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TDAP (ADACEL) Safety Reports

Total TDAP (ADACEL) reports: 939.

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TDAP (ADACEL) problem was reported from CT on Mar 12, 2007. Female patient , 57 years of age, was vaccinated with TDAP (ADACEL) on Mar 01, 2007. 3 days after vaccine-local forearms spreading redness with swelling. . . Patient recovered.

TDAP (ADACEL) problem was reported from MI on Mar 12, 2007. Male patient , 14 years of age, was vaccinated with TDAP (ADACEL) on Mar 02, 2007. Arm began swelling 2-28-07. 3-1-07 entire arm began to swell. 3-2-07 hand is swollen.. . NONE. Patient recovered.

TDAP (ADACEL) problem was reported from PA on Mar 12, 2007. Male patient , 15 years of age, was vaccinated with TDAP (ADACEL) on Mar 12, 2007. "Swelling, erythema and tender, left upper arm". "Benadryl, cold compress". NONE. Patient recovered.

TDAP (ADACEL) problem was reported from TX on Mar 12, 2007. Female patient , 53 years of age, was vaccinated with TDAP (ADACEL) on Mar 12, 2007. "On Thursday 3/8/07, left arm red and swollen, felt achy all over. Today, 3/12/07 arm still red and warm from elbow to shoulder.". . . Patient recovered.

TDAP (ADACEL) problem was reported from NJ on Mar 13, 2007. Male patient , 41 years of age, was vaccinated with TDAP (ADACEL) on Feb 28, 2007. "Fever, chills, nausea.". "NEXIUM, FLONASE, CLARITAN-D". "Allergies - PCN, low blood pressure, mild scoliosis, gastritis, migraines". Patient recovered.

TDAP (ADACEL) problem was reported from TX on Mar 13, 2007. Male patient , 39 years of age, was vaccinated with TDAP (ADACEL) on Mar 03, 2007. "Temperature of 103 degrees F, weakness, joint pain, diaphoretic for 2 days, treatment was rest and administration of 800 mg Ibuprofen every 6 hours.". . . Patient recovered.

TDAP (ADACEL) problem was reported from TX on Mar 13, 2007. Female patient , 45 years of age, was vaccinated with TDAP (ADACEL) on Mar 07, 2007. "Unable to process movement and sound at the same time for a window of 2-4 hrs. Increase temp 102 x 12 hours. Nausea and vomiting x 12 hours. Headache, swelling at injection site/severe redness. Swollen and very painful lymph nodes x 48.". . NONE. Patient recovered.

TDAP (ADACEL) problem was reported from CO on Mar 14, 2007. Female patient , 49 years of age, was vaccinated with TDAP (ADACEL) on Mar 07, 2007. C/O Welts around injection site.. . NONE. Patient recovered.

TDAP (ADACEL) problem was reported from PA on Mar 15, 2007. Female patient , 23 years of age, was vaccinated with TDAP (ADACEL) on Mar 14, 2007. "Patient called 3-2-07 to report ""reaction since 2-22-07 with c/o headaches and nausea which subsided 2-24-07. Physician with f/u with phone call if sxs. returned. 3-12/07 pt called with ""persistent cough waking her up at night""
TDAP (ADACEL) problem was reported from IN on Mar 16, 2007. Female patient , 16 years of age, was vaccinated with TDAP (ADACEL) on Mar 07, 2007. "Arm so sore could not lift up also, was very nauseous and sick for 2 days, brothers arm real sore but no sickness and could move it.". . . Patient recovered.

TDAP (ADACEL) problem was reported from CA on Mar 16, 2007. Female patient , 77 years of age, was vaccinated with TDAP (ADACEL) on Mar 16, 2007. "Erythema, edema, axillary pain.". . COPD. Patient recovered.

TDAP (ADACEL) problem was reported from CA on Mar 16, 2007. Female patient , child 11 years of age, was vaccinated with TDAP (ADACEL) on Mar 16, 2007. "Left arm swollen, red, warm hard. Hard red circle below site where given. Swelling started 3/14/07. Still swollen 3/16/07-worsened x 2 days.". . staph infection 2005-2006. Patient recovered.

TDAP (ADACEL) problem was reported from PA on Mar 19, 2007. Female patient , 38 years of age, was vaccinated with TDAP (ADACEL) on Mar 13, 2007. "3 layer area of flat erythema, warm to touch and tender upper right arm area". NONE. . Patient recovered.

TDAP (ADACEL) problem was reported from NY on Mar 19, 2007. Female patient , 21 years of age, was vaccinated with TDAP (ADACEL) on Mar 12, 2007. "Fever, vomiting, diarrhea, dizziness, headache. Onset several hours after administration of vaccine. Symptoms gradually resolving one subsequent few days.". . "PCN, Sulfa, Macrodantin, Allergies". Patient recovered.

TDAP (ADACEL) problem was reported from WI on Mar 19, 2007. Female patient , 60 years of age, was vaccinated with TDAP (ADACEL) on Mar 15, 2007. "Patient complained of ongoing pain to injection site, area about 3 inches around site, 3 weeks after injection. Pain started day after vaccine given. Rated ""4-5"" (1-10 scale) at that time. Now rated ""1"" (1-10), mostly with movement or pressure to area.". "Calcium, Hydrochlorothiazide, multivitamin". Hypertension. Patient recovered.

TDAP (ADACEL) problem was reported from MI on Mar 19, 2007. Male patient , 42 years of age, was vaccinated with TDAP (ADACEL) on Mar 19, 2007. Left upper arm shows redness approx. 5 inches in diameter surrounding injection site. No induration. Area warm to touch.. . . Patient recovered.

TDAP (ADACEL) problem was reported from WA on Mar 20, 2007. Male patient , 61 years of age, was vaccinated with TDAP (ADACEL) on Mar 20, 2007. "Patient called day of shot to report pain, swelling and redness on right arm that extends from shoulder to about 2 inches from elbow. ""It's hard as a rock"". No complaints of headache or fever but says feels kind of ""fluish"". Spoke to my supervisor who said suggest ice and ibuprofen. If no improvement or if swelling extends to fingers seek medical care". unknown. none reported. Patient recovered.

TDAP (ADACEL) problem was reported from MI on Mar 20, 2007. Female patient , 49 years of age, was vaccinated with TDAP (ADACEL) on Mar 20, 2007. "pain left arm progressively getting more sore/more painful, lump at site of injection, pink at injsection site". . None. Patient recovered.

TDAP (ADACEL) problem was reported from MN on Mar 20, 2007. Female patient , 26 years of age, was vaccinated with TDAP (ADACEL) on Mar 20, 2007. "Weakness, tingling, requiring hospitalization and IV gammaglobulin , severe headache from gammaglobulin, transfer hospital, Final diagnosis Guiallian Barret syndrome". none. neurofibromatosis type 1. Patient was hospitalized Patient recovered.

TDAP (ADACEL) problem was reported from CA on Mar 21, 2007. Female patient , 46 years of age, was vaccinated with TDAP (ADACEL) on Mar 19, 2007. "Warmth, erythema, swelling and tenderness below Adacel injection site. Started within 2 days after vaccine. Treated with Claritin and Keflex.". "Diflucan, Metrocel Vap". Thyroid nodule. Patient recovered.

TDAP (ADACEL) problem was reported from CA on Mar 21, 2007. Female patient , 53 years of age, was vaccinated with TDAP (ADACEL) on Mar 15, 2007. "Global myalgias, arthralgias, Ibuprofen 600 mg TID prn.". "Advair Diskus, Aciphex". "Asthma, GERD, Hypothyroid, allergic rhinitis, Pollen, trees, cat allergies.". Patient recovered.

TDAP (ADACEL) problem was reported from LA on Mar 21, 2007. Male patient , child 12 years of age, was vaccinated with TDAP (ADACEL) on Mar 12, 2007. "Arm red, swollen, tender". NONE. NONE. Patient recovered.

TDAP (ADACEL) problem was reported from MO on Mar 21, 2007. Female patient , child 10 years of age, was vaccinated with TDAP (ADACEL) on Mar 13, 2007. "She developed red indurated area 7 cm in diameter on left deltoid where shot given, minimally tender. But itchy. Seen again 3/13-1.5cm area of induration faint, remains. No redness or tenderness.". Albuterol prn. asthma. Patient recovered.

TDAP (ADACEL) problem was reported from MD on Mar 22, 2007. Female patient , 25 years of age, was vaccinated with TDAP (ADACEL) on Mar 20, 2007. """Throat closing, tongue swelling, nausea, eyes watering"" Pepcid 20mg IV, Solu Medrol1 25 mg IV, Benadryl 50 mg IV". NONE. NONE. Patient recovered.

TDAP (ADACEL) problem was reported from PA on Mar 23, 2007. Female patient , 27 years of age, was vaccinated with TDAP (ADACEL) on Feb 08, 2007. "Initial report received from a patient on 01 February 2007. A 27 year old, female patient (with an allergy to erythromycin) experienced arm soreness and mild lethargy, 1 day after she received a 0.5 mL IM injection of Adacel (lot number unknown) in the left deltoid on 24 January 2007. She was not treated with medicines. She did not have any illness at the time of vaccination. She received her last Td 10 year ago. The patient recovered from the adverse events in 3 days. The patient had a positive home pregnancy test on 29 January 2007. Her last menstrual period was ""16 December 2006"" or ""30 December 2006"" and her expected date of delivery is ""25 September 2007"" or ""05 October 2007"" (dependent on OB/GYN exam). The pregnancy has not yet been confirmed by the patient's OB/GYN and no prenatal testing has been conducted as of yet. She has had 3 previous pregnancies, 1 of which was a full term delivery and 2 of which were pre-term births. All had normal/viable pregnancy outcomes.". MULTIVITAMINS. Allergy to erythromycin. She did not have any illness at the time of vaccination. She received her last Td 10 years ago.. Patient recovered.

TDAP (ADACEL) problem was reported from VA on Mar 23, 2007. Male patient , 40 years of age, was vaccinated with TDAP (ADACEL) on Feb 13, 2007. "Initial report received from a healthcare professional on 08 February 2007. A 40 year old, male patient developed cellulitis at the site of vaccination and fever after he received an injection of Adacel (lot number ""C62644AA"". UNK. . Patient recovered.

TDAP (ADACEL) problem was reported from AZ on Mar 23, 2007. Male patient , 50 years of age, was vaccinated with TDAP (ADACEL) on Jan 16, 2007. "Initial report received on 15 January 2007 from a health care professional. A 50-year-old male patient, with no illness at the time of vaccination, had received an intramuscular, left deltoid injection of Adacel, lot number C2455AA, on 09 January 2007. Three days later, the patient developed pain and swelling of the left axilla that continues. At the time of this report, the patient had not recovered.". . The patient had no illness at the time of vaccination and no past medical conditions.. Patient recovered.

TDAP (ADACEL) problem was reported from NC on Mar 23, 2007. Female patient , 41 years of age, was vaccinated with TDAP (ADACEL) on Feb 07, 2007. "Initial report received on 15 January 2007 from a health care professional. A 41-year-old female patient, who denied any concurrent illnesses, and who is allergic to Septra, and has a history hypothyroidism, increase cholesterol and migraines, had received a left deltoid, intramuscular injection of ADACEL, lot number C2644AA, on 12 January 2007. At the time of the vaccination, the patient was taking concomitantly Levoxyl, Lipitor, Seasonale, Zyrtec, Midrin (prn), and multivitamins. Approximately eight hours post-immunization, the patient complained of rigors, headache, skin sensitivity, and mouth ulcers. The rigors lasted approximately 24-36 hours. The patient did not seek medical attention. Treatments received and diagnostic testing performed were not reported. At the time of this report, the patient was still complaining of headache and weakness, and it was unknown if the skin sensitivity and mouth ulcers were still persisting. The patient has not fully recovered. Follow-up information received on 31 January 2007. The patient did not have any illness at the time of vaccination. The patient did speak with a physician who advised Benadryl and Motrin. No testing done. The patient fully recovered in 3-4 days. The final diagnosis for the adverse events was unknown.". "LEVOXYL, MULTIVITAMINS, LIPITOR, SEASONALE, ZYRTEC, MIDRIN". "The patient is allergic to Septra, has hypothyroidism, increased cholesterol, and migraines. She denied any illnesses at the time of the vaccination on 12 January 2007.". Patient recovered.

TDAP (ADACEL) problem was reported from SC on Mar 23, 2007. Female patient , 45 years of age, was vaccinated with TDAP (ADACEL) on Feb 16, 2007. "A 45-year-old female patient, with a past medical history of migraines and who was taking blood pressure medication, had received an intramuscular, right deltoid injection of Adacel, lot number C2644AA, on 06 February 2007. Within one hour post-vaccination, the patient experienced dizziness. A few days post-immunization, the patient complained of nausea. She was examined during a doctor's visit and treated with Antivert and niacin ""without effect."" At the time of this report, the patient had not recovered.". "TIVAC, MONOPRIL, TOBRAMAX". The patient had a history of migraines and was taking blood pressure medication. She had no illness at the time of vaccination.. Patient recovered.

TDAP (ADACEL) problem was reported from WA on Mar 23, 2007. Female patient , 35 years of age, was vaccinated with TDAP (ADACEL) on Feb 16, 2007. "Initial report received on 14 February 2007 from a health care professional. A 35-year-old female patient , who had no illnesses, and a past medical history of allergy to gluten and nitrous oxide, had received a 0.1 ml, intradermal, left forearm, injection of Adacel, lot number C2556AA, on 11 February 2007. Intradermal injection of Adacel is not a recommended route of administration by the manufacturer. The patient was supposed to receive Tubersol intradermally instead of Adacel. Two days post-vaccination, the patient experienced redness, blisters, and 14 mm induration at the injection site. At the time of this report, the patient had not recovered.". . "The patient had no illnesses at the time of the vaccination on 11 February 2007. She is allergic to gluten, and nitrous oxide.". Patient recovered.

TDAP (ADACEL) problem was reported from MI on Mar 23, 2007. Male patient , 55 years of age, was vaccinated with TDAP (ADACEL) on Mar 19, 2007. "Chills, arthralgias, swelling at injection site, fever to 100.4 (F) w/chills, loose stools and nausea and headache. Took 2 doses of Ibuprofen + 1 dose of Tylenol for above symptoms. Sx began approximately 24 hours after injection - patient missed day of work (3/16/07) and symptoms treated 24 hours.". "Prevacid, Atenolol, Lisinopril, Metformin, Vytorin". "Allergies - NKMA, PMHx: (+) DM/HTN/ increase Cholesterol". Patient recovered.

TDAP (ADACEL) problem was reported from TX on Mar 23, 2007. Male patient , 30 years of age, was vaccinated with TDAP (ADACEL) on Mar 16, 2007. "Sweats, chills, myalgia, lethargy, injection site erythematous/tender". NONE. NONE. Patient recovered.

TDAP (ADACEL) problem was reported from ME on Mar 23, 2007. Male patient , 38 years of age, was vaccinated with TDAP (ADACEL) on Mar 20, 2007. "Swelling, redness, hot to touch, swelling under arm (lymph gland), temp 99-100. General malaise. Pain in arm, itchy at sight.". . . Patient recovered.

TDAP (ADACEL) problem was reported from PA on Mar 26, 2007. Female patient , 53 years of age, was vaccinated with TDAP (ADACEL) on Mar 21, 2007. NONE Explained. NONE. NONE. Patient recovered.

TDAP (ADACEL) problem was reported from NV on Mar 26, 2007. Female patient , 48 years of age, was vaccinated with TDAP (ADACEL) on Mar 26, 2007. "Pt received Tdap on Monday. Went to work that night although in pain. Took Tylenol with some relief. Took another Tylenol at end of shift and then went home and took a Percocet for the pain. Tuesday, called in sick and went to ER with arm swelling, temp 100.5, pain into neck from injection site. Dx with cellulitis and was hospitalized w/IV antibiotics. WBC's elevated. Pt fell while in Er--she states they had given her Morphine and Phenergan and when she stood up she passed out and hit her head. She states she did NOT have a seizure but ER staff said she did. When she lost conciousness she had ""twitching"" in her legs and was incontinent. ER staff thought she might have had hypotonic respiratory distress and did a CAT scan to r/o PE. Pt states she is doing much better and most of the sx have resolved". . "PMH: Appy 1984, Knee Arthroscopy, R hand Tenolysis. Allergies: Minocycline.". Patient was hospitalized Patient recovered.

TDAP (ADACEL) problem was reported from CT on Mar 27, 2007. Male patient , 30 years of age, was vaccinated with TDAP (ADACEL) on Mar 22, 2007. "Fever 101F, aching arms and legs, cramping, chills, traphorisis. Abdomen pain, mild nausea, headache. Treated with Ibuprofen, increase fluids". NONE. NONE. Patient recovered.

TDAP (ADACEL) problem was reported from NY on Mar 27, 2007. Male patient , 30 years of age, was vaccinated with TDAP (ADACEL) on Mar 22, 2007. Site of injection became swollen the size of a large orange. 50 mg Benadryl PO and ice applied. None. . Patient recovered.

TDAP (ADACEL) problem was reported from WV on Mar 27, 2007. Female patient , 49 years of age, was vaccinated with TDAP (ADACEL) on Mar 27, 2007. "Localized erythema, induration and pain at injection site.Systemic: body aches, chills, fever 101, nausea, rash(entire body appearing flushed)joint aches, diarrhea starting 24 hours after receiving vaccine. Went to ER and put on Keflex and pain relievers/fever reducer.". . She is fair-skinned red-headed caucasion. Patient recovered.

TDAP (ADACEL) problem was reported from PA on Mar 28, 2007. Female patient , 54 years of age, was vaccinated with TDAP (ADACEL) on Mar 27, 2007. "Received shot 3/2/07-very sore within an hour-swollen, hot, tender within an hour-stayed swollen hot, sore-20cm for 5 days. Then gradually subsided. No fever, chills, malaise, lymphadenopathy, joint pain, other skin no other symptoms.". Depakote. "Epileptic, Arthritis". Patient recovered.

TDAP (ADACEL) problem was reported from PA on Mar 28, 2007. Female patient , 50 years of age, was vaccinated with TDAP (ADACEL) on Mar 28, 2007. "Erythema (20x13cm), tenderness, warmth left deltoid. Treatment-prednisone, Benadryl, cool compress". . "Penicillin, sulfa, guaifenesin". Patient recovered.

TDAP (ADACEL) problem was reported from NY on Mar 28, 2007. Female patient , child 12 years of age, was vaccinated with TDAP (ADACEL) on Mar 26, 2007. "Marked swelling, erythema with multiple erythematous papules, (surrounded by halos) throughout torso/limbs.". . NONE. Patient recovered.

TDAP (ADACEL) problem was reported from CA on Mar 28, 2007. Female patient , 49 years of age, was vaccinated with TDAP (ADACEL) on Mar 28, 2007. "The day after her shot she got headache,severe body aches and fever. The symptoms lasted 3 days and went away on their own". "Atenolol, ranitidine". none other than hypertension and GERD. Patient recovered.

TDAP (ADACEL) problem was reported from UT on Mar 28, 2007. Female patient , 49 years of age, was vaccinated with TDAP (ADACEL) on Mar 28, 2007. "Patient came in to report that her left arm is extremely sore, red, swollen and feeling hot. This started 2 days after she had received the DTAP adult vaccine, in her left deltoid. She was advised to take benedryl and ibuprofen. She had no systemic symptoms. She had no known previous reaction to any vaccines.". . asthma. Patient recovered.

TDAP (ADACEL) problem was reported from MO on Mar 29, 2007. Female patient , 14 years of age, was vaccinated with TDAP (ADACEL) on Mar 21, 2007. "Recieved Tdap afternoon of 3-8-07. One hour later c/o fatigue and nausea. Experienced chills and fever temp 102.6. Body aches, no appetite, shallow R. Mom gave her Benadryl to help her calm down. Slept 16-20 hrs. s/s resolved when awoke.". . SEASONAL ALLERGIES. Patient recovered.

TDAP (ADACEL) problem was reported from VA on Mar 30, 2007. Male patient , 13 years of age, was vaccinated with TDAP (ADACEL) on Mar 29, 2007. """Right side of underarm is swollen and feels squishy,"" per patient after receiving Tdap - doctor advised parent to monitor and if it didn't go away, ultrasound would be needed.". . . Patient recovered.

TDAP (ADACEL) problem was reported from MN on Mar 30, 2007. Female patient , 55 years of age, was vaccinated with TDAP (ADACEL) on Mar 27, 2007. "SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 21 March 2007 from a healthcare professional. A 54 year old female patient received on 28 February 2007 intramuscular first dose of Adacel (lot# C2690AA) and immediately developed facial swelling including eyelids and generalized hives on face and chest. Treated with Benadryl, Tagament and prednisone. The event resolved and the patient recovered. No other vaccines were given concomitantly. At the time of vaccination the patient had vertigo. Received Fluzone on 11 October 2007 and experienced generalized hives and lump on elbow (case 2007-00862). The patient medical history included multiple environmental life threatening allergies and asthma. Concomitant medications included: ASA, fish oil, Spironolactone, Terbutaline prn, Benadryl prn, singulair, Combavent, Adver. The reporter is the same as in case 2007-00862.". "ASA, FISH OIL, SPIRONOLACTONE, TERBUTALINE, BENADRY, SINGULAIR, COMBAVENT, ADVER". Received Fluzone on 11 October 2007 and experienced generalized hives and lump on elbow. Multiple environmental life threatening allergies and asthma. At the time of vaccination the patient had vertigo.. Patient recovered.

TDAP (ADACEL) problem was reported from on Mar 30, 2007. Female patient , 13 years of age, was vaccinated with TDAP (ADACEL) on Mar 13, 2007. "Adverse reaction. HA, fever, fatigue, arthralgia, stomach upset without vomiting or diarrhea. 04/17/2007 MR received for OV for c/o fever, H/A, fatigue, arthralgia, and GI upset. PE: WNL except for ankle pain 2' to fx. and ill-appearing. Temp. 101.2'F Assessment: Drug reaction to Adacel vaccine. Right ankle sprain (later dx as fx by X-ray). No other tx. sought.". . PMH: Ankle fx. Allergies: none noted.. Patient recovered.

TDAP (ADACEL) problem was reported from VA on Mar 30, 2007. Female patient , 27 years of age, was vaccinated with TDAP (ADACEL) on Mar 30, 2007. C/o pain that wakes patient up at night taking 800 mgs motrin - using heat but not helping. unknown. none known. Patient recovered.

TDAP (ADACEL) problem was reported from VA on Mar 30, 2007. Female patient , 23 years of age, was vaccinated with TDAP (ADACEL) on Mar 30, 2007. "Fever 12 horus after vaccine , myalgias and achign joints. No shortness of breath, no hives, no warm or red joints.". "Motrin, lexapro". SYRINGOMYELIA IN PAST WITH MILD LOSS OF SENSATION IN FEET PERSISTING. Patient recovered.

TDAP (ADACEL) problem was reported from MA on Mar 30, 2007. Female patient , 41 years of age, was vaccinated with TDAP (ADACEL) on Mar 29, 2007. "Swollen, red 3cm area around injection site L deltoid within 2D. Treated with Ice, Ibuprofen, Cephalexin". None. None. Patient recovered.

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