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On 14-MAY-2008 the patient developed herpes zoster (HZ) on his trunk and extremities, along with severe illnesses including one was not diagnosed as pneumonia bilateral infiltration. At the time of this report, the outcome was unknown. A specimen was taken for polymerase chain reaction (PCR) analysis. The PCR result for the specimen was positive for varicella zoster virus (VZV) (wild-type). Follow-up information was received from a physician which reported the patient with Waldenstrom's macroglobulinaemia, dementia and Chronic kidney disease (CKD) who on 14-MAY-2008 to 15-MAY-2008 began to develop papular lesions on trunk and lower extremity. The patient had lower left chest discomfort around this time. On 17-MAY-2008, the patient was seen in emergency department (ED) and discharged. On 21-MAY-2008, the patient was admitted to hospital with confusion and short of breath (SOB). The patient had a disseminated vesicular eruption with lesions at different stage of development. The patient was hypoxic (ABG 7.42/20/66 on 3L) and had bilateral lower lobe infiltrates. He also had elevated hepatic transaminases- alanine aminotransferase (ALT) 127 and aspartate aminotransferase (AST) 185. He was started on IV acyclovir and ZOSYN and vancomycin. He had a low IgG (around 350) and received IVIG on HD # 3. He had the base of a lesion unroofed for culture and no virus was isolated. A skin biopsy was performed and culture was negative as well as VZV antigen by fluorescent antibody. He had completed a 7 days course of IV acyclovir. All skin lesions crusted over by the end of therapy. The patient had improvement in his respiratory status and was discharged to a rehab facility on day 12. This is one of several reports received from the same source. Additional information has been req" Waldenstrom's macroglobulinaemia; Immunosuppression; Dementia; Chronic kidney disease"skin biopsy, negative; VZV strain, 06/04/08, positive for VZV wild type; serum alanine, 127; arterial blood gas, 7.42/20/66; plasma aspartate, 185; serum immunoglobulin G, around 350" . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #322561
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 08/18/2008. NA patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 65 year old patient with high blood pressure and high cholesterol, and no known drug reactions/allergies. On 26-FEB-2008, the patient was vaccinated with ZOSTAVAX (Oka/Merck). The physician reported that during the week of 12-AUG-2008, the patient developed a ~nice case~ of shingles on his right chest. The patient is being treated with acyclovir. The patient sought medical attention at physician's office. At the time of the report the patient has not recovered. The physician considered the shingles to be an other important medical event, as it required. Additional information has been requested." Blood pressure high; Cholesterol highNone . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #322711
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 08/19/2008. Female patient, 30.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Pharmacist 38 1/2 weeks gestation broke out in shingles. When symptoms became bothersome, employee went into labor and was in the hospital. She received VALTREX. Had previously had chicken pox ~age 6. Employee was responsible for reconstituting ZOSTAVAX vaccine at clinic prior to and during pregnancy." . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #322858
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 08/20/2008. Female patient, 66.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, She received ZOSTAVAX 8/5/08 and developed shingles lesions on her right buttock with pain in right thigh NonePulmonary HTN . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #322908
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 08/21/2008. Female patient, 69.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Shingles Outbreak. Original visit 8/14/08- physician did not diagnose Shingles. Progress of lesions lead patient to revisit 8/18. Shingles verified. Valtrex prescribed. Patient will report on recovery process periodically. None available . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #323159
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 08/22/2008. Male patient, 78.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a company representative concerning her father a 78 year old male with diabetes, asthma and seasonal allergy who in August 2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). In August 2008, the patient was diagnosed with herpes zoster. Herpes zoster was affecting his bowels and the patient was experiencing nerve pain. The patient's herpes zoster and nerve persisted. The patient did not seek medical attention. No product quality complaint was involved. Herpes zoster, affecting bowels and nerve pain were considered to be disabling. No further information is available." Diabetes; Asthma; Seasonal allergyUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #323899
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/02/2008. Female patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Given NONE"Given Zostavax on 07/23/08-within 36 hours, developed large hot, raised, extremely itchy rasj over entire posterior upper arm. Within 10 days, have developed a large area of shingles over rt.lower abdomen with intense itching. Since this" . During the same period patient was treated with TOPROL. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #324031
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 08/30/2008. Male patient, 61.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "On Thursday, August 21, 2008 I received the ZOSTAVAX vaccine to prevent shingles. On Sunday, August 24, I started having a headache, each day it was getting worse and no over the counter pain medication would relieve it. On Wednesday August 27, I couldn't stand the pain anymore and I went to the hospital where I was diagnosed as having Shingles. I can give you the report. I have also printed the form out for my doctor to complete for you. They put me on Valtrex 1GM three times a day. I took them for 2 days and then started to get really sick and vomit. I went to my doctor, on August 29 and he gave me something to calm my stomach so I could eat. From the hospital they sent me to my ophthalmologist because the shingles was on my face and all around my eye. They can also tell you about this if you need their input. They said I did have a spot on the cornea and to watch carefully if anything affected my vision. It didn't but my eye became swollen and sore. I have a photo that my wife took today if you should need it to see. This is not a small side effect, it is full blown shingles. 10/17/08-records received for DOS 8/27/08-presented to ED with C/O headache since 8/24/08-now teeth hurting. Two days prior noted rash on scalp and left temple. Impression:headache, rash most consistent with shingles. DX: shingles. temporal arteritis. 1/27/2010 S/p CVA with residual dysarthmic." None 10/17/08-records received-PMH:DM.The hospital has report on Shingles. They did a cat scan because of my headache which was negative. I have a copy that I can send to you. 10/17/08-records received-CT head normal. . During the same period patient was treated with "One time injection given by my doctor, I will have them forward you all needed information". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #324129
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/04/2008. Female patient, 66.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient developed Herpes Zoster lesions on the left shoulder 6 weeks after administration of Zostavax vaccine. NoneSulfa allergy . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #324593
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/08/2008. Female patient, 80.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an 81 year old female with an allergy to codeine who on 23-FEB-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot #656608/0032U). Concomitant therapy included ADVAIR and VENTOLIN. On 27-JUL-2008 the patient developed shingles. Shingles began with pain on her left lateral chest wall. On 30-JUL-2008 the patient was seen in the office and had a small, ~quarter size~ rash and severe pain on her chest wall. No laboratory diagnostics studies were performed. The patient was prescribed VALTREX and PERCOCET. At the time of the report, the patient's shingles persisted. The reporting physician felt that the patient's shingles were an other important medical event. Additional information has been requested." Drug hypersensitivityNone . During the same period patient was treated with "VENTOLIN (albuterol), ADVAIR". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #324839
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/08/2008. Female patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Shingles on going - trunk and dental; Treated with pain control, anti viral, neurotin" "no, none"hypertensionX rays of mouth to confirm on going virus . During the same period patient was treated with Monopril. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #324941
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/11/2008. Male patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 64 year old male, weight 154lb, height 66 inches, with no pre-existing allergies or medical conditions, who on 04-JUN-2008 at 09:52 was vaccinated with ZOSTAVAX (Oka/Merck) (lot#: 659406/0298X) SQ into the left arm. On 06-JUN-2008 at 08:28 the patient developed shingles. The outcome of the shingles was not reported. The patient sought medical attention with a physician office visit. The reporter considered shingles to be disabling. Additional information has been requested." NoneUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #324961
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/08/2008. Male patient, 68.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient's wife reported having developed shingles after her husband received the ZOSTAVAX vaccine 1 1/2 weeks prior. . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #325164
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/15/2008. Female patient, 69.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician and a 77 year old female patient with allergy to codeine and a history of heart attack in December 2007, who on 02-JUL-2008 was vaccinated with a dose of ZOSTAVAX. The physician reported that the patient was vaccinated with the shingles vaccine by another physician. There was no concomitant medication. The patient reported that on 09-JUL-2008, she developed groin pain. On 11-JUL-2008, she developed a ~big rash in her groin and down the side of her leg~. The physician reported that on 12-JUL-2008, the patient was seen in the office with a rash in the inguinal area x 24Hrs; rash in gluteus at perineal area - red base with clear vesicles, the diagnosed was shingles. The patient was prescribed VALTREX and ZOVIRAX. The physician reported that on 14-JUL-2008, the patient was feeling better. The physician considered shingles to be an other important medical event because it required medical intervention. No further information is available." Drug hypersensitivityHeart attackNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #325255
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/16/2008. Female patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "November 20, 2007: Received Zostavax vaccine from Pharmacy. Vaccine shot given same date at doctor's office by his nurse. On or about May 25, 2008, noticed red blotches on upper left side of chest and front and back of her neck. On May 28, 2008 M.D. confirmed diagnosis: Shingles and provided Rx for seven days. Scabs fell off within next 45 days. Redness of skin (caused by scabs) now not noticeable." "Zostavax (in vial) taken to prevent ~shingles.~"Stricture within pancreas (Chronic since 1994).None. . During the same period patient was treated with Premarin 0.625; Tigan 300 mg; Amitripyline 50 mg; Lortab 7.5-500 tabs; Zocor 20 mg.. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #325266
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/15/2008. Female patient, 74.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "5/08 Given ZOSTAVAX -> 9/08 Had shingles abd. mod- severe, self limited." Noneclinical progress . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #325338
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/16/2008. Female patient, 68.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse (R.N.) concerning a 68 year old female who ~2 months ago~, in July 2008, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). ~A week ago~, on approximately 03-SEP-2008 the patient developed a severe case of shingles. Unspecified medical attention was sought. The patient was given FAMVIR within 48 hours to slow the progression of the rash. At the time of this report, the outcome was unknown. The nurse felt that the patient's shingles were an other important medical event. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #325606
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 08/11/2008. Female patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "8/3/08 - Itching, burning, blisters on one side of face and eyelid. Seen by opthamologist and treated with Valtrex for diagnosis of Shingles." NoneHypertension; High cholesterolN/A . During the same period patient was treated with Zocor 20mg; Tenoretic; Fusomax 70mg. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #325615
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/05/2008. Female patient, 91.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Got Shingles, occurred w/o rash. Shingles pain. Shortness of breath." NoneCodeineNone . During the same period patient was treated with Isosorb 30mg; Forosemido 20mg; Atenolol 50mg; Fosinopril 10mg; Ecotrin. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #325845
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/18/2008. Female patient, 88.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Developed shingles in right eye overnight - lost sight for several days. Eye painful and totally red. Treatment: Prednisone, famiciclovir, and triflunidine." shingles in right eyeNoneNone . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #326094
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse practitioner concerning a female in her 70's, with a history of Guillain-Barre syndrome who in Spring, approximately in March 2008, was vaccinated with ZOSTAVAX. On 01-MAY-2008, the patient developed zoster and post herpetic neuralgia. The patient has continued to have recurrent trigeminal lesions and post Herpetic Neuralgia. It was reported that the patient could not work. The patient's herpes zoster and post herpetic neuralgia were considered to be disabling. The patient sought medical attention in the physician's office. Additional information has been requested." Guillain-Barre syndromeUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #326185
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/25/2008. Female patient, 88.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Pt reported (3 months later) that she developed herpes zoster approximately 10 days after receiving Zostavax on 5/22/08. Pt did not seek medical treatment. Pt was on 15mg prednisone at time of vaccination and had been on 20 mg prednisone for months prior to decreasing dose 5 weeks prior to vaccination. "orbital inflammation, possible giant cell arteritis. Treated with long-term steroid therapy on a slow taper.""Sulfa allergy. osteoporosis, hypertension, anxiety, hyperglycemia, hyperlipidemia, esophageal reflux. Long term steroid therapy."None . During the same period patient was treated with "Prednisone 15mg daily, losartan 50mg daily, amolodipine 5mg daily, alprazolam 0.5 mg QHS, xalatan daily, MVI daily, calcium/Vit D daily, osteo biflex daily". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #326399
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/27/2008. Male patient, 69.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Shingles NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #326583
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 10/01/2008. Male patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient had significant outbreak of shingles rash within 24 hours of administration of the vaccine cover the upper right arm and down to the T10 dermatone. Patient was started on Valacyclovir greater than 48 hours after administration of vaccine as well as pain medication. He had improvement in his rash but pretty severe neuralagia that was being only modestly improved with the narcotics NonePatient has a history of prostate cancer- but was not on any chemotherapy at the time. He was only on Norco for pain in the right arm . During the same period patient was treated with Norco. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #326685
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 10/01/2008. Female patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Received Zoster vaccine 8/29/2008. Called administering clinic on 10/1/08 to inform that she was diagnosed by her physician on 9/30/2008 with Shingles. Said she had been having back pain, used a heating pad, noticed blisters, causing her to go to her doctor." . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #326955
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 66.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "While my general health has been excellent for years, on 5/28/2008, when I had my annual physical exam, my doctor suggested I receive a ZOSTAVAX injection. I had chicken pox as a child but never have had shingles. From early September, 2008 until the present I have had right side abdominal pains and extreme skin sensitivity but no rash. After ultrasound, cholangiogram, chest x-ray and blood tests, my doctor has prescribed VALTREX as he has diagnosed my condition as zoster sine herpete. I feel the vaccine I received in May not only did not prevent shingles but actually caused me to get shingles. 10/7/08 Reviewed PCP medical records of 5/28-10/3/2008. FINAL DX: neuritis pain of ? etiology Records reveal patient experienced achy joints on day of vaccination. RTC 9/9 w/right sided abdominal pain & back pain x 2 weeks. Dx w/probable gallbladder disease. RTC 10/3 w/skin sensitivity right flank. Dx w/neuritic pain of ? etiology. Tx w/antiviral meds. Referred for US of gallbladder, CT of thoracic spine/abdomen/pelvis. No results available." PMH: allergic PCN. Arthritis w/AM stiffness. Roseacea. Cholecystitis 20 yrs prior.LABS: BUN 21(H). CBC WNL. Liver & lipd profile WNL. . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327596
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer concerning his wife who ~1 year ago~ in approximately May 2007, was vaccinated with ZOSTAVAX. The patient experienced shingles ~1 week ago~ on approximately 20-MAY-2008. There was no product quality complaint. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327597
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 72 year old male patient who on 24-SEP-2007 was vaccinated with a 0.65 mLdose of ZOSTAVAX. Concomitant therapy included HYDROCHLOROT, MONOPRIL, RANIDINE, simvastatin (MSD), naproxen, metoprolol tartrate, COUMADIN, XALATAN, COMBIVENT and FLOVENT. In approximately January 2008, the patient experienced shingles. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. No diagnostic labs were performed. No product quality complaints were involved. Additional information has been requested." UnknownNone . During the same period patient was treated with "COMBIVENT, FLOVENT, MONOPRIL, HYDROCHLOROT, XALATAN, metoprolol tartrate, naproxen, RANIDINE, ZOCOR, COUMADIN". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327601
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 82.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning an 82 year old female patient who ~about 3 weeks ago~ on approximately 06-MAY-2008 was vaccinated with a dose of ZOSTAVAX. The patient developed a rash ~7 days later~ on approximately 12-MAY-2008. The patient went to the emergency room (time not specified) and was diagnosed with shingles. No product quality complaint was involved." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327602
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient, 61.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 61 year old male patient who in May 2007 (exact date unknown) was vaccinated with a dose of ZOSTAVAX. On 27-MAY-2008, the patient presented to the office with a rash. The physician stated that the rash was shingles and the patient is also experiencing postherpetic neuralgia (PHN). At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327604
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 74.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 75 year old female with hypertension, hypercholoesterolaemia, sinus bradycardia, osteoporosis, hand osteoarthritis, gastroesophageal reflux disease, hiatus hernia, penicillin allergy and sulfa allergy and a history of colonoscopy electrocardiogram, stress cardiolite, dual energy x-ray absorptiometry (DEXA scan) who on 29-JAN-2007 was vaccinated subcutaneously in the left arm with the first dose of ZOSTAVAX (lot # 652907/1411F). Concomitant therapy included DYAZIDE, CELEXA, ACTONEL, VIACTIV SOFT CALCIUM CHEWS, multivitamin and flaxseed. On 27-JAN-2008, the patient had painful rash under her right arm. On 01-FEB-2008 the patient was diagnosed with shingles. There were mild to moderate vesiculopustular grouped lesions to the right axilla and upper back following a dermatomal pattern. The patient started valacyclovir hydrochloride tablet and calamine lotion to help dry up the lesions. Subsequently the patient recovered from shingles." Hypertension; Hypercholoesterolaemia; Penicillin allergy; Sulfonamide allergy; Sinus bradycardia; Osteoporosis; Hand osteoarthriColonoscopy; Electrocardiogram; Stress test; Dual energy x-ray absorptiometry; Rash. . During the same period patient was treated with "VIACTIV SOFT CALCIUM CHEWS; CELEXA, 20mg; FLAXSEED; DYAZIDE, 25mg/3; ACTONEL, 35mg; VITAMINS, tab". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327605
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a over 60 year old female with a history of shingles who on approximately 20-MAY-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). Subsequently, the patient experienced pain, hardness and swelling at injection site shortly {1-2 days} after receiving ZOSTAVAX (Merck). The latter events ceased after one week. However, the patient experienced pain in lower back about 1 week after receiving ZOSTAVAX (Merck). This was the same area where the patient developed shingles previously. The physician was requesting a culture kit to diagnose shingles. The patient's pain at injection site and in lower back persisted. Unspecified medical attention was sought by patient. Additional information has been requested." ShinglesUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327617
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 33.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 33 year old female with no drug reactions or allergies and a history of reoccurring shingles from October 2007 through December 2007 who on 15-DEC-2007 was vaccinated with a dose of ZOSTAVAX (Merck). There was no concomitant medication. On 15-DEC-2007, late in the afternoon, the patient had a mild outbreak of shingles but it went away quickly and she did not experienced recurrence of shingles for 6 months. On 02-JUN-2008, in the morning, the patient noticed cold sores in her whole body and her nerves are tingling. An unspecified blood test was performed (results not provided). At the time of the report, the patient's events persisted. Unspecified medical attention was sought. The patient also reported that she received VALTEX prior to receiving ZOSTAVAX (Merck) for her shingles but it was not working for her. Additional information has been requested." ShinglesNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327619
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a patient who was vaccinated subcutaneously with a first dose of ZOSTAVAX (Oka/Merck). On an unspecified date the patient developed shingles. At the time of the report, it was unknown if the patient had recovered from the event. Unspecified medical attention was sought. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327621
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 70 year old male who on 19-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On 24-MAY-2008 the patient developed right leg pain. On 29-MAY-2008 he developed red ~splotches~ on his leg. The patient was seen in the office on 02-JUN-2008 and diagnosed as having shingles with L3, L4, L5 nerve root involvement. There were no vesicles. The patient had burning pain. The physician reported that the patient appeared to have early or late shingles (the physician could not tell which). The patient was prescribed FAMVIR. At the time of the report, it was unknown if the patient had recovered from the event. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327625
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a patient who on 02-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The patient is currently experiencing Shingles. The patient has not experienced any known symptoms. At the time of the report, it was unknown if the patient had recovered from the event. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327626
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning a female who was vaccinated with ZOSTER vaccine. Subsequently the patient developed shingles. The patient sought medical attention with office visit. Additional information has been requested. UnknownNone . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327635
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 60 year old female with no allergies, hyperlipidemia, multinodular goiter and a history of chickenpox (1952) who on 20-MAY-2008 at 1700 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merk) (lot # 659759/1873U) in the left deltoid. There was no illness at the time of vaccination. Concomitant therapy included SYNTHROID and LIPITOR. On 27-MAY-2008 the patient developed pain in her chest, back, right arm and also had a headache. The pain was rated 8 out of 10. On 27-MAY-2008, the patient still had post-herpetic neuralgia. On 29-MAY-2008 the patient developed rash. Other systemic symptom included chest/back pain, headache and right arm pain. The pain was treated with VALTREX 100mg, three times a day for one week and LIDODERM patch for pain. The type of rash was vesicular erythematous, the number of lesions was multiple and the lesions distributed to right upper to right upper chest. The patient visited the physician's office. The patient had Shingles. On 06-JUN-2008 vesicle specimen was obtained. At the time of the report patient's Shingles and post-herpetic neuralgia persisted. No product quality complaint was involved. The patient was enrolled in the VZVIP program: the vaccine Zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present and it is present to identify if it is associated with the wild type strain or with the Merck vaccine strain. The sample of the lesion was collected on 06-JUN-2008. The sample was taken form a vesicle. The result for the specimen was negative for B-Globin, no strain identified. The samples were noted to be inadequate. Follow-up information was received from a health professional which reported the patient still with some neuropathy. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2008. follow-up information was received from a health professional which reported the patient still with some post he" Hyperlipidemia; Goiter nodularChickenpox"VZV strain, 06/06/08, inadequate specimen, negative for B-Globin, no strain I.D.; body temp, 05/27/08, 102 degr" . During the same period patient was treated with LIPITOR; SYNTHROID. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327637
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a patient who was vaccinated with a dose of ZOSTAVAX (Merck). On 20-MAY-2008, the patient experienced rashes on left thigh and leg, as well as buttocks. The patient was in extreme pain because the rashes developed into welts and yellow blistering occurred as well. The patient went to a dermatologist and a neurologist, both of whom confirmed the fact that it was shingles and prescribed oral medication, pain killers and powders to use for soaking the areas. At the time of this report the outcome was unspecified. Follow up information was received which reported that on 30-MAY-2007 the patient was vaccinated with a dose of ZOSTAVAX (Merck). Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2008. Follow-up information was received from the physician's office which reported that they ~had no patient with any adverse reaction to ZOSTAVAX.~ There was no additional information. Additional information is not expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327639
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 60 year old male patient who on 23MAY-2008 was vaccinated with first dose of ZOSTAVAX (LOT # 659763/1875U), intramuscularly at 10:00 hours. There was no concomitant medication. The physician reported that on 04-JUN-2008, the patient developed paresthesian patch like, at the left anterior cervical region with skin eruption. it appeared patient developed zoster 15 days post vaccination. The patient's symptoms (unspecified symptoms) started 3 days before, in approximately 04-JUN-2008. The patient was given VALTREX. At the time of the report the patient was recovering. The patient sought medical attention. Diagnostic test was clinical exam only. No further information in available." UnknownNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327643
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient, 79.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received form a nurse concerning a 79 year old male who on 16-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Merck). The nurse reported that on 19-MAY-2008 the patient experienced dermatomal distribution of shingles. The patient sought medical attention ~yes nurse~. The patient was given VALTREX and unspecified pain medication. Lot # was not available. It was reported ~our patient that got ZOSTAVAX did not really have a adverse effect, he simply got shingles after having the vaccine~ ~ Date of ZOSTAVAX 11/07, Shingles dx 5/08~ It was reported that the physician said ~no follow-up is required. Patient recovered without incident~ No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327647
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient, 95.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse practitioner concerning a 95 year old male who on August 2007 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck), subcutaneously, 0.65ml. The nurse practitioner reported that on 09-JUN-2008, the patient developed a case of shingles. The rash was on his trunk. He was treated with VALTREX. At the time of the report the patient was recovering. Medical attention was sought. Follow-up information indicated no new information. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327652
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 73.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a medical assistant and a nurse practitioner concerning a 74 year old female who on 27-FEB-2008 was vaccinated with ZOSTAVAX vaccine (Oka/Merck) (lot number, route and site of administration not reported) one vial, once. On 05-JUN-2008, 2 months after receiving ZOSTAVAX vaccine the patient developed shingles which was located in T7-T9 dermatome on the left side. It was noted that the patient's case was ~pretty severe~ covering almost the entire dermatome. The patient's shingles persisted. The patient sought medical attention in the physician office. A sample was collected for testing. The patient was enrolled in the VZVIP program. The vaccine zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present and it is present to identify if it is associated with the wild type strain or with the Oka/Merck vaccine strain. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327653
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse practitioner concerning a patient who was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot number, injection site and route not reported). Subsequently the patient experienced shingles. The patient went to the doctor's office and sought unspecified medical attention. No product quality complain was involved." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327709
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 65 year old female with no pertinent medical history, drug reactions or allergies who on 04-JUN-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included ZETIAL, calcium (unspecified) and vitamin D (unspecified). On 06-JUN-2008 the patient experienced Shingles. At the time of the report the patient was recovering from Shingles. The patient sought medical attention by coming to physician. No product quality complaint involved. Follow-up information was received on 01-JUL-2008 from a practice manager concerning a patient who on 04-JUN-2008 was vaccinated in the left side with a 0.5 ml dose of ZOSTAVAX (Oka/Merck) (Lot #659406/0298X, expiration date 25-JUL-2009). On 06-JUN-2008 the patient developed rash in the left groin. Then blisters appeared in the left groin. The patient also had pain rated a 5 out of 10. She was treated with acyclovir cream. At the time of the report, the patient had recovered from the event. Additional information is not expected." NoneNone . During the same period patient was treated with calcium (unspecified); ZETIA; vitamin d (unspecified). Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327729
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 76.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 76 year old female with stress (recently) who on 09-JUN-2008 was subcutaneously vaccinated with a 0.64 ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included alendronate sodium (MSD). On 12-JUN-2008 the patient developed several red blotches on her right chest area and neuralgia pain behind her right ear and face. Approximately 6 days after vaccination, on 14-JUN-2008 the event broke out in shingles and the patient had a large amount of vesicles on her chest (a rather extensive distribution of shingles). Medical attention was sought, the patient was seen by a physician. The patient was given VALTREX. The patient's neuralgia recovered and her shingles persisted. On 16-JUN-2008 the VZV sample was obtained and on 26-JUN-2008 VZV identification program resulted indicated that it was a wild type strain. Follow up information was received which reported the patient had a history of chickenpox but no recent exposure to chickenpox or shingles and there were many lesions distributed in patient's left anterior wall and left upper extremity ~posterior cervical~, the patient was afebrile. The sample was collected from left axillary field. Additional information is not expected." StressChickenpox"VZV strain, 06/16/08, wild type strain" . During the same period patient was treated with FOSAMAX. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327730
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received form a 75 year old female patient with no pertinent medical history and drug reactions/allergies reported who on 11-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Merck) 0.65ml injection (route and administrating site not reported). There was no concomitant medication. On 14-JUN-2008 the patient developed shingles. The patient's shingles persisted. The patient did not seek medical attention. NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327735
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 87.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from physician concerning an 87 year old female with Polymyalgia rheumatics, hypertension, hypothyroidism, osteoporosis and a history of chickenpox and no drug reactions/allergies history reported who on 11-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot #659407/0295X) 0.65ml SQ in the right deltoid. Concomitant therapy included PREDNISONE (manufacturer unknown), FOSAMAX, LIPITOR, DIOVAN and SYNTHROID. On 14-JUN-2008 the patient experienced shingles. The patient sought medical attention in the office. On the morning of 14-JUN-2008, the patient noted the rash below the left breast which spread to her left trunk at night time. Lesions distribution was noted to be on the T1-T2 dermatome. The patient rated her pain an eight on a scale of zero (least) to ten (most). The patient had itching and a temperature of 99 degrees F. The patient had no recent exposure to shingles of chicken pox. A specimen was collected on 16-JUN-2008 from a crusted vesicle/papule. The patient was recovering. The patient was enrolled in the VZVIP program: the vaccine Zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present to identifyif it is associated with the wild type strain or with Oka/Merck vaccine strain. Follow-up information was received on 02-JUL-2008. The final PCR result was wild type strain. On 02-JUL-2008 the physician reported that the patient's rash was better, but she was still having pain which he was treating with medication. Additional information has been requested. This is one of several reports from the same source." Polymyalgia rheumatics; Hypertension; Hypothyroidism; OsteoporosisChickenpox"body temp, 99F - ; VZV strain, 06/16/08 - wild" . During the same period patient was treated with FOSAMAX; LIPITOR; SYNTHROID; prednisone; DIOVAN. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327744
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 80.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning an 82 year old female with hypothyroidism, hypertension, osteoarthritis and renal insufficiency and a history of hyperlipidaemia and asthma who on 28-OCT-2006 was vaccinated with 0.65 ml ZOSTAVAX vaccine (Oka/Merck) (lot number 652946/1012F) by subcutaneous injection (injection site not reported). Concomitant therapy included LISINOPROL (manufacturer unknown), FELOPIDINE, DICLOFENAC, ALENDRONATE SODIUM D, MSD, and SYNTHOROID. On 16-JUN-2008 the patient developed a shingles outbreak. At the time of reporting, the patient was experiencing an erythematous rash with vesicios which extends from her abdomen to back on her right side. Unspecified medical attention was sought. The patient's shingles outbreak persisted. Additional information has been requested." Hyperlipidaemia; Hypothyroidism; Hypertension; Osteoarthritis; Asthma; Renal insufficiencyUnknown . During the same period patient was treated with (therapy unspecified); FOSAMAX PLUS D; DICLOFENAC; SYNTHROID; LISINOPRIL. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327745
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient, 68.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse concerning a 68 year old patient who was vaccinated with zoster vaccine live (Oka/Merck) (lot number, injection site and route not reported). After the vaccine was given, the patient experienced a shingles rash, pain in arms and shoulders. Follow-up information was received from a physician on 23-JUN-2008 concerning a 68 year old male with no drug allergies and a history of chickenpox (onset when he was 6 year old) who on 27-MAY-2008 was vaccinated in the left arm with a dose of zoster vaccine live (Oka/Merck) (Lot #658863/1414U). There was no concomitant medication. The patient had no recent exposure to chickenpox and shingles. 48 hours post vaccination, on 29-MAY-2008, the patient developed 15 vesicular lesions and also had pruritus and pain ranked 4 out of 10 in the lateral aspect of the left upper extremity. On 20-JUN-2008 a specimen was obtained from scab for VZV identification (results pending). At the time of the report, the patient was ~in process~ of recovery. The patient was enrolled in Varicella Zoster Virus identification Program to identity if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. Follow-up information was received on 02-JUL-2008. The final PCR result was ~wild~. Follow-up information was received from a physician via telephone call on 08-JUL-2008. He reported that at the time of the report, the patient was about ~90% recovered~ from his shingles rash. The patient did not have any pain. The physician felt that the patient was ~on his way to recovery~. Additional information is not expected." ChickenpoxVZV strain - 06/20/08 - wild . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327753
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female in her late 70's who in December 2006, was vaccinated with ZOSTAVAX (Oka/Merck) (lot no., route and site of administration were not reported). On 16-JUN-2008 the patient had Shingles; back of neck, rash, no pain. It was reported in follow-up that on 18-JUN-2008 the patient developed rash. The patient did not experience pain or tingling prior to the onset of her rash. On 19-JUN-2008 the physician saw the patient and diagnosed her with Shingles in the C3 dermatome on the right. The patient was not having any pain and was treated with VALTREX. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327756
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 77.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician and a registered nurse concerning a 77 year old female with impaired fasting glucose and cholesterol high and a history of chickenpox as a child who on 15-JAN-2008 was vaccinated in the right upper arm with a 0. 65 ml (also reported 0.5 ml) dose of ZOSTAVAX (Oka/Merck) (Lot# 658867/1413U). Concomitant therapy included ACTONEL, CRESTOR, aspirin, calcium (unspecified) and vitamins (unspecified). On 12-JUN-2008 the patient experienced Shingles. The rash was vesicular with 30 lesions under her right breast to axilla. The pain was quantified as 4 as a scale from 0 (least) to 10 (most). The patient's temperature was normal. The patient did not has exposure to chickenpox or herpes zoster recently. The patient was recovering from Shingles. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain. The sample of the lesions was collected on 23-JUN-2008. The sample was taken from a vesicular lesion. The specimen was inadequate, negative for B-Globin and no strain was identified. Additional information has been requested." Impaired fasting glucose; Cholesterol highChickenpox"VZV strain, 06/30/08, inadequate specimen, no strain identified" . During the same period patient was treated with aspirin; calcium (unspecified); ACTONEL; CRESTOR; vitamins (unspecified). Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327760
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 87.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an 87 year old female with hypertension, Polymyalgia rheumatica, hypothyroidism and osteoporosis who on 11-JUN-2008 was vaccinated with ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included PREDNISONE, FOSAMAX, LIPITOR, DIOVAN and SYNTHROID. on 14-JUN-2008 the patient developed shingles. The patient went to see the physician. No lab diagnostics studies were performed. At the time of report, the patient's shingles persisted. The physician is interested in the VZV identification program. Additional information has been requested." Hypertension; Polymyalgia rheumatica; Hypothyroidism; OsteoporosisNone . During the same period patient was treated with "FOSAMAX, LIPITOR, SYNTHROID, PREDNISONE, DIOVAN". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327768
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 68.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a medical assistant concerning a 68 year old female with iodine and rofecoxib (MSD, WAES#0807USA02273) allergy, Barrett's esophagus and GERD who on 18-JUN-2008 was vaccinated with zoster vaccine live (Oka/Merck) (LOT #659409/0409X) 0.65 ml, intramuscularly in the right arm. Concomitant therapy included (CELEBREX) and (FLOMAX). The medical assistant reported that on 19-JUN-2008, the patient developed pain at the injection site. On 21-JUN-2008, the patient experienced pain. She had multiple vesicular lesions on her left T6-T9 dermatomes. Her temperature was 97.5. It was unknown if the patient had a recent exposure to chickenpox and there was no recent exposure to shingles. On 23-JUN-2008, the patient was diagnosed with shingles. The patient's symptoms were pain and an unspecified rash on the left chest under the left breast. The patient was prescribed (VALTREX) and (LORTAB) for symptom relief. No other symptoms or treatment reported. At the time of reporting the patient was recovering. As of 30-JUN-2008, the patient still had shingles on the abdomen. The patient sought medical attention. Additional information is not expected. This is in follow-up to report(s) previously submitted on 9/24/2008. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) ZVZ strain or with the OKA/Merck vaccine VZV strain. Follow up information was received from the VZV identification program which reported that the sample of the lesion was collected on 25-JUN-2008. The sample was taken from a vaccine. The VZV DNA was amplified, the VZV strain identification was wild type. The interpretation of the result was adequate specimen, wile type strain. This is an amended report. Information regarding results of the VZV identification program were added to the laboratory field and narrative. No further information is available." "Iodine allergy, Drug hypersensitivity, Barrett's oesohagus, Gastrooesophageal reflux disease""Unknown; VZV strain, 06/25/2008, VZV wild type strain" . During the same period patient was treated with "CELEBREX, FLOMAX (MORNIFLUMATE)". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327770
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse practitioner concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot no., route and site of administration were not reported). On an unspecified date the patient experienced what was assumed to be shingles rash. It was unknown if the patient sought medical attention or not. The patient's outcome was unknown at the time of reporting. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327773
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial information has been received from a 65 year old female with allergies to grass and mold and no known drug allergies. Follow-up information was received from a registered nurse. On 13-JUN-2008 the patient was vaccinated subcutaneously with a 0.65 ml dose of zoster vaccine live (Oka/Merck) (lot no. 659406/0298X). Concomitant therapy included (LOTREL) and (ZYRTEC). On 19-JUN-2008 (also reported as 16-JUN-2008) the patient experienced back pain, rash, burning sensation in the left posterior thorax and then shingles. On 21-JUN-2008 the patient went to the emergency room and her condition was diagnosed as shingles. The patient was started on (VALTREX) and (VICODIN). As of 25-JUN-2008, the patient was recovering from these events. On 27-JUN-2008 the patient was re-evaluated and diagnosed as post-herpetic neuralgia. The patient was treated with lidocaine (LIDODERM) patches and (LYRICA). Additional information is not expected." "Pollen allergy, Mycotic allergy"None . During the same period patient was treated with "LOTREL, ZYRTEC". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327774
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 74.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received fro a physician concerning a 75 year old female who on 21-AUG-2007 was vaccinated with a dose of 0.65 ml ZOSTAVAX vaccine (Oka/Merck). On 03-JUN-2008 the patient experienced shingles rash. The patient was seen by the physician. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327776
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a patient who was vaccinated with a dose of ZOSTAVAX vaccine (Merck). Subsequently the patient experienced shingles. At the time of the report, no outcome was reported. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Follow up information was received from the physician who reported that the 62 year old female patient on 15-JUN-2007 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). On 16-APR-2008 the patient developed a shingles on ~one side of the trunk~. On 30-SEP-2008 the patient developed her second case of shingles on ~the other side of the trunk~. The patient contacted the physician for medical attention. At the time of this report, the outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2008; 12/23/2008. Follow-up information received from a physician via a HZ questionnaire concerning a 62-year-old female patient with an allergy to lisinopril and a past medical history of chickenpox at age 3. On 15-JUN-2007 she was vaccinated in the left arm with a dose of ZOSTAVAX vaccine (Merck) (lot# 6576/0618U). Concomitant medication included amlodipine. On 16-APR-2008 the patient developed herpes zoster in the right thoracic dermatome, the patient reported pain of an 8-9. The lesions were reportedly papular and vesicular. It was reported that there was no recent exposure to chickenpox or herpes zoster. Unspecified medical attention was sought, no specimen was submitted. The patient recovered. Then on 30-SEPT-2008, the patient developed lesions in the left lumbosacral dermatome. She reported pain of a 5 out of 10 for this episode. The patient sough medical attention. It was reported that the patient recovered. Additional information is not expected." Drug hypersensitivityUnknown ChickenpoxUnknown . During the same period patient was treated with Unknown Amlodipine. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327781
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 84.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an 84 year old female with hypertension, hyperlipidaemia, hypothyroidism, bundle branch block right and a drug hypersensitivity to (LIPITOR) who on 26-APR-2008 was vaccinated with a 0.65 ml dose of zoster vaccine live (Oka/Merck) (lot # 656861/0329U). Concomitant therapy included (SYNTHROID), calcium (unspecified) and aspirin. On 08-JUN-2008 the patient experienced" Unknown . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327782
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 72 year old female with ~blood pressure~, Oesophageal acid reflux, arthritis, cholesterol high, sulfonamide allergy and allergic to LYRICA who in February or March 2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included ACIPHEM, piroxicam, Pravastatin Na, AVAPRO, ALLEGRA, AMARYL, AMBIEN, CYMBALTA, ROBAXIN and ZYDONE. three weeks ago, on approximately 19-MAY-2008 the patient experienced shingles on her ~rear end~. It was only about 3 to 4 itchy blisters. The physician prescribed and antiviral medication and the blisters went away however she was still experiencing itching and burning. No product quality complaint was involved. Additional information has been requested." Blood pressure; Oesophageal acid reflux; Arthritis; Cholesterol high; Sulfonamide allergy; HypersensitivityNone . During the same period patient was treated with ZYDONE; CYMBALTA; ALLEGRA; AMARYL; AVAPRO; ROBAXIN; piroxicam; Pravastatin sodium; ACIPHEX; AMBIEN. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327783
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist who stated that a physician's office called her and asked if shingles can be caused by zoster vaccine live (Oka/Merck). She thinks a patient is involved, but was not entirely sure. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327793
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a health professional concerning a over 60 year old female who was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot number, injection site and route not reported). Subsequently the patient developed shingles ~a couple days post vaccination~. The patient sought unspecified medical attention. Additional information has been requested." Unknowndiagnostic laboratory - . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327798
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning a 60 year old male who on an unspecified date was vaccinated with a single dose of ZOSTAVAX. On approximately 20-JUN-2008 the patient developed zoster. Zoster was improved after stopping therapy with ZOSTAVAX. No product quality complaint was involved. No further information is available. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327801
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician and a licensed practical nurse concerning a 72 year old female patient with no pertinent medical history or allergies who on 22-JUN-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot #652947/1411F). Concomitant therapy included vitamins (unspecified), LIPITOR, aspirin, METROGEL and triamcinolone topical. The nurse reported that on 23-JUN-2008, the patient developed herpes zoster on left knee to left buttock, L 4-5 distribution. The patient stated she had ~unbearable pain~. The same day, a viral culture was done; varicella zoster virus DNA detected and it was negative for herpes simplex type 1 and 2 DNA. The nurse was not interested in VZV Analysis by PCR. At the time of the report the patient was recovering. The patient sought medical attention at the physician's office. No further information is available." None"viral culture, 06/23/08, Varicella zoster virus DNA detected. Negative for herpes simplex type 1 and 2 DNA." . During the same period patient was treated with aspirin; LIPITOR; METROGEL; triamcinolone; vitamins (unspecified). Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327808
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning a female patient in her 70s with no pertinent medical history and no allergy who was vaccinated with ZOSTAVAX SC. There was no concomitant medication. The patient experienced ophthalmic zoster three times after vaccination. The patient sought medical attention and saw the physician. This is one of two reports from the same source. Additional information has been requested. NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327810
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2008. Female patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer concerning her friend, a 72 year old female who in approximately June 2006 (about two years ago) was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). ~Recently~, the patient developed shingles. The patient's outcome was unknown. It was unspecified if any medical attention was sought. Additonal information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327813
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning a female patient in her 70s with no pertinent medical history and no allergy who was vaccinated with ZOSTAVAX vaccine (Oka/Merck) SC. There was no concomitant medication. The patient developed shingles on her arm. The patient sought medical attention and saw the physician. This is one of two reports from the same source. Additional information has been requested. NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327821
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient, 67.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from two nurses and a consumer concerning the 67 year old male with type 2 diabetes mellitus, osteoarthritis, hypertension, obesity and a history of chickenpox in childhood and no allergies who on 19-JUn-2008 was vaccinated with ZOSTAVAX 0.5ml SC (lot # 658862/1415U). Concomitant therapy included LANTUS, metformin," . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327827
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 63 year old female patient with sulfonamide allergy and a history of shingles 15 years ago who on 06-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck). Concomitant therapy included PRAVACHOL, NASONEX, and vitamins (unspecified). On 25-JUN-2008 the patient experienced Shingles rash. On 02-JUL-2008, the patient recovered from Shingles rash. The patient sought medical attention and visited doctors. This is one of several reports from the same source. Additional information has been requested. 12/23/2008 This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a physician and a 63 year old female patient with sulfonamide allergy and a history of shingles 15 years ago who on 06-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) in the left arm. Concomitant therapy included PRAVACHOL, NASONEX and vitamins (unspecified). On 25-JUN-2008 the patient experienced shingles rash at the right T4 dermatome. On 02-JUL-2008, the patient recovered from shingles rash. The patient sought medical attention and visited doctors. This is one of several reports from the same source. Additional information has been requested." Sulfonamide allergyShinglesNone . During the same period patient was treated with NASONEX; PRAVACHOL; vitamins (unspecified). Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327830
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning himself, who was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Two weeks later, the patient developed Shingles. The patient's outcome was unknown. Unspecified medical attention was sought. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327833
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 67.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 67 year old female with cholesterol high, cardiac murmur and sulfonamide allergy and a history of Shingles in her 30's who on 29-NOV-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot# 658398/1087U). Concomitant therapy included atenolol, SYNTHROID, therapy unspecified (water pill), aspirin, calcium (unspecified) and ginkgo. On 19-DEC-2007 the patient experienced Shingles attack. The patient reported that she had history of Shingles since in her 30's and every time she's exposed to somebody with chickenpox or if she was on a stressful condition, she would always get Shingles attack. The patient reported that from the time she received ZOSTAVAX (Oka/Merck), she already had 5 Shingles attacks in 7 months. The patient's Shingles persisted. The patient sought medical attention. Follow up information was received from the physician. The patient reported rash that was never seen in the physician's office for it. It can not state that the patient actually has Shingles. Additional information is not expected." Cholesterol high; Cardiac murmur; Sulfonamide allergyShinglesUnknown . During the same period patient was treated with (therapy unspecified); aspirin; atenolol; calcium (unspecified) VYTORIN; ginkgo; SYNTHROID. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327834
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot number, injection site and route not reported). Subsequently the patient developed herpes zoster. The patient sought unspecified medical attention. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327835
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 66.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 66 year old female who was vaccinated with a dose of ZOSTAVAX (lot number, injection site and route not reported). Subsequently, the patient experienced shingles. The patient sought unspecified medical attention. At the time of reporting, the patient was recovering from the event. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/24/2008. Follow-up information was received from the physician which reported that the physician did not have all of the details other than the patient developed shingles and had previously received the vaccine. Additional information is not expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327932
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 67.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning a 67 year old female who on 19-SEP-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot#: 658085/0882U) subcutaneously. Subsequently the patient developed Shingles. The shingles are located on her upper arm, shoulder and her breast. The lesions were draining ~last week~ (beginning of July, 2008) and were starting to scab. On 03-JUL-2008, the patient was placed on antivirals. The patient sought unspecified medical attention and was seen by a dermatologist. A sample of the herpes zoster was not obtained since there was ~nothing to send~. The patient's final outcome was not known. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327944
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an over 60 year old male who ~a couple of months ago~ (in approximately May 2008), was vaccinated with the first dose of ZOSTAVAX subcutaneously. Subsequently, in approximately May 2008, the patient developed shingles. The shingles cleared on its own, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327945
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 63 female who on 27-DEC-2007 was vaccinated with a single dose of ZOSTAVAX (lot#: 656609/0015U). On 10-JAN-2008, the patient developed a mild case of shingles. There were blisters underneath one breast. The outcome of the shingles was not reported. The patient sought unspecified medical attention. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327949
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial and follow-up information has been received from a physician concerning a 61 year old female with a history of chickenpox as a child who on 31-JUL-2007 was vaccinated with a single 0.65 ml dose of ZOSTAVAX (lot no. 658086/0761U) into the right arm. Concomitant therapy included METFORM, lorazepam, LIPITOR and lisinopril (manufacturer unknown). On 07-JUL-2008, the patient developed ~shingles with pain.~ It was reported in follow-up that the patient had classic erythematous, vesicular rash in the right trunk around the right side the right breast (Dermatome: right thorax). The number was too numerous to count. The outcome was unknown. The patient sought unspecified medical attention. Additional information is not expected." ChickenpoxUnknown . During the same period patient was treated with LIPITOR; lisinopril; lorazepam; METFORM. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327952
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning a female patient who on 27-JUN-2008 was vaccinated with ZOSTAVAX vaccine (Oka/Merck) (lot # 659672/0294X), subcutaneously. The nurse reported that the patient developed zoster on her face and eye area. Her physician prescribed antivirals. The nurse stated she is interested in VZV analysis by PCR and that the physician reported to the nurse the case was reported to CDC." unknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327954
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female who ~about 3 weeks ago,~ on approximately 20-JUN-2008 was vaccinated with a dose of ZOSTAVAX. ~2 weeks after the dose,~ on approximately 04-JUL-2008 the patient experienced shingles. The patient went to see a physician. At the time of report, the event's outcome was unknown. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327955
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). The patient got shingles after getting vaccinated with ZOSTAVAX vaccine (Oka/Merck). The outcome was unknown. It was unknown if the patient sought medical attention or not. The pharmacist had no other information. No further information is available. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327957
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "This is in follow-up to report (s) previously submitted on 9/24/2008 Information has been received from a registered nurse concerning a 71 year old female with arthritis, bronchitis, hypertension, acute back pain, hypothyroidism, sulfonamide allergy and shellfish/iodine allergy who on 07-JUL-2008 was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX (lot # 659672/0294X). Concomitant therapy included BENICAR, CRESTOR, LASIX, and SYNTHROID. On 13-JUL-2008, the patient experienced a cold sore, headache and an enlarged lymph node. The patient called the practice. The patient was recovering. No product quality complaint was involved. Additional information has been requested. Follow-up information was received from physician's office notes and a registered nurse (R.N.) who reported a 71 year old white female with sinus disorder and a history of positive chicken poz titer, measles adn rubella disease, hepatitis A and B (1995) and influenza vaccinations (2007) who on 07-JUL-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (lot # 659672/0294X) in the left deltoid. Concomitant therapy included CELEBREX and methadone hydrochloride. There was no illness at time of vaccination. The patient had headache one to two days after vaccine that now had subsided and developed cold sore on right side of lip on 13-JUL-2008, with some swelling right lymph node/neck. No inflammation at site of injections (left side). The patient was counseled that she should refrain from taking VALTREX for 14 days after vaccination. The patient was advised to use topical creams, cold compresses. The patient started taking VALTREX on 15-JUL-2008, despite advice otherwise. The patient stated right side of face was swollen and very slight rash note on neck. The patient took VALTREX for ten days, then the rash disappeared and cold sore very small when VALTREX discontinued. On 24-JUL-2008, the physician's office called the patient regarding follow up after shingles and the cold sore and left a message. The physi" Arthritis; Bronchitis; Hypertension; Acute back pain; Hypothyroidism; sulfonamide allergy; Iodine allergyChickenpox; measles; rubellaNone . During the same period patient was treated with LASIX; SYNTHROID; BENICAR; CRESTOR;CELEBREX; methadone hydrochloride. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327963
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a pharmacist concerning a female patient who was vaccinated with ZOSTAVAX (Oka/Merck). The patient developed Shingles two weeks after vaccination. The patient did not seek medical attention. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327964
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female who was vaccinated with ZOSTAVAX. Subsequently, the patient developed a mild case of shingles. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327966
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient, 88.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning an 86 year old male who on 15-MAR-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot# 656607/0163U). On 08-JUL-2008 the patient experienced Shingles along the left side of his stomach. The patient's Shingles persisted. The patient sought medical attention. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327969
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient, 69.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 70 year old male with asthma and a history of back surgery and with no known drug reactions/allergies, who on 02-FEB-2008 had an outbreak of shingles. The patient mentioned that it was a bad case on his right leg and he had severe nerve pain. On 25-MAR-2008, the patient was vaccinated with a single dose of ZOSTAVAX (route and administrating site not reported) at a hospital. Concomitant therapy included montelukast sodium (MSD) (dose, duration and indication not reported), AZMACORT, INTAL, AZOR, ADVICOR and allergenic extract. Thereafter, the patient had three separate episodes of shingles. On 19-MAY-2008, the patient developed shingles on his right arm and right side. On 02-JUL-2008, the patient had shingles in his right leg and on the right side of his nose and face. Subsequently, the patient fully recovered from all of these outbreaks of shingles. The patient sought unspecified medical attention. Additional information has been requested." AsthmaBack surgery; ShinglesNone . During the same period patient was treated with allergenic extract; amlodipine besylate (+);INTAL; ADVICOR; SINGULAIR; AZMACORT. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327970
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 68.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning a 68 year old female with a history of Shingles who in October 2007, was vaccinated with ZOSTAVAX (Oka/Merck). In April 2008, the patient experienced Shingles outbreak 6 months after she was given ZOSTAVAX (Oka/Merck). The patient recovered from Shingles. The patient sought medical attention. Additional information has been request." ShinglesUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327974
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning a 64 year old male who on 02-NOV-2007 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck) SQ (lot# 658398/1087U). On 15-JUL-2008 the patient experienced Shingles. The patient was treated with VALTREX. The patient sought unspecified medical attention. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327980
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 82.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a physician and office records concerning an 83 year old female, weight 167lb 2oz, with chronic obstructive disease (asthma), type 2 diabetes mellitus with neurological manifestations and peripheral vascular disorders, increased lipids, hypercholesterolemia, osteoarthritis, gout, sciatica, acquired spondylolisthesis, spasm of muscle, pityriasis versicolor, neuralgia, plantar fascial fibromatosis, essential hypertension, pain in limb and lumbago and allergies to penicillin, KEFLEX (caused rash) and codeine (caused nausea), no recent exposure to chickenpox or Shingles, and a history of status asthmaticus, hysterectomy, cellulitis and abscess of unspecified digit and leg and bunion who in the afternoon of 15-FEB-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot#: 659759/1873U) 1ml SQ in the left deltoid. There was no illnesses at the time of the vaccination. Concomitant therapy included ADVAIR, ZANTAC, albuterol, magnesium hydroxide, FLONASE, CRESTOR, LOTREL, LASIX, allopurinol, hydralazine, PROVENTIL HFA, AVALIDE. Subsequently, in approximately April 2008 the patient developed blisters on left lower extremity which were initially treated as cellulitis, but later manifested as a blistering weeping rash and gradually spread to the entire body. The patient was seen in the office and was prescribed VALTREX, acyclovir, NEURONTIN. After three months had passed since her symptoms began the patient had not improved. On 21-JUL-2008 the patient was seen by the physician in the office for a follow-up evaluation of a left leg rash. The rash was slowing improving however she had blistering on her palmer aspect of her hand and increased swelling of her right leg as well. She had been developing random nonspecific pruritic spots on the upper extremity and back. The patient continued to have a rash on both legs. The patient was taking DARVOCET N100 and felt some relief without adverse reaction. Her physical exam noted a female" Penicillin allergy; Allergic reaction to antibiotics; Drug hypersensitivity; Chronic obstructive asthma (with obstructive pulmonCellulitis of finger; Abscess of finger; Abscess leg; Bunion; Cellulitis of leg; Hysterectomy; Nausea; Status asthmaticus; Rash"Unknown; VZV strain, INADEQUATE SPECIMEN, no strain identified" . During the same period patient was treated with albuterol; PROVENTIL HFA; allopurinol; LOTREL; FLONASE; ADVAIR; LASIX; hydralazine; AVALIDE; magnesium hydroxide; ZANTAC; CRESTOR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328039
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning a female patient who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) 0.65 ml SQ. The patient developed Shingles within 2 weeks of receiving the vaccination. The patient sought unspecified medical attention. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328136
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered physician assistant concerning a 71 year old female with diabetes mellitus and a history of chickenpox when she was 10 years old, who on 23-OCT-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 652947/1212F) 0.5 ml subcutaneously in her left deltoid (start date also reported as 11-SEP-2006). Concomitant therapy included citalopram, LIPITOR, DIOVAN, and LEVOXYL. The physician assistant reported that on 16-JUL-2008, the patient developed a mild case of Shingles on the right side of her chest, 4-6 small lesions, R T7 distribution. There were no other systemic symptom and no rash at the injection site post vaccination. The patient was treated with VALTREX. On 23-JUL-2008, the patient had a vesicle specimen collection send to the laboratory (test results not provided). At the time of the report, the patient was recovering. The patient sought medical attention at the physician's office. Follow up information was received which reported the results of the CPR. The specimen was obtain from a vesicle lesion. VZV DNA and B-globin DNA was amplified. Interpretation: adequate specimen, wild type strain. Additional information has been requested." Diabetes mellitusChickenpox"diagnostic laboratory, PCR from vesicle lesion, DNA amplified: wild type strain." . During the same period patient was treated with LIPITOR; citalopram; LEVOXYL; DIOVAN. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328138
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning his 64 year old female employee with no known drug allergies and no pertinent medical history, who on 07-JUL-2008 was vaccinated subcutaneously with ZOSTAVAX (Lot # 659406/0298X) 0.65 mL, into her left upper arm. There was no concomitant therapy. On 15-JUL-2008, the patient developed pain in her left shoulder and then a painful red, papular rash that ran under her left axillary area and down her arm. There were no vesicles present, but there were 15+ patches that ran along the left C4, C5 dermatome. There was no fever. The patient also had nerve pain, loss of sleep, sensitivity to touch & cold air, burning and itching. The patient sought medical attention at the office. The patient was diagnosed as definitely having shingles and was treated with VALTREX. At the time of the report the patient was recovering. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it was associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. The sample was collected on 23-JUL-2008. The result was inadequate specimen, negative for B-globin and no strain I.D. This is one of several reports received from the same source. Standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available." None"diagnostic laboratory, 07/23/08, VZV, inadequate specimen" . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328139
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 62 year old female with a medical history of chickenpox and no drug allergies who on 09-JUL-2008 was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX in her right upper arm (lot # 659406/0298X). There was no concomitant medication. On 14-JUL-2008, the patient developed cramps on her right side and a red, papular rash that ran from the right side of her waist down along L-1 and L-2 dermatomes. The rash went as far as the top of her right knee. There were no vesicles present, but there were groups of papules. There was no fever. The patient was sensitive to touch, burning itchy pain with no systemic symptoms. The patient was diagnosed with shingles and treated with VALTREX. The patient had no fever. The pain was starting across lower abdomen, moving to right upper leg and around to right hip. The area was swabbed and also crapped with slide to obtain an adequate sample. There was approximately 50 lesions 1 cm made up of confluent papules in each patch, starting above right knee and running up leg around up right buttock to waist. The patient was recovering. No product quality complaint was involved. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 23-JUL-2008. The sample was taken from a papular lesion. The results was inadequate specimen, negative for B-globin and no strain I.D. Follow up information was received concerning that a lot check was requested. Follow up information was received which reported that on 09-JUL-2008, the white patient received vaccine. There was no illness at the time of vaccination. On 14-JUL-2008, the patient began to get pain in lower abdomen. On 15-JUL-2008, pain increased and moved to lower right abdomen and top of right leg. On 17-JUL-2008, the patient's family doctor sent her to the hosp" Chickenpox"Ultrasound, 07/17/08, no sonographic evidence of right lower extremity deep venous thrombosis; VZV strain, 07/23/08, no vesicles noted" . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328140
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 88.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning an 88 year old female with hypertension who on 12-JAN-2007 was vaccinated with ZOSTAVAX. Concomitant therapy included VALTREX and cardiovascular medications. The pharmacist reported that approximately on 07-JUL-2008, the patient experienced shingles. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention." Unknown . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328142
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning a 71 year old female with a history of breast cancer who was recently vaccinated with a dose of ZOSTAVAX (Oka/Merck). There was no concomitant medication. About one week post vaccination the patient developed pain and went to the emergency room. The physician at the ER felt the pain might be caused by Shingles still in the prodromal stage. The patient was placed on an anti-viral medication and released. The patient was recovering from pain. No product quality complaint was involved. Additional information has been requested. Breast cancerUnknown . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328149
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 77.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 77 year old female with high blood pressure and no known allergies, who on 29-JAN-2008 was vaccinated with a first dose of ZOSTAVAX. On 11-JUL-2008, was vaccinated with a second dose of ZOSTAVAX. Concomitant therapy included NORVASC, TOPROL XL TABLETS and ZOLOFT. The patient reported that on 11-JUL-2008 she started to experience pain on her eye. Patient reported that the next day she was in agony and had a terrible pain coming down to her head. When the patient went to see her physician, the physician told her that she has shingles. Patient reported that right now, (23-JUL-2008) she can't see because of the pain in her eye and her eyelid has pustules. Patient noted that she doesn't have history of shingles prior to receiving ZOSTAVAX. The patient's adverse experiences persisted. No lab diagnostics were performed. The patient sought medical attention, she was seen in the physician office. There was no product quality complaint. Additional information has been requested." Blood pressure highNone . During the same period patient was treated with NORVASC; TOPROL XL TABLETS; ZOLOFT. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328152
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a patient who was vaccinated with ZOSTAVAX. The day after vaccination, the patient came back to the office and said the vaccination gave him/her shingles. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328175
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from an office manager concerning a 65 year old female who on 06-APR-2007 was vaccinated with ZOSTAVAX. The office manager reported that on 10-JUL-2008, the patient had a mild shingles outbreak. At the time of the report, the patient had recovered. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328180
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 74.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer concerning to his 74 years old wife with osteopenia and cholesterol who on 10-JUL-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included generic alendronate sodium (manufacturer unknown) and lovastatin (manufacturer unknown). On 21-JUL-2008, the patient experienced excruciating, terrible head pain and sores from the nape of her heck to the crown of her head, on 1 side. The sores were ~small, pink and rounded.~ The consumer and patient suspected it was shingles. Physician prescribed VALTREX. The patient went to the ER on Wednesday 30-JUL-2008. The patient sought medical attention at the emergency room. Additional information is not expected." Osteopenia; Cholesterol . During the same period patient was treated with FOSAMAX; lovastatin. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328191
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "This is in follow-up to report(s) previously submitted on 9/24/2008; 12/23/2008. Information has been received from a 65 year old female with depression, high blood pressure, chronic fatigue immune dysfunction syndrome, fibromyalgia and sensitivity to a lot of drugs. The patient also had a history of herpes outbreaks (not genital) and stomach upset which was caused by CELEBREX (manufacturer unspecified) who on 25-JUL-2008 was vaccinated subcutaneously in her left upper arm with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included hydrocodone, amitriptyline hydrochloride, UNIVASC, XANAX. On approximately 27-JUL-2008 (2 - 3 days after vaccination) the patient experienced a hot, red, encircled hematoma, arm soreness, diarrhea, flu symptoms, tiredness and feeling sick. The patient experienced a hematoma at the injection site, and the injection site was red and inflamed. She also had a tiny rash but it was went away. The patient had severe pain in the arm where she received the injection. The patient was feeling better after the pharmacist advised her to elevate her arm to reduce soreness. The patient said the flu-like symptoms felt like she felt during her non-genital herpes outbreaks or they might be chronic fatigue immune dysfunction syndrome. The hematoma was getting smaller and better. The patient's symptoms were resolving. The patient sought medical attention by taking to the pharmacist. Follow-up information was received from the patient who reported that she had constant pain in the arm that she received the ZOSTAVAX (Oka/Merk) injection. It got really bad at times but it was a constant ache. The patient continued to have severe aching radiating from her left shoulder down her left arm. She also had a hematoma at the injection site. The hematoma at the injection site was still present but it was greatly reduced in size. Initially, it was the sized of a baseball but now it was the size of a nickel. She was of the opinion that she had polymyalgia rheumatica. The patient had a weakened immune system at t" Depression; Blood pressure high; Immune system disorder; Osteoarthritis; Drug hypersensitivity; Chronic fatigue syndrome; FibromHerpes virus infection; Upset stomachNone . During the same period patient was treated with XANAX; ELAVIL; estradiol; hydrocodone bitartrate; UNIVASC. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328195
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a pharmacist student concerning a female who on an unknown date developed zoster after her husband was vaccinated with ZOSTAVAX (Oka/Merck) on 09-JUL-2008. The patient's outcome was not reported. The patient sought medical attention with a telephone call. No further information is available. unknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328198
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 76.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse practitioner concerning her 76 year old mother who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot number, injection site and route not reported). Two weeks after the vaccination the patient developed shingles. Unspecified medical attention was sought. Follow-up information was received which reported that the nurse practitioner did not work for the hospital for several years. No one knew of this case. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328200
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a 72 year old female who in 2007 was vaccinated with ZOSTAVAX (Oka/Merck). In January 2008, the patient developed Shingles. The patient required Oxycodone for pain. Subsequently, the patient recovered from the Shingles. No further information is expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328205
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 62 year old female with no known drug reactions/allergies who on 25-APR-2008 was vaccinated with the 0.65 ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included SYNTHROID, ACTONEL, BENICAR and albuterol. On 29-JUL-2008 the patient developed shingles. The patient's outcome was unknown. Unspecified medical attention was sought. Additional information has been requested. Additional information has been received form a health professional concerning the 62 year old female with sulfonamide allergy, asthma, emphysema, chronic obstructive pulmonary disease, house dust allergy and mycotic allergy and a history of measles, mumps and chickenpox as a child who on 25-APR-2008 was vaccinated with ZOSTAVAX (Merck) (Lot# 659760/0159X) in the right arm. Additional concomitant therapy included ZEFTA, VERAMYST. The patient was seen in the physicians office on 29-JUL-2008 with complaints of rash, skin feeling tender, joint pain, back pain. There were 3 small vesicles at the site of orgin of pain. The patient complained of constant right sided abdominal pain that occacionaly radiates to the left and down the leg at site of pain, right side back, bottom, upper quadrant. The patient was also noted to have neuralgia/neuritis. The patient had a gall bladder ultrasound (results not reported) and a HIDA scan was ordered. On 09-OCT-2008 the patient reported her shingles were gone. Additional information has been requested." Sulfonamide allergy; Astma; Emphysema; Chronic obstructive pulmonary disase; House dust allergy; Mycotic allergy.Unknown"Ultrasound, of gall bladder (results not reported); Hepatobiliary, (results not reported)" . During the same period patient was treated with "albuterol, SYNTHROID, BENICAR, ACTONEL ; FOSAMAX; Betamethasone; ZEFTA; VERAMYST; SYNTHROID; BENICAR; ACTONEL;". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328211
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 70 year old female with penicillin allergy and sulfonamide allergy, hypertension, hypothyroidism, osteoporosis and dyslipidaemia who on 29-JUL-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # 656394/0162U), SC, 0.5 mL, into the left deltoid. On 02-AUG-2008, the patient experienced herpes zoster. The patient was examined in the office and found to have vesicular rash in the right T1-T2 distribution, with 5 - 6 lesions extending from the right breast around to the right mid-back. The patient was prescribed topical ZOVIRAX cream. As of 06-AUG-2008 herpes zoster persisted. The physician has taken isolates from the lesions and is interested in the VZVID program. The patient was enrolled in the Varicella Zoster Virus Identification Program to Identify if VSV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/MERCK vaccine VZV strain. The sample of the lesion was collected on 06-AUG-2008. The sample was taken from a papulo vascular lesion in the T1-T2 dermatone. The PCR results for the specimen from a papulo vascular lesion in the T1-T2 dermatone, identified the presence of VZV WILD TYPE STRAIN. Telephone follow-up information was received which reported that the patient's lesions were healing and she was having a lot of pain. The patient was started on LYRICA for pain and ZOVIRAX cream. The physician waited for culture results prior to treating the patient and missed treated her with VALTREX. On 19-AUG-2008, another telephone follow-up was received which reported that the positive results for VZV WILD TYPE STRAIN made sense since the patient informed that she was exposed to shingles prior to vaccination and that was the reason she was vaccinated with ZOSTAVAX (Oka/Merck). The patient was doing better. No further information is available." Penicillin allergy; Sulfonamide allergy; Hypertension; Hypothyroidism; Osteoporosis; Dyslipidaemia"VZV strain, 08/15/08, VZV WILD TYPE STRAIN" . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328213
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 62 year old female who on 21-MAr-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). On 30-MAR-2008 the patient was seen in emergency clinic for painful rash on left neck area. The patient was told that she had shingles and was treated with VALTREX. Subsequently, the patient recovered from shingles. This is one of several reports received from the same source. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328217
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 40.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse practitioner concerning an 40 year old female with hypertension and a history of shingles who in April 2008, was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot number, injection site and route not reported).On approximately 29-JUL-2008, also reported as 2 weeks ago, the patient developed shingles. Unspecified medical attention was sought. The outcome of the patient was unspecified. Additional information has been requested." HypertensionShinglesUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328218
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 56.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 56 year old female with no known drug allergies and no pertinent medical history reported, who about 1 month ago, (approximately July 2008) was vaccinated with ZOSTAVAX vaccine(Oka/Merck). On 01-AUG-2008, the patient developed herpes zoster and had about 5 blisters on her right eyelid and forehead. The patient sought medical attention at the office. The patient has not recovered at the time of reporting. Additional information has been requested." NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328221
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a licensed practical nurse concerning a 63 year old female with arthritis, bronchitis, blood pressure high, cardiac disorder, sinusitis, hay fever, bad knee, PENICILLIN allergy, CODINE allergy, drug hypersensitivity and SULFONAMIDE allergy and a history of measles, mumps, chickenpox, infectious mononucleosis, hives, cancer, back discomfort, anemia, ulcer, hemorrhoids, bladder infection and hernia who on 04-MAR-2008 was vaccinated subcutaneously into left deltoid with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (lot no. 659759/1873U). Concomitant therapy included ALENDRONATE SODIUM (MSD), ZANTAC, INDERAL, NORTRIPTYLINE, CABBAGE PALM, ZYRTEC, WELLBUTRIN XL, DIOVAN HCT, FLUTICASONE FUROATE, METFORMIN, KLOR-CON, DYAZIDE, SIMVASTATIN (manufacturer unknown), METOPROLOL, DILTIAZEUM HCL, CECLOR, DILTIAZEM HCL, DOXYCYCLINE, NITROLINGUAL and ~other medications~. On 07-AUG-2008 the patient was diagnosed with shingles. the patient had rash on upper left leg which was painful and blistering redness. The patient had no other symptoms. The patient was treated with TYLENOL. On 11-AUG-2008 the patient was in office with draining lesions located on left upper thigh The physical examination was done. Blood pressure was 108/64. Pulse was 66. Respiratory rate was 18. Body temperature was 97.1 F. There was no abnormal discovery with the patient. The patient was well health and well nourish. Heart rate and rhythm. Lungs were clear to auscultation and no wheeze. there were multiple patches of painful. erythatous; vesicular erythema within the L2 dermatome of the left leg It was diagnosed that the rash was probably shingles infection. The patient was treated with VALTREX 1000 mg. three times per day for 7 days; triamcinolone cream 1%, VICODIN; 1-2 tablets, four times per day as needed for pain. The patient would be followed up in 2 weeks. At the time of this report, patient's shingles persisted. No further information is available." Arthritis; sinusitis; Drug hypersensitivity; Unspecified disorder of knee joint; Sulfonamide allergy; Penicillin allergy; Hay feMeasles; Mumps; Chickenpox; Infectious mononucleosis; Back discomfort; Hives; Anemia; Hemorrhoids; bladder infection; Hernia; Ulcer; Cancer"physical examination, 08/11/08, -, no abnormal discovery, well health, well nourish; blood pressure, 08/11/-8, 108/6, -; physical examination, 08/11/08, -, lungs: clear to auscultation, no wheeze; physical examination, 08/11/08, -, heart: r" . During the same period patient was treated with "(therapy unspecified) FOSAMAX, WELLBUTRIN XL, cabbage palm, CECLOR, ZYRTEC 10 mg, diltiazem hydrochloride, diltiazem hydrochloride, doxycycline, fluticasone furoate, DYAZIDE, DIOVAN HCT, metformin, meoprolol, NITROLINGUAL, nortriptyline, KL". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328224
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 61 year old female with no pertinent medical history or allergy reaction who in November 2007, was vaccinated with ZOSTAVAX. There was no concomitant medication. In May 2008, the patient experienced shingles. As of 13-AUG-2008, the patient has not recovered. The patient did not seek medical attention. No further information is available." NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328227
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a female patient who in the spring of 2007, was vaccinated with a dose of ZOSTAVAX. In approximately March 2008, the patient underwent a knee arthroscopy. Four weeks later, in April 2008, the patient developed an excruciating nerve pain which had made it difficult for the patient to walk (nerve injections had no effect on it). The patient was seen by a neurosurgeon who thought the pain was due to shingles. On approximately 25-JUL-2008, the patient developed shingles blisters which were in the location of the pain (thigh) a week or so after minor surgery (for an unspecified reason) in that area. At the time of report, the outcomes were unknown. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328229
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial and follow-up information has been received from a physician concerning a 65 year old female patient with a history of chicken pox as a toddler and herpes simplex in February, 1980, who was vaccinated with ZOSTAVAX, given at another facility. Concomitant therapy included alendronate sodium (MSD) and INDERAL. On 02-AUG-2008, the patient experienced shingles and in 04-AUG-2008, was seen in office. Vesicular rash over the right flank and right leg, of 1-2 weeks duration. There was no fever, no pain. On an unspecified date, the patient recovered from shingles. The patient contacted physician's office. The patient thought that she contracted shingles from her father-in-law who had shingles in July, it was also reported that there was no exposure to chickenpox or herpes zoster within the last five years. The patient was enrolled in the Varicella Zoster Virus Identification Program to Identify if VSV is present and if it is present to identify if it was associated with the wild-type VZV strain or with the OKA/MERCK vaccine VZV strain. On 04-AUG-2008, a blood sample was collected. No PCR was collected." Hypertension; osteoporosisChickenpox; Herpes simplex"serum Herpes simplex immunoglobulin G antibody, 08/04/08, 2.12 index, positive; serum Herpes simplex virus immunoglobulin M antibody test, 08/04/2008, negative" . During the same period patient was treated with FOSAMAX; INDERAL LA; calcium. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328230
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a male who in November 2007, was vaccinated with ZOSTAVAX vaccine (Oka/Merck) (lot number, injection site and route not reported). In August 2008, the patient developed mild zoster. The physician drew a serum. It was unknown whether the patient sought any medical attention. Additional information has been requested. Follow up information was received which indicated that no adverse effect and no action was needed. Additional information is not expected." Unknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328232
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female in her mid 60's who on approximately 15-AUG-2007 was vaccinated with a dose of ZOSTAVAX. On approximately 10-AUG-2008, the patient developed shingles. The patient's outcome was unknown. Medical attention was sought in the physician's office. Follow up information was received from the physician who reported that the 72 year old patient on 19-JAN-2007 at 1:51 pm was vaccinate dwith her forst dose of ZOSTAVAX (Merck) (lot # 657559/0462U) in the left deltoid. Concomitant therapy included amlodipine, MICARDIS, and unspecified medication and simvastatin. On 08-AUG-2008 the patient developed shingles in the left breast are. At the time of this report, the patient recovered. Additional information has been requested. Additional ifnromation is not expected." UnknownUnknown . During the same period patient was treated with amlodipine; ZOCOR; MICARDIS. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328236
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. NA patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician, concerning a 62-63 years old patient, who approximately 07-JUL-2008 (also reported as about 6 weeks ago) was vaccinated with a dose ZOSTAVAX. The patient developed zoster lesions at the injection site. The patient recovered on an unspecified date. The patient sought medical attention on office visit. There was no product quality complaint. Additional information is expected." UnknownNone . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328237
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a male patient over 65 years old, who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Lot # was not provided). The patient experienced a herpes zoster rash. The patient developed the rash on his lumbar or his chest. The patient sought medical attention. There was no product quality complaint. Additional information is expected." Unknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328238
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician and a 72 year old female consumer with thyroid disorder, cholesterol, acid reflux and sulfa allergy and a history of chickenpox as a child, who on 07-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Lot #658398/1087U) in her left deltoid. Concomitant therapy included LEXAPRO, ~gilzedene~ (unspecified) and unspecified therapies for thyroid disorder, cholesterol and acid reflux. The patient did not experience a rash at the injection site or elsewhere within 42 days of the vaccination. The patient reported that on 04-AUG-2008, she experienced pain and on 06-AUG-2008 she developed a rash and went to her physician on 07-AUG-2008. The physician reported in conflict that the patient first developed a rash on 04-AUG-2008. On 07-AUG-2008, the patient was diagnosed with shingles on the right side from her chest to her back, right trunk anterior and posterior from below the breasts to waist from T1-T11. The doctor gave VALTREX and hydrocodone, but the patient did not take hydrocodone. The patient took ibuprofen. As of 18-AUG-2008, the herpes zoster persisted. There was no product quality complaint. Additional information is expected." Thyroid disorder; Cholesterol; Oesophageal acid reflux; Sulfonamide allergyChickenpoxNone . During the same period patient was treated with (therapy unspecified); (therapy unspecified); cholesterol; LEXAPRO; thyroid. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328241
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician's assistant concerning a female with a history of shingles who on approximately 12-AUG-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The patient developed shingles under her chin and abdomen with little or no pain after getting ZOSTAVAX (Oka/Merck). The patient was seen by doctor. No product quality complaint was involved. Additional information has been requested. ShinglesUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328242
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 78.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 78 year old female with no pertinent medical history or drug reactions/allergies, who on 06-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) 0.65 mL. There was no concomitant medication. On approximately 27-JUN-2008 (about 3 weeks after receiving the vaccine), the patient experienced a mild case of shingles in her foot and buttock. The patient sought medical attention and saw the physician. A couple of weeks after getting shingles, the patient had recovered, no labs or diagnostics studies were performed. Additional information is not expected." NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328243
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient, 81.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning an 82 year old male who was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The patient experienced shingles at an unspecified time after receiving ZOSTAVAX (Oka/Merck). The patient sought medical attention and was seen by the physician. Additional information is not expected. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Initial and follow-up information has been received from a pharmacist concerning an 82 year old male with high cholesterol and history of varicella as a child, who on 08-JUN-2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # reported as 020900-invalid) 0.5 mL into his right arm. Concomitant medication included LIPITOR, aspirin and omega-3 marine triglycerides. On 01-AUG-2008, the patient experienced shingles after receiving ZOSTAVAX (Oka/Merck). The patient developed a rash and multiple lesions on his right axilla and chest. Distribution of herpes zoster lesions were found in T3 right dermatome. There was no pain in the lesions. Immediately post vaccination the patient was found to be hypothyroid with low testerone. He was good on prior testing. Patient was found to have hypothyroidism and low testosterone post zoster. There was no recent exposure to chickenpox or shingles. At time of reporting, the patient was recovered. The patient sought medical attention and was seen by the physician. Additional information is not expected." Cholesterol highVaricellaUnknown . During the same period patient was treated with LIPITOR; aspirin; omega-3 marine triglycerides. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328244
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a consumer concerning her husband with fibrosis of the lungs who was vaccinated with ZOSTAVAX (Oka/Merck). The patient developed shingles and his lidocaine patches (manufacturer unknown) and NEURONTIN put into a cream did not aid in soothing his shingles. This is one of several reports received from the same source. No further information is available. Pulmonary fibrosisUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328245
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX (Oka/Merck). The patient may have had a case of shingles. The physician didn't know if the patient had had the vaccine or not. Further information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328248
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a licensed practical nurse who reported that in the ~last 3 months~ (from approximately May, 2008) she had been administering zoster vaccine live (Oka/Merck) 0.65 ml SQ to an unspecified number of male and female patients over 60 years old. Subsequently, the nurse experienced shingles. On 07-AUG-2008 the nurse experienced pain in the right leg, buttocks and lower back. On 11-AUG-2008, the nurse went for a Doppler test because she thought something was wrong with her leg. Results of the test were unknown. On 14-AUG-2008 the nurse broke out in a rash (unspecified areas). The nurse did have some fluid filled vesicles but they have all dried up and now they looked like little red pimples, The nurse had taken VALTREX. As of 20-AUG-2008 the nurse had not recovered. This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a licensed practical nurse who reported that in the ~last 3 months~ (from approximately May, 2008) she had been administering ZOSTAVAX (Merck) 0.65 ml SQ to an unspecified number of male and female patients over 60 years old. Subsequently, the nurse experienced shingles. On 29-JUL-2009, the nurse gave ZOSTAVAX (Merck) to a patient who had bleeding. The nurse wiped the patient's arm with an alcohol swab. About 2 weeks later, around the week of 11-AUG-2008 the nurse experienced pain in the right leg, buttocks and lower back. On 11-AUG-2008, the nurse went for a Doppler test because she thought something was wrong with her leg. Results of the test were unknown. On 14-AUG-2008 the nurse broke out in a rash at her buttock and back. The nurse did have some fluid filled vesicles but they have all dried up and now they looked like little red pimples. The nurse had taken VALTREX. Subsequently, the nurse recovered, though she was off of work for one week. Additional information is not expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328249
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 85.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from an 85 year old female with sulfonamide allergy who in May 2007, was vaccinated with ZOSTAVAX (Oka/Merck). There was no concomitant therapy. In May 2008, a year later, the patient came down with a terrible case of shingles on her eyelids. The patient was still experiencing the nerve pain, and also became anemic and had tests done for that (colonoscopy, endoscopy). The patient also mentioned that VALTREX affected her kidneys. The patient sought medical attention. Additional information has been requested." Sulfonamide allergycolonoscopy; endoscopy . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328296
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female patient over 65 years old, who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot # was not provided). The patient experienced a herpes zoster rash. The patient developed the rash on her lumbar or her neck. Additional information is expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328301
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 65 year old female with environmental allergies who in October or November 2007, was vaccinated with a 0.65 mL dose of ZOSTAVAX (lot number, injection site and route not reported). Concomitant therapy included heart medication, thyroid and simvastatin (MSD). In approximately October 2007, also reported as 2 weeks after the vaccination, the patient experienced a case of shingles. The patient This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a 65 year old female with environmental allergies who in October or November 2007, was vaccinated with a 0.65 mL dose of ZOSTAVAX (Oka/Merck) (lot number, injection site and route not reported). Concomitant therapy included heart medication, thyroid and simvastatin (MSD). In approximately October 2007, also reported as 2 weeks after the vaccination, the patient experienced a case of shingles. The patient has had 5 cases of the shingles since receiving the vaccine. The patient developed a lot of blisters underneath her arms. The patient would be seeing a neurologist to determine why the shingles kept reoccurring. Two weeks ago, the patient recovered from shingles. Additional information is not expected." Environmental allergyNone . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328306
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer who read on a online blog that a male patient with Parkinson's disease on a date not reported, was vaccinated with ZOSTAVAX (Oka/Merck). The patient developed shingles two weeks after he got vaccinated with ZOSTAVAX (Oka/Merk). This is one of several reports received from the same source. No further information is available." Parkinson's diseaseUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328309
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a practice manager concerning a patient who in October 2007 was vaccinated with ZOSTAVAX (Oka/Merck) and developed shingles. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328314
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a patient who was vaccinated with a dose of ZOSTAVAX. On an unknown date, the patient developed shingles. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328315
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 72 year old female with history of chickenpox in her childhood, who on 01-AUG-2008 was vaccinated with a dose of ZOSTAVAX (LOT # 658859/0411X) 06.5mL subcutaneously into her left deltoid. Concomitant therapy included alendronate sodium (MSD), atenolol and lovastatin (manufacturer unknown). On 04-AUG-2008, the patient developed shingles. The patient had 6-7 patches with vesicles on her left C-5 dermatome. On 05-AUG-2008, the patient began to experience pain in her left thumb. On 07-AUG-2008, the patient developed rash on the fingers of her left hand and spread to her arm. On 11-AUG-2008, the patient's vesicles on her left arm were diagnosed as shingles. Pain was quantified as 8, being 10 the most painful. The patient was being treated with VALTREX and ibuprofen. At th etime of reporting, the patient was recovering. There were no laboratory diagnostic studies performed. At time of reporting, the patient was recovering. Additional information is not expected. Follow up: The patient was enrolled in the Varicella zoster virus Identification program to identify if VZV is present and if it is associated with the wild type VZV strain or with the Merck vaccine VZV strain. The sample of the lesion was collected on 13-AUG-2008. The sample was taken from a not fluid filled vesicle lesion in her left arm. VZV DNA was not amplified. The PCR rersults for the specimen from the not fluid filled vesicle lesion, identified an inadequate specimen, negative for B-Globin, no strain I.D. Additional information is not expected." Chickenpox"VZV strain, 08/25/08, Inadequate specimen, Negative for B-Globin, no strain I.D." . During the same period patient was treated with FOSAMAX; atenolol; MEVACOR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328316
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Female patient, 76.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer concerning her wife 76 year old with high blood pressure and no known allergies who about one year ago in approximately August 2007, was vaccinated with ZOSTAVAX. Concomitant therapy NORVASC. The husband reported that her wife developed an increase in the episodes of shingles since receiving ZOSTAVAX, about one year ago (date unspecified). To patient had a history of shingles episodes 3-4 times per year before receiving ZOSTAVAX. The patient developed an episode of shingles about 3 months after received ZOSTAVAX and had continued with episodes about every 5 weeks. The patient told the physician of the first episode but, not the subsequent shingles. The symptoms were a groin rash radiating to the buttocks that resolved in an unspecified time frame (also reported as recovering). The episodes of shingles are reported as more frequent but less severe than the episodes prior to ZOSTAVAX. No other symptoms and treatment reported. There was no product quality complaint. Additional information has been requested." Blood PressureShinglesUnknown . During the same period patient was treated with NORVASC. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328318
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 09/24/2008. Male patient, 91.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 91 year old male patient who on 20-APR-2007, was vaccinated with ZOSTAVAX. On 09-MAY-2007, the patient got shingles. The patient sought medical attention at physician's office and phone called the physician. On an unspecified date, the patient recovered from shingles. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #327844
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 10/09/2008. NA patient, 73.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Patient had Zoster vaccine on 7-8-08. Went to doctor on 8-15-08 after having pain and 3-4 blisters on face for approximately 1 week and was dx with Shingles. Dr. tx with Azithromycin pack and Prednisone at that time. On 10-4-08, patient had a reoccurrence of Shingles in the waistline area and was seen by the doctor on 1--6-08 and was tx with Famciclovir 500mg TID x 3 days with 1 refill. Patient still has lesions but much improved and pain is also lessened." NoneNone . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328424
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 10/14/2008. Male patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Herpes Zoster onset 9/29/08, diagnosed 10/3/08 V1 distribution. Disseminated zoster diagnosed 10/6/08 requiring hospitalization for IV acyclovir 10/6/08 to 10/9/08 at Hospital. Recovered. 10/20/2008 MR received for DOS 10/6-9/2008 with D/C DX: Disseminated zoster. Asthma. Hx of HTN. Hx of tubular adenoma. Pt presented with Shingles rash already Dx'd for antiviral tx. Itchy rash is on L side of face, and scalp as well as multiple small eruptions on trunk and R arm. Mild h/a for last week. Ophth r/o ophthalmic involvement. Tx with Acyclovir." Hypertension"Allergy to morphine, allergic rhinitis. PMH: Asthma. HTN. Tubular Adnenoma. allergy to morphine""unremarkable. Labs and Diagnostics: CT scan Abd & Pelvis unremarkable. CXR (+) for mild atelectasis, otherwise WNL. Labs unremarkable." . During the same period patient was treated with "Advair, Spiriva, Aspirin, folic acid, multivitamin". Patient was hospitalized Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328501
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 10/14/2008. Male patient, 73.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 73 year old male with type 2 diabetes mellitus and hypertension who on 20-MAR-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot #658210/1079U). Concomitant therapy included sitagliptin phosphate (MSD), insulin, PRECOSE, BYSTOLIC, PRAVACHOL, ezetimibe (MSD), SYNTHROID and DETROL LA. Subsequently the patient experienced vaccine failure. The patient had no prior history of shingles when he received ZOSTAVAX (Oka/Merck). On 16-SEP-2008, after receiving ZOSTAVAX (Oka/Merck), he had an outbreak of shingles. The physician's notes state that he had LT to L2 distribution of shingles. The shingles began in the middle of the back and went around on the left side to the buttocks and down the buttocks to the left groin area. Then from the left groin area they went down the left leg to just above the knee. The patient had severe itching and experienced a slightly elevated temperature. On 18-SEP-2008, two days after the shingles first appeared, the patient had weakness in his legs and collapsed. He had to be admitted to the hospital for four days. The patient was recovering from the shingles and had some residual marks and scarring and sometimes experiences itching. Additional information has been requested." Type 2 diabetes mellitus; HypertensionNone . During the same period patient was treated with PRECOSE; ZETIA; insulin; SYNTHROID; BYSTOLIC; PRAVACHOL; JANUVIA; DETROL LA. Patient was hospitalized Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #328909
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 10/16/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX (Oka/Merck) (date and dose was not reported). Subsequently the patient experienced shingles and was hospitalized. The outcome of the shingles was not reported. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #329232
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 10/20/2008. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "6 inch local injection site reaction, hard, painful, red, and itchy for one week following the injection. Patient had previously experienced 5 episodes of very painful shingles. New episode started on October 19th following vaccination on October 8th." None"Allergy to statins, Previous shingles diagnosis"None . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #329285
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 10/20/2008. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from an office manager concerning a 63 year old female with cardiac failure congestive and diabetes and a history of breast cancer and chemotherapy in late 1990's who on 01-OCT-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot #658208/0886U). Concomitant therapy included LANOXIN, SYNTHROID, hydrochlorothiazide, losartan potassium (MSD), DIGITEK, simvastatin (MSD) and GLUCOPHAGE. On 04-OCT-2008 the patient developed a zoster rash on her left thorax area. The patient was in pain. The patient was seen in a physician's office and was prescribed VALTREX. The outcome of the patient was not reported. The reporter considered zoster rash on left thorax area and pain to be disabling because ~the patient is unable to work until lesions dry up~. Additional information has been requested." Cardiac failure congestive; DiabetesBreast cancer; ChemotherapyUnknown . During the same period patient was treated with LANOXIN; DIGITEK; hydrochlorothiazide; SYNTHROID; COZAAR; GLUCOPHAGE; ZOCOR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #329411
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 10/21/2008. Female patient, 64.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "On 9/10/08 patient had terrible pain down right side of chest and right arm; went to ED and was discharged with ~sprained arm~ and a splint. Went to family physician the next day and was diagnosed with shingles; was referred to dermatologist for second opinion and diagnosis was confirmed. Patient placed on Valtrex. Sts pain and swelling on right elbow was excruciating. States ~felt like a huge boil that wouldn't erupt.~ Unable to bend arm for a few days. Pain lasted approx. 3 weeks." NoneNoneNo known diagnostic tests completed. . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #329911
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 10/21/2008. Female patient, 78.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Approximately 6 1/2 months after receiving the ZOSTAVAX Shingles vaccine, diagnosed with bad case of Shingles - large, red painful rash radiating from middle of back, under (L) arm and breast. Treated with VALTREX, Lidocaine Gel, ATARAX; DARVOCET. Mod to mild pain after Shingles rash dried up. Still recovering." NoneDM; HTN . During the same period patient was treated with LIPITOR; ZETIA; Insulin; LASIX; Potassium; ASTELIN. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #329919
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 10/21/2008. Male patient, 80.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Approx. 4 months after receiving ZOSTAVAX vaccine, diagnosed with bad case of shingles - large red painful rash around L trunk. Severe pain after blisters heated. Pt said it took 7-8 wks to fully recover." None . During the same period patient was treated with Zyrtec. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #330104
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 10/17/2008. Female patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, 10/15/2008 Contacted office-ask to return call. 10/16/08 Return call -received vaccine ZOSTAVAX 10/30/08 and noted rash on (R) leg. Saw PCP-confirmed shingles-10/10/08 started on VALTREX and steroids per PCP. Pt states pain (R) leg shin area with rash (+) pain fine. None"Allerg: PCN, COUMADIN (Cardiac- LOVENOX 90 mg, IBS-ASOCOL bid)" . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #330323
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 10/18/2008. Female patient, 69.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Despite vaccination, pt developed severe case of zoster in perineal and rectal region (L) side" Seizure disorder . During the same period patient was treated with KEPPRA. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #331292
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 11/11/2008. Female patient, 61.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, First outbreak of shingles both sides of face. 2nd outbreak of shingles; both sides of face. Never any shingles rash prior to vaccine 2/08. NoneNoneConfirmed by MD - shingles . During the same period patient was treated with Multivitamins. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #331332
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 10/29/2008. Male patient, 76.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Developed shingles, diagnosed on 10/22/08 by culture" None KnownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #331466
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 11/05/2008. Female patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient stated that she started feeling cramps & bloating in June (received shingles vaccine on 8/27/08). Patient claims that symptoms began the Saturday after receiving the vaccine. Dr diagnosed patient w/shingles @ the ER. Patient was given pain medication & told that nothing else could be done. Since then she has followed-up w/her PCP who per patient performed an ultrasound on her abdomen & found nothing wrong w/her pain meds & laxatives were given for condition. None~"Had Emphysema in 1993~"Ultrasound done 10/24/08 @ PCP's office. . During the same period patient was treated with "(after onset of sx) Pain medication did not specify, Laxatives, flu vaccine 10/24/08". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #331858
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 11/06/2008. Male patient, 82.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Started Prednisone 50 mg x 2d, Phen 40 mg x 2d etc (in tapering fashion) on 10/31. Left leg pain and rash. Started 11/1 or 11/2, seen on 11/5 had typical Zoster rash. Distribution left leg." NoneAtrial fib; HTN; COPD; BPH; Anxiety; OsteoarthritisNone . During the same period patient was treated with Coumadin; Metoprolol; Diltiazem; Terazosin. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #332723
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 11/18/2008. Female patient, 66.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, 11-11-2008 Developed rash on right buttocks and right legs with itchiness and pain. Saw Dr. on 11-13-08 Diagnosis Shingles Rx Zovirax pills and Kenalog cream given. Spoke with patient on 11-18-08 patient states rash looks like it is getting better. None"Hypertension, Hyperlipidemia, Asthma"None . During the same period patient was treated with "Proventil, atrovent,Lipitor, Benacar HCT, Vitamins OTC". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #333151
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 11/24/2008. Male patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Pain in right shoulder starting 11/12/2008. Initial visit to orthopedic surgeon. He felt pain was from inflammation of the shoulder and prescribed naproxen. Pain did not go away and by 11/14/2008 a rash appeared. I visited my Internist and he thought the rash was some type of allergic reaction. On 11/17/2008 I went back to my internist and he confirmed a diagnosis of shingles. He then prscribed an antiviral med. NoneNone . During the same period patient was treated with "Atenolol, protonix, crestor.". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #333191
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 11/24/2008. Male patient, 78.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Pt phoned 11/24/2008- 2 days after vaccine developed rash on buttocks (red bumps, blisters) about area of 3 square inches-~slightly itchy~. Pt went to dermatologist, who informed him it was ~shingles~ and gave him Zovirax and informed Dr. Rash still present 11/24." NoneNone reportedNone mentioned/given . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #333240
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 11/24/2008. Male patient, 78.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a 78 year old male with a history of unspecified prostatic operation who on 07-NOV-2008 was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included statin (unspecified) and unspecified prostate medication. On 13-NOV-2008 the patient developed shingles. The patient was put on BANCTROBAN and was feeling much better ~today~ (19-NOV-2008). At the time of this report, the patient was not recovered. The patient sought medical attention by office visit. Shingles was considered to be immediately life-threatening and disabling. Additional information has been requested." Prostatic operationNone . During the same period patient was treated with [therapy unspecified]; Statin (unspecified). Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #333241
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 11/24/2008. Female patient, 20.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse (R.N.) concerning her 20 year old grand daughter who got a letter from her in late August or early September (WAES# 0809USA03784). The R.N. developed shingles on 01-SEP-2008. On 06-SEP-2008 her grand daughter was diagnosed with shingles on the left side of her face. At the time of this report, the outcome was unknown. Follow up information was received from the R.N. who reported that in the morning of 01-SEP-2008 her granddaughter with no pre-existing allergies, birth defects and medical conditions who developed blisters which fluid filled, painful line broke out on left upper cheek tracking to and into left eye. On 08-SEP-2008 the patient went to emergency room and was diagnosed with shingles. At the time of this report, the outcome was unknown. Shingles was considered to be disabling and an other important medical event. Additional information is not expected. This is one of several reports from the same source." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #333242
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 11/24/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse (R.N.) concerning herself who in late June 2008 vaccinated her husband with a dose of ZOSTAVAX (Merck). About a week later, her husband developed a mild, red, ~heat~ rash (WAES# 0809USA02419). On 01-SEP-2008 she started to develop shingles lesions on the left side of her face. On 05-SEP-2008 she was diagnosed with shingles by her family physician. She was treated with ZOVIRAX ointment and TYLENOL WITH CODEINE #3. She was already on therapy with hydrochlorothiazide, atenolol, aspirin and CRESTOR. She developed about 12 vesicular lesions. At the time of this report, the patient was recovering. Follow up information was received from the R.N. who reported that at 9AM on 12-JUL-2008 she vaccinated her husband with a first dose of ZOSTAVAX (Merck) (lot# 659409/0409X) subcutaneously in his right arm. She had no pre-existing allergies, birth defects and medical conditions. In the morning of 01-SEP-2008, she experienced blisters with fluid filled, lesion on left side of lung, painful line broke out on left lower jaw tracking to left lower lip and pain left ear. On 06-SEP-2008 she visited a physician and was diagnosed with shingles. At the time of this report, she recovered. Shingles was considered to be disabling and an other important medical event. Additional information is not expected. This is one of several reports from the same source." UnknownUnknown . During the same period patient was treated with aspirin; atenolol; hydrochlorothiazide; CRESTOR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #333334
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 11/25/2008. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial and follow-up information has been received from a physician concerning a 63 year old female with high blood pressure and high cholesterol and no allergies, who on 15-JUN-2007 was vaccinated with ZOSTAVAX (Merck). Lot # 657676/0619U, intramuscularly into her left deltoid. Concomitant therapy possibly included Simvastatin (MSD) and Lisinopril (manufacturer unknown). It was reported that the patient on 30-JAN-2008 developed shingles. It began as pain only, in back and to right side at about T6-T8 level dermatome. Pain increased and red, vesicular rash appeared in dermatomal band on 06-FEB-2008 (previously reported as shortly before 07-FEB-2008). Patient was given ZOVIRAX, prednisone, and LYRICA. But she still developed postherpetic neuralgia. The symptoms persisted for approximately two months. On approximately 18-MAR-2008 (previously reported as by April 2008), the patient has completely recovered. There were no laboratory test performed, in follow-up information the physician also reported ~unfortunately, no testing of vesicles was done (because the rash and pain were pathognomonic for herpes zoster)~. In follow-up information shingles and post-herpetic neuralgia were considered to be and other important medical events. No further information is available." Blood pressure high; Cholesterol highNone . During the same period patient was treated with Lisinopril; ZOCOR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #333564
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 11/19/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "11/11/08 PM developed swelling and tenderness below left breast in a 4-5~ bend from mid chest ground left side to mid back. went to good 5 am . No symptoms at injection site. Improved ZANTAVAC, surgeon diagnosed Shingles treatment 11/13/08, she developed rash and blisters on front of trunk and on back. 11/17/2008 filled prescriptions for PREDNISONE 20mg and FAMATEVIX? 500mg from local dermatologist." NoneLeft breast cancer; Migraine; restless leg syndrome; sleep apnea; OrthopeniaCBC; Chest X- Ray . During the same period patient was treated with NEXIUM; ATENOLOL; TREZADONE; REQUIP; MAXALT. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #333568
ZOSTER (ZOSTAVAX) vaccine side effect was reported . NA patient, 79.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient developed herpes Zoster shingleo in Nov 2008 Vaccine given 6/17/08 None . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #333623
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/01/2008. Male patient, 69.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial and follow-up information has been received from a pharmacist and a certified medical assistant, concerning a 70 year old male with hypertension, hypercholesterolaemia and not known drug allergy and a history of gastrooesophageal reflux disease and chickenpox in his childhood, who on 27-OCT-2008 at 9:00 a.m., was vaccinated with ZOSTAVAX, Lot number 662970/1207X, 0.65 mL, subcutaneously in back of the left arm. The certified medical assistant reported that concomitant therapy included ezetimibe (+) simvastatin (MSD), aspirin (ASA), AVAPRO and LOPRESSOR. The patient on unspecified dates, was also vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscularly into the deltoid and influenza virus vaccine (unspecified) (manufacturer unknown), 0.5 ml, intramuscularly into the deltoid. The pharmacist reported that the patient was diagnosed with zoster after receiving ZOSTAVAX. The patient was being treated with VALTREX 1 gram three times a day for 7 days. The certified medical assistant reported that the physician was interested in collecting and sending isolates for a VZVID analysis. The office scheduled a call on 05-NOV-2008. At the time of the report the patient had not recovered. The patient sought medical attention at office visit. In follow-up received on 05-Nov-2008, the physician reported he planned on asking the patient to return to the office and obtain a specimen. The physician did not further describe the status of the patient other than to report that the patient's rash which he felt was herpes zoster was on his forehead. In follow-up information, received from a questionnaire, the certified medical assistant reported that the event begun on 04-NOV-2008 and the rash did not occur at the site of injection post-vaccination. The pharmacist was not sure of a rash occurred at the site of injection post-vaccination. The patient had a dermatome C2 and the rash was located on his forehead into scalp. It was reported that the maximum patient's temperature was 98.6 degrees and the patient felt pain quantified as 4 (b" Hypertension; HypercholesterolaemiaGastrooesophageal reflux disease; Chickenpox"lesion excision, 11/10/08, lesion for PCR test; body temp, 98.6 degrees, maximum temp, VZV strain, 11/12/08, inadequate specimen, no strain identified" . During the same period patient was treated with aspirin; VYTORIN; AVAPRO; LOPRESSOR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #333714
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 11/10/2008. Female patient, 73.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Pt received ZOSTAVAX on 2/13/08 and had reported having shingles. Anti-viral and pain meds were given for ADR . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #333919
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/03/2008. Female patient, 66.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Vaccine administered 10/30/08. Diagnosis of shingles made 11/14/08. (1) with onset of symptoms 11/6/08. (2) with onset of symptoms of rash 11/8/2008. NoneNoneNone . During the same period patient was treated with CARTIA; METOPROLOL SR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #334372
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/04/2008. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Twelve hrs after vaccines, had dry cough, 4 days later progressed to chest pain, seen at hospital, CXR showed pneumonia ; and shingles rash developed (L) abdomen. The day she was seen for pneumonia! Both diagnosed by doctor." None"HTN, DM, hyperlipidemia, GERD, asthma, diverticulosis""chest xray, exam" . During the same period patient was treated with "LIPITOR, PREVACID, ZIAC, ALTACE, OTC PRV". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #334498
ZOSTER (ZOSTAVAX) vaccine side effect was reported . NA patient, 76.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Shingles herpes zoster virus. Had shingles. Dr. sent letter for me to take vaccine ZOSTAVAX, CPT code 90736. Took vaccine on 12-17-07, has not heal yet." Hurting; itching"Feb. 15, 2007" . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #334625
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/09/2008. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Patient received shingles vaccine on 11/21/2008. Outbreak of shingles on 12/1/2008. MD visit on 12/5/2008 and was informed by MD to call to report to manufacturer. NoneNoneConfirmed shingles by Pmd . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #335426
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/16/2008. Male patient, 47.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Patient was given vaccine in 11-5-08. She had soreness of upper extremities before ZOSTAVAX was given. Over the last 6 weeks, she has complained of her left shoulder being numb. She was using Diclofenac Gel on shoulder for pains. Saw Dr. 12/16/08, confirmed Shingles." Previous Shingles outbreak; Joint PainNone . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #335766
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/19/2008. Male patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, local shingles; cellulitis none . During the same period patient was treated with "seroquel, lisinopril, atenolol, sertraline, diclofenac". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #336206
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/29/2008. Male patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, 3 1/2 year old grandson developed herpes zoster skin lesions two days after exposure to patient getting Zostavax vaccine. NA . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #336987
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 79.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received form a Registered pharmacist concerning an 80 year old female with no pertinent medical history and no drug reactions or allergies, who on 28-SEP-2007 was vaccinated with ZOSTAVAX (Oka/MERCK) (lot # not reported), via subcutaneously. The patient experienced an out break of shingles. The patient sought an unspecified medical attention. No further information is available at this time. Additional information has been requested." NoneUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #336989
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 06/24/2009. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 62 year old female with no pertinent medical history and no drug reactions or allergies, who in February 2008 was vaccinated with ZOSTAVAX (Merck) (lot # 659672/0294X, dose, route not reported). There was no concomitant medication. In June 2008, the patient experienced an outbreak of shingles mostly on her face. The most recent case of shingles was in October 2008 and she was still experiencing it. The patient's eyes are almost swollen shut. The patient never had shingles before getting the vaccine. The patient sought unspecified medical attention. No lab diagnostics studies performed. The events were not recovered. No further information provided. Additional information is not expected. This is in follow-up to report (s) previously submitted on 12/23/2008. Follow up information has been received from the consumer. She stated that she had been diagnosed with dermatitis and not shingles. Additional information is not expected." NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #336992
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received concerning an approximately 75 year old male patient who in ~early summer 2008~ (in June 2008), was vaccinated with ZOSTAVAX (Lot # not available) and subsequently the patient broke out with shingles along his back and shoulders shortly afterward. The patient's persisted. The patient sought medical attention. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #336993
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 65 year old female with drug reaction/allergy to Tiazac, Ultram, Diflunisal (MSD) (WAES # 0811USA01605), Cymbalta, Enablex, Lyrica, Mobic, Coreg, Topamax and Keppra who in approximately 2007 (reported as ~approximately one year ago~) was vaccinated with ZOSTAVAX. Concomitant therapy included Cardene, MSD, Vagifem, Atrovent, MSD, Astelin, Nasonex, Celebrex, Restasis, Cafergot, Midrin, Reglan, Lamictal, Lidoderm, vitamin A, vitamin D (unspecified), glucosamine, fish oil, folic acid, omeprazole and guaifenesin. The physician reported that on approximately 23-OCT-2008 (reported as ~2 weeks ago~) the patient was experiencing a mild case of shingles. At the time of reporting the patient had not recovered. No labs/diagnostic tests were performed. The patient sought medical attention: was seen by the physician. There was no product quality complaint. Additional information has been requested." Drug hypersensitivityNone . During the same period patient was treated with Midrin; Astelin; Cafergot; Celebrex; Restasis; Vagifem; Folic Acid; Glucosamine; Guaifenesin; Atrovent; Lamictal; Lidoderm; Cozaar; Reglan; Nasonex; Singulair; Cardene; omega-3 marine triglycerides; omeprazole; tizanidine hydrochloride; vit. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #336994
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 69.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a 71 year old female who in 2006 was vaccinated with ZOSTAVAX (Merck), 0.65 ml and had a case of shingles just recently in November 2008. Follow-up information was received from a pharmacist which reported that the patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the Merck vaccine VZV strain. The date of vaccination was on 17-APR-2007, dose 0.5ml, in the right upper arm (lot# 656394/0162U). Concomitant therapy included ATENOL, Calcium (unspecified), TYLENOL, CADUET, COMBIVENT and vitamins (unspecified). The patient did not develop a rash at injection site or elsewhere within 42 days of the vaccination. The patient did not develop a rash at injection site or elsewhere within 42 days of the vaccination. The patient had multiple lesions in her head, right arm including shoulder. There was pain in the lesions. There was no recent exposure to chickenpox or shingles. At time of reporting, the patient was recovered. Additional information is not expected." Osteoarthritis; Drug hypersensitivitySmokerUnknown . During the same period patient was treated with TYLENOL; COMBIVENT; CADUET; ATENOLOL; CALCIUM (unspecified); FUROSEMIDE; VITAMINS (unspecified). Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #336996
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a male with history of about 6 cases of shingles, and no drug reactions or allergies, who in May 2006, was vaccinated with ZOSTAVAX, 0.65 ml injection (lot # not reported). Concomitant therapy included Valtrex. In September 2008 two years went by, the patient developed another case of the shingles. The patient sought unspecified medical attention. Routine labs were performed. The patient's shingles was not recovered. No further information was provided. Additional information is not expected." ShinglesUnknown . During the same period patient was treated with Valtrex. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337002
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 81.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an 81 year old female patient who in approximately 2007 was vaccinated with a dose of ZOSTAVAX. On 23-OCT-2008 the patient experienced sore throat and went to an urgent care facility then the ER the next day. The patient then developed shingles. She had a rash on her face (cheek) and lesions in her mouth, exactly on half the mouth. At the time of this report, the patient was recovering. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337007
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 71 year old female with allergic to Codeine , History of allergic to dust and many other things, who on 04-Nov-2008 was vaccinated with ZOSTERVAX. Concomitant therapy included NEXIUM, ALLEGRA, NASONEX and unspecified thyroid medication. On 04-Nov-2008 the patient experienced tingling sensation on the top of her head shortly after receiving ZOSTERVAX. The next day it became a burning and stinging pain. The patient went to the emergency room and they felt that it could be shingles out break but were unsure because there was no rash along with the pain. Many unspecified tests were performed. The events have not been recovered. Additional information is not expected." Multiple allergies; Drug hypersensitivityUnknown . During the same period patient was treated with "NEXIUM, ALLEGRA, NASONEX". Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337008
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX (lot @ not provided). 3 months after the vaccination, the patient experienced shingles. The patient saw the physician. At the time of the report, on 11-NOV-2008, the outcome of the patient was unknown. Additional information has been requested." Unknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337009
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 92.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 92 year old female who ~a year and a half ago~ in approximately May 2007, was vaccinated with ZOSTER (Oka/Merck). On 11-NOV-2008 the patient experienced shingles. The patient had sought medical attention from the physician. At the time of reporting, the outcome of the shingles was unknown. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337021
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 52.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer who on 14-NOV-2008 was vaccinated with a dose of ZOSTER (Oka/Merck). She reported that ~3 days ago~, on 14-NOV-2008, her 52-year-old son who lives with her started to experience fever, chills and soreness on the right side of his head and he was in bed for 3 days. Per mother, when her son went to a physician, he was advised that he had shingles because of his symptoms. ~Visual examination~ was performed. At the time of the report, on 17-NOV-2008, the patient had not recovered from the event. Additional information has been requested." HepatitisUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337110
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning a female patient who was vaccinated with 0.65 ml dose of ZOSTER vaccine and after receiving the vaccine developed a case of shingles. Eventually the patient experienced herpetic neuralgia. The patient sought medical attention. At the time of reporting. the patient had not recovered. This is one case of two cases received from the same source. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337117
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 81.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an 81 year old female with penicillin and sulfa allergies and hypothyroidism, hypertension, gastroesophageal reflux disease and sleep apnoea who on 7-NOV-2008 was vaccinated with ZOSTER vaccine (lot # 663196/1417X) (dose not reported). There was no concomitant medication. On 17-NOV-2008, ten days after the vaccination the patient developed shingles after receiving ZOSTER vaccine. The patient developed non painful vesicular rash behind her right ear. The physician saw the patient. No lab diagnostics studies was performed. As of 24-NOV-2008 the patient was recovering from shingles. No further information is available. Additional information has been requested." Hypothyroidism; hypertension; Gastroesophageal reflux disease; sleep apnoea; sulfonamide allergy; penicillin allergyNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337119
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse concerning a 70-year-old male patient who in March 2008 was vaccinated SQ with a dose of 0.65 ml ZOSTER vaccine (lot number and injection site unknown). Subsequently, ~within about 5 days of getting ZOSTER vaccine, the patient developed shingles. The patient was treated and sent to a dermatologist. The patient's outcome was not reported. The reporter also stated that the ZOSTER vaccine caused the shingles. No product quality complaint was involved. Additional information has been requested." Unknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337121
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has bee received from a registered nurse concerning a 70 year old male patient who in approximately March 2008, was vaccinated with a dose of ZOSTER vaccine (lot # not provided). In approximately March 2008, within 5 days of getting vaccinated with ZOSTER vaccine, the patient developed shingles. The patient sought medical attention, he was ~treated and sent to dermatologist~ The registered nurse felt that shingles was related to therapy with ZOSTER vaccine. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337124
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 03/27/2009. Male patient, 79.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a health professional concerning an 80- year old male patient who sometime in late April or early May 2008 was vaccinated with a dose of ZOSTAVAX vaccine at another site. On 21-NOV-2008, the patient developed the shingles. The patient sought unspecified medical attention. At time of reporting, it is unknown if the patient recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/23/2008. Follow-up information has been received from a completed questionaire on 10-FEB-2009, from a nurse practitioner. It was reported that the 80 year old male patient with rheumatoid arthritis, gastroesophageal reflex disease, coronary artery disease, chronic obstructive pulmonary disease, osteopenia, protate cancer, vitamin B12 deficiency and chronic renal insufficiency and a history of chickenpox in childhood, in April 2008, was vaccinated with a dose of ZOSTAVAX vaccine at a local pharmacy. Concomitant therapy included methotrexate,REMICADE, PRILOSEC, metoprolol, ACTONEL, TYLENOL, and cyanocobalamin. On 31-NOV-2008 the patient developed 3 small clusters of vesicles in the right side of back and lateral chest. Systemic symptoms included mild skin eruptions and neuralgia. A rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. The patient had a maximum body temperature measurement of 98.6. There was no a direct fluorescence antibody done and the specimen was not collected for Polymerase Chain reaction. There was no a photo taken. As of 08-JAN-2009 the patient recovered. Additional information is not expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337125
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 83.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician and a nurse concerning an 83 year old male patient with diabetes and on dialysis who in 2007 was vaccinated with 0.65ml dose of ZOSTER vaccine. The physician stated that the patient developed shingles this year after receiving ZOSTAVAX last year. At the time of this report it is unknown if the patient recovered. The patient sought unspecified medical attention. Additional information has been requested. Diabetes; DialysisUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337126
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 73.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 74 year old female concerning himself, with a history of chickenpox (when was little) and sulfonamide allergy, who on 08-JAN-2008 was vaccinated with ZOSTER vaccine (Lot # 658396/0967U), 0.65 ml, subcutaneously. Concomitant therapy included SIMVASTSTIN (MSD). The caller stated that in November 2008, the patient developed shingles in the left side of her scalp after having been vaccinated with the vaccine. Her physician prescribed VALTREX. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested." Chickenpox; sulfonamide allergyNone . During the same period patient was treated with ZOCOR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337127
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 66.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial information has been received from a physician and follow up information from a health professional concerning a 66 year old female patient who with no known allergies who on 21-Oct-2008 was vaccinated intramuscularly in her right deltoid with 0.65ml dose of ZOSTER vaccine (lot# 659406/0298X). Concomitant therapy included vitamins (unspecified). On 25-Oct-2008 the patient developed an eruption on the left side of her neck with approximately 5 lesions, along a dermatome consistent with shingles (also reported as mild shingles) and no pain (0 on a scale of 0 to 10 with 10 being the highest). A direst fluorescent antibody was not performed. A photo was not taken. At the time of this report the patient had recovered. The patient was enrolled in the VARICELLA ZOSTER virus identification program to identify if VZV is present and if it is present to identify if it is associated with the wild- type VZV strain. No further information is available." UnknownUnknown . During the same period patient was treated with Vitamins (unspecified). Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337212
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer and a physician concerning his 63 year old wife with no pertinent medical history and no drug reactions or allergies who on 03-OCT-2008, was vaccinated with a 0.5 ml dose of ZOSTAVAX (Oka-Merck) (lot number not provided). Concomitant therapy included vitamins (unspecified). On approximately 07-OCT-2008 (~October 7th or 8th~) the patient experienced an outbreak of shingles on her legs and has been in severe pain since. The patient still had blisters on her legs. No lab diagnostics studies were performed. Therapy with ZOSTAVAX was discontinued on 03-OCT-2008. At the time of reporting, the adverse events were ongoing. The patient has been to the dermatologist twice. Additional information has been requested. 03/27/09 This is in follow-up to report(s) previously submitted on 12/23/2008. Follow up information was received from a physician who reported that the patient had typical zoster of the right lower leg with pain. The patient stated that she received ZOSTAVAX (Oka/Merck) approximately 5 days prior by her family physician. The patient was placed on VALTREX 1 gm TID for 7 days and resolved except for some granulation at one persistent lesion. Additional information is not expected." NoneNone . During the same period patient was treated with Vitamins (unspecified). Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337219
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse concerning a patient who was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) at the lower arm. On an unspecified date, the patient developed mild shingles. The patient's shingles persisted. No lab tests were performed. The patient was seen in the office and sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested." UnknownNone . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337220
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning a patient who was vaccinated SC with a 0.65ml dose of ZOSTAVAX at the lower arm. On an unspecified date, the patient developed mild shingles. Subsequently, the patient recovered from shingles. No lab tests were performed. The patient was seen in the office and sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested." UnknownNone . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337223
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a ~mid to late seventies~ female patient, who on an unspecified date, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The pharmacist reported that the patient developed a case of shingles after receiving the ZOSTAVAX vaccine. The patient sought unspecified medical attention. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337232
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received concerning an over 60 year old female who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # not reported) just recently. Subsequently the patient experienced shingles. At the time of reporting, it was unknown if the patient recovered. Additional information is not expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337235
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 56.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 56 year old female who in July 2008, was vaccinated with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included ACTONEL. The patient reported that ~in the morning~ of 28-OCT-2008 she woke up with shingles. At time of reporting, the patient stated that she was now experiencing the tingling and the itching and hadn't seen a physician yet. The patient already had shingles in May 2008 and it was in the same spot and it started the same way. She started taking VALTREX that the physician prescribed the last time she had shingles. At time of reporting, the patient had not recovered. There were no lab diagnostic studies performed. Additional information is not expected." ShinglesNone . During the same period patient was treated with ACTONEL. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337236
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 79.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 79 year old overweight female with hypertension who on 06-MAR-2008 was vaccinated with ZOSTAVAX (Oka/Merck), injection (lot # not provided). For the most part, the patient appeared to be healthy with no evidence of any immunodeficiency. In the beginning of October 2008, the patient experienced shingles. The patient sought medical attention and got treated in early October 2008. The outcome of the patient was unknown. Additional information has been requested." Hypertension; OverweightUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337240
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning an approximately 63 year old female with a history of five different cases of the shingles who was vaccinated with single dose of ZOSTAVAX (Oka/Merck). Subsequently the patient broke out with a case of the shingles ~one week later~. The patient was treating herself with VALTREX. The patient sought unspecified medical attention. The patient did not have any diagnostic studies or lab work done. At time of the report the patient was recovered. No further information is available." ShinglesNone . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337254
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse concerning a female who on 11-OCT-2007 was vaccinated with ZOSTER (lot # not reported). On 17-OCT-2008, ~about 1 year after~ vaccination with ZOSTER, the patient experienced shingles. The patient sought medical attention. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337256
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 45.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial information has been received from a nurse supervisor concerning a female nurse Practitioner who held a ZOSTAVAX clinic last week and administered ZOSTAVAX to numerous patients over 2-day period. As of 21-Oct-2008, it was reported that nurse practitioner was having red blotches and vesicles all over her body and was not recovered. The nurse District Health Department 4 was planning to see her physician that day. Follow-up information was received from the 45 year old nurse practitioner. She reported that she had current open wound infection in lower leg, allergy to DEMEROL, allergy to cephalosporins and a history of chickenpox disease in 1992. On 14-Oct-2008 she administered several doses of ZOSTAVAX (lot# 658207/0883U) to people. The last doses were given at around 3:30 pm that day. She reported that she also gave one varicella vaccine. She mentioned that she had no recent exposure to chickenpox and shingles but one patient may have had shingles . concurrently, she also took TOPROL XL tablets, ORTHO-CYCLEN. On 17-Oct-2008, Friday midday, vesicles were noticed. The herpetic/ vesicles rash started on arms, most of rash located on both arms, chest and scalp. There were also lesions on both legs, abdomen, back, buttocks, perineal area, ears and hands. The maximum body temperature was 99.0. She also experienced burning skin and itching. She developed herpes zoster. The rash remained. The nurse practitioner was enrolled in the Zoster Virus Identification program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Mereck vaccine VZV strain. The sample of the lesion was collected on 22-Oct-2008. The sample was taken from a vesicle lesion on the right arm and right leg. The results revealed negative for the sample from the right leg and inadequate for the sample from the right arm. Additional information is not expected." "Wound infection, Drug hypersensitivity; Allergic reaction to antibiotics"Chickenpox"VZV strain, 10/22/08, (-) for the sample from the R leg; VZV strain, 10/22/08, inadequate for the sample from the right arm" . During the same period patient was treated with Ortho-Cyclen; TOPROL XL Tablets; Omeprazole. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337257
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a male patient who was vaccinated with a dose of ZOSTER (Oka/Merck) on an unspecified date. Subsequently, six months after vaccination, the patient developed shingles on the face. The shingles was reported as a mild case. On an unspecified date, the patient recovered from shingles. The patient sought medical attention and was seen by a physician. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337263
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 71.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse concerning a 71 year old male (this conflict to previous report which was female) with coronary artery disease, hypertension, depression, type 2 diabetes mellutis and allergies to clams and crab who in October-2008 (previous report was in April 2008), was vaccinated with ZOSTAVAX (duration and dose not reported). There was no rash at the site of injection or elsewhere within 42 days of the vaccination. Subsequently on 16-OCT-2008 (previous report was on 15-OCT-2008) the patient was diagnosed with shingles, he was noted to have 7 vesicles with clear discharge on the T8-T9 dermatomes neck and head. The patient experienced pain which was rated 8/10 (with 0 being the least and 10 being the most). The patient had no recent exposure to chickenpox or herpes zoster. At the time of report the patient had not recovered and he remained on Acyclovir. The patient sought medical attention. Additional information has been requested." Coronary artery disease; Hypertension; Type 2 diabetes mellitus; Shellfish allergy; DepressionBody temp; 97.7 degr . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337264
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 66.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 66 year old female with no pertinent medical history who in approximately October 2007, was vaccinated with ZOSTAVAX 0.6ml, SC. On approximately 01-Oct-2008 the patient started experienced pain and developed a rash on her abdomen about 1 week ago. The patient was diagnosed with shingles. The patient was being treated with LYRICA and VALTREX. As of 16-Oct-2008, the patient had not recovered. The patient sought medical attention at the doctor's office. Additional information has been requested." NoneUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337265
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. NA patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a patient who on 04-DEC-2007 was vaccinated with a dose of ZOSTAVAX and was just diagnosed with a mild case of shingles. Patient's age was not specified, but was indicated age for ZOSTAVAX. At time of reporting, the patient had not recovered. The patient sought unspecified medical attention. Additional information is not expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337273
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning a 63 year old female with cardiac disease, a history of chickenpox and allergies to COUMADIN and PENILILLIN who on 03-OCT-2008 was vaccinated with ZOSTER (Oka-Merck) (lot # 662970/1207X) 0.65ml SQ into the left arm. Concomitant therapy included LOVENOX, ASACOL, omega-3 marine triglycerides, calcium (manufacture unspecified) and red rice yeast. On 10-OCT-2008 (also was reported with 14-OCT-2008) the patient developed shingles described as a vesicular rash on right shin area with approximately 50 vesicles. Affected area included right leg area 2 x 3 and 1x1 inch area to right shin area. The patient also developed ~right leg-shin area with foot swelling~. No fever was noted. The patient reported pain as ~9~ on a scale of 1 to 10. It was not sure that there was recent exposure to chickenpox or herpes ZOSTER. The patient's shingles persisted. The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. Additional information has been requested." Cardiac disorder; Penicillin allergy; Drug hypersensitivityChickenpoxUnknown . During the same period patient was treated with calcium (unspecified); LOVENOX; ASACOL; omega-3 marine triglycerides; red yeast. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337275
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse practitioner (N.P.) concerning a 62 year old male patient with a history of chickenpox who on 26-SEP-2008 was vaccinated with a single dose of ZOSTER (Oka/Merck). Subsequently, the patient developed shingles on 13-OCT-2008. The patient sought unspecified medical attention. At the time of report, the outcome of shingles was unknown. Follow-up information has been received from a nurse practitioner (N.P.). Concomitant medication included COUMADIN and HYTRIN. It was reported that the herpes ZOSTER began on 13-OCT-2008. There was no recent exposure to chickenpox or shingles. The patient reported pain of a 7 on a scale of 1 to 10. No additional information was available. Additional information has been requested." ChickenpoxUnknown . During the same period patient was treated with HYTRIN; COUMADIN. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337276
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 84.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an 84 year old female with hypertension, no drug reactions/allergies who on 18-FEB-2008 was vaccinated with ZOSTER vaccine (therapy route, site unknown). Her concomitant medication was numerous medications (unspecified). She was irate that on 01-AUG-2008 she developed shingles and ~never knew that efficacy in her age group is low percentage.~ She sought medical attention and ~her physician stopped prescribing ZOSTER vaccine for the latter reason~. At the time of report the patient didn't recovered. Additional information has been requested." HypertensionUnknown . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337277
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "This is in follow-up to report (s) previously submitted on 12/23/2008. Information has been received from a registered nurse concerning a 70 plus years old female with medical history unspecified who on 29-MAR-2008 was vaccinated with ZOSTER vaccine (Lot # was not provided), SC in his left arm at 11:00 AM. Concomitant therapy was unspecified. After receiving the ZOSTER vaccine, the patient experienced shingles. The patient was seen by a physician. At the time of reporting, the patient was recovering. Follow-up information was received from this registered nurse. On 08-APR-2008, after receiving the vaccine, the patient experienced rash and pain on the inside of his left thigh. He went to a ~walk in clinic~ and was treated with an antiviral drug for 7 days. The reporter also stated that the patient experienced great difficulty sleeping for 2 months (since approximately September 2008). The patient was treated by a physician. He went to a chiropractor and took a Tai Chi Chik Class for 8 weeks. The patient was seen by the physician. Lab and diagnostic test was unspecified. The patient recovered in July 2008. No further information is available." unknownUnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337278
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 61 year old patient with no known drug allergies and a history of L1 compression fracture and asthma who on 05-APR-2008, was vaccinated with a dose of ZOSTER (Oka/Merck) (lot # 658863/1414U) in the left arm. Concomitant therapy included fluticasone propionate (+) ADVAIR. Subsequently the patient developed a case of shingles and was seen in the office on 06-OCT-2008. The patient's outcome was not reported. The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion from vesicle was collected on 13-OCT-2008. The result indicated that VZV DNA was not amplified and B-globin DNA was not amplified but also reported the specimen was inadequate. This is one of several reports from the same source. Additional information has been requested." AsthmaCompression fractureVZV strain - VZV DNA and B-globin DNA were not implied and SPECIMEN was INADEQUATE . During the same period patient was treated with ADVAIR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337281
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 67.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer concerning his partner, a 67 year old male patient with medical history unspecified who in approximately 2006 was vaccinated with ZOSTER vaccine (Lot# was not provided). On an unspecified date, the patient experienced shingles. The outcome of shingles was not reported. This is one of several reports received from the same source. Additional information has been requested." NoneNone . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337282
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 83.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an 84 year old female with a sulf allergy, lymphoma, hypothyroidism and a history of splenectomy, chickenpox and hysterectomy who on 05-SEP-2007 was vaccinated right side with ZOSTER (Oka/Merck) (Product Lot # 657767/0740U). Concomitant therapy included CELEBREX, NORVASC, lovastatin (manufacturer unknown), DYAZIDE, SYNTHROID, NEXIUM and DITROPAN. On 09-OCT-2008 the patient experienced a full blown case of shingles and was seen in the office. No rash was reported at the injection site. The lesions began at the level of the T8 on the back and wrapped around the body to the breast/thoracic on the left side. The symptom was worse in afternoon. The physician collected cultures from Herpes Simplex Virus and ZOSTER Virus. The patient's shingles persisted. The patient was enrolled in the Varicella ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample was taken from lesion was collected on 09-OCT-2008. The PCR result identified that VZV DNA was amplified and B-globin DNA was not amplied but also reported the specimen was adequate, wild type strain. This is one of several reports from the same source. Additional information has been requested." Sulfonamide allergy; Lymphoma; HypothyroidismSplenectomy; Hysterectomy; Chickenpox"VZV strain - VZV DNA was amplified and B-globin DNA was not amplied, the specimen was adequate, WILD TYPE STRAIN" . During the same period patient was treated with NORVASC; CELEBREX; NEXIUM; DYAZIDE; SYNTHROID; LOVASTATIN; DITROPAN. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337283
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 70 year old male consumer concerning himself with no medical history who in approximately 2006 (two years ago) was vaccinated with ZOSTER vaccine (lot# was unspecified). At the time of reporting, the patient experienced shingles. He contacted with the physician, and had no lab and diagnostic tests. At the reporting time, the patient's shingles persisted. No further information was available from the consumer. This is one of several reports received from the same source. Additional information has been requested." NoneNone . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337284
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 75 year old female with chronic obstructive pulmonary disease and a history of chicken pox and shingles who on 19-SEP-2007 was vaccinated with a dose of ZOSTER vaccine. Concomitant medication included unspecified inhalers. On 2-OCT-2008 the patient developed 3 little eruptions on the right side of her chest. She was seen by the physician on 7-OCT-2008 and reported having pain, the physician ~was surprised at the amount of pain she was reporting~ and reported that the patient got shingles after receiving ZOSTER vaccine. She was prescribed acyclovir and lidocaine (LIODERM patch). At the time of the report, the outcome of AE was unknown. Additional information has been requested." Chicken pox; shingles; chronic obstructive pulmonary diseaseUnknown . Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337288
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 84.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial follow-up information has been received from a registered nurse concerning a 84 year old female with allergy to ampicillin and medical history of chicken pox, who on 18-SEP-2008 (previously reported as 29-SEP-2008) was vaccinated with the first dose of ZOSTER, Lot #658397/1820U, 0.625 ml, subcutaneously into the left arm. Concomitant therapy included ADALAT, CELEXA and lorazepam. It was reported that on 18-SEP-2008 (previously reported as 02-OCT-2008) the patient experienced herpes zoster rash that was ~very painful~ with dermatome (L1) after getting ZOSTER. Patient got pain and antiviral medications. In follow-up information from the questionnaire it was reported that the patient on 18-SEP-2008 also experienced nausea,diarrhea,vomiting and abdominal discomfort. It was reported that the patient's maximum temperature ~did not feel it~. At the time of the report the patient had recovered. Additional information is expected." Chicken poxPenicillin allergyUnknown . During the same period patient was treated with CELEXA; lorazepam; ADALAT. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337289
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 79.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer, concerning her friend, a 79 year old male with prostate cancer and no known drug allergies who on 4-SEP-2008 was vaccinated with ZOSTER (therapy route, site unknown) and then around 26-SEP-2008 the patient had tingling down the back of the leg and then a rash developed on his left groin. The patient did not see his regular physician, but he saw a neurologist who diagnosed the patient with the shingles. Concomitant therapy included triptorelin pamoate (TRELSTAR injection), ~CATHADEX~. At the time of report, the patient was not recovered. Additional information has been requested." Prostate cancerNone . During the same period patient was treated with Triptorelin pamoate. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337290
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 63.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 64 female with asthma and an allergy to imipramine hydrochloride and a history of back pain, trigeminal neuralgia, chickenpox in 10 years old and usually childhood diseases who on 02-JAN-2008, was vaccinated with ZOSTER (Oka/Merck), 0.65ml, injection in the right arm (lot # 658602/1080U). Concomitant therapy included aspirin, KLONOPIN, ZOLOFE, ZOVIRAX, BENADRYL, QVAR and NEURONTIN. On approximately 20-Sep-2008 the patient started to have itching on her back. Then each day when waking up the itching circled around the left side of her trunk and then about seven days later the itching went on the inner aspect of the arm and under the arm pit. The patient stated that the itching was mostly on her back and she had a shooting stabbing pain in her arm, where it felt like ~a hot nail going into her skin.~ The patient stated she did see her physician on 26-Sep-2008 but they could not do anything since there were no blisters, but told her to come back if blisters appear. The patient stated that a couple days ago the blisters appeared on her back, left side of her trunk and on the arm and arm pit, but once the blisters appeared the itching went away. The patient reported that she saw her physician on 01-Oct-2008 and they diagnosed her with the shingles and provided her with VALTREX. The patient was enrolled in the Varicella ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated wit the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. There was no sample specimen obtained. The physician reported this as a mild typical herpes ZOSTER rash of approximately 7-9 lesions distributed on the upper back and axilla in dermatome T2. There was no recent exposure to chicken pox or shingles. Other systemic symptoms included 6/10 pain, intense itching, rash and post herpetic neuralgia. The maximum temperature of the patient was 98.5. At the time of the report, the patient recovered from all the symptoms exc" Drug hypersensitivity; Asthma"Back pain, Trigeminal neuralgia; Chickenpox"None . During the same period patient was treated with ZOVIRAX; aspirin; QVAR; KLONOPIN; BENADRYL; NEURONTIN; ZOLOFT. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337291
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 53.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 53 year old female with no pertinent medical history and no known drug reaction/allergies who on 18-APR-2007 was vaccinated with a single dose of ZOSTER. Concomitant therapy included thyroid medication. On 26-SEP-2008 the patient had broken out in a rash on her abdomen, sides and back. The patient went to her physician and did blood work. She was diagnosed with the shingles. The patient's events persisted. Additional information has been requested." None"Diagnostic laboratory, shingles" . During the same period patient was treated with Thyroid. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337292
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 80.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse concerning an 80 year old male with an allergy to tetanus vaccine, who in October 2007, was vaccinated with a dose of ZOSTER subcutaneously. In September 2008 (this week), the patient developed shingles across her lower back after administration of vaccine. The patient had ~a lot of lesions~. The nurse was not interested in VZV analysis by(polymerase chain reaction) PCR. The patient sought medical attention with an office visit. At the time of reporting, the patient had not recovered. This is on of two reports from the same source. Additional information is not expected." Allergy to vaccineUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337293
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 81.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning an 81 year old female with allergy to antibiotics, NEURONTIN, MORPHINE and iodine, who in October 2007 , was vaccinated with a dose of ZOSTER (lot no. 658207/0883U). Last week, on approximately 24-SEP-2008, the patient developed shingles on her face and head area after administration of ZOSTER. The patient reported that she is in a lot of pain. The nurse is not interested in VZV analysis by PCR. The patient sough medical attention, via telephone. At the time of the reporting, the patient was recovering. This is one of several reports received from the same source. No further information is available." "allergic reaction to antibiotics, hypersensitivity"Iodine allergyUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337295
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received form a registered nurse concerning a 60 year old male who on 3-JUL-2008 was vaccinated with ZOSTER and ~5 to 6 weeks later~ on approximately 6-AUG-2008 the patient called the office because he had 3 very tiny bumps on his face. The patient was diagnosed of a mild case of shingles by a physician. On an unspecified date the patient recovered from mild case of shingles. The patient sought unspecified medical attention. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337297
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 78.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist concerning a patient who on an unknown date was vaccinated with ZOSTER . The pharmacists reported that on an unknown date the patient developed a rash and shingles after vaccination with ZOSTER. The pharmacist reported that the patient was the friend of the friend of other patient. The person who developed shingles was ~very ill for 3 months~. No further information is available. Information has been received from a pharmacist concerning a 71 years old male patient who on 21-SEP-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) abdominal, intramuscularly. Concomitant medication includes a 13th dose of influenza virus vaccine (Glaxosmithkline), intramuscularly int o the left deltoid on 23-SEP-2008. The pharmacist reported that on 24-SEP-2008 the patient developed a rash and shingles after vaccination with ZOSTAVAX. The pharmacist reported that the patient was the friend of the friend of other patient. The person who developed shingles was ~very ill for 3 months~. Follow-up information received on 08-JAN-2009 stated that the patient developed localized breakout of rash and shingles with discoloration of skin. The patient recovered in 10 - to 14 days. The recovery date was reported to be 14-OCT-2008. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337312
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 47.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a physician concerning a 47 year old female nurse got splashed on her hand with ZOSTAVAX (Merck) solution while she was withdrawing a syringe from the vial. On 21-SEP-2008 the nurse developed shingles rash on her right side of her back. The nurse's shingles persisted. No further information is available. The medical attention was sought by the patient. Additional information has been requested. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337313
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 70.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a nurse concerning a female patient in her 70's who were vaccinated subcutaneously with ZOSTAVAX (Merck) and developed shingles after receiving the vaccine. This is one of two reports from the same source. No further information is available. UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337314
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 80.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial and follow up information has been received from a physician concerning a 80 years old female patient with diabetes type II, who on an unknown date at private doctor's office/hospital was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included PREDNISONE (manufactured unknown). The physician reported that the patient experienced herpes zoster (shingles) on 17-SEP-2008. On 01-OCT-2007, the patient recovered it, reported that the physician's office does not carry the vaccine but they give the vaccine if brought to them. There were no lab diagnostic studies performed. Additional information has been requested." Type II diabetes mellitusUnknown . During the same period patient was treated with PREDNISONE. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337315
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial and follow-up information has been received from a pharmacist concerning a 63 year old white female who in January 2008 was vaccinated with a dose of ZOSTAVAX (Merck) SQ. Subsequently the patient had a mild case of shingles in August 2008, 7 months after the vaccine was given. It was also reported that on 15-AUG-2008, the patient had pain on left back (trunk). The pain was mild to moderate. The patient was most concerned when couldn't determine what problem was. The patient recovered from shingles. The patient recovered from the pain on left back (trunk) on 15-SEP-2008. In further follow-up, the patient reported that her pain on left back (trunk) had an onset date on 05-AUG-2008. It was also reported that the patient was treated with famciclovir 500 mg and MOBIC ~7.5~ for pain. The patient reported that on 05-AUG-2008 she also experienced a major itching on stomach. The patient also reported that her rash didn't occur at the site of injection. She assessed her pain as 4 (10 as the most painful). The patient had a history of chickenpox in 1953 and had not been exposed recently to herpes zoster. No additional information is expected." ChickenpoxUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337317
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning a 62 year old female pacemaker user with mild pulmonary hypertension and tachycardia after taking antihistamines and a history of lateral mastectomy with chemo completed on October 2006 who on 10-SEP-2008 was vaccinated with ZOSTAVAX (Merck) (lot # reported as 659326/1824U) subcutaneously in right arm. Concomitant therapy included RYTHMOL, CARDIOL, LASIX, K-LOR, ATACAND, MSD, CELEXA, FEMARA, and ZITHROMAX. On 14-SEP-2008. The patient experienced urinary urgency with itching and then found a patch of blisters in the buttock and vaginal regions (also reported by the patient as shingles or chickenpox). The patient was taking ZITHROMAX for a sinus infection and thought the itching was related to antibiotic use. The patient contacted the physician on 17-SEP-2008 and a culture of the lesions was performed. Then she returned to the physician on 19-Sep-2008 and was placed on FAMCICLOVIR 500 mg three times a day. The patient is reporting continued zoster at the original location and blisters in the mouth at the time of the report. Follow-up information was received from the nurse who reported that she was not interested in VZV analysis by polymerase chain reaction (PCR), but the physician may be interested. The nurse was going to provide information to the physician about the VZV program. This is a consolidation of two reports concerning the same patient. Additional information has been requested." Pulmonary hypertension; Drug hypersensitivity; TachycardiaMalignant breast lump removal; Chemotherapy; Cardiac pacemaker insertion"Viral Culture, 09/17/08 -" . During the same period patient was treated with ATACAND mg; CARDIOL (CARVEDILOL) mg; CELEXA mg; LASIX (FUROSEMIDE SODIUM) mg; FEMARA; K-LOR mEq; RYTHMOL; ZOCOR 10 mg. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337368
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 87.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an 80 year old female who in January 2008, was vaccinated with ZOSTAVAX (Merck), and a few weeks ago she presented with ophthalmic zoster. At the time of this report, the patient was recovering. The patient sought medical attention in the physician's office. Follow up information has been received concerning the female patient with Penicillin allergy who on 30-JAN-2008 at 12:00 PM, was vaccinated in the physician's office with the first dose of ZOSTAVAX (Merck) (Lot # 658210/1079U), subcutaneously, under the left arm. On 09-SEP-2008, the patient developed pain and typical lesions of ZOSTER but not lesions that could be swabbed for viral culture. The patient experience required an ER/doctor visit. Additional information has been requested." Penicillin AllergyUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337369
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 82.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 82 year old female patient with diabetes, penicillin and TOPROL allergies, who on 17-MAR-2008, was vaccinated with a dose of ZOSTAVAX (Merck) S.Q. into the left arm. Concomitant therapy included insulin. The patient received the vaccine while she already had shingles and shortly after on 17-MAR-2008, her shingles worsened. She had experienced severe nerve damage. The patient's shingles and severe nerve damage persisted. The patient sought unspecified medical attention. No further information is expected." Shingles; Diabetes; Drug hypersensitivity; Penicillin allergyNone . During the same period patient was treated with insulin. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337371
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician and a 76 year old female retired registered nurse with chronic obstructive pulmonary disease and drug hypersensitivity to codeine and aspirin who on 27-Feb-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 659324/1835U) SQ in her left deltoid. Concomitant therapy included MAXZIDE, SPIRIVA, ADVAIR, vitamins (unspecified) and LIPITOR. On an unspecified date the LIPITOR was discontinued for liver function abnormal. On 11-SEP-2008 the patient developed shingles (nonspecified rash on left leg, possible shingles). The rash developed around the knee. The patient was examined by the physician on 12-SEP-2008 and was prescribed FAMVIR and MEDROL dose pack. The patient was seen by the physician on 16-SEP-2008, it was documented that the patient's rash had decreased. The patient had a follow-up visit schedule for 19-DEC-2008. Follow-up information was received from an office manager. The patient was not exposed to chickenpox. The patient did not have a direct fluorescent antibody drawn and the patient did not have a specimen collected for PCR. It was reported that the patient did not have a biopsy. It was reported that the patient's rash decreased after four days. Subsequently, the patient recovered from the shingles. The outcome of liver function abnormal was not reported. Additional information is not expected." Chronic obstructive pulmonary disease; Drug hypersensitivityNone . During the same period patient was treated with LIPITOR; ADVAIR; MAXZIDE; SPIRIVA; vitamins (unspecified). Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337373
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 75 year old female who on 28-MAY-2008 was vaccinated with ZOSTAVAX (Merck) (lot #659325/1823U) via IM into her right deltoid. On 09-SEP-2008 the patient experienced prodromal pain followed by a shingles rash on her lower abdomen. An ultrasound was performed (results not provided). As of the reporting date, the patient was recovering." Unknownultrasound - . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337376
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacy student concerning a female patient who in March 2008 (~6 months ago~) received a dose of ZOSTAVAX (Merck) (lot number, route and injection site not reported). On approximately 09-SEP-2008 (~within the past week~), 6 months after the vaccination, the patient developed ~a zoster rash on her right side mid-section~. The patient sought medical attention via telephone. At the time of reporting, she was not recovered from the event. Follow-up information has been received from a questionnaire concerning the patient, a 79-year-old female who has a history of allergy to penicillin. She received a dose of ZOSTAVAX (Merck) via subcutaneous route in her right arm on 14-JAN-2008 (previously reported as in March). No rash occurred the site of injection or elsewhere within 42 days of the vaccination. Around 09-SEP-2008, she developed ~a zoster rash on her right side mid-section~. Additional information has been requested." Penicillin AllergyUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337379
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 45.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse concerning a 45 year old male who on 09-SEP-2008 was vaccinated with ZOSTAVAX (Merck). There was no concomitant medication. On 11-SEP-2008, two days after receiving vaccine, the patient developed shingles. The patient sought medical attention as an office visit. He reported that the outbreak was minimal with no pain and only itching. The duration of the blister like rash was ~a couple of days~ and only a red spot described as centimeter in length remains at the rash site (right lower back). No other symptoms or treatment reported." NoneNone . During the same period patient was treated with None. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337383
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 66.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 66 years old male, with no illness at time of vaccination, with gout, hypertension and hypercholesterolaemia and a history of chickenpox who on 22-FEB 2008, was vaccinated with a first dose of 0.65 ml of ZOSTAVAX (Merck) (lot no 659267/1836U) IM, into the left arm. Concomitant therapy included LIPITOR, allopurinol, DYAZIDE (also reported as MAXZIDE), aspirin and sotolol. On 29-AUG-2008, the patient developed shingles on left mid thorax. The number of lesions was unknown. There was no rash at the site of elsewhere within 42 days of the vaccination. The patient had no recent exposure to chickenpox or herpes zoster. Two weeks after the onset date of the event adverse, on approximately, 12-SEP-2008, the patient recovered from shingles. The patient was seen by physician and sought unspecified medical attention. A specimen was not collected for PCR. No further information is available." Hypertension; Gout; HypercholesterolaemiaChickenpoxUnknown . During the same period patient was treated with allopurinol mg; aspirin mg; LIPITOR mg; DYAZIDE mg; sotalol hydrochloride mg. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337386
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 65.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from physician concerning a 65 year old female who on 20-Aug-2008 was vaccinated with ZOSTAVAX (lot#659407/0295X) via IM into her left deltoid. On 01-Sep-2008 the patient also experienced prodromal pain followed by a shingles rash. The patient also experienced ~clumsiness~ on her left side especially in the use of her hand. The patient sought unspecified medical attention. As of the reporting date, the patient" UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337387
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a pharmacist and follow up information from a physician concerning a patient who received ZOSTAVAX and ~broke out with full blown VZV~. The physician stated that a 72 year old male patient with Lisinopril (manufacturer not reported) hypersensitivity and hypertension was vaccinated with ZOSTAVAX (lot #658859/0411X) in his left arm on 05-SEP-2008. Concomitant therapy included clonidine, simvastain (MSD), hydrochlorothiazide (+) Metoprolol Succinate, Omeprazole and Oxbutynin. 2 days after the vaccination, the patient experienced ~small blisters~ on his forearm and lower abdomen. The physician also stated that the patient experienced a headache and fatigue, but the patient was afebrile. The physician also stated that the patient's rash ~looks like shingles~. The symptoms were ongoing at the time of the report In follow up the physician also described the event as a rash with vesicular lesions occurring 3 days after vaccination. The patient had not had recent exposure to chickenpox or shingles. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 12-SEP-2008. The sample was taken from a vesicular lesion. The PCR result for the specimen was inadequate specimen no strain identified. No further information is available." Hypertension; Drug hypersensitivity"VZV strain, 09/12/08, inadequate specimen, no strain identified" . During the same period patient was treated with Clonidine; Hydrochlorothiazide (+) Omeprazole; Oxbutynin; Zocor. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337388
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 74.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 75 year old female patient with blood cholesterol abnormal who in April or May 2007 was vaccinated with ZOSTAVAX. On 26-AUG-2008, the patient developed shingles on her upper right corner of her face. Routine lab tests were done, but results not reported. The pain and rash was healed about 10 days after her diagnoses. No further information was provided." Blood cholesterol abnormalUnknown . During the same period patient was treated with (Therapy unspecified). Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337392
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 88.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 88 year old male patient with many chronic health issues, who in January 2007 was vaccinated with ZOSTER vaccine, In September 2008 the patient had a case of shingles around his eye. The patient was started on treatment and seen by opthomologist. The physician was not interested in obtaining specimen and was not interested in being contacted. The reporting physician reported that shingles had nothing to do with ZOSTER vaccine the vaccine just did not work. No further information is available." General symptomUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337397
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Information has been received from a consumer concerning his wife who participated in an unspecified study for ZOSTAVAX on an unspecified date. At first the patient received a placebo and later she was administered the actual ZOSTAVAX. A year after that she developed a mild case of shingles. The shingles went away after about 3 days. It was not reported if the patient sought medical attention. No further information is available UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337399
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a consumer concerning an ~around 60 year old~ female who was vaccinated with ZOSTAVAX (Merck) ~single dose of series~. After receiving ZOSTAVAX (Merck) the patient came down with flu like symptoms, was very achy, very fatigue and had developed blisters on her back side. The patient was diagnosed with shingles. The patient's shingles persisted. No further information is available. This is in follow-up report(s) previously submitted on 12/23/2008. Follow-up information was received from the consumer. The consumer reported the patient was also a nurse who in approximately December 2006 ~about two year ago~ received ZOSTAVAX (Merck) and then in approximately September 2008, ~about two or three months~ ago she came down with flu like symptoms and then developed a bad case of the shingles. The patient believed that because she fell a few times while hiking that trauma of falling may have caused the outbreak of singles she had. Follow-up information was received from the consumer. The patient said that she had gotten her vaccine 2 years prior to becoming ill and breaking out with shingles. She believes that at the time she received the vaccine that perhaps knowledge of refrigeration methods was not available that her vaccine may not have been effective for that reason. She was fine at the report time. This is one of several reports from the same source. Additional information is not expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337404
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 77.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a 79 year old male with ice cream and butter allergy and a history of chickenpox, who on 27-MAR-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot# 656394/0162U) into the right deltoid (upper arm subcutaneous). Concomitant therapy included DURABAC, aspirin, ferrousSO4, SYNTHROID, lisinopril-HCTZ, ZOCOR, tamsulosin hydrochloride, folic acid, amiodarone hydrochloride, travoprost, COUMADIN, clobetasol propionate, VALTREX and ALLEGRA. On 05-SEP-2008 the patient developed four lesions distributed in the lower right side towards his abdomen, the patient had some bloody discharge and he complained of he was having fever 101.5 and was diagnosed as shingles. He had large oozing blisters and pain, which he quanitified as a 9 out of 10. He was given samples of LEVAQUIN 750 mg and LYRICA 75 mg PO HS x 1 week, then to increase to BID if still symptomatic. Shingles was persisting. No PCR sample was taken. No further information is available." Food allergyChickenpox"temperature measurement, 09/05/08, 101.5" . During the same period patient was treated with DURABAC; amiodarone hydrochloride; aspirin; chronium polynicotinate; clobetasol propionate; ferrous sulfate; ALLEGRA; folic acid; hydrochlorothiazide (+); SYNTHROID; ZOCOR; tamsulosin hydrochloride; travoprost; VALTREX;COUMADIN. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337405
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 78.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 78 year old female with no known allergies or pertinent medical history who on 26-MAR-2008 was vaccinated with ZOSTAVAX (Oka/Merck). Concomitant therapy included LIPITOR and SYNTHROID. A few days after administration, the patient experienced a mild case of shingles on her face. It looked like a rash formed and then a few days later little blisters formed. The patient's physician prescribed her VALTREX and it cleared right up. Routine labs were performed every ninety days. A month after administration of ZOSTAVAX , April 2008 the patient recovered. Additional information has been requested." UnknownUnknown . During the same period patient was treated with LIPITOR; SYNTHROID. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337406
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. NA patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning an around 60 year old patient who on approximately 29-AUG-2008, ~1 week ago~, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On approximately 31-AUG-2008, ~2 days after ZOSTAVAX (Oka/Merck) was given~, the patient developed shingles-like rash. The patient contacted the physician and was started on anti-viral medication and the rash was starting to improve. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337412
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 78.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse practitioner concerning a 79 year old female with hypothyroidism, hypercholesterolaemia, lupus erythematosus, hypertension, osteoporosis and allergic to ~EES~ and lisinopril (Refer to WAES # 0809USA01786) and a history of chickenpox in childhood who on 11-JUN-2007 was vaccinated with ZOSTER vaccine live (Oka/Merck), Lot # 657558/0461U, 0.65 mL, in her right deltoid, subcutaneously. Concomitant therapy included ATENOLOL, LOVASTATIN (manufacturer unknown), SYNTHROID, PLAQUENTL, and RECLAST. On 25-AUG-2008 the patient experienced shingles. It was reported that the patient had vesicular rash with more than 20 lesions in her right T4 - T5 dermatome under breast. The patient had severe pain and had a maxim of temperature of 98.6 degrees. It was reported that the patient was not exposed recently to chickenpox or herpes ZOSTER, there was no direct fluorescent antibody done and there was no specimen collected for PCR. The patient sought medical attention, contracted physician's office. At the time of the report the patient recovered from shingles, but was still being treated with VICODIN and NEURONTIN. Additional information has been requested." Hypothyroidism; Hypercholesterolaemia; Lupus erythematosus; Hypertension; Osteoporosis; Drug hypersensitivityChickenpoxbody temp 98.6 - . During the same period patient was treated with atenolol; PLAQUENIL; SYNTHROID; lovastatin; RECLAST. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337413
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 62.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning herself, a 63 year old female with a history of herpes zoster and a penicillin allergy who at 4pm on 27-SEP-2007 was vaccinated with a dose of ZOSTER vaccine. Concomitant therapy included vitamins (unspecified). On 29-AUG-2008 the patient developed 2 inch segmented lines of vesicles on the left side if her mid abdomen which were very tender touch. She applied lidocaine to the area and began taking VALTREX 500 mg daily, adjusting the dose to TID when the outbreak was worst, She continued to break out, mostly on the upper part of her legs for the next 2 1/2 weeks. She indicated that this was a mild case of shingles compared to what she experienced prior to ZOSTER vaccine. She indicated that she was concerned that she had this outbreak. She did not seek any medical attention. Additional information is not expected." Herpes zosterPenicillin allergyNone . During the same period patient was treated with Vitamins. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337416
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female who in October 2007, was vaccinated with ZOSTER vaccine injection, and ~over this past weekend~, on approximately 30-AUG-2008, the patient developed shingles. The patient was recovering from shingles. As of 3-SEP-2008, the date of this report, the patient sought unspecified medical attention. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337498
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 66.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 66 year old female with no known drug allergies and abnormal cholesterol and blood pressure who in February 2008, was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included CRESTOR, MSD, LEVAQUIN, doxazosin mesylate and hydrochlorothiazide (manufacturer not specified). The patient reported getting shingles after receiving ZOSTAVAX (Merck). Two weeks ago, on approximately 20-AUG-2008, it started as a blister on her forehead and moved to her hairline and down to her left eye. Then she had a scab on her left eyelid. She noted that ~I looked like a gargoyle~. She was given ~generic VALTREX~ and she went to her ophthalmologist every 2 days to make sure it did not advance to her cornea. No labs/diagnostics were performed. The patient reported she was not warned of the efficacy rate. She was told ZOSTAVAX (Merck) would prevent shingles entirely, or she might only develop a mild case. At that time of the report the patient had not recovered. Additional information has been requested." Cholesterol; Blood pressureNone . During the same period patient was treated with DOXAZOSIN MESYLATE; ZETIA; HYDROCHLOROTHIAZIDE; LEVAQUIN; CRESTOR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337501
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 88.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse in physician's office, concerning an 88 year old female who in June 2007, was vaccinated with ZOSTER (Oka/Merck) in her left deltoid. It was reported that the patient on 08-AUG-2008 experienced symptoms of herpes ZOSTER that began with tingling. Nurse reported hat the patient on 21-AUG-2008 was diagnosed with shingles. No lot number was provided." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337504
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 80.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from an 80 year old female with blood pressure and thyroid problems, allergy to penicillin and ~betadine~ and ~problems with hormones~, who 1.5 years ago, in approximately March 2007, was vaccinated with ZOSTAVAX (Oka/Merck) 0.65 ml, subcutaneously. Concomitant therapy included ~blood pressure medicine~ and ~thyroid medicine~. The patient reported that 3 weeks ago (on approximately 19-AUG-2008) she developed shingles on her waist and back on her left side, she also was experiencing ~itchiness~ and pain. At the time of reporting the patient had not recovered. The patient sought medical attention. Additional information has been requested." Blood pressure; thyroid disorder; penicillin allergy; iodine allergy; hormonal imbalanceNone . During the same period patient was treated with [therapy unspecified]; [therapy unspecified]. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337508
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a female who on an unspecified date was vaccinated with ZOSTAVAX (Merck). Per physician, the patient received ZOSTAVAX (Merck) and later developed a bad case of shingles. Per physician, ~this is the worst case of shingles he has ever seen~. Lot # was not available. It is unknown whether the patient had history of shingles prior to receiving ZOSTAVAX (Merck). The patient's bad case of shingles persisted. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337509
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a physician concerning a male who on an unspecified date was vaccinated with ZOSTAVAX . Per physician, the patient received ZOSTAVAX and developed a bad case of shingles. Lot # was not available. At the time of reporting the patient's shingles persisted. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337511
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 68.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from two nurses concerning a 68 year old female with allergies to morphine, amoxicillin, sulfonamides, aspirin, DAYPRO, CELEBREX, and codeine, hypertension, arthritis and hypothyroidism who on 11-AUG-2008 was vaccinated with the first dose of ZOSTER (Oka/Merck) (lot # 658325/1429U) into her left arm (also reported as 13-AUG-2008 by the follow up nurse). Concomitant therapy included K-DUR, omeprazole, RESTASIS, SYNTHROID, metoprolol, AVAPRO, PREMARIN and ibuprofen. On 28-AUG-2008, the patient experienced a rash type vesicular on the left side of her forehead in the supraorbital nerve distribution above in left eye with multiple vesicular lesions. The patient was examined by her primary physician and unspecified ophthalmologist on that day. She did not have any recent chicken pox or shingles exposure. The physician noted an early shingles rash above the left eye and described it as herpes ZOSTER and prescribed ZOVIRAX as well as CLOBETASONE topical cream. The eye exam was normal. The patient had a follow-up appointment in one week. At the time of the report, the patient's shingles and rash on the left side of her forehead persisted. The sample of the lesion was collected on 02-SEP-2008. The sample was taken from a vesicular lesion (site not specified). The results of the varicella ZOSTER virus identification polymerase chain reaction test were: The VZV DNA was amplified, which showed the wild-type and it was not B-globin DNA amplified. Interpretacion: Adequate specimen, wild type strain. Additional information has been requested." Drug hypersensitivity; Sulfonamide allergy; Hypertension; Arthritis; Hypothyroidism; Penicillin allergy"ophthalmological exam - normal VZV strain 09/09/08 - adequate specimen, wild type strain" . During the same period patient was treated with RESTASIS; PREMARIN; ibuprofen; AVAPRO; SYNTHROID; metoprolol; omeprazole; E-DUR. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337514
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 78.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a registered nurse concerning a 78 year old male who on 21-MAR-2007 was vaccinated with ZOSTER (Oka/Merck), one dose, subcutaneously. On 23-JUN-2008, the patient experienced a severe case of shingles. The patient also had pain. The patient's present status is not recovered. The patient sought medical attention at the office. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337517
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 60.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a certified medical assistant concerning a 61 year old female with no drug allergies or drug reactions, with hypertension and hypercholesterolamia, osteopenia and gastroooesophageal reflux disease who on 19-NOV-2007 was vaccinated with ZOSTER (Oka/Merck) (lot # 658361/1090U), 0.65ml, subcutaneous. Concomitant therapy included hydrochlorothiazide, LIPITOR, NEXIUM and MSD. Subsequently, the patient had been diagnosed with shingles. Medical attention was sought via office visit. No lab diagnostics studies were performed. The outcome of shingles was not specified at the time of reporting. Additional information has been requested." Hypertension; Osteopenia; Hypercholesterolaemia; Gastrooesophageal reflux diseaseNone . During the same period patient was treated with FOSAMAX; LIPITOR; NEXIUM; hydrochlorothiazide. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337521
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 75.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a 75 year old female with no medical history, no known allergies, who on the first week of June 2008 was vaccinated with a dose of ZOSTER (Oka/Merck). Concomitant therapy included unspecified blood pressure medication. In approximately June 2008, shortly after receiving ZOSTER (Oka-Merck) the patient experienced a case of shingles on her head. She had maybe one or two break-outs, however she was experiencing bad headaches and a little bit of nausea. An MRI was performed: results not provided. Unspecified medical attention was sought. At the time of reporting the patient was recovering. There was no product quality complaint No additional information is expected." NoneUnknown . During the same period patient was treated with (therapy unspecified). Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337522
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Female patient, 72.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Information has been received from a nurse concerning two female patient's in their early 70's who were vaccinated subcutaneously with ZOSTAVAX and developed shingles after receiving the vaccine. Follow-up information was received from a physician which reported that a 73 year old white female patient with allergies to Lyrica, Ceftin, Vancomycin and Sulfanoamides who on 13-SEP-2006, was vaccinated subcutaneously into the left arm with ZOSTAVAX. On 25-AUG-2008, the patient developed a cataract in her left eye and developed eye pain and saw an ophthalmologist and was diagnosed with shingles at her right temple and eye brow area, treated with acyclovir. This is one of several reports from the same source. No further information is available." Allergic reaction to antibiotics; Sulfonamide allergy; Drug hypersensitivityUnknown . During the same period patient was treated with Unknown. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #337525
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/23/2008. Male patient, 85.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, "Initial information has been received from an 86 year old male physician with no illness at the time of vaccination or pertinent medical history or allergies, who is also the patient and follow-up information was received from a physician. On 10-JUN-2008 at 9:25 AM the patient was vaccinated into the left deltoid with the first dose of ZOSTAVAX (Merck) (lot # 659407/0295X). Concomitant therapy included NORVASC. On 25-AUG-2008 the patient developed erythematous papular lesions on his chest. The patient further stated that the above lesions were confined to one dermatome. The physician reported in follow up that the patient called to report that he had developed shingles rash. The patient was treating with VALTREX. The outcome was unknown. Additional information is not expected." UnknownUnknown . During the same period patient was treated with NORVASC. Patient recovered.
ZOSTER (ZOSTAVAX) Side Effects Report #336304
ZOSTER (ZOSTAVAX) vaccine side effect was reported on 12/30/2008. Male patient, 74.0 years of age, was vaccinated with ZOSTER (ZOSTAVAX). Patient symptoms: Herpes zoster, Pt developed shingles lesions x 3 on scalp approx 10 days post vaccine; resolved without SEQUELAR; Flu call 12/30. Lesions drying - no further outbreak. NoneOsteopenia; Artificial R kneeNone . During the same period patient was treated with LIPITOR; FOSAMAX; MIPTAZAPRO. Patient recovered.