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TDAP (ADACEL) Safety Reports

Total TDAP (ADACEL) reports: 939.

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TDAP (ADACEL) problem was reported from MN on May 08, 2007. Female patient , 28 years of age, was vaccinated with TDAP (ADACEL) on May 04, 2007. "5/2/07 Local - Red 1/4 area Midday - 24 hrs later, local area became swollen. Systemic - stiff neck and achy joints, wrists ankles, knees, jaw - hot - cold flashes through head 5/2, s5/4 stiff neck and hot flashes continue, face flushed slightly". . "Penicillin, Erythromycin, Cephalozin, Monohydrate, Ciprofloxicin, Neomycin". Patient recovered.

TDAP (ADACEL) problem was reported from IL on May 08, 2007. Male patient , 34 years of age, was vaccinated with TDAP (ADACEL) on May 02, 2007. "Given Tdap 5-1-07 at approx. 0830. On 5/2/07, at OC, felt aching in joints, flu-like symptoms, and generalized weakness (no strength). Progressively getting worse.". None. Allergy to Penicillin-no birth defects/medical conditions. Patient recovered.

TDAP (ADACEL) problem was reported from UT on May 08, 2007. Male patient , 36 years of age, was vaccinated with TDAP (ADACEL) on May 02, 2007. "starting day after administration describes flu like symptoms, fatigue all joints painful not swollen/red. Fever to 102 degrees. Pain to left arm with a localized reaction of red/swollen/warm. No neurologic sx. Sx gradually resolved. Seen today first since injection with feeling near normal and much deminished scar/slight reddened/painful (L) arm at injection site. No joint pain and full use of muscles. No recent other vaccinations/illnesses. No other known cause for home sx. No relatedness with sx.". none. none. Patient recovered.

TDAP (ADACEL) problem was reported from ID on May 09, 2007. Female patient , 39 years of age, was vaccinated with TDAP (ADACEL) on Apr 18, 2007. "did fine 1st day, next day had leg muscle weakness and that night had nausea and vomiting. 3rd day-all muscle hurt but not as intense. Had a headache but relieved with pain me. 4/19-much better.". none. none. Patient recovered.

TDAP (ADACEL) problem was reported from GA on May 09, 2007. Female patient , 46 years of age, was vaccinated with TDAP (ADACEL) on Apr 26, 2007. "Vomiting, dizziness, headaches". "Neurontin, Scima, Loreat, Epidwal inj". "Allergic morphine, HTN, Hypothyroidism, Herniated Disc". Patient recovered.

TDAP (ADACEL) problem was reported from GA on May 09, 2007. Female patient , 57 years of age, was vaccinated with TDAP (ADACEL) on Apr 26, 2007. "aching, chills, pain from injection site radiation to left side neck. dry hacking cough". . "Septra, Talwin, Insulin, Lanoxin, Cardizem, ASA, Lipitor". Patient recovered.

TDAP (ADACEL) problem was reported from NY on May 09, 2007. Male patient , child 11 years of age, was vaccinated with TDAP (ADACEL) on May 09, 2007. "Tdap administered approximately 10:00 am at school clinic. As reported per school nurse, reddness and warmth were noted at the injection site almost immediately. Patient awoke the next morning with a fever of 102 degrees F and he complained of headache and an upset stomach. He was absent from school. The child returned to school in 48 hours with continued redness and swelling, but afebrile.". unknown. Non reported. Patient recovered.

TDAP (ADACEL) problem was reported from CA on May 10, 2007. Female patient , 29 years of age, was vaccinated with TDAP (ADACEL) on May 11, 2007. "Woke up 4/11/07 with 102 fever, body aches and redness, induration at site right deltoid and shoulder. Resolved after approx. 12 hours.". . None. Patient recovered.

TDAP (ADACEL) problem was reported from MI on May 10, 2007. Male patient , 52 years of age, was vaccinated with TDAP (ADACEL) on May 10, 2007. "H/A, abd pain, fever, chills, increased BP, pain and swelling at injection site". . Hep C. Patient recovered.

TDAP (ADACEL) problem was reported from GA on May 10, 2007. Female patient , 59 years of age, was vaccinated with TDAP (ADACEL) on May 02, 2007. "Aphasia, paraesthesia, (L) eye not blinking on closing. Intermittent flushing of face and feeling of warmth. Unstable B/P; rapid pulse". "Levaquin 750, Wellbutrin 300 Vitorin". Sulfa allergy. Patient recovered.

TDAP (ADACEL) problem was reported from TX on May 10, 2007. Female patient , 51 years of age, was vaccinated with TDAP (ADACEL) on May 02, 2007. "enlarge nodes Rt axilla, cervical and occipital area. (approx 20 min) fever, chills.". Prempro. none. Patient recovered.

TDAP (ADACEL) problem was reported from CA on May 10, 2007. Female patient , 23 years of age, was vaccinated with TDAP (ADACEL) on May 11, 2007. "5/10/07 Telephone consult with patient stated nausea and extensive swelling at Tdap site (R) Deltoid. Described (L) sided numbness (L) leg and arm and buttocks, High fever, Headache, and extreme weakness. 48 hours later, most symptoms resolved but patient still c/o (L) shoulder swelling at site.". oral contraception (Levlen). . Patient recovered.

TDAP (ADACEL) problem was reported from NY on May 10, 2007. Female patient , 59 years of age, was vaccinated with TDAP (ADACEL) on May 10, 2007. "Approximatley 12 hours after receiving the vaccination patient developed a hard, swollen red area the size of an apple on her left arm. This area was not at the site of the injection but directly opposite it on the same arm. Upon questioning, patient revealed that she had had a mastectomy many years ago on that side which she did not report to the vaccinator.". Unknown. History of Breast Cancer with left Mastectomy (many years ago).. Patient recovered.

TDAP (ADACEL) problem was reported from IL on May 10, 2007. Female patient , 57 years of age, was vaccinated with TDAP (ADACEL) on May 10, 2007. "pt had the adacel injection, she felt sick , and area was sore.". . . Patient recovered.

TDAP (ADACEL) problem was reported from IL on May 10, 2007. Male patient , 13 years of age, was vaccinated with TDAP (ADACEL) on May 10, 2007. "pt was vomiting,fever x1 day.". . . Patient recovered.

TDAP (ADACEL) problem was reported from MS on May 11, 2007. Female patient , 34 years of age, was vaccinated with TDAP (ADACEL) on May 02, 2007. "TDAP GIVEN @ APPROXIMATELY 11:30. BEGAN ITCHING WITH FINE RED RAISED RASH BEGINNING ON NECK. AND SPREADING TO CHEST, BACK, THEN ARMS AND LEGS AND FACE OVER 24 HOUR PERIOD". BACTRIM DS bid 4/23-5/3/07. ABCESS RIGHT BUTTOCK. Patient recovered.

TDAP (ADACEL) problem was reported from OR on May 14, 2007. Male patient , 30 years of age, was vaccinated with TDAP (ADACEL) on May 14, 2007. "Continuing severe arm pain, tingling, possible brachial neuritis". "Allegra, flonase, wellbutrin, albuterol". none. Patient recovered.

TDAP (ADACEL) problem was reported from IL on May 14, 2007. Female patient , 63 years of age, was vaccinated with TDAP (ADACEL) on May 14, 2007. "5/3 Headache started that evening. 5/9 worsening headache, beginning rash. RX Vicodin and Zyrtec. 5/9 later -went to ER - Had CT of Brain, RX IV Benadryl 5/11 back to ER for HA, had spinal tap.". . . Patient recovered.

TDAP (ADACEL) problem was reported from SC on May 14, 2007. Female patient , 40 years of age, was vaccinated with TDAP (ADACEL) on May 08, 2007. "Fever, body aches, Arm red and hard. Tx'd with Claritin, Tylenol, Celestone". . "Amoxil, Emitrex, Septra, IVP dye". Patient recovered.

TDAP (ADACEL) problem was reported from MD on May 14, 2007. Female patient , child 12 years of age, was vaccinated with TDAP (ADACEL) on May 01, 2007. 10 x 7 1/2 cm erythema with central raised area tender to touch. . None. Patient recovered.

TDAP (ADACEL) problem was reported from ND on May 14, 2007. Female patient , 32 years of age, was vaccinated with TDAP (ADACEL) on May 07, 2007. Pt received Adacel about 900 am - woke up that night around 0130am with fever of 102.5F and body/joint aches. These symptoms lasted 48 hrs. She took ibuprofen to help decrease fever. Injection site was also warm to touch and hard - although today (5/7/07) this has resolved but arm is still sore.. . . Patient recovered.

TDAP (ADACEL) problem was reported from ND on May 14, 2007. Female patient , 26 years of age, was vaccinated with TDAP (ADACEL) on May 07, 2007. Started itching around 3pm day of administration (given about 1030-1045am) noticed large hives around 5pm. Next morning got a prescription for prednisone. On 5/7/07 mostly cleared - although still has some hives and itching.. . . Patient recovered.

TDAP (ADACEL) problem was reported from VA on May 14, 2007. Female patient , 56 years of age, was vaccinated with TDAP (ADACEL) on May 08, 2007. "intense flu-like symptoms, severe pain in both shoulders, entire left arm felt strange and painful, very large, hard swelling at injection site, very large swelling and lump in arm pit so much so that arm could not rest at side of body comfortably. Heavy nausea, unusual sleepiness, light headedness, sore throat, sometimes needed assistance when walking, loss of appetite. Still feel some residual pain and discomfort at injection site and in armpit. Temperature reached 100.4 at its peak.". "Atenolol, Lisinopril, Norvasc, Diovan, Glipizide". "Diabetes, Hypertension". Patient recovered.

TDAP (ADACEL) problem was reported from SC on May 14, 2007. Male patient , 58 years of age, was vaccinated with TDAP (ADACEL) on May 09, 2007. "Over the first 24 hours after receiving vaccine, pt developed swelling and redness in the L arm with some edema. Area was painful, but denies fever,chills, SOB, or chest pain. Took Benadryl before OV. Gave Decadron in the office.". . . Patient recovered.

TDAP (ADACEL) problem was reported from WI on May 14, 2007. Female patient , 34 years of age, was vaccinated with TDAP (ADACEL) on May 08, 2007. "Vaccine received on 5-3-07. Lump and redness at site noticed on 5-5-07. Continues on 5-8-07. Some tingling sensation at injection site noted on 5-8-07. Tender 3cm nodule at injection site, 5-8-07, no wheezing, no distent rash, no orthostatic, hypotension, no oral swelling.". . . Patient recovered.

TDAP (ADACEL) problem was reported from CA on May 15, 2007. Female patient , 43 years of age, was vaccinated with TDAP (ADACEL) on May 10, 2007. "Patient had Tdap approximately 7am. 5 Minutes after she experienced tightness of her neck; warm feeling; started to cough; had SOB took prednisone; Zyrtec; Combivent inhaler brought to E.R. Admitted overnight. 05/17/2007 MR received for an o/n admission for c/o lip swelling following her DPT vax. She was treated for an allergic reaction and the pt. developed PVCs and acute vertigo. Pt was unable to walk after that due to vertigo and was admitted. Pt. reports fatigue and ""room spinning"" PE: Somnolent. Horizontal nystagmus to the right. Ataxic gait. DX: Anaphylaxis. Acute on Chronic Vertigo". "Prednisone, Zyrtec, Combivent inhaler". "Asthmatic. PMH: Asthma. Vertigo. C-sec. SAB. Hordeolum of L eye. Allergies: PCN, ASA.". Patient was hospitalized Patient recovered.

TDAP (ADACEL) problem was reported from MI on May 15, 2007. Male patient , 28 years of age, was vaccinated with TDAP (ADACEL) on May 06, 2007. Patient states approx 14 hrs after receiving Tdap started running temp of 103. Has been taking Motrin for fever. No localized reaction. none. none. Patient recovered.

TDAP (ADACEL) problem was reported from TX on May 15, 2007. Female patient , 38 years of age, was vaccinated with TDAP (ADACEL) on May 07, 2007. "Tdap given 5-4-07; onset 5-5-07 a.m. of armpit pain left side on 5-6-07 noted pain continued in left armpit but spread across left breast, no swelling, hardness, redness noted. Today still sore across left upper breast and armpit.". Zoloft. None. Patient recovered.

TDAP (ADACEL) problem was reported from CO on May 15, 2007. Female patient , 59 years of age, was vaccinated with TDAP (ADACEL) on May 02, 2007. "Joint Pain-> Shoulders, Hips and Knees began 4/26/07". "Indocin, Zyrtec, acetaminophen, Estrogen". "ASA, Sulfa, EDTA, Teflon, Macrodantin". Patient recovered.

TDAP (ADACEL) problem was reported from NM on May 16, 2007. Male patient , child 12 years of age, was vaccinated with TDAP (ADACEL) on May 16, 2007. "given Adcel Tdap, instead of Boostix Tdap". . NONE. Patient recovered.

TDAP (ADACEL) problem was reported from NM on May 16, 2007. Male patient , 14 years of age, was vaccinated with TDAP (ADACEL) on May 16, 2007. "given Adacel Tdap, instread of Boostrix Tdap". . none. Patient recovered.

TDAP (ADACEL) problem was reported from TX on May 16, 2007. Female patient , 30 years of age, was vaccinated with TDAP (ADACEL) on Apr 23, 2007. "right shoulder pain (deltoid) with a nodule, noted swelling under armpit". none. no. Patient recovered.

TDAP (ADACEL) problem was reported from MI on May 17, 2007. Female patient , 64 years of age, was vaccinated with TDAP (ADACEL) on May 17, 2007. "Day after administration, tenderness and redness at site noted. Symptoms increased by end of day to include edema, warmth, and soreness at site. Also, body aches, weakness and headache. Slight elevation of temperature.". . . Patient recovered.

TDAP (ADACEL) problem was reported from OH on May 18, 2007. Female patient , 48 years of age, was vaccinated with TDAP (ADACEL) on May 14, 2007. "Initial report received on 08 May 2007 from a health care professional. A 48 year old female patient with medical history of migraines and hypothyroidism received on 28 April first dose of Adacel (lot# unknown) (site, side and route of administration were unknown) and at the same day, after injection the patient reported temperature of 100 (F), headache and malaise that lasted for 48 hours, and then the patient felt better. On 06 May 2007 the patient developed headache described as ""worse of life"" and was presented to the Emergency Room, with temperature of 103 (F), headache, neck stiffness, positive Kernig's sign and nausea. MRI of head was scheduled on 08 May 2007. The reporting physician was her treating physician. The patient was hospitalized (on an unknown date) for 2 days. The patient received vaccine at work and did not have record of lot number or that chart. Relevant diagnostic test that were done: CT of head- negative, LP - negative, BC and MRI- pending, CBC and electrolytes- Within normal limits. Treatment was not reported. The patient has not recovered. Then patient had no illness at vaccination time. The patient's concomitant medications included: Synthroid and Tylenol #3.". "SYNTHROID, TYLENOL #3". migraines and hypothyroidism. Patient was hospitalized Patient recovered.

TDAP (ADACEL) problem was reported from VA on May 21, 2007. Female patient , 45 years of age, was vaccinated with TDAP (ADACEL) on May 21, 2007. Pt stated hives started 5/18/07 in the evening and became worse over the weekend. Pt has taken Benadryl without any improvement. Referred pt to prescribing doctor for evaluation of symptoms.. "antibiotic cream, lupus medication". Lupus. Patient recovered.

TDAP (ADACEL) problem was reported from TX on May 21, 2007. Male patient , 36 years of age, was vaccinated with TDAP (ADACEL) on May 21, 2007. "Vaccine administered 5/17 immediate pain and induration at injection site; by 5/19 fever started (102) controlled with Tylenol for cold; intermittent fever until present, 5/21/07 left deltoid muscle swollen, skin is red and indurated, c/o numbness in upper left arm; Dicloxacillin 500 mg 1 PO qid x 7d called in to pharmacy". . . Patient recovered.

TDAP (ADACEL) problem was reported from NM on May 21, 2007. Female patient , 20 years of age, was vaccinated with TDAP (ADACEL) on May 15, 2007. "3CM induration with erythema and warm to touch. Also c/o headache, chest and neck discomfort". none. Insomnia. Patient recovered.

TDAP (ADACEL) problem was reported from NC on May 21, 2007. Female patient , 35 years of age, was vaccinated with TDAP (ADACEL) on May 15, 2007. "Patient received vaccine on 5-8-07. 5-09-07 normal slight of sore arm muscle. 5/10/07 gland in Left armpit and left neck swelled and became painful. Glands continue to be swollen and painful-armpit>neck. Patient reports very painful to lift left arm above head. No fever. Advised to see primary provider, today.". . none. Patient recovered.

TDAP (ADACEL) problem was reported from NE on May 21, 2007. Female patient , 46 years of age, was vaccinated with TDAP (ADACEL) on May 08, 2007. "5-3-07 - Received Adacel vaccine. 5-4-07 - pm right arm swollen, sore, tender to touch. 5-5-07 Right side of neck and right arm very sore with limited ROM.". . . Patient recovered.

TDAP (ADACEL) problem was reported from NE on May 21, 2007. Female patient , 49 years of age, was vaccinated with TDAP (ADACEL) on May 08, 2007. Arm became very tender and Swollen and warm to touch x 6 days muscle strength reduced x 2-3 days. None. None. Patient recovered.

TDAP (ADACEL) problem was reported from AZ on May 22, 2007. Female patient , 39 years of age, was vaccinated with TDAP (ADACEL) on May 16, 2007. "Localized edema and erythema at injection site within 24 hours. NSAID therapy, heat and ABX given. Signs of cellulitis began 7 days after injection. ABX at that time". . "NKDA, GERD, migraine, HA". Patient recovered.

TDAP (ADACEL) problem was reported from CO on May 22, 2007. Female patient , child 11 years of age, was vaccinated with TDAP (ADACEL) on May 22, 2007. "vaccine given at 1245 on 5/17. At 1300 complained of dizziness. 1325 noted rash around face, neck and upper back.". . . Patient recovered.

TDAP (ADACEL) problem was reported from AZ on May 22, 2007. Male patient , 44 years of age, was vaccinated with TDAP (ADACEL) on May 21, 2007. Large Induration and erythema following vaccination. TX with Keflex. . None. Patient recovered.

TDAP (ADACEL) problem was reported from NC on May 24, 2007. Female patient , 46 years of age, was vaccinated with TDAP (ADACEL) on Jan 11, 2006. "Two days following administered Tdap, noticed swelling in Left supraclavicular region.". none. . Patient recovered.

TDAP (ADACEL) problem was reported from PA on May 24, 2007. Male patient , 41 years of age, was vaccinated with TDAP (ADACEL) on May 18, 2007. "Patient called an stated that he received a Tdap shot on 5/12/07. The following day he had no energy. He slept most of that day. On 5/14 and 5/15 he felt ok. On 5/16 he stated his body ached, he was hot then cold, He had no energy. Temperature ranged between 99.5-100.1degF on 5/17 he slept from 12:30pm Through till 9am on 5/18/07. Patient also has a lump at injection site.". HCTZ 25 mg once daily prn. "Hyperlipidemia, Hyperpotassium in 9/2006, cellulitis on leg 9/2006". Patient recovered.

TDAP (ADACEL) problem was reported from SD on May 24, 2007. Female patient , 57 years of age, was vaccinated with TDAP (ADACEL) on May 24, 2007. "Fever of about 100 degrees, slight swelling in the arm, tenderness, warmth and red. She is taking ASA for the fever and is doing alright". N/A. "20 years ago had a reaction to a Td vaccine, temp 104 and up unabel to work for 4 day. 10 years ago had a booster with no side effects". Patient recovered.

TDAP (ADACEL) problem was reported from PA on May 24, 2007. Male patient , child 10 years of age, was vaccinated with TDAP (ADACEL) on May 18, 2007. "Acute vertigo, otalgia and headache 20 days after Varicella booster Provisional diagnosis - Neuronitis.". None. None. Patient recovered.

TDAP (ADACEL) problem was reported from MA on May 25, 2007. Male patient , 46 years of age, was vaccinated with TDAP (ADACEL) on May 25, 2007. "Left deltoid site became reddened, swollen and indurated, resolved completely". "Vitamin, Lisinopril". no. Patient recovered.

TDAP (ADACEL) problem was reported from OR on May 25, 2007. Male patient , 14 years of age, was vaccinated with TDAP (ADACEL) on May 25, 2007. "Swelling at injection site, chills, fever, nausea, sore throat, muscle aches in arms and legs.". Clindamycin. none. Patient recovered.

TDAP (ADACEL) problem was reported from IL on May 29, 2007. Female patient , 55 years of age, was vaccinated with TDAP (ADACEL) on May 29, 2007. Patient reports to LHD today with mild edema in ankles and feet.States that edema is greatly improved since initial onset on evening of vaccine administration.Vaccine was given between 4:30-5 pm.Patient states acute onset of edema noticed at bedtime.States swelling was enough to make legs and feet hurt.. Premarin 0.625. none. Patient recovered.

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