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TDAP (ADACEL) Safety Reports

Total TDAP (ADACEL) reports: 939.

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TDAP (ADACEL) problem was reported from NC on Apr 02, 2007. Female patient , 33 years of age, was vaccinated with TDAP (ADACEL) on Mar 28, 2007. "SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 23 March 2007 from a health care professional. A 33-year-old female patient, with no concurrent illnesses and no known allergies, had received a left deltoid, intramuscular injection of Adacel, lot number C2559AA, on 24 August 2006. On 29 January 2007, 158 days post-immunization, the patient developed cold-like symptoms, shortness of breath and persistent cough. She was evaluated in the physician's office four days later on 02 March 2007, and had a serology test for Bordetella pertussis IGG/IGM. The result of the IGG was 24 and IGM was 13. She was started on a ""z-pack"" for five days. No cultures were done. At the time of this report, the patient had recovered.". . The patient had no illnesses at the time of the vaccination on 24 August 2006. She has no known allergies. Use of other medications were not provided to the reporter.. Patient recovered.

TDAP (ADACEL) problem was reported from AR on Apr 02, 2007. Female patient , 30 years of age, was vaccinated with TDAP (ADACEL) on Mar 14, 2007. "Patient states that the next morning about 7:30 after receiving vaccines she noticed Right upper arm was sore, red and warm to touch. States she started running fever that got up to 101.6, had a headache, felt weak in both legs and had nausea. Area is about 4 inches in diameter on R deltoid. Is red, swollen and warm to touch today. Fever broke last night patient states.". "Lexapro, Birth control pills". NONE. Patient recovered.

TDAP (ADACEL) problem was reported from MA on Apr 02, 2007. Female patient , 62 years of age, was vaccinated with TDAP (ADACEL) on Apr 02, 2007. "Fever, chills, nausea for three days, diarrhea, swelling, redness, weakness, pain all over, given antibiotics on Monday 4-2-07.". "Protonix, Evista, Prednisone, Singulair, Zoloft, Clonazepam". Sarcoidosis. Patient recovered.

TDAP (ADACEL) problem was reported from IN on Apr 03, 2007. Male patient , 33 years of age, was vaccinated with TDAP (ADACEL) on Apr 03, 2007. "2 Days after vaccine (Adacel) patient had fatigue, headache, body aches.". . None. Patient recovered.

TDAP (ADACEL) problem was reported from CA on Apr 03, 2007. Female patient , 33 years of age, was vaccinated with TDAP (ADACEL) on Mar 27, 2007. "Chest pains, rapid breathing, vomiting, neck, arm and shoulder pains. Fever of 104, lethargic, very dry mouth, swollen arm (arm injected), dizziness and more.". . . Patient recovered.

TDAP (ADACEL) problem was reported from CT on Apr 03, 2007. Female patient , 43 years of age, was vaccinated with TDAP (ADACEL) on Mar 26, 2007. Day after Tdap patient started itching on right supraorbital region with progressed to swelling over the weekend. Started on Prednisone 60mg x 5 days.. "Betamethasone, dipropionate, Augmentin, topical 0.05%,. Nexium, ibuprofen". None. Patient recovered.

TDAP (ADACEL) problem was reported from PA on Apr 03, 2007. Female patient , 13 years of age, was vaccinated with TDAP (ADACEL) on Mar 28, 2007. "Gave shot 3-27-07 that night arm very sore could not lift. 3-28-97 started with fever of 101.9 and rash just below injection site. Very tired, nauseous, no rash present when seen in office at 1845 on 3/28/07.". . Eczemal allergies. Patient recovered.

TDAP (ADACEL) problem was reported from TX on Apr 03, 2007. Male patient , 15 years of age, was vaccinated with TDAP (ADACEL) on Apr 03, 2007. "pain with redness and warmth at immunization site with swelling extending underarm to upper lateral rib area. generalized muscle aches, with temperature x 2 days of 100.4- medicated with ibuprofen and tylenol and rest". . seasonal allergies. Patient recovered.

TDAP (ADACEL) problem was reported from TX on Apr 04, 2007. Female patient , 52 years of age, was vaccinated with TDAP (ADACEL) on Apr 04, 2007. "body aches, pain, malaise, fever 101.2, nausea, headache began approximately 72 hours after administration of vaccine. Resolved within 48 hours". "Celebrex, Premarin, Lipitor, HCTZ, ASA". "osteoarthritis, hyperlipidemia". Patient recovered.

TDAP (ADACEL) problem was reported from CA on Apr 04, 2007. Female patient , 39 years of age, was vaccinated with TDAP (ADACEL) on Apr 04, 2007. "RN had a significant local reaction to the TDAP shot. She also reported a fever as high as 103 and feeling very lethargic and feeling ""sick"" and excessively sore throughout her arm and across her shoulders after recieving the vaccine. Dr looked at her vaccination site, and told her it looked like she had developed cellulitis. Her arm is red, and swollen from her deltoid to the mid portion of her upper arm. STARTED ON BACTRIM AND RIFAMPIN". NONE. NO. Patient recovered.

TDAP (ADACEL) problem was reported from MI on Apr 04, 2007. Male patient , 49 years of age, was vaccinated with TDAP (ADACEL) on Apr 04, 2007. arm pain at site. myalgias.. 0. H/O GULLIAN BARRE SYNDROME. Patient recovered.

TDAP (ADACEL) problem was reported from NC on Apr 04, 2007. Female patient , 49 years of age, was vaccinated with TDAP (ADACEL) on Apr 04, 2007. "Noted nickel size induration nodule, redness, edema, painful to touch, painful ROM, body aches, chills/flushed and H/A". . . Patient recovered.

TDAP (ADACEL) problem was reported from NC on Apr 04, 2007. Female patient , 29 years of age, was vaccinated with TDAP (ADACEL) on Apr 04, 2007. "noted LA painful to touch and pain with ROM, axillary pain, redness, edema, body aches, also left hand middle finger noted redness and edema.". . . Patient recovered.

TDAP (ADACEL) problem was reported from GA on Apr 04, 2007. Male patient , child 11 years of age, was vaccinated with TDAP (ADACEL) on Apr 04, 2007. "Within 1 wk - flu symptoms, within 2 wks - constant headache,crushing chest pain,overall achy. Within 7 wks lost upper body movement for 2 days only, since then no lower body movement in the mornings.Some days till late afternoon, sometimes at night.". None. Pt had known allergy to Themerisol I asked RN if this vaccine had it and she said no.. Patient recovered.

TDAP (ADACEL) problem was reported from LA on Apr 04, 2007. Female patient , 62 years of age, was vaccinated with TDAP (ADACEL) on Apr 04, 2007. "Localized redness in R deltoid injection site, first aid, warm compresses". . . Patient recovered.

TDAP (ADACEL) problem was reported from LA on Apr 04, 2007. Female patient , 38 years of age, was vaccinated with TDAP (ADACEL) on Apr 04, 2007. "R deltoid injection site, sore, tender radiation to neck, warm to the touch, redness. S/B ER MD prescription for steroids/prednisone.". . "Reglan, rocephin, PCN". Patient recovered.

TDAP (ADACEL) problem was reported from DC on Apr 05, 2007. Male patient , 40 years of age, was vaccinated with TDAP (ADACEL) on Mar 29, 2007. Significant pain at injection site and throughout upper arm (6/10) subjection numbness some distribution slight swelling at site.. . . Patient recovered.

TDAP (ADACEL) problem was reported from MO on Apr 05, 2007. Female patient , 38 years of age, was vaccinated with TDAP (ADACEL) on Mar 16, 2007. "Only warm red, raised local reaction, some myalgia, fatigue day after - some.". . Irritable bowel syndrome. Patient recovered.

TDAP (ADACEL) problem was reported from NY on Apr 05, 2007. Female patient , 54 years of age, was vaccinated with TDAP (ADACEL) on Mar 30, 2007. Approximately 5 days after 2/22/07 developed skin soreness progressing to painful movement with abduction of L upper arm and hyper extension. There is a tightness and burning sensation to entire upper L arm. Advil and Heat do not help movement. Denies. Denies. Patient recovered.

TDAP (ADACEL) problem was reported from FL on Apr 05, 2007. Female patient , 55 years of age, was vaccinated with TDAP (ADACEL) on Apr 05, 2007. "FEVER 104, NAUSEA, FATIGUE, BODY ACHES NASAL CONGESTION". "ALLEGRA, LEXAPRO, ACTONEL, VAGIFEM, DECONSAL, NASACORT, ALOMIDE, CALCIUM, MAGNESIUM, VITAMIN D, MULTIVITAMIN, L-TRIPTOPHAN, AMINO ACIDS, EVENING PRIMROSE OIL, FISH OIL, EXCITACOR". "SLEEP APNEA, ALLERGIC RHINITIS, DEPRESSION, OSTEOPENIA, MENOPAUSE, DIVERTICULOSIS". Patient recovered.

TDAP (ADACEL) problem was reported from NH on Apr 06, 2007. Male patient , 22 years of age, was vaccinated with TDAP (ADACEL) on Apr 05, 2007. "24 hours after injection experienced headache, chest pain, nausea, heart racing, fatigue, muscle aches, lasting about 24 hours. Also soreness at injection site lasting 5 days and redness. Heat to arm (Pt entered 4/4/07).". "Advair, Albuterol". none-except environmental allergies/asthma. Patient recovered.

TDAP (ADACEL) problem was reported from CA on Apr 06, 2007. Male patient , 18 years of age, was vaccinated with TDAP (ADACEL) on Apr 02, 2007. "nausea, persistent vomiting, diarrhea began a few hours after Tdap s/s x 4d not gradually resolved, not hospitalized.". . none. Patient recovered.

TDAP (ADACEL) problem was reported from FL on Apr 09, 2007. Female patient , 42 years of age, was vaccinated with TDAP (ADACEL) on Apr 09, 2007. "After receiving Tdap patient experienced redness at site and headache. While removing band-aid she scratched the scab off injection site with her nail and consequently developed redness, warmth, and tenderness at injection site. Patient was treated for cellulitis with doxycycline 100mg PO BID for 10 days. Will monitor injection site for increased signs and symptoms.". "benecar HCT, prozac, offcon, levoxyl, prevacid". "HTN, hypothyroidism, asthma". Patient recovered.

TDAP (ADACEL) problem was reported from SC on Apr 09, 2007. Female patient , 55 years of age, was vaccinated with TDAP (ADACEL) on Apr 09, 2007. "Swelling/redness at injection site within hours of injection. Flulike symptoms with myalgias, malaise, more swelling/pain/redness, lymphadenopathy (axillary, supraclavicular) within 24 hours. 4 days postinjection: 10 x 7 cm induration, heat, redness at injection site. Treatment with dicloxacillin 500mg qid for cellulitis.". hctz 25mg 1/2 tablet q day womens today vitamin 1/2 tablet q day.....singulair 10 mg q day. hypertension allergic rhinitis. Patient recovered.

TDAP (ADACEL) problem was reported from UT on Apr 09, 2007. Female patient , 58 years of age, was vaccinated with TDAP (ADACEL) on Apr 09, 2007. Swelling started 4/6/07 with swelling of the earlobe on one rt side of face.Swelling moved from front of ear to ear lobe straight across cheek bone dropped in jowls/ neck. Rash in temple area.. UNKNOWN. UNKNOWN. Patient recovered.

TDAP (ADACEL) problem was reported from TN on Apr 09, 2007. Female patient , 47 years of age, was vaccinated with TDAP (ADACEL) on Apr 09, 2007. Employee complained of pain in the trapezius muscle radiating up to neck in the arm vaccine given. NONE. NONE. Patient recovered.

TDAP (ADACEL) problem was reported from MO on Apr 09, 2007. Female patient , 16 years of age, was vaccinated with TDAP (ADACEL) on Mar 30, 2007. "Co health center did not see client after adm of Tdap. School nurse contacted health center stating student had app 1/2: wide and 3 1/2"" long faint but visible red area, streak from injection site. Health center called mom and ref. pt to her local doctor. Follow up calls to the home. Left message with pt for her mom to call health center. No response from parent. Pt stated they saw Dr. and no RX was made.". . . Patient recovered.

TDAP (ADACEL) problem was reported from WI on Apr 10, 2007. Female patient , 20 years of age, was vaccinated with TDAP (ADACEL) on Mar 21, 2007. Emergency C-Section - Stillbirth - 37 weeks. Pt has Tdap earlier in day.. . Pregnant - 37 weeks. Patient was hospitalized Patient recovered.

TDAP (ADACEL) problem was reported from WA on Apr 10, 2007. Female patient , 27 years of age, was vaccinated with TDAP (ADACEL) on Apr 03, 2007. "10 days after varicella vaccine pt had redness, swelling, itching, and axillary nodes at injection site.". None. None. Patient recovered.

TDAP (ADACEL) problem was reported from CA on Apr 10, 2007. Female patient , 35 years of age, was vaccinated with TDAP (ADACEL) on Dec 22, 2006. "2 inch diameter red lump at site, where Tdap was given. painful 8/10 pain scale, lasted 1 1/2 weeks long. Ice applied, but did not help, difficult to use R arm. Took Tylenol which helped.". "Betseron, Synthroid, Percocet, HTZ". . Patient recovered.

TDAP (ADACEL) problem was reported from VA on Apr 11, 2007. Male patient , 17 years of age, was vaccinated with TDAP (ADACEL) on Apr 02, 2007. "Pt states arm was sore on evening of 3/21/07. On 3/22/07 early am-severe arm pain prescribed with Ibuprofen. At 11am on 3/22/07 pt presented with 'Body Aches All Over"". PUB. none before vaccine. Patient was hospitalized Patient recovered.

TDAP (ADACEL) problem was reported from NE on Apr 11, 2007. Female patient , 37 years of age, was vaccinated with TDAP (ADACEL) on Apr 11, 2007. "Patient experienced no symptoms for 48 hours and then noted increased redness, swelling and purple tinge with warmth to the area in the upper right deltoid. At time of exam, pt had warmth to the area, approximately 2 cm x 2 cm. Pt was treated with Prednisone 40 mg daily for five days and Topicort 0.25% topical cream bid.". . Cephalexin Allergy. Patient recovered.

TDAP (ADACEL) problem was reported from NJ on Apr 11, 2007. Male patient , 17 years of age, was vaccinated with TDAP (ADACEL) on Apr 11, 2007. "PLEURITIC CHEST PAIN, MACULAR CHEST RASH 45 MIN. TO ONE HOUR AFTER ADM. OF Tdap (ADACEL). TREATED IN ED WITH NEBULIZED LEVALBUTEROL AND DIPHENHYDRAMINE WITH RESOLUTION OF SYMPTOMS; PREDNISONE TABLETS". . NONE. Patient was hospitalized Patient recovered.

TDAP (ADACEL) problem was reported from OR on Apr 11, 2007. Male patient , 49 years of age, was vaccinated with TDAP (ADACEL) on Apr 11, 2007. Left deltoid my region day after injection. Left arm forearm paresthesias 2 weeks following injection - possible early brachial neuritis.. None. PCN-allergic. Patient recovered.

TDAP (ADACEL) problem was reported from TX on Apr 13, 2007. Female patient , 29 years of age, was vaccinated with TDAP (ADACEL) on Apr 02, 2007. "Onset 1800 3/24 numbness radial side of L arm no weakness, tingling 3/25 0600 radial 8100 L arm 8100 L arm tingle numb, 10000 R side of face numb, 1300 L arm/shoulder numb, 3/26 Facial numbness resolved 3/27 numbness shed to hypersensitive.". BCP. . Patient recovered.

TDAP (ADACEL) problem was reported from WI on Apr 13, 2007. Female patient , 49 years of age, was vaccinated with TDAP (ADACEL) on Mar 21, 2007. "Swelling, redness 12-15 cm circular area. Next day after immunizations, Painful red. Seen 5 days later, redness diminished Instr. Benadryl for comfort". . "Ampicillin, Percocet and Codeine, PCN". Patient recovered.

TDAP (ADACEL) problem was reported from MO on Apr 13, 2007. Female patient , 53 years of age, was vaccinated with TDAP (ADACEL) on Apr 09, 2007. 4-3-07 a few hrs after shot given-soreness got worse-Thursday 4-5 she felt very tired-slept 9 hrs when laid down for nap. Friday-redness and pain about 5: in diam. Reported on Mon 4-9 and states it is getting better. Not as painful or swollen did not seek treatment. Prilosec q od. fibromyalgia. Patient recovered.

TDAP (ADACEL) problem was reported from KY on Apr 13, 2007. Female patient , child 1.3 years of age, was vaccinated with TDAP (ADACEL) on Apr 12, 2007. "eyes, welts, coughing, wheezing, Pulse Ox=90% RA- Angioedema-DTaP ordered-pt inadvertantly given Tdap". . None. Patient recovered.

TDAP (ADACEL) problem was reported from CA on Apr 16, 2007. Male patient , 13 years of age, was vaccinated with TDAP (ADACEL) on Apr 13, 2007. "Tdap given 4/12 and next day. Patient with F to 102.6, HA and nausea. Sx care at home recommended for virus vs vaccine rexn.". None. Cefaclor. Patient recovered.

TDAP (ADACEL) problem was reported from NC on Apr 16, 2007. Female patient , 37 years of age, was vaccinated with TDAP (ADACEL) on Mar 29, 2007. "The day after receiving Tdap vaccine, pt c/o soreness, pain, erythema, edema and arm warm to touch. Seen in clinic 2 days later with same symptoms. Was taking Tylenol with no relief. Referred to MD for evaluation.". . None. Patient recovered.

TDAP (ADACEL) problem was reported from KS on Apr 16, 2007. Female patient , 25 years of age, was vaccinated with TDAP (ADACEL) on Apr 16, 2007. "Client called to report nausea and dizzines noted 4/13/07 after receiving Tdap vaccine 4/12/07. Client states she attributes symptoms to the ""flu"" as several coworkers have come down with it. Denies other symptoms. Temp 99.2". none. none. Patient recovered.

TDAP (ADACEL) problem was reported from NJ on Apr 17, 2007. Female patient , 56 years of age, was vaccinated with TDAP (ADACEL) on Apr 04, 2007. "Patient reported fever, chills, headache and rash two weeks after dose of Tdap, was also receiving avalox for sinusitis PCP believed symptoms due to the vaccine and not the Avalox". . . Patient recovered.

TDAP (ADACEL) problem was reported from AK on Apr 17, 2007. Female patient , 24 years of age, was vaccinated with TDAP (ADACEL) on Apr 11, 2007. "Tdap given 4-6-07 (Friday) Sunday night 4/8/07 T=101, redness noted distal to injection site, swelling, warmth. Monday-no fever until Monday night T=100. 4/11/07 1130 Redness, warmth, swelling, persistent-distral to injection site 3-4 cm. Redness measures 10x 11 cm. Ice/heat, elevation of arm.". Rx: Doxycycline given at visit. "Amoxicillin, Sulfa". Patient recovered.

TDAP (ADACEL) problem was reported from VA on Apr 17, 2007. Female patient , 35 years of age, was vaccinated with TDAP (ADACEL) on Apr 06, 2007. "Fever x 10 hrs, starting about 24 hrs after receiving vaccine, only other symptom: nausea. No redness, swelling or tenderness at immunization site. No other concurrent illness.". . none. Patient recovered.

TDAP (ADACEL) problem was reported from MI on Apr 17, 2007. Female patient , 61 years of age, was vaccinated with TDAP (ADACEL) on Apr 17, 2007. "Localized swelling, erythema and fatigue/malaise. Treated symptomatically with NSAIDs, Acetaminophen.". "Advair Diskus, Cyclobenzaprine, Enalapril Maleate, Prilosec OTC". "COPD, IBS, Atopic eczematous dermatitis". Patient recovered.

TDAP (ADACEL) problem was reported from CO on Apr 18, 2007. Female patient , 60 years of age, was vaccinated with TDAP (ADACEL) on Apr 18, 2007. "Pt strated to experience swelling, pruritus, erythema, and warmth 4 days after vaccination. Pt says sx's are getting worse. Treated patient with cipro 500mg po BID x 7 days, benadryl, and hydrocortisone cream". "lisonopril, premarin cream, tums, MVI, ASA, B12 MVI". asthma. Patient recovered.

TDAP (ADACEL) problem was reported from CO on Apr 18, 2007. Male patient , 35 years of age, was vaccinated with TDAP (ADACEL) on Apr 18, 2007. "pain over the right medial and lateral elbow. Diagnosis medial greater than lateral epicondylitis, probable related to work-related activities though.". Vitamins and occasional Allegra. congenital cataracts.. Patient recovered.

TDAP (ADACEL) problem was reported from WI on Apr 19, 2007. Female patient , 53 years of age, was vaccinated with TDAP (ADACEL) on Apr 19, 2007. "Local reaction started 5 days after administration of vaccine, given unknown antibiotic by PMP". unknown. unknown. Patient recovered.

TDAP (ADACEL) problem was reported from WI on Apr 20, 2007. Female patient , 51 years of age, was vaccinated with TDAP (ADACEL) on Apr 20, 2007. Local reaction - did not seek medical attention. . . Patient recovered.

TDAP (ADACEL) problem was reported from MS on Apr 20, 2007. Female patient , 48 years of age, was vaccinated with TDAP (ADACEL) on Apr 20, 2007. "Received injection. On day of injection, patient experienced soreness and throbbing. On Wednesday 4/19 night, saw increased redness with streaks below site of injection. Lymp nodes started to enlarge. On Thursday 4/19, used warm packs throughout the day since arm very sore and red. Now, has raised, red, warm area the size of palm of hand about 12 mm below the injection site. Injection site very hard and red. Lymph nodes enlarged. States has been febrile releived by 3 doses of Ibuprofen since 4/17/2007. Dr. notified and asked to refer to Dr. Health Department for follow up. Dr. and Health Dept notified employee enroute to Health Dept. States has not taken Benadryl or any other over the counter or prescription meds. Previous dose in PIMS 11/04/2005. States forgot had this shot.". . None. Patient recovered.

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