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TDAP (ADACEL)

TDAP (ADACEL) Safety Reports Total TDAP (ADACEL) reports: 939.

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TDAP (ADACEL) problem was reported from OH on Aug 10, 2007. Female patient , 14 years of age, was vaccinated with TDAP (ADACEL) on Aug 07, 2007. "Mother called office 8-3-07 - low grade fever, joints hurt, dizzy - chills, headache on 8-2-07. Irritable". None. None. Patient recovered.

TDAP (ADACEL) problem was reported from MA on Aug 10, 2007. Female patient , 56 years of age, was vaccinated with TDAP (ADACEL) on July 27, 2007. "Site of vaccination became sore, swollen, working up Deltoid region became painfully sore and she developed left rotator tendonitis and could not use arm. Now referred to orthopedic MD". . . Patient recovered.

TDAP (ADACEL) problem was reported from NY on Aug 10, 2007. Female patient , 43 years of age, was vaccinated with TDAP (ADACEL) on Aug 09, 2007. "Tdap given 8/6/07. Next morning: pain, redness left upper arm. Area of redness about 12cm around.". . Seasonal allergies. Patient recovered.

TDAP (ADACEL) problem was reported from PA on Aug 10, 2007. Female patient , child 11 years of age, was vaccinated with TDAP (ADACEL) on Aug 10, 2007. "Sxs started 8/9/07 in afternoon with redness, swelling, hardness and itchiness. Area very large in size, 10cm x 8cm. Sxs are at Varicella vaccine site.". None. . Patient recovered.

TDAP (ADACEL) problem was reported from HI on Aug 10, 2007. Female patient , child 12 years of age, was vaccinated with TDAP (ADACEL) on July 29, 2007. "1720 Tdap given. 1725 nauseated - diaphoretic BP 100/70 laying down, color pale. 1745 BP 100/68 laying, nauseated. 1820 Sat up, H2O given, freezer popsicle given, BP 100/60 laying, started to get diaphoretic again. 1815 BP same, 110/60. 1830 watching TV, color pink, warm. 1850 BP 120/80. Discharged home.". Albuterol inhaler PRN. "Allergies - shellfish, dust/on hyposensitization". Patient recovered.

TDAP (ADACEL) problem was reported from OK on Aug 13, 2007. Male patient , 33 years of age, was vaccinated with TDAP (ADACEL) on June 19, 2006. "Arm swell with not, flu like symptoms, joint pain". Aspirin; Lipitor 40mg; Prozac 20ml; Depkota; Enapril .15. Allergy for PCN. Patient recovered.

TDAP (ADACEL) problem was reported from OK on Aug 13, 2007. Female patient , 41 years of age, was vaccinated with TDAP (ADACEL) on June 27, 2006. "6-26-06 Pt states ""I had fever, body aches, rash all over body, swollen lymph nodes in neck""". . . Patient recovered.

TDAP (ADACEL) problem was reported from OK on Aug 13, 2007. Female patient , 22 years of age, was vaccinated with TDAP (ADACEL) on July 11, 2006. Client reported red raised rash to (R) forearm with pustules for 2 weeks saw doctor no treatment given.. . "Allergies- amoxicillin, Thimerosal". Patient recovered.

TDAP (ADACEL) problem was reported from OK on Aug 13, 2007. Female patient , 61 years of age, was vaccinated with TDAP (ADACEL) on June 14, 2006. "6-7-06 states saw redness below immunization, hot to touch, 6-8-06 become redder and hot. 6-12-06 saw doctor who stated bacterial infection due from shot. Started on Cephalexin 500 mg BID x 10 day and Prednisone 20mg BID x 5 days.". HCTZ 25mg/day; Veralan 500 mg/day. Hypertension. Patient recovered.

TDAP (ADACEL) problem was reported from PA on Aug 13, 2007. Female patient , 40 years of age, was vaccinated with TDAP (ADACEL) on Aug 09, 2007. Patient developed cellulitis 1 day after Tdap administration on 8/6/07. On 8/9/07 patient treated with Keflex x 7 days.. None. . Patient recovered.

TDAP (ADACEL) problem was reported from VA on Aug 13, 2007. Female patient , 36 years of age, was vaccinated with TDAP (ADACEL) on Aug 08, 2007. "4cm x 7cm red, raised, warm, tender area at site of injections of Adacel and Typhoid on 8/3/07. Patient reports sx began 8/4/07 and was seen at facility 8/8/07 with patient report of sx worsening. Treatment: Augmentin 875mg 1 PO BID x 7 days, Ibuprofen 400,g q 8 hours with food, Loratadine 10mg qd x 3-5 days, warm compresses QID. RTO 8/13/07 and call 8/10/07.". Fertility meds. hx asthma - no current medicines. Patient recovered.

TDAP (ADACEL) problem was reported from TX on Aug 13, 2007. Female patient , 50 years of age, was vaccinated with TDAP (ADACEL) on Aug 13, 2007. "3/9/07 AM left arm became tender and sore. Later that afternoon began to feel achey.Left work early around 3:30pm. Continued to feel very achey all over and felt ""flu-like"". 3/10/07 Called in sick at work. Seen by Administrator: Left arm very sore, slightly swollen, warm to touch, no redness. No fever. 3/11/07 stayed in bed and rested. Took Ibuprofen. Symptoms subsided by 3/12/07. Returned to work 3/13/07. Mild tenderness in arm only.". "Nexium, YAZ (birth conrol), saline sinus rinse". seasonal allergies (non-specific sinus symptoms). Patient recovered.

TDAP (ADACEL) problem was reported from AK on Aug 13, 2007. Male patient , 15 years of age, was vaccinated with TDAP (ADACEL) on Aug 13, 2007. "Fever, head ache and body ache for several days post vaccine. Documented Temp of 101.0 F, pulse 68 and otherwise normal exam.". Ibuprofen post fever onset.. none known.. Patient recovered.

TDAP (ADACEL) problem was reported from MA on Aug 14, 2007. Female patient , 24 years of age, was vaccinated with TDAP (ADACEL) on Aug 09, 2007. "Left deltoid area of erythema 30mmx90mm warm, painful to touch, itchy around area. Benadryl. 3rd day placed on Zyrtec, Benadryl and Augmentin.". BCP. N/A. Patient recovered.

TDAP (ADACEL) problem was reported from MA on Aug 14, 2007. Female patient , 28 years of age, was vaccinated with TDAP (ADACEL) on Aug 14, 2007. "8 hours after administration patient complained of ""severe"" total body aches and lethargy, fever ""over 102"" and ""uncontrollable emotional lability"". Pt self administered Tylenol. Symptoms resolved completely by 8/11/07.". None. Human Papilloma Virus infection. Patient recovered.

TDAP (ADACEL) problem was reported from WI on Aug 14, 2007. Female patient , 44 years of age, was vaccinated with TDAP (ADACEL) on Aug 14, 2007. Adacel given in left deltoid then she had tingling down arm into fingers right away then over the next days start with spot like rash all over body.. . . Patient recovered.

TDAP (ADACEL) problem was reported from NC on Aug 14, 2007. Female patient , 32 years of age, was vaccinated with TDAP (ADACEL) on Aug 07, 2007. "Reports of having redness, swelling, tenderness from right shoulder half way to elbow. Seen in ER 7/21 - given pain med and advised to use ice packs. Report swelling x2 week. Last Td in ER in 2005.". None. Recovered from breast cancer. Patient recovered.

TDAP (ADACEL) problem was reported from VA on Aug 14, 2007. Female patient , 13 years of age, was vaccinated with TDAP (ADACEL) on Aug 10, 2007. "Brief (< 4-5 seconds) loss of consciousness, decreased BP/pale skin/decreased heart rate". . Psychological disorders/allergic rhinitis. Patient recovered.

TDAP (ADACEL) problem was reported from CA on Aug 14, 2007. Female patient , 62 years of age, was vaccinated with TDAP (ADACEL) on Aug 10, 2007. "The day after the vaccine, pt had a 5 inch by 3.5 inch erythematous, inflamed hot area around injection site. She also had a fever of which she took Advil.". . "H/O liver dz., past hx of HTN". Patient recovered.

TDAP (ADACEL) problem was reported from OH on Aug 14, 2007. Male patient , child 11 years of age, was vaccinated with TDAP (ADACEL) on Aug 09, 2007. 24 hrs after injection of Varivax developed moderate and local reaction-erythema and induration 5 1/2 cm x 9 cm-cool compresses off and on and watch closely per physician. Concerta 54 mg QD. None. Patient recovered.

TDAP (ADACEL) problem was reported from MN on Aug 14, 2007. Female patient , 71 years of age, was vaccinated with TDAP (ADACEL) on Aug 05, 2007. "Severe headaches - 5 days + nites bad headache - 4 days, very - very tired - 9 days arm still aches.". Augmentin 7-19-07. . Patient recovered.

TDAP (ADACEL) problem was reported from WI on Aug 14, 2007. Female patient , 64 years of age, was vaccinated with TDAP (ADACEL) on Aug 08, 2007. "R upper arm became red and swollen on 8/3/07. Significant redness noted on 8/8/07. Tissues warm to touch. Tissues involved included around injection site to just above elbow. Seen doctor 8/8/07. Conservative tx ordered: Benadryl, Ibuprofen, Cool packs. No future tetanus containing vaccines.". None. Allergy to Bee stings. Patient recovered.

TDAP (ADACEL) problem was reported from DC on Aug 14, 2007. Female patient , 47 years of age, was vaccinated with TDAP (ADACEL) on Aug 14, 2007. "Difficulty walking, tingling hands, feet, and tongue. Later transported to St. Elizabeth hospital in Belleville, Illinois and diagnosed with GBS. 8/27/07-records received for DOS 6/20-6/28/07- DC DX: Guillain-Barre syndrome. Secondary diagnoses: latent tuberculosis. chronic low back pain. erosive esophagitis. migraine headache. hyperlipidemia. C/O weakness. Presented to ED with leg weakness and sluggishness for approximately two days. Initially legs felt slightly stiff and now having difficulty walking fast. Feels pins and needles in fingers and toes and tip of tongue. Legs feel weak. Expresses anxiety about need to return to work in Africa. No difficulty swallowing. No trouble breathing. Positive for headache. Denies vision changes, memory loss, shortness of breath, nausea, vomiting and diarrhea. Had the beginning of a cold approximately three weeks ago, states she felt run down, however did not develop into any specific illness. Lives and works in Africa. PE: Mild Diminished reflexes in lower extremities. Treated with IVIG. Progressively developed ascending paralysis including facial nerve paresis. Lower extremity weakness began to improve on 6/24/07-Facial weakness continued at time of discharge to rehab. Difficulty chewing and difficulty moving her tongue". . none. Patient was hospitalized Patient recovered.

TDAP (ADACEL) problem was reported from MT on Aug 14, 2007. Female patient , child 12 years of age, was vaccinated with TDAP (ADACEL) on Aug 14, 2007. Client had what mother described as a seizure following vaccination. Mother denies previous seizure activity.. . none known. Patient recovered.

TDAP (ADACEL) problem was reported from NC on Aug 14, 2007. Female patient , 65 years of age, was vaccinated with TDAP (ADACEL) on Aug 09, 2007. "Local skin reaction at injection site. Red hardened area at injection site. Pt reports area is improving less redness, edema since onset". Chlonthalidone; Skelexan; Atenol; Crestor; Allopurinol; Privadnol. NKA. Patient recovered.

TDAP (ADACEL) problem was reported from VA on Aug 15, 2007. Male patient , child 11 years of age, was vaccinated with TDAP (ADACEL) on Aug 15, 2007. "Headache, redness, swelling, pain, fever, fatigue, swollen lymph nodes". . . Patient recovered.

TDAP (ADACEL) problem was reported from FL on Aug 15, 2007. Female patient , 35 years of age, was vaccinated with TDAP (ADACEL) on Aug 15, 2007. "Achy joints, rednes, swelling, hot to the touch to entire bicep of left arm, nausea, muscle sorness, headache, and chills.". Multi vitamins. No. Patient recovered.

TDAP (ADACEL) problem was reported from GA on Aug 15, 2007. Female patient , 34 years of age, was vaccinated with TDAP (ADACEL) on Aug 15, 2007. "PAIN AT THE INJECTION SITE, PAIN TRAVELED FROM INJECTION SITE DOWN THE ENTIRE LEFT ARM, THEN THE ENTIRE LEFT SIDE OF MY BODY WAS IN TERRIBLE PAIN. BECAME VERY NERVOUS, FATIGUED AND DIZZY. DEVELOPED HEADACHE, HIGH FEVER, BODY ACHES, CHILLS, SORE JOINTS. THROAT/TONSIL AREA BECAME IRRITATED AND SWOLLEN. VERY PAINFUL TO SWALLOW. COULD NOT SWALLOW SOLIDS - VERY LITTLE LIQUIDS.". NONE. NONE. Patient recovered.

TDAP (ADACEL) problem was reported from MN on Aug 15, 2007. Female patient , 75 years of age, was vaccinated with TDAP (ADACEL) on Aug 15, 2007. Patient given vaccine out of recommended age range. Patient reports her arm was sore for 2 days. . . Patient recovered.

TDAP (ADACEL) problem was reported from CA on Aug 16, 2007. Female patient , 19 years of age, was vaccinated with TDAP (ADACEL) on Aug 16, 2007. "Swollen, heated, mild lump, red left arm.". . Sulfa. Patient recovered.

TDAP (ADACEL) problem was reported from CT on Aug 16, 2007. Female patient , 27 years of age, was vaccinated with TDAP (ADACEL) on Aug 16, 2007. "After 2 days felt numbness and tingling left arm (50mmx50mm), (+) erythema and no edema. Left mid tricep region. Ibuprofen Rx.". None. None. Patient recovered.

TDAP (ADACEL) problem was reported from CT on Aug 16, 2007. Female patient , 61 years of age, was vaccinated with TDAP (ADACEL) on Aug 16, 2007. "Lt upper arm had erythema, edema, hives on body, employee not feeling well. To clinic. Augmentin and Prednisone Rxs.". None. None. Patient recovered.

TDAP (ADACEL) problem was reported from CT on Aug 16, 2007. Female patient , 61 years of age, was vaccinated with TDAP (ADACEL) on Aug 16, 2007. "Lt arm 3 in x 3 in area of erythema and edema. Hard to touch, warm and uncomfortable. Treated with Augmentin Rx.". None. None. Patient recovered.

TDAP (ADACEL) problem was reported from GA on Aug 16, 2007. Female patient , 51 years of age, was vaccinated with TDAP (ADACEL) on Aug 16, 2007. "Pt c/o Headache, body aches, muscle weakness, chills, sore and swollen joints, nausea,diarrhea, fever.". "estradiol, testosterone, progesterone, flonase, maxalt mlt, vitamins". "Levaquin, Cipro, Shellfish, phenergan, reglan, dairy". Patient recovered.

TDAP (ADACEL) problem was reported from MN on Aug 16, 2007. Male patient , 13 years of age, was vaccinated with TDAP (ADACEL) on Aug 16, 2007. pt is c/o sore red arm- fever of 101- fatigue and aches. . none. Patient recovered.

TDAP (ADACEL) problem was reported from CA on Aug 17, 2007. Female patient , 48 years of age, was vaccinated with TDAP (ADACEL) on Aug 10, 2007. "Vaccine given 8/7/07 - pt with fever, headache, vomiting, diarrhea, injection site edema, erythema and tenderness. Pt treated with antibiotic Keflex QID x 7 d, Atarax 25mg IM and Prednisone 20mg x 5d.". Ibuprofen. . Patient recovered.

TDAP (ADACEL) problem was reported from MI on Aug 17, 2007. Female patient , child 11 years of age, was vaccinated with TDAP (ADACEL) on Aug 17, 2007. "Fever, Swelling, redness, tenderness at injection site.". none. "Bactrim, Penicillin, Amoxicillin". Patient recovered.

TDAP (ADACEL) problem was reported from NC on Aug 20, 2007. Female patient , 55 years of age, was vaccinated with TDAP (ADACEL) on Aug 14, 2007. "Tdap given 7/19/07 s/s of leg pain, neck swelling and chest heaviness experienced by 7/20/07. Reported s/s to EHS on 7/24/07. Seen by PA-C on 7/25/07, blood work drawn r/o infection or Lyme disease or tick bite. Rx for Allegra. All blood work received back on 8/8/07 - neg.". "LEVOTHYROID, PILOCARPINE, VIVELLOPATCH OPTH 1%". "Allergies: Sulfa, Augmentin". Patient recovered.

TDAP (ADACEL) problem was reported from MN on Aug 20, 2007. Female patient , 50 years of age, was vaccinated with TDAP (ADACEL) on Aug 10, 2007. "On 8/3/07 right upper arm swollen, red and at injection site hard. Next day she awoke with a racing heart rate of 124, dizziness and fever of 101.0. Seen in Urgent Care and below tests done. Sent home on a Medrol dose pack and by 8/13 symptoms resolved and by end of week arm swelling/ redness gone.". HCTZ once day. Hypertension and water retention. Patient recovered.

TDAP (ADACEL) problem was reported from IL on Aug 20, 2007. Female patient , 35 years of age, was vaccinated with TDAP (ADACEL) on Aug 20, 2007. Stated that immediately after injection had pain radiating down arm and into shoulder and remained very tender. Stated was unable to sleep on it at night due to pain. C/o of NO redness at injection site. Had low grade temp 99 on 8/17 at Drs office. 8/20 no redness seen at injection site but still c/o of pain in right arm.. "Synthyroid , Hydrochlorothiazide prn". "Iodine, Hypothryoidism". Patient recovered.

TDAP (ADACEL) problem was reported from on Aug 21, 2007. Female patient , 34 years of age, was vaccinated with TDAP (ADACEL) on July 24, 2007. "Generalized muscle aches, arm swell, pain and redness. Resolved with time and medication.". . Required treatment with Plavix. Patient recovered.

TDAP (ADACEL) problem was reported from WI on Aug 21, 2007. Female patient , 62 years of age, was vaccinated with TDAP (ADACEL) on Aug 09, 2007. "Fever 101 - 8-6 to 8-7. Right arm red warm and swollen at injection site 8-6 to present. Instructed to notify MD if fever persists, use ice to injection site, notify agency with any further symptoms.". None. No. Patient recovered.

TDAP (ADACEL) problem was reported from OK on Aug 21, 2007. Male patient , 79 years of age, was vaccinated with TDAP (ADACEL) on Aug 20, 2007. None observed or noted. Motrin; Lisinopril; Nifedipine; HCTZ. . Patient recovered.

TDAP (ADACEL) problem was reported from NE on Aug 21, 2007. Male patient , child 12 years of age, was vaccinated with TDAP (ADACEL) on Aug 20, 2007. "Received Tdap Wed, 08/15/07. Returned to clinic on Fri, 08/17/07 with red raised macular rash with itching on head and trunk. Treated with Prednisone 20mg po daily x 5 days. 08/20/07 - have place a f/u call to mother to check on status of patients' rash. 8/21/07 Spoke with father, and rash is almost gone; hardly see any spots.". None. Mild to moderate autism. Patient recovered.

TDAP (ADACEL) problem was reported from MI on Aug 21, 2007. Male patient , 13 years of age, was vaccinated with TDAP (ADACEL) on Aug 21, 2007. "Went to ER, was given steroids, breathing treatment and IV. Started with high fever.". None. """Seizures r/t by hypoglycemia""". Patient recovered.

TDAP (ADACEL) problem was reported from PA on Aug 21, 2007. Male patient , child 11 years of age, was vaccinated with TDAP (ADACEL) on Aug 16, 2007. Temp 103 in 24 hours. . Allergic Rhinitis. Patient recovered.

TDAP (ADACEL) problem was reported from VA on Aug 21, 2007. Male patient , child 11 years of age, was vaccinated with TDAP (ADACEL) on Aug 21, 2007. "Tdap administered 8/20/07, 10:45 am. Pt began c/o severe headache at 7:30 pm followed by body aches, fever of 102F. Began vomiting at 11:30 pm. PMD notified at 12:00 am, 8/21/2007 by phone. Vomiting continued until 8 am 8/21/2007. Con't to have 102 fever with chills 8/21/2007.". "Singulair, Zyrtec, Advair QD". "food allergies - chicken, apple, chocolate, wheat, pears, nuts, rice". Patient recovered.

TDAP (ADACEL) problem was reported from NY on Aug 22, 2007. Male patient , child 12 years of age, was vaccinated with TDAP (ADACEL) on Aug 17, 2007. "Initial report from a health care provider in the United States on 15 August 2007. A 12-year-old male with a history of seasonal allergies, had received a dose of Adacel (lot number, route and site not reported) on 01 August 2007 and nine days later complained of malaise and presented with erythema multiforme on hands, feet, elbows, and inside of moth (two lesions). The patient had no illness at the time of vaccination. The reporter stated the patient had not experienced any adverse events with prior pediatric vaccinations. The patient was last immunized with DTaP on 30 June 1999. The patient had not yet been evaluated by their physician for this event and their recovery status has been reported as ""not recovered"". No additional information had been provided at the time of this report.". CLARITIN. The patient has a history of seasonal allergies. Concomitant medication: Claritin. Patient recovered.

TDAP (ADACEL) problem was reported from OH on Aug 22, 2007. Female patient , 27 years of age, was vaccinated with TDAP (ADACEL) on Aug 22, 2007. 1 hr. after receiving Adacel - felt like needed to clear throat - took inhaler and then better (Albuterol inhaler). Noticed red bump 8/21/07 5x4cm red area - sl. raised - sl. warm to touch. Achy started yesterday AM - no fever - took Motrin to help sl. itchy.. "Paxil 20mg, Albuterol inhaler". Asthma. Patient recovered.

TDAP (ADACEL) problem was reported from MD on Aug 22, 2007. Female patient , child 11 years of age, was vaccinated with TDAP (ADACEL) on Aug 20, 2007. "Left upper arm with diffuse erythema, warm to touch, vesicular rash. Tx with Bactrim DS, Benadryl, Ibuprofen.". "Patanol, Flonase, Zyrtec, Singulair". Environmental allergic rhinitis. Patient recovered.

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