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Lymphadenopathy from HPV (GARDASIL) 2009

Vaccine Manufacturer:MERCK & CO. INC.
Vaccine Code:HPV4
Vaccine Type:HUMAN PAPILLOVAVIRUS QUADRIVALENT
Vaccine Name:HPV (GARDASIL)
Year Reported:2009
Symptom Reported:Lymphadenopathy

HPV (GARDASIL) Side Effects Report #336853
HPV (GARDASIL) vaccine side effect was reported on 01/07/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a physician concerning a female patient with a history of mouth ulcers who on an unknown date was vaccinated with a dose of GARDASIL, lot # unspecified. The patient came back to the physician's office 4 hours after getting GARDASIL with ~vulvar ulcers~ diagnosed as ~bipolar aphthosis~. The physician stated that the patient had gotten the shot when she was experiencing symptoms of West Nile virus; however it was not diagnosed after she had been given GARDASIL. The patient became sexually active ~shortly before~ she got GARDASIL. At the time of reporting, the outcome of the event was unknown. Follow-up information was received from the physician who reported that the patient had a history of canker sores. The physician also reported that the patient had a viral illness (not specified) prior to receiving the third dose of GARDASIL. The physician stated that the patient had experienced bipolar aphthosis every month for over one year. Follow-up information was received from the physician, who reported that the patient was vaccinated with the third dose of GARDASIL IM, on 18-AUG-2007. The physician reported that within 4 hours of vaccination, the patient had the first outcome of nonherpetic vulvar ulcers. Major work up negative. Presumed to be bipolar aphthosis. At the time of reporting, the patient had not recovered. The patient had numerous cultures and laboratories (unspecified) and a presumptive positive West Nile virus test. The physician considered the event to be disabling. This is one of two reports from the same source. No further information is available. 2/17/09 Received Immunology Clinic records of 7/15-9/26/2008. FINAL DX: Bechet's disease Records reveal patient did not have symptoms when initially evaluated. Valtrex d/c. Had bout of depression w/suicidal ideation. Being seen by counselor & tx w/meds. Developed oral canker sores that waxed & waned & by 9/18 had over 40+ vulvar ulcers w/exudate & bilateral lymph node adenopathy. Depression aggravated by eruption," Vulval ulceration; West Nile viral infection"Mouth ulceration; Canker sores oral; Viral infection PMH: PCOS, ? DMII on oral meds. Allergy: sulfa.""Diagnostic laboratory, STD testing LABS: pathergy test neg. ESR 32(H), CRP 10.5(H). CBC, chemistry, LFTs WNL. HSV/PCR neg. HSV I (+), HSV II(-). Biopsy vulvar lesion." . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #336933
HPV (GARDASIL) vaccine side effect was reported on 01/09/2009. Female patient, 26.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "HAD THE SERIES OF 3 GARDISIL VACCINES, HAVE BEEN EXPERIENCING PAIN IN FEET, HANDS, THEN OTHER JOINTS, BEEN TO DOCTORS, JUST BEEN TOLD MAY HAVE RHEUMATOID ARTHRITIS!! AT AGE 28. THESE SYMPTOMS STARTED AFTER THE VACCINE,BUT HAVE WORSENED OVER LAS 9-12 MONTHS!! I THNIK IT IS FROM THIS VACCINE! WHAT CAN WE DO? DON'T WANT MY DAUGHTER TAKING RA MEDS IF SOMETHING ELSE CAN HELP!! 2/2/09 Rheumatology consult received for eval of joint pain dated 12/19/08. Pt initially c/o sore feet, particularly in MTP joints x 2 yrs. Hand pain x 1 yr. Recent hand swelling jaw pain, and R shoulder, elbow and wrist pain with morning stiffness x 30 minutes. (+) canker sores and fever blisters. PE (+) for L posterior cervical lymph node, decreased thumb flexion, joint tenderness, synovitis, and swelling. Presntation c/w inflammatory arthritis such as RA." NONENONE. PMH: 30 lb wt loss 2' to stress"BLOOD WORK, XRAYS AT UVA, FONTAINE RESEARCH CENTER. Labs and Diagnostics: Anti-CCP (+), CRP 1.0. X-rays (+) for osteophytosis of the R foot, otherwise WNL. Complement CH 50 (H) at 386. UA (+) for 14 WBCs and few bacteria. ANA (+) at 1:640" . Patient recovered.

HPV (GARDASIL) Side Effects Report #336947
HPV (GARDASIL) vaccine side effect was reported on 01/10/2009. Female patient, 31.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Low grade fever, sore throat, swollen neck lymph nodes, runny nose, muscle aches and fatigue. Taking ibuprofen." NoneNone . During the same period patient was treated with "Seasonale, zoloft 50mg". Patient recovered.

HPV (GARDASIL) Side Effects Report #337427
HPV (GARDASIL) vaccine side effect was reported on 01/10/2009. Female patient, 21.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Prior to 3 doses of GARDASIL I had all normal pap tests between the years 2004 to 12-1-20066. After 3 doses of GARDASIL I had 2 abnormal pap tests. I also had a yeast infection on my right armpit, and on/ about 11-2008, I was seen by my OBGYN for a swollen gland in my groin area." No KnownPAP tests after GARDASIL: 11-20-07 = ASCUS; 5-21-08 = ASCUS; 12-3-08 = Normal . Patient recovered.

HPV (GARDASIL) Side Effects Report #338678
HPV (GARDASIL) vaccine side effect was reported on 01/16/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a nurse practitioner concerning a 22 year old female patient with hypothyroidism and no know allergies who on 07-AUG-2008 was vaccinated with the first dose of GARDASIL. On 08-OCT-2008 the patient was vaccinated with 0.5 ml of her second dose of GARDASIL intramuscularly. Concomitant therapy included ~thyroid medication~. On 08-OCT-2008 the patient developed unilateral rash on the left side of her neck along with inflamed lymph nodes. The rash disappeared 3 weeks later, on approximately 29-OCT-2008. The rash re-occurred on the same area (2008) and again lasted for 3 weeks (recovered , 2008). The patient had not received the third dose. On an unspecified date the patient recovered (2008). Additional information has been requested." HypothyroidismNone . During the same period patient was treated with Thyroid. Patient recovered.

HPV (GARDASIL) Side Effects Report #338681
HPV (GARDASIL) vaccine side effect was reported on 01/16/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a medical assistant concerning a 19 year old female patient with no pertinent medical history and a history of an allergic reaction to Amoxil (reaction unspecified), who on 13-JUN-2008 was vaccinated with her first dose of GARDASIL (Lot: 659962/1740U). On 13-AUG-2008 received the second dose of GARDASIL (Lot: 660393/0067X) and 19-DEC-2008 received the third dose of GARDASIL (Lot: 660393/0067X). On 27-NOV-2008 the patient developed swollen lymph nodes on her neck. The patient sought medical attention with her primary physician. MRI and CT scan were negative. As of 29-DEC-2008 the patient's symptoms persisted. Additional information has been requested. 2/5/09 Received GYN vaccine & medical records of 6/13-12/29/2008. FINAL DX: lymphadenopathy Records reveal patient experienced good health on 6/13 1st HPV. Received call form parent 12/29 about painful neck lymphadenopathy since week of Thanksgiving. Had seen PCP & tx w/antibiotics. Improved initially but then recurred. Had been referred to ENT who had CT/MRI done which revealed benign lymph nodes." "Penicillin allergy PMH: constipation. Yaz contraception. Allergy: amoxil. Pap smears normal. Family hx: DM, osteoporosis, blood clotting disorder, heart disease, cancer. HPV #3, lot # 0067X given LA on 12/19/08""Magnetic resonance, ?/?/08, negative results; computed axial, ?/?/08, negative" . Patient recovered.

HPV (GARDASIL) Side Effects Report #338682
HPV (GARDASIL) vaccine side effect was reported on 01/16/2009. Female patient, 23.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a physician concerning a 23 year old female patient with depression, who on an unspecified date, was vaccinated with the first dose of GARDASIL and on approximately 29-NOV-2008 was vaccinated with GARDASIL. Concomitant therapy included TRAZODONE HC1, CLONAZEPAM, METHYLPHENIDATE and YASMIN. The physician reported that the patient reported feeling weak, dizzy, tremulous over her entire body and her subclavian lymph node was enlarged on the same side where the vaccine was received. The physician reported that the patient experienced the same reaction after both doses of the GARDASIL vaccine. The symptoms were more severe after her 2nd dose. Exact dates of vaccinations were not available. It was 4 four weeks post dose 2 and patient still did not ~feel herself~. The patient reported she still felt weak and is unable to concentrate. At the time of the report, the patient had not recovered. The patient sought medical attention and was seen at the physician's office. Additional information has been requested." DepressionUnknown . During the same period patient was treated with CLONAZEPAM; YASMIN; METHYLPHENIDATE; TRAZODONE HYDROCHLORIDE. Patient recovered.

HPV (GARDASIL) Side Effects Report #337817
HPV (GARDASIL) vaccine side effect was reported on 01/20/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a physician concerning a 11 year old female with no pertinent medical history who on 12-SEP-2008 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot #660618/0572X). There was no concomitant medication. ~Three months after administration of her first dose of GARDASIL~, on 12-DEC-2008 the patient experienced weakness, sore throat, nausea, vomiting, diarrhea, paleness and abdominal pain. ~One month later~, the patient's symptoms had not resolved and she was also experiencing chest pain, headaches, dizziness, swollen lymph nodes, chills and myalgia. The patient had office visits. ~White blood cell differential count and white blood cell count~ were normal. ~Four weeks ago~, on approximately 12-DEC-2008, the patient was prescribed PRILOSEC. At the time of the report, 09-JAN-2009, the patient had not recovered. Follow-up information received on 12-JAN-2009 from the physician via medical records indicated that on 18-DEC-2008 the patient was taken to the physician's office for follow-up. It was reported that the patient had a sore throat and abdominal pain which persisted one month. The patient vomited for four times on 08-DEC-2008 (previously reported as 12-DEC-2008) and had a diarrhea ~last week~. There was no blood. The patient was treated with omeprazole, 2-3 times daily for 3 weeks. At the time of the follow-up visit, the patient's abdominal pain worsened and she also had chest pain with deep breath, cough, headaches which happened ~every day for one week~ and cough. Lab tests performed on 18-DEC-2008 included: giardia antigen was negative, stool culture revealed no salmonella, shigella or campylobacter SP. isolated, white blood cell count and white blood cell differential count were normal, Epstein-Barr viral capsid antigen immunoglobulin M antibody was negative, EBV capsid antigen immunoglobulin G antibody and nuclear antigen immunoglobulin G antibody were positive. It was reported that the patient's mother was suspecting that her daughter's ~r" None. PMH: none"Stool Giardia lamblia, 12/23/08, negative; WBC count, 12/18/08, 7.3 thou; Red blood cell count, 12/18/08, 4.73 mill; Hemoglobin, 12/18/08, 14.0 g/dL; Hematocrit, 12/18/08, 39.9%; Mean corpuscular volume, 12/18/08, 84 fL; Mean corpuscular, 1" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #339312
HPV (GARDASIL) vaccine side effect was reported on 02/09/2009. Female patient, 21.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a gynecologist, concerning a 21 year old female patient with history of pollinosis who was vaccinated with a third dose GARDASIL (Lot number 0277U, Batch number NG00020, injection route and site not reported) On 13-MAR-2008. On 28-MAR-2008, the patient developed gastrointestinal cramps with postprandial diarrhea for, the first time. She recurrently complained of abdominal cramps with diarrhoea. After one of these episodes, in September 2008, she went to the emergency room. Clinical examination, lab tests and abdominal sonography were without pathologies. Suspected diagnosis was enteritis. During months she had a weight loss of 5 kg of weight. Within a few months p.v. the patient also experienced generalized itching and an eczema on the right hand. The patient additionally complained of impaired memory, amnesic aphasia, concentration impairment, bad mood, aggression, listlessness, arthralgia, headache, pain and numbness in the whole left arm (from shoulder to fingertips) so that temporarily driving a car was not possible. Also, the patient experienced intermenstrual bleeding, sleeping disorder because of pain in legs, dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with lymphadenopathy followed by ear pain and reduced hearing. In June 2008, the patient consulted a pneumologist because of frequent dyspnoea and unusual cough. Diagnosis of allergic bronchial asthma was diagnosed for the first time (long time history of pollinosis). Treatment with beclometasone and salbutamole inhalatives was started. The outcome was not reported. Upon internal review report considered medically significant. Other business partner numbers included: E2009-00384. Additional information has been requested." Pollinosis"Abdominal ultrasound, 09/??/08, without pathologies; diagnostic laboratory 09/??/08, without pathologies" . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #339351
HPV (GARDASIL) vaccine side effect was reported on 02/10/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Chronic headache pain. 2/18/09MR received from PCP including vax rec and numerous consultations. Initially c/o with visual changes 10/3/07. PE (+) for R posteriar auricular node. Dx: Lymphadenopathy. Multiple OVs 1/2008-1/2009 for H/A with increasing freqeuncy and severity. Occur daily with blurry vision. Dx: Chronic H/A, Migraine. Back and leg pain noted 1/29/08 with photophobia. Sinusitis with Sinus surgery 4/08 and 5/08. Nothing helping H/A pain by 12/08 despite Botox, steroids and analgesics.DX: Intractable H/A pain. Depression and Anxiety noted 1/20/09. Multiple consults beginning 2/2008. ENT consult-severe cephalgia-out of proportion with sinus disease. ? Migraine. Neuro consult 2/26/08 -H/A- multifactorial. F/U 8/25/08. Recent psych admission for Major Depressive Episode with med adjustment. Pain mgmt consult 10/3/08 for constant H/A. Chronic Daily H/A with tension-type H/A features and occipital neuralgia. Occipital nerve blocks helped temporarily. Multiple F/Us. Scalp muscles possibble as source of pain. Accupucture started 2/09." NoneSeasonal allergies. PMH: ADD. Asthma. Seasonal allergies. AcneCT; MRI. Labs and Diagnostics: CT scan (+) for sinus disease. MRI brain WNL. . During the same period patient was treated with PROZAC; Doxycycline; ASTELIN; NASONEX; CLARINEX. Patient recovered.

HPV (GARDASIL) Side Effects Report #339366
HPV (GARDASIL) vaccine side effect was reported on 02/10/2009. Female patient, 35.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Left axillary lymphadenopathy: swollen, tender. There was no source of infection, so I had mammogram plus ultrasound done. Multiple suspicious nodes on US. Pathologists recommended a biopsy. Had core bx which failed, so went to OR to have 2 lymph nodes removed for diagnosis on 2/8/09. All path was benign. 3/6/09-records received for DOS 1/28/09-received Gardasil vaccine. No C/O at time of visit. 3/11/09-records received-abnormal lymphadenopathy left axilla. Excision on 2/10/09-" nonenonepathology including flow cytometry of LNs were negative. 3/11/09-records received-pathology report no abnormality identified. . During the same period patient was treated with doxycycline 40mg PO q day. Patient recovered.

HPV (GARDASIL) Side Effects Report #339656
HPV (GARDASIL) vaccine side effect was reported on 02/16/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Patient received 1st dose of Gardasil vaccine on 8/8/08 in Dr. office, since having the vaccine she has had recurring headaches, severe joint pain, chronic fatigue syndrome, and chronic swollen glands, chills, fever, sore throat, ear pain, numness in arms. On 12/2/08 she received her 2nd MMR and Menoccical vaccine at her pediatrician. 3/11/09 MR received from PCP from 8/7/08-2/15/09. Seen 9/28/09 with c/o sore throat and congestion. DX: sinusitis. Pharyngitis. Seen again 10/6/08 after falling off horse with c/o neck pain. DX: Spasm-R SCM muscle. URI and BSOM 10/13/09. Sinusitis 11/12/08. MCV4 and MMR given 12/2/08. Seen again 2/5/09 for c/o ear pain, chills, fever with congestion. DX: allergy. RSOM. Seen 2/12/09 for c/o fever, scratchy throat,cough, lip swelling,congestion and achy joints. DX: Pharyngitis. Bronchitis. Seena 2/15/09 with c/o difficulty breathing, cough, wheezing, H/A. DX: URI." none"Penicillin, Advil PMH: OCs.""flu test, CBC, Chem profile. Labs and Diagnostics: CXR WNL. T4 high at 15.4. CBC WNL." . During the same period patient was treated with Synthroid 50 mg. Patient recovered.

HPV (GARDASIL) Side Effects Report #340454
HPV (GARDASIL) vaccine side effect was reported on 02/13/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a physician concerning a 16 year old female patient who on unspecified dates was vaccinated with the first dose and the second dose of GARDASIL vaccine. Concomitant therapy included hepatitis A Vaccine (inactive) (manufacturer unknown) when the patient received the first dose of GARDASIL vaccine. Subsequently, the patient developed 2 nodes on her neck and her ~glands~ were swollen within 24 hours after receiving the first dose of GARDASIL vaccine. Subsequently, the patient recovered. The physician also noted that the patient experienced the same symptoms after receiving the second dose of GARDASIL vaccine. The patient was seen by the physician. Subsequently, the patient recovered. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #340761
HPV (GARDASIL) vaccine side effect was reported on 02/13/2009. Female patient, 21.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a consumer concerning her 21 year old daughter with no previous medical history reported who on 06-APR-2007 was vaccinated with the first dose of GARDASIL. On 07-JUN-2007, the patient was vaccinated with the second dose of GARDASIL and on 10-OCT-2007 with the third dose of GARDASIL. Concomitant therapy included birth control (unspecified). She had her papanicolaou test on 20-OCT-2007 and on 21-MAY-2008 and both came back ASCUS, and her last papanicolaou test on 03-DEC-2008 came back normal. In December 2007 and April 2008, the patient experienced yeast infections. In November 2008, the patient experienced swollen gland in her groin. Subsequently, the patient recovered. The patient sought unspecified medical attention. This is one of several reports provided by the same source. Additional information has been requested." None"Pap test, 10/20/07, ASCUS; Pap test, 05/21/08, ASCUS; Pap test, 23/03/08, normal" . During the same period patient was treated with hormonal contraceptives. Patient recovered.

HPV (GARDASIL) Side Effects Report #340360
HPV (GARDASIL) vaccine side effect was reported on 02/19/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "My daughter had the vaccine GARDASIL and now her arm is bruising up looks really nasty and she saying she's got numbness of the arm and Dr. don't think it's the GARDASIL I'm very worried, she does allergies but Dr. did say shot was ok for her. 3/18/09 Received vac records & PCP medical records of FINAL DX: purpuric rash LUE; allergies; urticaria Records reveal patient experienced good health on day of #1 & #2 HPV vaccines. RTC 1/15/09 w/rash, redness, itching & bruising LUE which had started in wrist area & moved up arm. Dx w/insect bite (spider) LUE. Tx w/IV antibiotic & antihistamine. RTC 2/2/09 w/URI & pain left arm. Dx w/strep throat & URI. Tx w/antibiotics. Seen in ER 2/3/09 for probable insect bite LUE & enlarged bilateral axillary lymph nodes. Tx w/continued antibiotics & antihistamines. RTC 2/19 w/purpuric rash left arm & 2/24 w/bruising & tenderness of both arms, chest pain & taste alteration. Dx w/allergies & urticaria. Tx w/antihistamines." "She does have allergies PMH: asthma, seasonal allergies.""LABS: Blood c/s, CRP, PT/PTT all WNL." . Patient recovered.

HPV (GARDASIL) Side Effects Report #340584
HPV (GARDASIL) vaccine side effect was reported on 02/23/2009. Female patient, 24.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Patient calls VHC x 3 in past week. ~Just don't feel like myself; very tired, achy, constant HA, nodes on side of neck and under chin are enlarged.~ Reports chills, general malaise, ongoing, constant frontal HA with changes in vision- not as sharp with glasses on and blurry with glasses off, photophobia, some noise sensitivity, slight nausea (negative prior hx migraines), decreased appetite, loose stools s/p GARDASIL #1 on 02-11-09. Seen by PCP on 02-20-09, who Dx'd as ~Acute Cervical Lymphadenitis.~ Bloodwork: CBC with DIFF, CMP, ESR, HIV-1 AB, RPR, Reticulocytes, TSH sensitive ALL WNL with exception of slightly decreased Hgb of 11.7 - patient states she was at the end of her menstrual cycle when the labs were drawn. HIV-1 AB and RPR results pending-advised patient to call PCP for results. Patient is very anxious because her cousin was recently dx'd with HIV. Patient is currently not sexually active- her husband, AD military spouse, is deployed at present." None"NKDA. Patient had recent (10FEB09) Allergy work-up, which was negative for environmental allergens per skin testing. Normal Pulmonary Function testing. Dx was vasomotor rhinnitis."CBC with Diff; ESR; TSH-sensitive; CMP; HIV-1 AB; RPR . During the same period patient was treated with Ibuprofen 800 mg po tid with food; EXCEDRIN prn for HA's; OTC Super B-Complex. Patient recovered.

HPV (GARDASIL) Side Effects Report #340882
HPV (GARDASIL) vaccine side effect was reported on 02/28/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "AFTER FIRST GARDASIL VACCINE (administered 9/13/06): experienced dizziness, light-headed, nauseous, headaches, leg cramps, and shooting leg pain. AFTER SECOND GARDASIL VACCINE (administered 11/13/06): experienced same symptoms after first dose plus hair loss, abdominal bloating, menstrual cycle stopped, weakness, poor circulation. AFTER THIRD GARDASIL VACCINE (administered 3/13/07): experienced all symptoms listed above plus excessive hair loss, pale/purple skin, always cold, loud ringing in ears, extreme digestive problems, stomach pain, gastrointestinal discomfort, chronic constipation, joint pain, facial swelling, chronic fatigue, irritability, easily agitated, extreme weakness and all-over muscle fatigue (with difficulty in walking, talking, moving, etc.). TREATMENT: had to seek alternative medicine doctors to receive nutritional supplementation because other doctors could do nothing for me. Recently have been referred to a clinic. (scheduled appt. for 3/30/09). 3/18/09-records received for DOS 5/18-5/20/08-DC DX: Chronic constipation. Exercise induced asthma. Cyanosis. Pancytopenia. Presented to ED with increased generalized weakness and constipation since 2/08.Taking a Chinese herbal formula for chronic fatigue astra lsatis. Possibility of viral syndrome secondary to hepatitis C. PE: differential in pulses bilaterally, cyanotic in extremities pulse ox O2 saturation 87% at exercise but increased at rest. Follow-up: Leg pain, numbness, stiffness, partial organ failure, anemia low platelets, cardiac arrhythmia, low body temperature, EBV onset, Hep C onset, UTIs, pancreatitis, amenorrhea, melanosis coli, gout, boils, Baker's cyst, swollen glands hypothyroidism, hypoglycemia, chronic somnolence episode tachycardia, dysphagia, orthopnea, thrombocytopenia." none"none 3/18/09-records received-Recurrent sinusitis, status post rhinoseptoplasty. hepatitis C. Questionalbe history of Epstein-Barr virus infection. Gastroesophageal reflux disease.""Diagnosed with: Thrombocytopenia, Pancytopenia, Ammenorrhea, Hypothyroidism, Anemia, low blood pressure, Autoimmune Disorder, partial organ failure, digestive disorder, Epstein Barre, Orthopnoea, hormonal imbalance, urinary tract infection," . During the same period patient was treated with none. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #342159
HPV (GARDASIL) vaccine side effect was reported on 03/13/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a nurse practitioner concerning a 15 year old female patient with endometriosis who on unspecified dates was vaccinated with the first two doses GARDASIL (lot number not specified). There was no concomitant medication. The patient experienced nausea, ~gagging~, flu-like symptoms and felt miserable 2 weeks after she received the second dose of GARDASIL. At the time of reporting, 2-Feb-2009, the patient had recovered. Additional information has been requested. 09/04/2009 Received vaccine & PCP medical records. FINAL DX: arthralgia; lymphadenopathy w/u benign; endometriosis; dyspepsia/gastritis. Records reveal patient experienced LLQ pain radiating into groin w/lymphadenopathy x approx 1 year; gagging in AM; heavy menstruation w/clots when seen 12/12/08. 12/16/08 Referred to Rheum when ANA was elevated;referred to surgeon to eval lymphadenopathy; referred for CT abd/pelvis to eval LLQ pain. Rheum consult of 8/20/09 reveals patient w/joint pain; abdominal pain & nausea x approx 2 yrs, worse at night & disturbs sleep; fatigue. Had been dx w/endometriosis & on BCPs which helped symptoms." Endometriosis"9/4/09 Medical records received w/PMH: Allergy: amoxicillin, biaxin. Family hx: MS, hypothyroid. HPV #3 given 7/1/09, LA, Lot # 0315Y""Medical records received w/LABS: EGD 12/08 (+) gastritis. ESR 9, ANA 1:80 speckled. RF neg." . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #342647
HPV (GARDASIL) vaccine side effect was reported on 03/13/2009. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a physician concerning a 20 year old female patient with no pertinent medical history and no known allergies/drug reactions who on 25-Jan-2008 was vaccinated with the first dose of GARDASIL (lot#659962/17400) 0.5ml intramuscularly. The patient received the second dose of GARDASIL (lot# 660389 / 1968U) 0.5ml intramuscularly on 29-Apr-200. Concomitant therapy included ~~~~ 4/8/09 GYN records received. OV 1/28/08 with HPV#1 given-1740U. HPV#2 given-1968U. Report states no prior rxn to vaccine. 4/21/09 Office notes received from PCP for 2 OVs 3/4/09 with dx: Anxiety and 3/24/09 with DX: Herpes simplex oral-resolving. First seen for c/o 1-2 month hx of anxiety, tenseness, tremoulousness, palpitations, dyspnea, irritability, insomnia and difficulty relaxing r/t heavy school load. PE WNL. Returned 3/24/09 with R sided oral cold sore and swollen gland under the neck, now resolving. Pt reports no other c/o." NoneUnknown . During the same period patient was treated with Minocycline. Patient recovered.

HPV (GARDASIL) Side Effects Report #342177
HPV (GARDASIL) vaccine side effect was reported on 03/19/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, supraclavicular lymphadenopathy on same shot was given for gardasil #1 and #2 nonenonen/a . Patient recovered.

HPV (GARDASIL) Side Effects Report #342281
HPV (GARDASIL) vaccine side effect was reported on 01/30/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Reactive Lymphadenopathy, cervical, BIL." . Patient recovered.

HPV (GARDASIL) Side Effects Report #342541
HPV (GARDASIL) vaccine side effect was reported on 03/16/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Mom reports fever started 3/14/09. Rash started Sunday on chest & face. Itching. Swollen glands. Mucous in throat. Seen at ER- Dx chick pox. Seen at clinic- rash face, belly, neck, chest, arms, mouth and thighs. Papular rash on face + chest min influence to arms, some on abd, some lesions with clear tops. Given ZYTREC." . Patient recovered.

HPV (GARDASIL) Side Effects Report #343756
HPV (GARDASIL) vaccine side effect was reported on 04/08/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "I had the HPV vaccine Gardisil on March 31, 2009. The next day I was feeling soar and tired, but did not think anything about it. By Friday evening (April 3) I was still feeling tired, my body was aching, in general I did not feel well. I also noticed that my lymph nodes in me neck and groin were very swollen and very painful. This continued throughout the weekend and did not get better. It became very painful to sit, stand and walk. Pain radiated through my pelvis, so I went to an urgent care clinic on Monday March 6th. There I went through a pelvic exam, palpation of my swollen glands, lab work and an ultrasound. I recieved a shot of rochephin and rocephin to take at home for 10 days, in case there was some kind of infection. I have had no fever. My sonogram was normal, other than showing my swollen glands. Labs are not back yet, but I believe they will be normal. However I still have painful swollen neck and groin glands. The groin glands are bothering me the most. 4/13/09-records received for DOS 9/6/08-C/O allergies. 4/6/09-C/O swollen glands and not feeling very good." No"Seasonal allergies, have been reciebing allergy shots weekly for 3 1/2 years, No allergies to yeast. I have never had a reaction to any vaccine before this one 4/13/09-records received-PMH:migraines.""Pelvic exam- noramal, palpation of swollen glands, labds including a cbc- results not back, pelvic sonogram- normal, other than swollen glands" . During the same period patient was treated with "I take lo estrin 24 daily, No other daily home medications, No other medications were taken that week, I do recieve allergy shots nut skipped the week of March 31, 2009". Patient recovered.

HPV (GARDASIL) Side Effects Report #345213
HPV (GARDASIL) vaccine side effect was reported on 04/14/2009. Female patient, 21.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a 21 year old female with hypersensitivity to yeast who on 3-MAR-2009 was vaccinated with the first dose of GARDASIL. Concomitant vaccination included hepatitis A vaccine (unspecified) and typhoid vaccine (unspecified). On 17-MAR-2009 the patient experienced weak, swollen glands, muscle weakness and flu like symptoms. The patient's weak and swollen glands and muscle weakness and flu like symptoms persisted. No lab diagnostics study was performed. At the time of reporting the patient had not recovered from the above events. No further information is available." HypersensitivityNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #345277
HPV (GARDASIL) vaccine side effect was reported on 04/14/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a consumer concerning her 15 year old daughter with allergies to penicillin and other antibiotic and no pertinent medical history who in approximately 2008 (~about a year ago~), in fall 2008, and on 26-JAN-2009 was vaccinated with the first, second and third dose of GARDASIL respectively (lot # not provided). There was no concomitant medication. On approximately 26-JAN-2009 (~right after she received the third dose~) the patient experienced extreme fatigue, vomiting and headache that seemed to be getting worse everyday. Blood panel and CAT scan were performed (no results provided). At the time of reporting, the patient's extreme fatigue, vomiting and headache persisted. The patient sought medical attention via visiting primary care physician and pediatrician. Additional information has been requested. 5/13/09 medical records received DOS 1/26/09 to 3/31/09. FINAL DIAGNOSIS: Nausea and vomiting secondary to psychological issue. Post-vaccination feeling weak, tired, abdominal pain, fever, projectile vomiting, diarrhea. Bloody urine and cramps. Sore throat and swollen glands. Upper quandrant tenderness. Burning sensation in chest. Dizzeness, not eating well. Othostatic hypotension. Referred to counseling center. To schedule STD screening and pelvic exam." "Penicillin allergy; Allergic reaction to antibiotics 5/13/09 medical records received DOS 1/26/09 to 3/31/09. Tinea corporis,"5/13/09 medical records received DOS 1/26/09 to 3/31/09. Rape"Unknown 5/13/09 medical records received DOS 1/26/09 to 3/31/09. LABS and DIAGNOSTICS: CBC - MPV 7.1 fL (L) NE% 73.0 (H) BA% 1.4 (H) Lymph% 28 (L). EBV Antibody (-) CMV Antibody (-). CT Head WNL. Urine Culture no growth. UA - hazy, bili" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #345283
HPV (GARDASIL) vaccine side effect was reported on 04/14/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a registered nurse concerning her daughter, an 11 year old female patient with no pertinent medical history and no known drug allergies, who on 23-OCT-2008 was vaccinated with the first dose of GARDASIL (lot# not reported) and 20 minutes later developed a stiff neck while riding home from the doctor's office. There was no concomitant medication. The stiff neck resolved after the ride. On 23-DEC-2008, the daughter had a second dose of GARDASIL (lot# not reported) and within 11 days she developed a ~constant cough and an enlarged lymph node at the cervical area~. There was no concomitant medication. Patient was seen at the doctor's office. No abnormal labs. The cough lasted all of January and February and impeded in her basketball activity. She was given Z-PACK and TESSALON PEARLS but it did not help. She was also given Hydrocodone and TUSSIONEX that helped some days but made her drowsy. Both the cough and enlarged lymph nodes resolved by March. Additional information has been requested." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #345288
HPV (GARDASIL) vaccine side effect was reported on 04/14/2009. Female patient was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, Information has been received from a physician concerning a registered nurse who was vaccinated with her first dose of GARDASIL. 6 weeks after her first vaccination the patient experienced a fever and swollen cervical lymph nodes. The patient was treated with steroids. The nurse also experienced a fever and swollen cervical lymph nodes after her second dose of GARDASIL. She was treated again with steroids. The physician reported that the nurse approached her while working at the hospital for medical attention. The physician did not have any additional information since the nurse was not her patient. It was also reported that the patient underwent a CT scan (results not reported). No further information is available. Unknowncomputed axial . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #344616
HPV (GARDASIL) vaccine side effect was reported on 04/22/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Mother reports child woke up ~Sunday night at 1:30~ (April 12) with c/o not feeling well, sore throat and swollen glands on side of neck. Reports c/o headache and aching ~all over~. Reports child was seen by Dr 4/13/09 and diagnosed with ~allergies~. On 4/14/09 was seen at ED with diagnosis of ~virus~." NoneAsthma4/13/09--negative strep test; 4/14/2009 Negative Mono test and Negative Mumps . During the same period patient was treated with Singular for Asthma. Patient recovered.

HPV (GARDASIL) Side Effects Report #345607
HPV (GARDASIL) vaccine side effect was reported on 05/09/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Tremors in R hand started 12-24 hours after injections. Dizziness - resolved.5/18/09 records received-office visit 12/28/08 C/O swollen glands, lethargic, strep 1 month prior. 12/31/08-C/O fever times 3 days, started 5 weeks ago with sore throat, headache, malaise, headache, tired. 2/19/09-lump onleft side of hip. HX of strep 3 times since 11/08-shoddy nodes at neck. Impresion lymphadenopathy. 3/4/09-rash all over, swollen lymph nodes, had mono, strep. C/O headache, body aches, red face. 5/4/09-C/O shakiness right hand, tremors. Referred to neurologist." NoneEBV-Mono 1/18/09"5/18/09-records received Epstein Barr virus BCA IgM 1.42, IgG 2.84" . Patient recovered.

HPV (GARDASIL) Side Effects Report #346229
HPV (GARDASIL) vaccine side effect was reported on 05/01/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Dx-encephalitis etiology unkonwn. Five weeks after administration pt experienced stiffness of neck. Neck pain, back pain, lethargy, no appetite fever for 7 days then began having seizures which lead to respiratory failure. 1 1/2 yr later seizures are ongoing & numerous developmental problems due to brain atrophy. 5/13/2009-records received-ER visit 9/22/07 presented with C/O one day history of fever, sore throat and right-sided neck pain. DX: Viral pharyngitis, right cervical adenopathy most likely due to viral etiology. Office visit 9/26/07-Fever and sore throat, stiff back and shoulders for 4 days. Tiredness, decreased appetite. No neck pain.Office visit 6/8/07-immunization visit received Gardasil, Menactra and Varicella. Assessment: viral infection, pharyngitis. 5/20/09 - ICD-9 codes received. 99669 infection and inflammatory reaction due to other internal prosthetic device/implant/graft, 3159 Unspecified delay in development, E8782 Surgical operation, anastomosis/bypass/graft, with abnormal reaction/later complication, no surgical misadventure, V1251 Personal history of venous thrombosis and embolism, Z8981 Primary hypercoagulable state, V1251 Personal history of venous thrombosis and embolism, 78039 Convulsions, 326 Late effects of intracranial abcess/pyogenic infection, 34839 Encephalopathy, 1390 Late effects of viral encephalitis, 27651 Dehydration, 3154 Developmental coordination disorder, 31539 Developmental speech disorder. 5/20/09 ED and hospital records received DOS 9/22/07 to 4/12/09 FINAL DIAGNOSIS: Seizure disorder Post vaccination: Intially presented to ED with one day history of fever, sore throat and right-sided neck pain. Then repeated ED visits due to seizures. Slurred speech, motor delay. Tachycardia. Skin graft anterior right foot, followed by cellulitis. Repeated febrile illness with photophobia. Hit her head several times. Disconjugate gaze. Facial twitching. Temporal lobectomy. Choreoathetoid movements of head. Venous thrombosis and embolism left lower extremity, intracranial" NoneNone 5/13/09-records received-PMH: ITP."During hospitalization complete workup performed: Labs, spinal infections disease, genetic Hx etc.. 5/13/09-records received-Throat culture:negative. 5/20/09 ED and hospital records received DOS 9/22/07 to 4/12/09 LABS and Diagnostics" . During the same period patient was treated with "None 5/20/09 ED and hospital records received DOS 9/22/07 to 4/12/09 Keppra, Dilantin, phenobarbital, Ativan, Prevacid, Diastat, Lovenx, IV antibiotics". Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #346708
HPV (GARDASIL) vaccine side effect was reported on 05/14/2009. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a Nurse Practitioner (N.P) concerning a 20 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 16-MAR-2009 was vaccinated with the first 0.5 ml dose of GARDASIL vaccine (Lot # 1702X) intramuscularly. There was no concomitant medication. It was reported that on 26-MAR-2009 the patient the patient developed cervical and inguinal lymphadenopathy. It was reported that the patient also developed ~pimple-like bumps~ in the groin area. The patient called to the office. There were no laboratory diagnostic tests performed. It was reported that the patient was scheduled to be examined in the office on 02-APR-2009. It was reported that the patient had not recovered at the time of the report. Additional information has been requested." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #346715
HPV (GARDASIL) vaccine side effect was reported on 05/14/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a nurse practitioner concerning a 19 year old female patient with no pertinent medical history or no known drug allergies who on 04-FEB-2009 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 661766/0652X). There was no concomitant medication. On 07-FEB-2009 the patient developed enlarged lymph nodes on her neck. The nurse practitioner saw the patient on 16-FEB-2009 and the lymph node was about 1 cm in diameter. She had been taking AUGMENTIN, to treat the symptom. Subsequently, on an unspecified date the patient recovered. Additional information has been requested." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #346862
HPV (GARDASIL) vaccine side effect was reported on 05/14/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a consumer concerning her daughter, a 15 year old patient with no pertinent medical history and no known drug allergies who on 07-APR-2009 was vaccinated with the first dose of GARDASIL (lot# not provided). There was no concomitant medication. Subsequently, on 07-APR-2009 the patient started feeling hot, clammy, and had blurred vision, and ~had to sit down~. The patient did not actually faint. She did experience some pain at the injections site and on 09-APR-2009, she called her mother and told her that her glands were swollen. No lab diagnostic studies were performed. Additional information has been requested." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #348105
HPV (GARDASIL) vaccine side effect was reported on 05/28/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a nurse practitioner concerning a 22 year old female with unspecified drug reactions/allergies and medical history who on 13-FEB-2009 was vaccinated IM with 0.5ml first dose of GARDASIL (lot number:661531/1311X) and second dose on 6-APR-2009 (Lot number 661952/1129X). Concomitant therapy included hormonal contraceptives (unspecified) and Adderall. Laboratory test were not performed. The nurse practitioner stated the patient received the second dose of the vaccine and experienced swollen glands on the left side of the neck. On 30-APR-2009, the patient went to see her primary care physician with neck pain and then a chiropractor. Subsequently on 6-MAY-2009, the patient came to see the nurse practitioner and she felt that intervention to prevent serious criteria was referring the patient to an ENT physician (Ears, nose, throat physician) to determine if a biopsy was needed. The outcome of the patient was not recovered and she sought medical attention by nurse and physician's office. Additional Information has been requested. 6/2/09 Medical records received DOS 2/13/09 to 5/27/09. FINAL DIAGNOSIS: Lymphadenopathy. Post vaccination reports feeling tired, sits with head turned to left, neck pain. Took several doses of Advil followed by nausea and vomiting. Headaches. Tenderness left lateral neck, palpable lymph node. Later several swollen glands. Chiropractic adjustments. Vaginal discharge. Vaginitis. Vaginal dryness." "None 6/2/09 Medical records received DOS 2/13/09 to 5/27/09. Migraine, bacterial vaginosis, asthma, ADD, appendectomy.""None. 6/2/09 Medical records received DOS 2/13/09 to 5/27/09. LABS and Diagnostics: Pending - CBC, monospot, HIV." . During the same period patient was treated with "Adderall tablets; Hormonal contraceptives. 6/2/09 Medical records received DOS 2/13/09 to 5/27/09. Imitrex, Advil, Keflex, Ortho Tri-Cyclen, Advair, Adderal". Patient recovered.

HPV (GARDASIL) Side Effects Report #348262
HPV (GARDASIL) vaccine side effect was reported on 06/01/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "severe swelling in lympyh node on side of chest. Site swollen, warm to the touch. Lasted approx. 5 days. Doctors perplexed at the location of the swollen node(s) since they bypassed others before settling a distance away for the shot site, but on the same side of the body as injection site. Problem appeared within 48 hours" nonenone . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #348425
HPV (GARDASIL) vaccine side effect was reported on 05/20/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "I took my daughter to a physician she had never been to before. While we were there the nurse suggested my daughter get the GARDASIL injection. I asked her 2 X's what are the side effects of this injection and she said only a slight chance of redness and swelling at the injection site. The Dr came in and AGA IN I asked her about ANY side effect of the GARDASIL, shot and she assured me that there was SIDE EFFECT. I said yes IF you ARE SURE there is NO CHANCE of any side effects.. 3 times I asked her BEFORE the injection. As soon as my daughter got the shot within SECONDS she felt sick. She became hot and clammy. At the check out desk at the Dr's, she felt very weak and dizzy..I asked the receptionists to call back and tell the Dr how my daughter was feeling, the Dr said it would pass. Within 10 minutes after the shot my daughter had extremely bad leg pain on the right side and could not walk. When we got home she felt very SAD and tired. During the night my daughter started throwing up. I called the ER and they said that that was not a normal reaction to an injection. That was Monday night, today is Wednesday and she still is having A LOT of symptoms and problems including muscle weakness, feeling sick, nauseous, chest pain, swollen glands, stomach pain. She went for blood work today and tomorrow a visit to the Dr who gave her the shot. This is CRAZY, she is suffering for what reason???? Because a Dr gave an injection WITHOUT either knowing- ignorantly-what can happen as a side effect on just not TELLING us. THIS MEDICATION SHOULD BE REMOVED..I my daughter should continue to suffer ANYTHING from this injection the makers will be SUED by US. 6/9/09 Medical records received DOS 5/18/09 to 5/20/09. Pt in for 14 yr WCC with 2-3 c/o coughing congestion. Vax given. Returned next day with c/o arm not feeling right since injections. Returned again 5/21/09 with c/o myalgias, abdominal pain and R-sided (illegible) pain and feeling ill since vax. PE . T=99.9. Assessment: Allergy. Myalgia. H/A. ? reaction to Gardasi" 6/9/09 Medical records received DOS 5/18/09 to 5/20/09. PMH: legally blind R eye."6/9/09 Medical records received DOS 5/18/09 to 5/20/09. LABS and DIAGNOSTICS: Urine - blood (+) CBC - Lymph 30.1% (L) ALT 28 U/L (L) Results Pending: C3, C4, Insulin Level. 6/22/09 Labs received: C3 131 (N), C4 30 (N), Insulin 3 (N)." . During the same period patient was treated with 6/9/09 Medical records received DOS 5/18/09 to 5/20/09. Tylenol. Patient recovered.

HPV (GARDASIL) Side Effects Report #348435
HPV (GARDASIL) vaccine side effect was reported on 05/26/2009. Female patient, 34.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Close to 9 months after being given the GARDASIL vaccine. I had a ct scan done, which showed that my lymph nodes were enlarged. A little over a year later. I was diagnosed with Hodgkin's Lymphoma -HL-. I am now undergoing chemotherapy treatment for this illness. This vaccine needs to be researched properly. I am convinced there is an increased risk for Lymphoma in women who were vaccinated. How many people have to die or get seriously sick for this vaccine to be investigated? I known of several women who became sick with Lymphoma months following vaccination with GARDASIL. I do not believe this is a mere coincidence. Statistical data would prove a connection, I'm certain. No oncologist or other doctor has ever asked me whether I was vaccinated with GARDASIL. 6/15/09 Oncology records received DOS 12/23/08 to 5/5/09. FINAL DIAGNOSIS: Hodgkin's Disease Lymphocytic Depletion, Unspec Site. Presented with complaints of fever and swollen cervical lymph nodes. Fatigue, pain/discomfort right neck. Night sweats. Decreased appetite. Muscle weakness and soreness in joints. Numbness right hand. Peri-anal itching, diarrhea, rectal fissure pain. Undergoing six cycles of chemotherapy. Has chemotherapy related side effects. ICD-9 Code: 201.70 6/19/09 PMH records received. PMH: Appy, ankle fx, ovarian cyst, blocked duct, UTI. 6/24/09 Medical, vaccine records received. DOS 4/23/07 to 5/17/07. Medical records consist of laboratory studies only." "6/19/09 PMH records received. PMH: Appy, ankle fx, ovarian cyst, blocked duct, UTI.""6/15/09 Oncology records received DOS 12/23/08 to 5/5/09. LABS and DIAGNOSTICS: CT Scan - paratracheal, pretracheal and prevascular lymph nodes. Nodules in lungs. MRI Brain - WNL. PET - involvement in mediastinal, pretacheal, and cervical" . Patient recovered.

HPV (GARDASIL) Side Effects Report #348807
HPV (GARDASIL) vaccine side effect was reported on 06/09/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Gardasil #1 (1423X) given in right arm on 4/23/09. Adverse reactions symptoms began 4/24/09 exhibited by: dizziness, headache, stomach pain, nausea, chest pains, shortness of breath, pins/needle sensations to feet, burning of skin, nerve pain to right elbow, fatigue, muscle weakness to legs, nausea, swollen lymph nodes to neck. Physician contacted 4/28/09 because this was felt to be in direct relation to the vaccine. She felt it was viral. 6/03/09 Same physician seen due to symptoms becoming more severe. Lab work drawn to rule out Mono due to swollen lymph nodes. 6/08/09 Pediatric Neurologist seen who confirmed that the symptoms were directly related to the Gardasil injection. Diagnosed peripheral neuropathy. 6/17/09 Medical and immunization records received DOS 4/23/09 to 6/3/09. Assessment: Pain & tingling, fatigue, lymphadenopathy. Patient presented with fatigue, headache, dizzy, chest pain, tingly feeling in arms and legs, pale, tender cervical lymph nodes. Referral to neurologist. LABS and DIAGNOSTICS: Planned CBC, ESR, CRP, Electrolytes, EBV, IgG, IgM. 8/3/09 Consultant medical records received DOS 12/12/08 to 6/29/09. Assessment: New onset symptoms after Gardasil. Patient presents with dizziness and waves of nausea. Chest pain, shortness of breath, and intermittent bifrontal headaches. Tingling of feet and hands with associated pain. Burning sensation in hands and quadraceps muscles. Off balance. Back pain. EB Virus pending. Neuropathic type pain - ulnar region. Allodynic pain. Tender in C2 to C6. Heart rate 74 and standing heart rate 100. Flat affect and dysphoric mood." Healthy"OCD. 6/17/09 Medical and immunization records received DOS 4/23/09 to 6/3/09. OCD, depression, anxiety, suicide attempts. Kidney stones. Weakness, dizziness. Allergy - Lamictal. 8/3/09 Consultant medical records received DOS 12/12/08 to 6/29/09. Tremor with intention, obsessive-compulsive dysfunction, mood disturbance. Allergy to Lacmictal. Kidney stone. Flexion of torso occuring m""CBC with diff/ plt, C-reactive protein, SED rate, electrolyte panel, Epstein Barr AB panel 6/17/09 Medical and immunization records received DOS 4/23/09 to 6/3/09. LABS and DIAGNOSTICS: Planned CBC, ESR, CRP, Electrolytes, EBV, IgG, IgM." . During the same period patient was treated with Lexapro. Patient recovered.

HPV (GARDASIL) Side Effects Report #348873
HPV (GARDASIL) vaccine side effect was reported on 05/20/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Diagnose Juvenile Rheumatoid Arthritis-> seen at medical center. Tx Prednisone, Methotrexate, LEUCOVORIN. 1/09 started having back pain, unilateral shoulder, arm pain, followed by progressive knee pain and swelling, limitation of activity. 8/4/09 Rheumatology consult records received DOS 3/5/09 to 5/15/09. Assessment: Polyarticular Juvenile Rheumatoid Arthritis. Patient presented with pain in back, knees, shoulders, ankles, feet, elbows and wrists. Pain started in back and then started involving other joints. Difficulty with range of motion and activities in school. Involves 1 or 2 joints for 2-3 joints then moves on to a different joint. She has noticed swelling in knees and hands. Recent URI, fever, chills, sore throat, and cough. Posterior pharynx has erythema with mucus. Wamth of elbows with synovial boggy tissue. Swollen MCP joints. Right hip decreased ROM and pain. Warm both ankles. Synovitis PIP joints. Swelling of knees. Slight scoliosis. Pes planus. Later refusing to walk. Screams when leg or foot touched. Difficulty with ADLs. Chiropractic treatment. Physical therapy. Nearsighted. Rash on arms. Itchy rash on foot. Anxious, depressed affect. Cervical lymphadenopathy. Uses wheelchair." None"None. 8/4/09 Rheumatology consult records received DOS 3/5/09 to 5/15/09. Hives - back and face. Allergic to dogs, cats, walnuts, oak tree and pollen. Claritin for hives. Nosebleeds from Nasonex. Oral ulcer. Sinus problems, headaches, double vision. Parotitis. Tonsillectomy. Toe fracture."Elevated ANA; Elevated Rheumatoid Factor. 8/4/09 Rheumatology consult records received DOS 3/5/09 to 5/15/09. LABS and DIAGNOSTICS: CBC - WBC 15.26 K/uL (H) RDW-CV15.3% (H) Seg 77% (H) Lymph 21% (L) Polychromasia (slight) Target Cell (few . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #349088
HPV (GARDASIL) vaccine side effect was reported on 06/12/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a consumer concerning his 15 year old daughter who was vaccinated with GARDASIL. After the patient received the first dose of GARDASIL the patient had a headache. The patient was hospitalized after the second dose of GARDASIL with a lymphadectomy, lymphadenopathy of the neck and the heart, a thyroid lesion, intracranial hypertension and was hospitalized. The patient was 17 years old at the time of reporting. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #349324
HPV (GARDASIL) vaccine side effect was reported on 06/12/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a physician concerning a female who was born on 09-Jun-1988 was vaccinated the first dose of GARDASIL (Merck) (LOT # 0210U), 0.5ml, on 23-MAY-2007. On 07-AUG-2007 she got the second dose of GARDASIL (LOT # 655620/0171U). There were no concomitant medications. Subsequently the patient experienced lymphomatoid papulosis after getting the first dose and second dose of GARDASIL. After that the patient sought medical attention. The patient never received the third dose. At the time of the report, the outcome was unknown. A medical assistant reported the patient's mother advised that the patient was undergoing treatment (no further information given) and would not be receiving the third dose. Additional information has been requested. 6/25/09 Medical records received DOS 12/28/07 to 12/24/08. Assessment: Lymphoid papulosis and iron deficiency. Patient presented with hives on upper extremities. Acne on face. Cellulitis L thigh, lymphadenopathy in groin. Lymphoid papulosis lesions on face, eyelid, legs buttocks. Shotty adenopathy neck. Infection R thigh. Oral contraceptives. Vaccine record: HPV-1 Merck 0210U RA 22.Nov.09 6/29/09 Medical records received 12/28/07 to 12/24/08. Additional information abstracted: Patient presented to oncology center with sweats at night, weight loss, rash and itching. Multiple open weeping papules yellowish in nature, others erythematous and reddish/brown, some are papulopustular. Present on eyelids, neck, arms, back, and posterior portion of legs. 8/24/09 Dermatology consult received. FINAL DX: lymphomatoid papulosis, type C, leaving scars. Records reveal patient experienced widespread & painful nodular lesions, ulcer on left hand, intermittent mouth sores, fatigue, nausea. Tx w/methotrexate starting 6/08, clobetasol propionate cream & folic acid. Developed MTX-induced pneumonitis. MTX d/c'd. Punch biopsy done when developed scaly patches c/w eczematous dermatitis. Tx w/PUVA & Oxsoralen starting 12/08 w/good results." None. 6/25/09 Medical records received DOS 12/28/09 to 12/24/08. Surgery for wrist fracture.None. 6/25/09 Medical records received DOS 12/28/09 to 12/24/08. LABS and DIAGNOSTICS: Chest X-ray negative for lymphoma. PET CT scan negative for lymphoma. Blood work normal. Bone marrow - low ferritin. . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #349327
HPV (GARDASIL) vaccine side effect was reported on 06/21/2009. Female patient was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a licensed practical nurse concerning a female who was vaccinated with a dose of GARDASIL. Subsequently, the patient developed swollen lymph nodes after one vaccination with GARDASIL. Nodes haven been swollen for more than one week. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #349545
HPV (GARDASIL) vaccine side effect was reported on 06/18/2009. Female patient, 25.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a 25 year old female with a history of overgrowth bacterial and ~ZIPORO~ (therapy unspecified) allergy who in March 2009, was vaccinated with the first dose of GARDASIL. Concomitant therapy included neomycin, erythromycin, ~Saczimin~ (therapy unspecified), NASOCORT and NASONEX. In March 2009, the patient had a large bump on her arm after the vaccination. Afterwards the patient experienced swollen glands, headaches, nausea, rash, loss of breath and kidney stones and was hospitalized. The patient had an outpatient visit in April, 2009. Her physician diagnosed her as having a yeast allergy. She underwent a CAT scan, MRI and ultrasound (results not reported). At the time of report, the patient's status was not recovered. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination, dose number, lot number, date of event, recovery status. Additional information has been requested." Drug hypersensitivityOvergrowth bacterialUnknown . During the same period patient was treated with NASOCORT; erythromycin; NASONEX; neomycin. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #350553
HPV (GARDASIL) vaccine side effect was reported on 06/30/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Erythema, edema, hives, lymphadenopathy, treated with prednisone" Mononucleosis . During the same period patient was treated with acetaminophen. Patient recovered.

HPV (GARDASIL) Side Effects Report #351150
HPV (GARDASIL) vaccine side effect was reported on 07/10/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "1 day after GARDASIL developed fever, myalgias, swollen eyes; diagnosed with ~mono~. Monospot (+) however EBV titers all negative. Never felt completely well -> recurrent myalgias, swollen glands, headache. EBV IgG titers (+) 11/08. Multiple complaints myalgias, knee pain; erythema nodosum diagnosed 4/09." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #351970
HPV (GARDASIL) vaccine side effect was reported on 07/20/2009. Female patient, 37.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from an investigator concerning a 37 year old female with HIV and a history of migraine headaches and methamphetamine abuse for 20 years who entered a study. On 08-MAY-2009 the patient was enrolled in A5240 and vaccinated IM with the first dose of GARDASIL, 0.5ml, in deltoid. On 22-JUN-2009 the patient developed the following adverse events: altered mental status grade 3 (dysarthria, anomia, confusion); headache grade 3 (presented to HD 22-JUN-09 with AMS, HA). CT angle of head showed diffuse cerebral edema); left hand numbness grade 2. On 02-JUL-2009 the patient developed decreased neurological reflexes grade 4 (life threatening), pupils fixed and dilated bilaterally grade 4 (life threatening), and death. The report was as follows: The patient presented to emergency department on 22-JUN-2009 with migraine-like headache, left hand numbness, dysarthria and anomia. CT read as normal, patient discharged, the patient returned on 23-JUN-2009 with persistent headache, anomia. At that time, she was not on treatment for HIV and her CD4 count was 263. She was admitted to the neurology service and empirically treated with antibiotics for bacterial and HSV meningitis. Lumbar puncture showed borderline low glucose, elevated protein and a lymphocytic pleocytosis without red blood cells, CSF tests for EBV, HSV, VZV, Cryptococcus, VDRL, AFB smear were negative as well as CSF culture for bacteria, fungus and mycobacteria. CSF cytology was negative, flow cytometry was not performed. JC virus PCR was ordered, but results not reported. Toxoplasma IgG was negative. Blood cultures, coccidioidomycosis titers, serum cryptococcal antigen, RPR were all negative. Prior quantiferon testing in 2004 was positive without subsequent isoniazid treatment chest X ray during admission was negative as were 2 sputum for AFB smear and culture. MRI showed diffuse cerebral edema with leptomeningeal enhancement. Repeated lumbar puncture showed normalization of glucose. During the hospitalization, her symptoms had improved." HIV infectionMigraine; Amphetamine abuse; Bell's palsy"head computed axial tomography, 06/22/2009, see narrative; spinal tap, 06/23/2009, see narrative; spinal tap, 06/23/2009, normalization of glucose; magnetic resonance imaging, 06/23/2009, brain: see narrative; head computed axial tomography" . During the same period patient was treated with None. Patient was hospitalized Patient died on 2//09/07/0.

HPV (GARDASIL) Side Effects Report #352399
HPV (GARDASIL) vaccine side effect was reported on 07/24/2009. Female patient, 34.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Swollen glands around neck, breast and armpit area where injection was adminstered. The area was very tender." NoneNo . Patient recovered.

HPV (GARDASIL) Side Effects Report #352921
HPV (GARDASIL) vaccine side effect was reported on 08/02/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "After first gardasil shot on 03/27/08 my symptoms included: Pain in my arm, dizziness, acute pharyngitis, sore joints and mucles. After my 2nd Gardasil shot on 05/27/08 my symptoms were arm was sore, dizzy, weak, fatigued, whole body ached, severe lower pelvic pain a couple times, Flue off and on, colds, acute pharyngitis a few times, ear aches and infections, sore joints, back and neck pain, headaches off and on, IBS with constipation and bouts of diarrhea,had colonoscopy done, frequent UTI's, kidney infection, hard to concentrate, confusion, had rash on left shoulder for awhile then went away,sensitivity to light, racing heart sometimes, when dizzy my palms sweat, I become clumsy and heart races, grinding teeth, and on 05/29/09 went to OBGYN for Yearly Pap smear and every year it has been normal, no problems but this year, one year after I had my second Gardasil shot the results came back as abnormal. Showed HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION moderate dysplasia CIN 2. Doctor then gave me a colposcopy on 6/26/09 my protien level in urine was high +3 as well said I had ACUTE CERVICITIS. Then had Leep Biopsy done on 7/15/09 for the HIGH GRADE SIL the results were, I had HIGH GRADE SQUAMOUS INTRAPITHELIAL LESION CIN 3 SEVERE DYSPLASIA. They removed all abnormal cells. now bleeding on and off. Been on antibiotics 6 different times in one years time since I had the Vaccine. Never got sick before the shot. I believe these symptoms are caused by the Gardasil Vaccine. I believe I might have something wrong with my immune system or nervous system now. 8/5/09 PCP medical records received DOS 08/16/06 to 7/20/09. Assessment: Acute Cervicitis. High Grade Squamous Intraepithelial Lesion (CIN 3, Severe Dysplasia of Cervix. Patient presents with sore throat, productive cough, and sinus drainage. Oral contraceptives. Pharyngitis. Ear ache. Hurts to swallow. Neck anterior lymphadenopathy. Strep throat. Fatigue, headaches, needing more sleep at night. Bronchitis, chest discomfort with hx of rib contusions. Constipat" nonenone. 8/5/09 PCP medical records received DOS 08/16/06 to 7/20/09. Eye surgery. Caffeine use. Pelvic pain. Oral contraceptives. Penicillin allergy. Hives. Bacterial vaginosis"pap smear,leep biopsy, colposcopy, CBC was normal but Glm filtration Rate, Es was 70 normal is 60,strep screen negative, mono screen negative,colonoscopy, UA showed glucose at 250, bilirubin LARGE, ketones 15, specific gravity <1.005, blood" . During the same period patient was treated with Birth control pills thats it.. Patient recovered.

HPV (GARDASIL) Side Effects Report #353760
HPV (GARDASIL) vaccine side effect was reported on 08/11/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Body aches, fatigue, blisters inside mouth, swollen glands, sores on lips and gums, swollen lips." NoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #354421
HPV (GARDASIL) vaccine side effect was reported on 08/15/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Vaccine on 8-7-09. 8-10-09 elevated temp 104, nausea, vomiting (x1) severe nausea sore. No diarrhea. No local reaction. Swollen glands. BRAT diet, elevated fluids, Prilosec OTC OD." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #354520
HPV (GARDASIL) vaccine side effect was reported on 08/18/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "My daughter had been suffering from extreme full body Uticaria for three years and had been treated with benadryl, allergy medications, hydrocortisone creams and occasionally would be put on prednisone med pacs to control the uticaria. Two or Three weeks after her second vaccine of gardisil she noticed a lump on her neck. I took her to her pediatrician and was prescibed an antibiotic for possible glndular infection. After the course of the antibiotics were finished she came to me about 20 days later and said the lump never went away and now it was bigger. I immediately went back to my pediatricians office the next day. He sent her for an iimmediate cat scan. The cat scan results were enlarged lymph glands in her head neck and chest.We rushed her to the hospital rigth from his office where she was admitted. A biopsy was performed and she was diganosed with lymphoma cancer stage two.(Hodgkins) I am sure that this was caused by the gardisil vaccine. 8/25/09-record received for DOS 5/12/06-for allergy specialist visit for C/O difficulty controlling hives present since 9/05. Impression: idopathic urticaria. 8/24/09 PCP and oncology medical records received DOS 4/15/08 to 5/15/09. Assessment: Hodgkin Lymphoma Nodular Sclerosing Type, Stage IIAd. Patient presents with painful burning rash on extremities. Urticaria, obesity, polydipsia. Hypertension. Ear pain. Cervical lymphadenitis. Chemotherapy and radiation. Pain neck and back - resolving radiation reactions." consistant extreme full body Uticaria"Same as #18. 8/24/09 PCP and oncology medical records received DOS 4/15/08 to 5/15/09. Persistant urticaria, penicillin allergy, allergy cat dander. \ksk""too many to list. would have to get medical records. 8/24/09 PCP and oncology medical records received DOS 4/15/08 to 5/15/09. LABS and DIAGNOSTICS: Cervical Lymph Node Biopsy - Abnormal, Hodgkin Lymphoma. CT Neck - Abnormal, diffuse cervic" . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #354671
HPV (GARDASIL) vaccine side effect was reported on 08/19/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Pt received the Gardasil series of shots on July 20, 2007, Sept. 26,2007 and Feb. 20, 2008. In Jan. 2009, she told me (her mother) about a large lump on her neck. It had clearly been there for sometime based on it's size (4cm x 3cm) and consistency. The pediatrician thought this was a benign swollen lymph node, but subsequently, this was biopsied by a surgeon and Jennifer was diagnosed with Hodgkin's Lymphoma, nodular sclerosis type. While we understand that there is not live virus in the vaccine, we believe that there is an association between the generated immune reaction to the HPV recombinant protein and Hodgkin's Lymphoma. My daughter is now undergoing chemotherapy for her cancer. I sincerely hope the CDC will collect data on Gardasil and the onset of Hodgkin's lymphoma in young girls. 9/1/09 PCP medical records received DOS 7/15/08 to 1/19/09. Patient presents with anxiety, migraines, sinusitis. 9/1/09 PCP medical records received 2/17/09 to 7/17/09. Assessment: Lymphadenopathy. Patient presents with headache frontal, associated with nausea and vomiting. Three migraines last two weeks, throbbing, photophobia. Sore throat, unable to swallow. Cervical lymph nodes bilateral. Rash on abdomen. Swollen cervical lymph nodes 2 months left side. 9/21/09 Received ENT & Heme/Onc consults. FINAL DX: Hodgkins lymphoma, nodular sclerosing, stage IIA. Records reveal patient was pale & had firm left clavicular lymph node. Excisional biopsy done 7/23/09 revealed diagnosis. Tx w/chemotherapy & possibly radiation tx when chemo completed." 9/1/09 PCP medical records received DOS 7/15/08 to 1/19/09. Minocycline allergy. Fasting glucose elevated. 9/1/09 PCP medical records received 2/17/09 to 7/17/09. Allergy to nuts. 9/21/09 Received medical records w/PMH: acne under treatment. migraines. Allergy: tetracycline. Family hx: cancer & leukemia."CBC, CMP, CT, PET, supraclavicular lymph node biopsy. 9/1/09 PCP medical records received DOS 7/15/08 to 1/19/09. LABS and DIAGNOSTICS: Strep (-). 9/1/09 PCP medical records received 2/17/09 to 7/17/09. LABS and DIAGNOSTICS: Rapid Strep" . Patient recovered.

HPV (GARDASIL) Side Effects Report #355482
HPV (GARDASIL) vaccine side effect was reported on 08/26/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Initial near syncopal episode at time of vaccination on 7/30/09. Approximatley 8/11/09, she began to have intermittent problems with easy bruising, tingling, 9/25/09 Received PCP medical records which reveal patient in good general health on day of vaccination & had brief vasovagal syncope after shot. RTC 8/28 after symptoms began 8/11/09 of malaise, tiredness, easy bruising & near fainting episodes while driving. Exam revealed shotty cervical lymph nodes, erythematous throat, macular bruising on arms & nodule on right shin. 9/11 labs revealed + strep & had recent tick bite. Tx w/oral antibiotics." NoneHistory of pyelonephritis 9/25/09 Medical records received w/PMH: pyelonephritis. Allergy: amoxicillin.cbc - WNL; glu 85; ekg: sinus bradycardia; other labs pending 9/25/09 Medical records received w/LABS: (+)ASO . Patient recovered.

HPV (GARDASIL) Side Effects Report #355629
HPV (GARDASIL) vaccine side effect was reported on 08/26/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Initial and follow-up information was received from a physician and a cardiac surgeon concerning his 15 year old daughter with no known drug allergies and had no significant medical history who was described as a healthy girl. She was an active flutist, accomplished and participating in an adult orchestra in her hometown, a soccer player and track runner. On 26-AUG-2008, she was vaccinated with first dose of GARDASIL (Lot # 660555/0279X) and her second dose was administered on 03-DEC-2008 (Lot #660618/0572X). There were no concomitant medications or vaccinations. About mid February 2009 she started to develop what seemed at the time like a viral illness with a sore throat, felt unwell, developed a low grade fever and swollen glands. She rapidly progressed to severe headaches which were accompanied by nausea, photophobia, phonophobia, sensitivity to odors and a complete loss of appetite. The patient also developed severe lower limb weakness and balance/gait disturbance. A multitude of testing including two magnetic resonance imaging (MRI's), electromyography (EMG's), neurovascular checks (NVC's) and multiple labs had been unrevealing. She had been out of school since February 2009 with home tutoring. She became interested in nothing but laying on the couch in a dark and quiet room. She had been unable to tolerate her flute, and had no stamina for any activity including soccer and track. On 26-FEB-2009 the patient saw a doctor, to investigate if the patient was experiencing migraine headaches. Standard migraine treatment including IV DEPAKOTE had not been helpful. The patient was also treated with LORTAB and IMITREX which did not help. Her headaches worsened and were described as a 10 out of 10 on the pain scale and she began to have difficulty walking. She was then sent for a neurology consult and was treated with DEPAKENE and ANTIVERT with no effect. The patient had a battery of laboratory testing done (not otherwise specified) which revealed nothing. On 06-MAR-2009 the patient was seen in the Emergency Room (ER)" None"magnetic resonance, 03/18/09, venus and arterial phase which was negative; magnetic resonance, 05?/??/09, negative; electromyography, 05?/??/09, negative; diagnostic laboratory, 05?/??/09, vestibular testing which came back negative" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #355647
HPV (GARDASIL) vaccine side effect was reported on 08/21/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Developed Hodgkins lymphoma. We diagnosed patient's cancer in August, 2008, and she is continuing chemotherapy. She will have a stem cell transplant too. 9/28/09 Hospital records received, multiple admissions and outpatient visits, DOS 8/22/09 to 9/09/09. Assessment: Hodgkin's Lymphoma stage II-A, bulky disease. Patient c/o ~losing my voice'. (L) vocal cord paralysis. Dysphagia. Mediastinal mass. Chemotherapy. Fever. Neutropenia. Radiation therapy. Relapsed with positive B symptoms, mediastinal mass, neck and lung involvement. Cervical lymphadenopathy. Chemotherapy. Nausea, decreased appetite. Throat pain. Lung sounds diminished (R). Dry nonproductive cough and rhinorrhea. Stem cell harvest." none-preventativeNone. 8/27/09 PCP medical records received DOS 4/16/08 to 5/15/08. PMH: Wart on hand - Histofreezer - Cryosurgery."9/28/09 Hospital records received, multiple admissions and outpatient visits, DOS 8/22/09 to 9/09/09. LABS and DIAGNOSTICS: Laryngoscopy - Abnormal. MRI - Abnomal. Blood cultures - No growth. Thoracoscopy with Mediastinal Biopsy - Abnormal" . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #355831
HPV (GARDASIL) vaccine side effect was reported on 08/27/2009. Female patient, 26.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a Nurse Practitioner concerning a 26 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who in February 2009 was vaccinated with the first dose of GARDASIL with no problems reported. The patient received the second dose of GARDASIL at the beginning of June 2009. Concomitant therapy included hormonal contraceptives (unspecified). It was reported that ~three or four weeks after dose two~, approximately on 21-JUN-2009, the patient developed nausea and abdominal pain. The patient was seen in the office on 29-JUN-2009 regarding her nausea and abdominal pain. An ultrasound, and computed axial tomography of the lower abdominal quadrant were performed (results not provided). It was reported that ~a month after the symptoms began~, approximately on 21-JUL-2009, the patient had recovered. Nausea and abdominal pain were considered to be disabling. It was reported that the patient missed work for 1 week. Additional information has been requested. 9/14/09 Medical records received DOS 8/25/08 to 8/27/09. Assessment: Abdominal pain. Patient presents with lower right abdominal pain and lymphadenopathy. Chills, nausea, diarrhea, constipation. Oral contraceptives." "None. 9/14/09 Medical records received DOS 8/25/08 to 8/27/09. Acne vulgaris, Acute pharyngitis Streptococcus, Asthma, contact dermatitis, headache, hematochezia, UTI, laceration left thigh. Vertigo. Falls. Folliculitis. Lymphadenopathy."Unknown. 9/14/09 Medical records received DOS 8/25/08 to 8/27/09. LABS and DIAGNOSTICS: Colonoscopy - WNL. CBC - WNL. CT Abdomen / Pelvis. Urinalysis (-). Pregnancy test HCG Urine (-). Chest X-ray. US Pelvis. . During the same period patient was treated with Hormonal contraceptives. Patient recovered.

HPV (GARDASIL) Side Effects Report #355916
HPV (GARDASIL) vaccine side effect was reported on 08/27/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "When child woke up next morning after getting Tdap & HPV vaccines afternoon before she felt itching on her neck, both sides. Glands felt swollen per child. It itched on neck & top of shoulders for 3-4 days. Red spots on neck (over glands). Went away after 3-4 days." NoneNo known allergies; No birth defects; No med. conditionNone done . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #356662
HPV (GARDASIL) vaccine side effect was reported on 09/04/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Onset of chest pain, SOB, cough - 2/09. CT chest 2/11/09 - R pulmonary artery occlusion secondary to massive PE. 2/12/09 R atriotomy removal of R atrial mass. 9/11/09 Hospital records received DOS 2/11/09 to 2/17/09. Assessment: Pulmonary embolism/right atrial thrombus. Birth control pill initiated 2-3 months prior. Cough with sputum production past month and a half. Hemoptysis with palpitations. Injured knee 4 days ago. 2 days ago suddenly became short of breath, persisted at rest and with exertion. Patient presents with dyspnea at rest. Sharp chest discomfort anteriorly over sternal area. Tachycardia, tachypnea, epigastric tenderness. Mild adenopathy. Right atriotomy and removal of right atrial mass. Right pulmonary thromoendarterectomy. Massive occlusive pulmonary embolus with suspicion of pulmonary infarct. Thrombus in left inferior vena cava. 9/22/09-ICD-9 codes received-429.89, 415.19, 287.5, 285.1, 286.9, 453.2, 416.8, 785.0, 785.6, 722.10, 447.6, V183, V1200 and V586.9." nonebee sting allergy; L5-S1 disc herniation; Lyme 8/06. 9/11/09 Hospital records received DOS 2/11/09 to 2/17/09. Lyme disease. Herniated disc. Burns to fingers of left hand. Allergic to bee stings. Alcohol use."2/11/09, CT chest; 2/11/09, D dimer 1960. 9/11/09 Hospital records received DOS 2/11/09 to 2/17/09. LABS and DIAGNOSTICS: Echocardiogram - abnormal. CT Abdomen, chest, pelvis - Abnormal. Heart Rate 107 - 123 min. Chloride 100 (L). CBC - WBC" . During the same period patient was treated with none. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #356699
HPV (GARDASIL) vaccine side effect was reported on 09/08/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "9-3-09 Rec'd T/C from MGM, advised client developed enlarged node Left side of her neck,close to the clavicle on 8-21-09. States client has been very tired but has been going to school. MGM stated client did not have any fever, sore throat or headache. PHN advised MGM to take client to Urgent Care, as she does not have a PCP." "9-8-09 T/C to parent, states she has not taken client to Urgent care due to cost. State she doesn't have a PCP, doesn't qualify for assistance, state there is no Free Clinic. PHN strongly enc. parent to have client seen by a physician. Gave" . Patient recovered.

HPV (GARDASIL) Side Effects Report #356928
HPV (GARDASIL) vaccine side effect was reported on 09/10/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "My daughter has passed out TWICE since receiving these injections and experiences increased headaches while the finishing up the series. She has no previous history of passing out and has always been the picture of health. We are very concerned over the long term effects of Gardisil and want the consequences of her receiving these shots documented with both the FDA and her PCP office. Thank you. 9/15/09 PCP medical records received DOS 7/10/07 to 8/24/09. Assessment: Acute strep pharyngitis. Mother says child fainted after first HPV vaccine but did fine with 2nd and 3rd doses. Presents with sore throat, decreased appetite, decreased activity, cough. Tonsils +3 with exudate, mild erythma oropharynx, tender enlargement of anterior cervical nodes. Acute pharyngitis. Headache. Difficulty swallowing, problems falling asleep, nasal congestion/discharge, abdominal pain. Left forearm deformed, tender, numbness, tingling. Left breast tender." No. 9/15/09 PCP medical records received DOS 7/10/07 to 8/24/09. Prior to vaccination on 7/10/09 patient c/o painful ankle and pNone. 9/15/09 PCP medical records received DOS 7/10/07 to 8/24/09. Allergy Sulfa Drugs. Broken left arm. Concussion.9/15/09 PCP medical records received DOS 7/10/07 to 8/24/09. LABS and DIAGNOSTICS: Rapid Strep (+). Mono (-). . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #357474
HPV (GARDASIL) vaccine side effect was reported on 09/16/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "at 25 days after shot she developed the worst headache of her life 10/10, swollen glands in her neck, malase, significant hypersensitivity to touch, myalgia and myositis. She was hospitalized for 4 days with negative work up for any infection, menningitis or known viral illness. She was on multiple narcotic and non narcotic pain medications that did not help her pain. 9/17/09 Received hospital medical records for 9/9-9/12/20009. FINAL DX: headache, neck stiffness, & abdominal pain Records reveal patient experienced HA & neck stiffness x 6 days w/photophobia/phonophobia & abdominal pain x 1 day. Tx w/IVF, pain & nausea meds, IV antibiotics, & oral steroids. ENT consult done & dx w/cervical lymphadenitis secondary to viral syndrome & muscle spasms. D/C to home w/PCP f/u, on pain meds & steroid taper." NONELACTOSE INTOLERANCE 9/17/09 Received medical records w/PMH: Allergy: PEN."Negative LP, Mono spot, EBV titers, Strep Screen, CBC, CMP, UA, CMV titers, Mumps titers. 9/17/09 Received medical records w/LABS: CBC, CMP, CSF, mono & UA all WNL. Throat c/s (+) grp B strep." . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #357475
HPV (GARDASIL) vaccine side effect was reported on 09/16/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Per mother, pt awoke on Saturday, 7/18/09, with pain in right arm and neck with lumph node swollen like cyst. Per mother, pain pt had shooting pain from shoulder blade down right arm. No redness noted. Pt taken to ER and told could have been reaction to vaccines. Mother states pt given a medication to take for ten days, and pt was better three days after ER visit. Mother does not remember what medication was. Mother states pt to continue HPV series with personal physician." none knownunknownunknown . During the same period patient was treated with unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #357561
HPV (GARDASIL) vaccine side effect was reported on 09/17/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Five days after receiving the guardisil shot in her left arm she awoke with a painful lump above her left clavicle. Ten days after the lump, she saw the doctor who ran strep and mono quick tests, both were negative. The doctor ordered E.B.titers, CBC and sed rate. All tests results were normal. On 9-3-09 she was back in the Doctor's office with low grade fever. Doctor thought it might be sinus infection and gave her Azithromycin. The lump did not go away during the course of treatment with antibiotics it just became less tender. On 9-16-09 the tenderness of the lump has increased again. The size of the lump remains the same to date. We do not know if the lump formed immediately after her shot or if the level of pain on the 5th day led her to find the lump. 9/22/09 Received PCP medical records. Visit on 8/27/09 w/neck stiffness, swelling & tenderness & left supraclavicular node x 10 days; HA & vomiting x 2 days. Also noted pimple of left cheek that enlarged & burst spontaneously then scabbed over. Dx w/Torticollis left side & cervical adenitis. All labs neg. RTC 9/3 w/cold s/s, red throat, nasal congestion & backache. Tx w/oral antibiotics. No further medical records available." noneExercise induced asthma.Allergy to amocicillin. . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #357908
HPV (GARDASIL) vaccine side effect was reported on 09/21/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a medical assistant concerning a 17 year old female with no medical history or drugs allergies, who on 02-JUL-2008 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 660555/0279X), intramuscularly. The patient received a second dose of GARDASIL vaccine (lot 660612/0229X) on 03-SEP-2008 and a third dose of GARDASIL vaccine (lot # 661046/0381X) on 15-SEP-2009. There was no concomitant medication. The patient experienced reactions after her third dose of GARDASIL vaccine. The patient had vomiting, nauseas, and swollen glands. Her throat tightened also. The patient did not have any reactions from the first and the second doses of GARDASIL vaccine. No laboratories studies performed. The patient went to an emergency room but recovered within 10 minutes. A lot check has been initiated. Throat tightened was considered to be immediately life-threatening. Additional information has been requested." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #358992
HPV (GARDASIL) vaccine side effect was reported on 09/30/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Notable increase in allergic reactivity and unwellness after first shot. Shot extremely painful going in. Patient has high pain tolerance, and stated it was the most painful thing that ever happened to her. Left tonsil and lymph node in left arm swollen and painful. After second shot anaphylactic reactions with symptoms increasing and cascading into respiratory distress, feeling heavy pressure on chest, severe digestive issues. Muscle heaviness and dibilitating fatigue and mental fog. Heaviness and weakness more pronounced in limbs. Symptoms exacerbated by even minor exertion. Each episode lasted longer than previous and became disabling to the point patient needed wheelchair. Could not stand up to shower, or raise arms to wash hair. Became airborne and skin reactive to strong chemical and food odors. Heart palpitations. Dizziness and faint feelings. Intolerant of even trace amounts of citric acid, and soy lecithin. Intolerant of all fruits, all vegetables or products source from them. Did not have menstruation for almost 2 years. Now has heavy cycles lasting weeks. Metallic taste in mouth. Heavy grey buildup on teeth despite no change in oral hygiene (meticulous oral hygiene). Severe skin problems on face. All over bloating, especially in face and abdomen. Rashes, hives, tongue swelling, painful eruptions on tongue. Episode of tongue swelling witnessed by allergist upon accidental exposure in office to trigger. Seen by Allergists, ENTs, Gastroenterlogists, Speech Therapist, Dietician, Screened for Asthma (negative), Multiple blood tests, and CT scans. Given protocol of multiple antihistamines, Gastrocrom, nebulizer. No effect. Seen at Neurology, various MRIs. Seen by Allergist, and Neurologists. Seen by PA. Had to take medical leave from college. Acupuncture for past year. 10/22/09 and 10/23/09 Medical records received from dates 9/11/08 to 5/6/09 DX: Anaphylactic reaction, secondary to multiple food products, worse with citric acid.Presenting symptoms: Pt. with strong complex history of allergic" None"Allergic to Dairy, egg, peanut, penicillin, ragweed, dust. 10/22/09 and 10/23/09 Medical records received from dates 9/11/08 to 5/6/09 PMH: anaphylactic reactions, multiple food allergies including peanuts, dairy, eggs, citric acid. PCN allergy, cefuroxime allergy. Pneumonia, migraines, syncope, menorrhagia, vocal cord dysfunction.""MRIs, CT scans, Blood tests for allergic disease indicators. All normal. Ischemic forearm test 10/22/09 and 10/23/09 Medical records received from dates 9/11/08 to 5/6/09 Diagnostics/Labs: CT sinus(-), PFT WNL, Ischemic Exercise test for" . During the same period patient was treated with "Zyrtec D, Depoprovera". Patient recovered.

HPV (GARDASIL) Side Effects Report #359858
HPV (GARDASIL) vaccine side effect was reported on 10/06/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Information has been received from a physician concerning a female who on 02-JUL-2009 was vaccinated intramuscularly with a dose of GARDASIL (lot no. not reported). After vaccination, on an unknown date, the patient started experiencing flu like symptoms and had swelling in her groin area. Subsequently, the patient recovered. Follow up information has been received from a licensed practical nurse who regarding a 17 year old female at 134 pounds weight and 52 inches with drug allergies to AUGMENTIN, OMNICEF, BACTRIM who on 02-JUL-2009 was vaccinated intramuscularly in the right deltoid with her first dose of GARDASIL (Lot#661954/1131X) at 11:50 am. It was reported that 5 - 7 days following GARDASIL first injection on 07-JUL-2009, the patient experienced cervical lymphadenopathy, sore throat, headache, dizziness, fever (TM 102.3), hives, nausea, diarrhea and loss of appetite. On an unknown date some symptoms dissipated but the patient had prolonged (10 weeks) of out cervical lymphadenopathy, fatigue and dizziness. Extensive work-up by a hematologist, ENT (ears, nose, and throat), infectious disease and endocrinology. At the time of the report the patient was improving. the liscensed practical nurse considered the patient's experience to be disabling. Additional information has been requested. 10/19/2009 records from PCP, ENT, Hematologist and Endocrinologist visits. Patient 5 days post vaccine had sx of: cervical lymphadenopathy, headache, sore throat, fever, urticaria, nausea, diarrhea, dizziness , malaise, fatigue and anorexia. Initially dx'd with strep pharyngitis and was on ABX x 2 and Medrol dose pak, lymph node size decreased at first but then rebounded and have continued to enlarge since then. PE notes tender , mobile bilateral enlarged cervical lymph nodes appox 2-3 cm. ED visit 9/10/2009: sx frequent urination, hematuria. DC Dx UTI, Tx'd with ABX/Pyridium. Final Dx: Hashimoto's Thyroiditis, Viral lymphadenitis with mono-like illness. Tx: modify activities/rest. 11/5/2009 records from OB-GYN MD" Drug hypersensitivity"PMH: Migraines, Asthma Allergies: Amoxicillin, Augmentin, Omnicef, Sulfa""oral T, 102.3 Lab: CBC, Lipid profile, CMP, LDH, ESR, CMV titer, IgM titer, Toxoplasmosis serology WNL, TSH 5.1 high, Cat scratch panel. Mono-test, PPD, EBV, ANA negative, ACE normal, Monocyte ct 15.6 high, Basophil ct high at 2.05, Thyro" . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #361035
HPV (GARDASIL) vaccine side effect was reported on 10/15/2009. Female patient, 21.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "2 swollen lymphnodes on left neck and 1 on right neck. After blood work December and again in May (with a chest X-ray), results came back inconclusive and was concluded to be a result of vaccination. LAD still present today. Lymph nodes seemingly more reactive to illness than ever before. 10/26/2009 records from multiple MD visits. Patient with c/o's swollen cervical lymph nodes, noted since 9/2008. PE: noted multiple rt and lt sided subcentimeter nodules that were mobile and non-tender. No tx noted, patient to return if any enlargement or change in nodules is noted." NoNo PMH: none Allergies: NKDA"Blood work Chest X-ray negative for LAD in chest. Labs: Cbc, rbc and mchc low. Thyroxine 13.3 high, Bmp wnl, Esr normal at 11, cat scratch, monotest neg Dx tests: Cxr wnl Received follow up doses in January and August 2008 (approximate" . During the same period patient was treated with Nuva Ring. Patient recovered.

HPV (GARDASIL) Side Effects Report #361427
HPV (GARDASIL) vaccine side effect was reported on 10/19/2009. Female patient, 23.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, 09/2008 GASTROINTESINAL PROBLEMS 10/2008 WEIGHT LOSS 11/2008 SWOLLEN GLANDS LEG PAINS/RESTLESS LEGS LOST 30 LBS IN 3 MONTHS/TIRED FATIGUE/WEAKNESS -CONTINUED UNTIL PRESTENT DAY NONE"NONE. PMH: ADD, Anxiety, Heart Murmur, tonsilectomy.""ENDOSCOPY, COLONOSCOPY, TONSILECTOMY, BLOOD WORK, SWALLOWED CAMERA." . Patient recovered.

HPV (GARDASIL) Side Effects Report #365909
HPV (GARDASIL) vaccine side effect was reported on 11/08/2009. Female patient, 23.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Lymph node in neck became swollen. Feeling tried and exhausted and dizzy all day. Cannot perform normal daily functions because of tiredness and near syncope.11/12/2009 MD records for 10/20/2009, patient with c/o's lump lt side of neck. PE noted a small, mobile, 1cm mass. Tx: observation Dx neck mass ICD-9 code 784.2" noasthma PMH: Asthma Allergies: KeflexDx studies: US of the neck impression lymph node . During the same period patient was treated with "Birth Control (Seasonique), Asmanex, Albuteral, Mobic". Patient recovered.

HPV (GARDASIL) Side Effects Report #366111
HPV (GARDASIL) vaccine side effect was reported on 11/09/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Lymphadenopathy, "Developed fevers, joint pains, chronic urticaria. Seen by multiple subspecialists over course of several months." No; unsure exact date of vaccination. 2nd dose given January 2009"Elevated inflammatory markers, negative auto-antibodies. Further workup included skin biopsy (neutrophilic infiltrate, question of vasculitis), as well as pan-CT (mild lymphadenopathy) and lymph node and bone marrow biopsies to rule out ma" . Patient recovered.


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