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DTAP (INFANRIX) Safety Reports

Total DTAP (INFANRIX) reports: 971.

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DTAP (INFANRIX) problem was reported from FL on Mar 14, 2007. Male patient , child 1.7 years of age, was vaccinated with DTAP (INFANRIX) on Mar 14, 2007. "Extensive swelling of left thigh, started next day (mother noticed), size of an orange and redness from upper thigh to approx 3-4 cm above left knee and laterally. Patient went to ER and admitted with diagnosis of Cellulitis (suspicion). Admitted 3/4/07-D/C 3/6/07. 03/15/2007 MR received for an ER visit for c/o an erythematous area on the right thigh at the site of the DTaP 2 days prior. PE: WNL except a 10cm area of moderate swelling on the right thigh. There is evidence of infection as manifested by moderate erythema, induration, warmth, and mild to moderate tenderness. Diagnosis: Leg cellulitis. Confirmed with vaccine administrator (who verified with mother) that vaccine was given in the LEFT thigh.". Meds: none.. Bronchiolitis-Pneumonia. PMH: none noted. Allergies: none.. Patient was hospitalized Patient recovered.

DTAP (INFANRIX) problem was reported from AZ on Mar 14, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Jan 09, 2007. "Redness mild swelling, mild tenderness at site if injection, spreading to involve most of Right upper extremity.". . NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from NM on Mar 15, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 08, 2007. "Rash on fingers R>O, fever no, vomiting no. Seen on 03/08/2007 by doctor.". NONE. Was admitted 4/26/03 to rule out sepsis. Patient recovered.

DTAP (INFANRIX) problem was reported from OH on Mar 15, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 15, 2007. "LOCAL VACCINE REACTION. ON RIGHT LATERAL PROXIMAL THIGH, TWO VERY CLOSE PINPOINTS SLIGHTLY RAISED SOMEWHAT VESICULAR LOOKING LESIONS.INDURATION SURROUNDING LESION. LOCAL SKIN RACTION EITHER FROM VARICELLA OR MMR IMMUNIZATION IN RIGHT THIGH. PATIENTS GRANDMOTHER TOLD TO WATCH FOR ANY SIMILAR LESIONS OR HIGH FEVER, CHILLS AND TO RETURN TO OFFICE IF THEY OCCUR, OTHERWISE LOCAL WOUND CARE WTIH TOPICAL BENADRYL OR ORAL BENADRYL AS NEEDED FOR ITCHING. SYMPTOMS BROUGHT TO GRANDMOTHERS ATTENTION ON 3-11 DUE TO ITCHY AREA ON PATIENTS THIGH. PATIENT HAD NO OTHER SYMPTOMS.". NONE KNOWN/PRESCRIBED. NONE KNOWN. Patient recovered.

DTAP (INFANRIX) problem was reported from TX on Mar 15, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 15, 2007. "Patient noted redness/swelling of right leg at site of injection 2 days after. Seen in office, redness and warmth noted. Ceftriaxone given. Duricef prescribed. Improved rapidly with treatment.". None. None. Patient recovered.

DTAP (INFANRIX) problem was reported from CO on Mar 15, 2007. Female patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 15, 2007. "Right thigh red, swollen, hot to touch, and itchy. Infected area approx 5"" x 5"".". N/A. NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from AZ on Mar 15, 2007. Female patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 15, 2007. "Had Dtap on 3/13/07 with in 24 hrs developed redness and swelling, resembling cellulitis.". . . Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Mar 15, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 15, 2007. "L arm edema/ery developed at 2100 3/14/07 about 6-8 hours after vaccine given. L arm with full ROM. color, movement, sensation good, within normal limits.". . NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from TN on Mar 16, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 16, 2007. Large erythema-itches-hot to touch-non tender-no groin nodes. Good R.O.M. First noted 3/15/07-increased size 3/16/07.. . NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from TN on Mar 19, 2007. Male patient , child 1.2 years of age, was vaccinated with DTAP (INFANRIX) on Mar 09, 2007. "Phone call from mom on 3/9/07 stating child has red, raised rash to abdomen, back and buttocks after getting shots 2 days ago. Took child to MD who gave ""Benadryl and a steroid."" States rash had spread to legs by the time she got to doctor's office. Denies fever.". . NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Mar 19, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 08, 2007. "Localized swelling, redness, itching 3 cm x 2cm area around injection site.". . . Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Mar 19, 2007. Male patient , child 2.8 years of age, was vaccinated with DTAP (INFANRIX) on Mar 19, 2007. Swollen left arm. Warm to touch and swelling. Depo Medrol 12 mg given to patient and prescription for Keflex.. . NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Mar 19, 2007. Male patient , child 1.4 years of age, was vaccinated with DTAP (INFANRIX) on Feb 22, 2007. "Deltoid swollen, erythematous warm to touch and minimum tender to touch.". . . Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Mar 20, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 15, 2007. "Redness and swelling at site TX Cortisone cream, cold compresses.". . . Patient recovered.

DTAP (INFANRIX) problem was reported from OH on Mar 20, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 12, 2007. Cellulitis vaccine reaction L arm.. . . Patient recovered.

DTAP (INFANRIX) problem was reported from VA on Mar 20, 2007. Male patient , child 0.6 years of age, was vaccinated with DTAP (INFANRIX) on Mar 08, 2007. NONE. . . Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Mar 20, 2007. Female patient , 21 years of age, was vaccinated with DTAP (INFANRIX) on Mar 19, 2007. NONE. . . Patient recovered.

DTAP (INFANRIX) problem was reported from FL on Mar 20, 2007. Male patient , child 0.5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 20, 2007. "Admitted to hospital through ER for suspected seizure episode without fever and no other symptoms/problems-EEG=WNL, Brain CT scan=WNL". NONE. NONE. Patient was hospitalized Patient recovered.

DTAP (INFANRIX) problem was reported from TN on Mar 20, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 20, 2007. Woke up in am of 3-20-07 with 8 cm redness and swelling on the left deltoid region. Also complains of some itching.. . . Patient recovered.

DTAP (INFANRIX) problem was reported from NM on Mar 21, 2007. Female patient , child 0.5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 21, 2007. Left sided focal seizure 13 hours after recieving vaccine. Presented to ER with temp of 103. Total time of seizure was 30 minutes. Pt hospitalized for 3 days. 3/30/07 Received medical records from hospital which reveal patient experienced a left sided focal seizure consisting of focal twitching of left arm & leg w/unresponsiveness. 13 hrs s/p vax w/fever of 103. Seizure lasted approx 30 min & abated w/ER tx. Transferred from outlying ER to higher level of care. Admitted 3/13/07-3/16/07. Admit exam revealed lethargy & slight gen muscle hypotonia. No further fever or seizure activity & muscle tone improved but remained slightly hypotonic at d/c to home w/follow up arranged w/PCP & ped neuro. FINAL DX: Left sided focal seizure associated w/fever occurring s/p 6 mo immunization series.. . "Agenesis of the corpus callosum. PMH: absent corpus callosum, mild global neural developmental delay. Mild seborrheic skin dermatitis.". Patient was hospitalized Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Mar 21, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 12, 2007. "Child received 1Z 3/8/07 exam 3/10/07 received redness, swelling, mild tenderness, warmth L thigh 7.5 x 12 cm, R thigh 16.5 x 19.5 cm no evidence of cellulitis.". NONE. "Microcephaly, Dev delay.". Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Mar 22, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 22, 2007. R Deltoid red and swollen.. . none. Patient recovered.

DTAP (INFANRIX) problem was reported from FL on Mar 22, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 22, 2007. "Swelling R arm, erythematous, warm, non tender. A small open blister. No induration , no LNE or d/c. No further treatment (given 30 mg PO Prednisolone in ER).". NONE. NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from WI on Mar 23, 2007. Female patient , child 3 years of age, was vaccinated with DTAP (INFANRIX) on Mar 23, 2007. "Patient was noted to have 2 by 3 cm area of mildly raised, red, mild swelling in right deltoid area with no associated pain, warmth, itching or fever. This was first noted by parent approx 0800 on 3/21/07 and by time of visit that afternoon mom felt it was less red. Advised to use ice to area and Benadryl only if itching.". . NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from NH on Mar 23, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 22, 2007. "Local reaction at injection site in left arm with erythema, swelling, and warmth to touch. Noted by parents 1 day after injection. Seen in ED 2 days after and again by PCP 4 days after- erythema still present 4 immunes given in total on 3/15. DTaP and Varivax given in left arm.". NONE. NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from MO on Mar 23, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 19, 2007. "Received shots on Wednesday, 3-14-07, started getting a little red and sore to touch on Thursday. By Friday the right upper arm red, swollen, hot to touch down to the elbow. Took child to MD at ER. Child has cellulitis of right arm. Treated with antibiotic Keflex by mouth". . . Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Mar 26, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 19, 2007. on 3-17-07 patient woke up in the AM with swelling redness and fever at injection site. On 3/18/07 swelling had gone down slightly.. . NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from NY on Mar 26, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 19, 2007. "Itching, mild erythema and small hive at Proquad injection site.". . "history asthma, allergic to Aumentin (hives).". Patient recovered.

DTAP (INFANRIX) problem was reported from IA on Mar 26, 2007. Female patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 16, 2007. "24 hours after shot noted 1 small ""bug bite"" like sore at site of Left thigh vaccination. 32 hour after shot-8cmx8cm raised, hard, red, warm area. Itching. Seen 3-9-07 by Medical doctor-Prednisone, Benadryl, monitor ordered. Follow up 3-13-07 redness gone, site less hard. 3/15 no redness left, 25 cent hard area yet tender skin. 3-16-07 25 cent area under skin felt knot.". NONE. NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from WY on Mar 26, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 26, 2007. "Left Arm began to swell day of vaccination. Swelled to 3 times normal size of arm, ""hard as rock"" and hot. Child also experienced fever 101.7. Admitted to hospital and was given antibiotics. MD diagnosed as Cellulitis. Today still with Fever.". . None. Patient was hospitalized Patient recovered.

DTAP (INFANRIX) problem was reported from WY on Mar 26, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 26, 2007. "Right arm swollen, red and hot, day after vaccination. Complained of site being ""itchy"" on 03/25/07. Redness decreased. No Md visit.". None. None. Patient recovered.

DTAP (INFANRIX) problem was reported from AZ on Mar 26, 2007. Female patient , child 2.2 years of age, was vaccinated with DTAP (INFANRIX) on Mar 26, 2007. "Child woke up from bap with low grade fever 100.6, slight swelling at injection sites. Mother gave 1 tsp of children's Tylenol. Fever came down. Today child has mottling of skin along upper arms bilaterally. No severe swelling, limb is warm to touch.". None. Mother states none. Patient recovered.

DTAP (INFANRIX) problem was reported from MO on Mar 27, 2007. Female patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 22, 2007. "Immunization given 3/19/07, child had slight runny nose at time Now until sneezing, cough and low grade temp.". . . Patient recovered.

DTAP (INFANRIX) problem was reported from MS on Mar 27, 2007. Male patient , child 6 years of age, was vaccinated with DTAP (INFANRIX) on Feb 27, 2007. Reports that child experienced redness and moderate pain the day of the immunization as well as the next day in both the right and left legs. No fever reported. . NO. Patient recovered.

DTAP (INFANRIX) problem was reported from TX on Mar 27, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 27, 2007. "APPROXIMATELY 8 HOURS AFTER VACCINES WERE GIVEN DEVELOPED LETHARGY, MALAISE, FEVER (102 DEGREES), NAUSEA/VOMITING X 3. THE LEFT UPPER ARM BECAME SWOLLEN AND RED. THE SKIN WAS TIGHT. IT WAS WARM AND TENDER. WAS SEEN BY DR ON 3/24/07 WITH THE FOLLOWING FINDINGS. THE ERYTHEMA/SWELLING WAS 12 CM ACROSS THE LEFT SHOULDER, 12 CM FROM SHOULDER TO MIDDLE AREA OF CHEST, AND 13 CM FROMT HE TOPOF THE ARM TO THE BOTTOM OF THE SWELLING. WAS GIVEN ZYRTEC AND ORAPRED. WAS SEEN BY DR ON 3/26/07 WITH SOME IMPROVEMENT. THE LEFT UPPER ARM WAS SLIGHTLY SWOLLEN WITH ERYTHEMA. NOT OBVIOUSLY TENDER. NO BRUISING. NORMAL PAINLESS RANGE OF MOTION IN THE SHOULDER AND ELBOW.". . . Patient recovered.

DTAP (INFANRIX) problem was reported from PR on Mar 28, 2007. Male patient , child 0.4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 13, 2007. "Vomit x1, hypoactive, hipotonico, cianotico. Treatment-IV's 17060 in 2 hours. 3:15pm Dl .4555 70cs 2hrs.". . NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from KS on Mar 28, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 27, 2007. Induration with mild erythema at the site of administration - Right lateral thigh. Induration measuring 3 x 4cm.. . None. Patient recovered.

DTAP (INFANRIX) problem was reported from OK on Mar 28, 2007. Male patient , child 2.3 years of age, was vaccinated with DTAP (INFANRIX) on Mar 28, 2007. "Redness on injection area (2in x 2 1/2in), warm to the touch (left thigh).". None. "Bronchial asthma, allergic rhinitis". Patient recovered.

DTAP (INFANRIX) problem was reported from NY on Mar 29, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 29, 2007. "Approximately 24 hours after vaccines were given, child developed redness and swelling which initially was small area and progressed to left upper arm. In ER Benadryl was given to r/o allergic reaction. No change noted. Admitted for IV antibiotics and area so responding treatment.". None. None. Patient was hospitalized Patient recovered.

DTAP (INFANRIX) problem was reported from WI on Mar 30, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 26, 2007. Redness to left deltoid and itching developing less then 24 hours after immunization. Symptoms waxed and waned and improved by clinic appointment. Treatment with Benadryl as needed. Fever to 102 within 48 hours of immunization treatment with Tylenol.. NONE. NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from CO on Mar 30, 2007. Male patient , child 1.0 years of age, was vaccinated with DTAP (INFANRIX) on Mar 26, 2007. "Transient measles no nausea, vomiting diarrhea or fever. No other symptom except rash.". NONE. NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Mar 30, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 22, 2007. "Left upper arm swollen and red and warm to touch (localized cellulitis), afebrile.". Unknown. Unknown. Patient recovered.

DTAP (INFANRIX) problem was reported from NC on Mar 30, 2007. Male patient , child 1.5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 29, 2007. "Patient received IM of vaccines in anterior right thigh on 27 Mar 2007 mom states redness at injection site and circumferential erythema, swelling, tenderness and warmth began 28 Mar 2007. Less today. Child, also presents with bronchiolitis today. Treated with Augmentin, Ibuprofen, Prednisone syrup.". "Sodium 4 mg, Montelukast, Sodium Cl nasal,". "Anemia, RAD, Asthma, secondary burn left finger, Abnormal EKG, decease with neonatal jaundice". Patient recovered.

DTAP (INFANRIX) problem was reported from MO on Mar 30, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 30, 2007. "Red, hard, warm, swollen area on right deltoid measuring 115mm x 85mm, Child has been chilling, and generally not feeling well per mother. Symptoms started around 2:00 PM 3/29/07. Child has had cool pks and Motrin.". . . Patient recovered.

DTAP (INFANRIX) problem was reported from IL on Mar 30, 2007. Female patient , child 1.4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 30, 2007. Patient developed cellulitis of the right leg where Dtap was given. Patient was taken to Sherman Family Healthcare Ambutal at 9:58 pm by mother Griselda Perez and patient treated by Dr. Gancayco and given an antibiotic.. None reported. None reported. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Mar 30, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 30, 2007. "LEFT DELTOID WITH REDNESS, SWELLING OVER 2 INCH AREA. DR WATERFILL ADVISED TYLENOL OR MOTRIN AS DIRECTED. IF CONDITION WORSENS GO TO EMERGENCY ROOM.". N/A. NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from AR on Apr 02, 2007. Male patient , child 3 years of age, was vaccinated with DTAP (INFANRIX) on Mar 29, 2007. Papular rash to left arm for one day after injection of Hep A. . . Patient recovered.

DTAP (INFANRIX) problem was reported from MI on Apr 02, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 30, 2007. L thigh cellulitis as DX'd by ER 3/28/07 S/P imms. Motrin. L Tib FX 3/3/07. Patient recovered.

DTAP (INFANRIX) problem was reported from IN on Apr 02, 2007. Male patient , child 1.4 years of age, was vaccinated with DTAP (INFANRIX) on Apr 02, 2007. "red raised macular rash on legs, face and trunk. Treated with Benadryl. Follow up as needed per Dr.'s office". None. None. Patient recovered.

DTAP (INFANRIX) problem was reported from NH on Apr 02, 2007. Male patient , child 21 years of age, was vaccinated with DTAP (INFANRIX) on Mar 03, 2007. "3-21-08 at 1am patient began vomiting, diarrhea, fatigue, no fever. Vomiting & diarrhea hourly until 7am. Diarrhea persisted, and patient developed fever & lethargy on 3-22-07 (T 101). Evaluated in physician's office afternoon of 3-22-07, 3pm. Diagnosis = viral illness, per office nurse.". . . Patient recovered.

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