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DTAP (INFANRIX) Safety Reports

Total DTAP (INFANRIX) reports: 971.

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DTAP (INFANRIX) problem was reported from VT on May 08, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on May 08, 2007. "5/7/07: Received vaccines. 5/8/07: Mom calling to report large red raised area, warm to touch and pain temp - 101.0. Mom to apply ice, give Motrin also itch.". Fluoride. "none, NKQA". Patient recovered.

DTAP (INFANRIX) problem was reported from AZ on May 08, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on May 08, 2007. "Swelling in left arm from injection site to elbow measuring 8"" long + 8-9"" in cir/dia 8 inches. Tx-Benadryl x 3 qd, ice, Report x 3d to re-check". . . Patient was hospitalized Patient recovered.

DTAP (INFANRIX) problem was reported from NH on May 08, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on May 03, 2007. swelling of Rt leg thigh to knee some redness elevated pain. none. none. Patient recovered.

DTAP (INFANRIX) problem was reported from WI on May 08, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 20, 2007. Patient evaluated on 4/20/02. about 8cm warm red swollen area on left upper arm extending up shoulder. No Fluctance. Temper 98.1. Normal mobility. Treated with Keflex 500 BID x 10 days.. . none. Patient recovered.

DTAP (INFANRIX) problem was reported from IL on May 08, 2007. Male patient , child 6 years of age, was vaccinated with DTAP (INFANRIX) on May 02, 2007. "Swelling, red and arm to touch at injection site. Benadryl given with success per pt's mother.". . None. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on May 08, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on May 08, 2007. "Mother brought child into the clinic for PPD reading. Stated that the school called her on Monday, 7 May 07, that the left upper arm was red and swollen, from the shoulder to the elbow. Mother stated child complained of minimal pain but that the arm was warm to touch and itchy. Child was seen by doctor and prescribed cool compresses to area and may use hydrocortisone for itchy as needed. Follow up appointment made for 10 May 07 to observe site for increased swelling.". None. None. Patient recovered.

DTAP (INFANRIX) problem was reported from ID on May 09, 2007. Male patient , child 1.4 years of age, was vaccinated with DTAP (INFANRIX) on Jan 25, 2007. Swelling induration at injection site <24 hr after injection. Swelling and erythema approx 15-20 cm in diameter. Mild 101 deg fever. none. none. Patient recovered.

DTAP (INFANRIX) problem was reported from ID on May 09, 2007. Female patient , child 1.7 years of age, was vaccinated with DTAP (INFANRIX) on Mar 15, 2007. "Severe local reaction-(L) thigh swollen, mild diffuse erythema and tenderness". . Childhood asthma. Patient recovered.

DTAP (INFANRIX) problem was reported from ID on May 09, 2007. Female patient , child 3 years of age, was vaccinated with DTAP (INFANRIX) on Mar 29, 2007. Leg cellulitis ? abx given / pt. recovered just fine.. . none. Patient recovered.

DTAP (INFANRIX) problem was reported from ID on May 09, 2007. Female patient , child 1.3 years of age, was vaccinated with DTAP (INFANRIX) on Apr 20, 2007. fever to 103.6 2 brief generalized seizures. Tylenol. none. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on May 09, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on May 05, 2007. Mother reports child's arm got swollen and itching in area of shot - noticed 6 hours after shot given. Nothing has helped itching. none. none. Patient recovered.

DTAP (INFANRIX) problem was reported from MD on May 09, 2007. Female patient , 14 years of age, was vaccinated with DTAP (INFANRIX) on May 09, 2007. Child received a DTaP vs a Tdap.. None. None. Patient recovered.

DTAP (INFANRIX) problem was reported from FL on May 10, 2007. Male patient , child 0.3 years of age, was vaccinated with DTAP (INFANRIX) on May 10, 2007. "This case was reported by a nurse on behalf of an immunologist, and described the occurrence of double sterile abscesses in a 4 to 5-month-old male subject who was vaccinated with Pediarix, or Infanrix plus Engerix B for Prophylaxis. The nurse stated that it was uncertain whether the subject was vaccinated with Pediarix or alternatively with Infanrix Plus Engerix-B, but stated that the manufacturer was known. On 07 March 2007, the subject was also vaccinated with Hib vaccine (manufacturer unspecified) and Prevnar. On 7 March 2007 the subject received his ""four month"" vaccines including unspecified dose of Pediarix (unknown, unknown thigh), or unspecified dose of Infanrix (unknown, unknown thigh) plus unspecified dose of Engerix B (unknown, unknown thigh). In 2007, at an unspecified time after vaccination with Engerix B - Infanrix or Pediarix, the subject developed double sterile abscesses. Following vaccination on 07 March 2007, the subject developed a hard mass on both thighs and a ""large local reaction"". The subject subsequently developed infection, and the areas became ""raised, red, and almost puffy"". On 28 April 2007 the subject was evaluated by a pediatric surgeon, who reportedly felt the reaction was related to the vaccinations. The abscesses required surgical intervention, and were removed. The subject was hospitalized and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. The healthcare professional stated that the pediatric surgeon considered the events were related to vaccination with Pediarix, or Infanrix plus Engerix B. The healthcare professional also stated that the double sterile abscess were unrelated to vaccination with Pediarix, or Infanrix plus Engerix B.". . "Milk, soy protein allergy, GERD, was on Nutramigen formula for reflux.". Patient was hospitalized Patient recovered.

DTAP (INFANRIX) problem was reported from IA on May 10, 2007. Female patient , child 6 years of age, was vaccinated with DTAP (INFANRIX) on May 10, 2007. "AT INJECTION SITE, REDNESS AND WARM TO TOUCH. RX ZYRTEC BY DOCTOR AND TOLD TO GET RECHECKED IF NO IMPROVEMENT.". NONE. NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on May 11, 2007. Female patient , child 1.5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 29, 2007. "24-28 Hours after DTaP shot in right thigh, father noted redness and swelling approximately 5 inches. Took daughter to ER. This report may have been submitted by them: hospital ER.". None. Upper respiratory infection. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on May 11, 2007. Female patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 29, 2007. "About 24 hours after patient was vaccinated, mother noticed her left arm had a red, swollen area (10 area of DTaP). No other symptoms and child not in pain. (Child came in for PPD read and they mentioned this reaction).". . None. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on May 11, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 08, 2007. "Hot, red, swollen right upper arm (deltoid), no fever.". . . Patient recovered.

DTAP (INFANRIX) problem was reported from CA on May 11, 2007. Male patient , child 1.3 years of age, was vaccinated with DTAP (INFANRIX) on May 11, 2007. "RIGHT DELTOID RED HOT TO TOUCHM NO FEVER, NO PAIN. PATIENT EATING AND SLEEPING HABITS HAVE NOT CHANGED AT ALL. CHILD SEEMS TO BE FINE OTHER THAN SWELLING TO RIGHT DELTOID AND SOME DISCOMFORT. PATIENT WAS GIVEN 5TH DTaP.". NONE. NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from AZ on May 14, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on May 10, 2007. "DX: Allergic Reaction, redness, swelling at site of injection warm to touch pain at site of injection. Benadryl - cool compress". Carbratrol. Hx of seizures. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on May 14, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on May 07, 2007. "On 1st left arm red, seen on day 3 after immunization slight erythema and induration 2.7 cm upper arm indurated.". . Overweight. Patient recovered.

DTAP (INFANRIX) problem was reported from IN on May 14, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on May 07, 2007. Reaction at site from Dtap injection at upper right thigh. . none. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on May 14, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on May 08, 2007. "5-8-07 seen in clinic 24 hours after vaccinations L upper arm - deltoid muscle - swollen, red, tender, warm to touch. Tx with Keflex TZD X 10D 2 cellulitis.". . Reactive Airway Disease. Patient recovered.

DTAP (INFANRIX) problem was reported from UT on May 15, 2007. Female patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on May 10, 2007. "Patient had Varivax, DTaP, IPV 11:30 Mom came out 5 minutes later stated patient with hives, head pain, hard time breathing. Epi-pen given left thigh, I.V. placed normal saline fluid given. Vital signs taken - pen order doctor. Patient transported to hospital via ambulance. Stable at time of d/c to hospital.". None. MMR - Anaphylactic Reaction 8/17/2005. Patient was hospitalized Patient recovered.

DTAP (INFANRIX) problem was reported from OH on May 15, 2007. Female patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on May 08, 2007. "3 x 4"" Redness, swelling, (fever 101), warm to the touch at injection sites. Went to hospital ER 5-4-07 Dx: Cellulitis both legs. Rx of Augmentin 600mg - given.". . . Patient recovered.

DTAP (INFANRIX) problem was reported from FL on May 15, 2007. Male patient , child 1.5 years of age, was vaccinated with DTAP (INFANRIX) on May 10, 2007. Large 10cm x 5cm area of erythema on right thigh swollen and tender one day following immunization.. . . Patient recovered.

DTAP (INFANRIX) problem was reported from IL on May 15, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on May 13, 2007. Severe swelling of L thigh down to the knee - resolved in 5 days.. . None. Patient recovered.

DTAP (INFANRIX) problem was reported from IL on May 15, 2007. Female patient , child 1.3 years of age, was vaccinated with DTAP (INFANRIX) on May 16, 2007. "Crying inconsolably - no treatment given. Child was never brought: for evaluation. Crying began to improve 5/12, improving daily". . . Patient recovered.

DTAP (INFANRIX) problem was reported from IL on May 15, 2007. Male patient , child 1.5 years of age, was vaccinated with DTAP (INFANRIX) on May 15, 2007. Rash began this morning after the vaccine. Worse at injection site (left deltoid) generalized urticarial. Treated with Benadryl. Then 1D later Prednisolone by PCP.. Amoxicillin. Recent Otitis Media. Patient recovered.

DTAP (INFANRIX) problem was reported from ND on May 16, 2007. Female patient , child 2.0 years of age, was vaccinated with DTAP (INFANRIX) on May 07, 2007. "Mom stated ""on Friday night I noticed her leg getting red."" I looked at leg on Saturday a.m. and right leg is swollen, warm and redness the size of a softball around injection site. Mom called on 4-23-07 and site was back to normal.". . . Patient recovered.

DTAP (INFANRIX) problem was reported from ND on May 16, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on May 07, 2007. "On 5-5-07 child had a ""hot"". PUB. . Patient recovered.

DTAP (INFANRIX) problem was reported from FL on May 16, 2007. Male patient , child 1.0 years of age, was vaccinated with DTAP (INFANRIX) on May 16, 2007. "HAD MMRV 5/4/07 AND BROKE OUT IN RASH 5/11/07.SKIN REDDISH,PAPULAR/MACULAR TO VERSICULAR ERUPTION ALL OVER.". NONE. TRISOMY-21. Patient recovered.

DTAP (INFANRIX) problem was reported from IN on May 17, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on May 15, 2007. "4:40pm On 5/11/07 parent brought in child - Left thigh swollen, skin tight, warm to the touch, child was limping, child states leg was itchy. No Peds Physician on site to examine child. Instructed mother to take child to Peds Urgent Care for evaluation. Mom ended up taking.". None. None. Patient was hospitalized Patient recovered.

DTAP (INFANRIX) problem was reported from IN on May 17, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on May 17, 2007. Patient received a DTaP and IPV vaccines in left thigh and developed cellulitis of left thigh. None. None. Patient recovered.

DTAP (INFANRIX) problem was reported from WI on May 17, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on May 17, 2007. "LeftArm is red and swollen, itchy and painful. more than the typical reaction. Came to see Doctor two days after vaccines given". none. none. Patient recovered.

DTAP (INFANRIX) problem was reported from PA on May 17, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on May 17, 2007. "This case was reported by a healthcare professional and described the occurrence of arm cellulitis in a 4-year-old male subject who was vaccinated with Infanrix and ProQuad for prophylaxis. The subject's medical history included extrinsic asthma, respiratory infections and an unspecified reaction to oxybenzoyl described as a rash from baby oil. Concurrent medications included Albuterol and Pulmicort Nebulised. On 3 May 2007 the subject received 5th dose of Infanrix (.5 ml, unknown, left arm), and the 2nd dose of ProQuad (unknown, left arm). On 4 May 2007, within 24 hours of receiving the vaccinations, the subject's left arm became swollen and red, and he developed a fever of 104 degrees Fahrenheit. The subject was treated with ibuprofen (Motrin) and Benadryl with no improvement in symptoms. On 5 May 2007 at 3:43 p.m., the subject presented at the physician's office and was diagnosed with cellulitis. The subject's left arm was swollen from the deltoid to the elbow, his skin was taut, warm to the touch, and red. This case was assessed as medically serious by manufacturer. The subject was prescribed Augmentin for 10 days. At the time of reporting the arm cellulitis, swelling, redness, and warmness to the touch were improved, but the outcome of the fever and skin tautness was not specified. The healthcare professional considered the events were possibly related to vaccination with Infanrix and ProQuad. Per the source document, the healthcare professional in uncertain if cellulitis was due to Infanrix or ProQuad. Per the source document, the healthcare professional in uncertain if cellulitis was due to Infanrix or ProQuad since both vaccines were received on the same day.". "Salbutamol Sulphate, Budesonide". . Patient recovered.

DTAP (INFANRIX) problem was reported from CA on May 17, 2007. Male patient , 13 years of age, was vaccinated with DTAP (INFANRIX) on May 23, 2007. Child didn't need Dtap already had Tdap 2/14/07. None. None. Patient recovered.

DTAP (INFANRIX) problem was reported from TN on May 18, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on May 13, 2007. "Extreme swelling, redness, and tenderness to injection site - reaction involved the entire left thigh as the reaction progressed it included a red streak around the back of the thigh. Patient first treated in ER, given oral steroids. Followed up at our clinic 2 days later - thigh still swollen and red but with some improvement per mom, Doctor recommended Benadryl.". "FLOVENT, NASONEX, SINGULAIR, ALBUTEROL". RAD. Patient recovered.

DTAP (INFANRIX) problem was reported from NY on May 18, 2007. Male patient , child 1.3 years of age, was vaccinated with DTAP (INFANRIX) on May 17, 2007. C/O swelling and redness at L arm where pt received immunization (Dtap) no fever.. None. . Patient recovered.

DTAP (INFANRIX) problem was reported from MO on May 18, 2007. Female patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 30, 2007. Mild erythema to left deltoid with mild induration. Benadryl PRN.. . . Patient recovered.

DTAP (INFANRIX) problem was reported from SC on May 18, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on May 18, 2007. Pain and swelling in right deltoid. Itching and red. Mother applied ice and gave Benadryl. Symptoms subsided by 04/25/07.. NONE. NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from GA on May 18, 2007. Female patient , child 1.2 years of age, was vaccinated with DTAP (INFANRIX) on May 18, 2007. Sm Localized area red and warm to touch on her Lt thigh and rt thigh. . dx with eczema. Patient recovered.

DTAP (INFANRIX) problem was reported from KY on May 20, 2007. Male patient , child 0.2 years of age, was vaccinated with DTAP (INFANRIX) on May 20, 2007. "intussusception, reduced via air contrast enema. 5/21/07 Received hospital medical records which reveal patient experienced fever, inconsolable fussiness, loose stools. Exam revealed abdominal tenderness & distention. Admitted 5/19-5/20/07 for overnight observation after contrast enema revealed no IS, probable spontaneous resolution. Continued to have fever but abdomen was benign & was able to tolerate oral feeds at d/c to home. FINAL DX: Reduced intussusception & fever.". . BIRTH HX: 37 wk vag del. Hx of neonatal jaundice.. Patient was hospitalized Patient recovered.

DTAP (INFANRIX) problem was reported from NY on May 21, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on May 18, 2007. "approx Two minutes after 3 vaccines (Proquad, DTaP, IPV) administered, pt developed cough. He then vomited x once. This cough continued. Benadryl (12.5/g) 1 1/2 tsp po given. flushed face, puffy eyes and few hives on palms/wrist developed. Epinephrine 0.15mg IM given. Pt sx improved. Pt transported to hospital via EMS. 05/29/2007 MR received for o/n hospitalization for an allergic reaction to vaccinations. W/in 2 minutes of receiving vax child began to cough and vomited x 1. He developed hives, puffy eyes, facial flushing and began to itch. Continued coughing. Admitted for observation. DX: Allergic reaction after immunization.". None. Mild Allergic Rhinitis/mild RAD. PMH: Mild RAD. ? Allergic rhinitis. Allergies: NKDA.. Patient was hospitalized Patient recovered.

DTAP (INFANRIX) problem was reported from IN on May 21, 2007. Female patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on May 21, 2007. "Right upper arm red, swollen, warm and painful to touch two days after Dtap immunization given. Ice pain, reliever.". . . Patient recovered.

DTAP (INFANRIX) problem was reported from CA on May 21, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on May 21, 2007. "Local swelling, erythema, pruritis to left deltoid area.". none. . Patient recovered.

DTAP (INFANRIX) problem was reported from PA on May 21, 2007. Male patient , child 2.2 years of age, was vaccinated with DTAP (INFANRIX) on May 21, 2007. "This case was reported by a healthcare professional and described the occurrence of localized cellulitis left arm in a 2-year-old male subject who was vaccinated with Infanrix for prophylaxis. Co-suspect vaccination administered on 19 April 2007 included Ipol (subcutaneous, left arm). Concurrent vaccination included Recombivax HB (unknown; right arm) given on 19 April 2007. Concurrent medication included Albuterol. On 19 April 2007 the subject received the fourth dose of Infanrix (.5 ml, unknown, left deltoid), and unspecified dose of IPV (subcutaneous, left arm). On 20 April 2007, one day after vaccination with Infanrix and IPV, the subject experienced swelling and redness in his left arm, accompanied by fever. He presented to the emergency room, and was diagnosed with cellulitis. The reaction was characterized by the reporter as localized. This case was assessed as medically serious by manufacturer. The reporter also identified a product quality complaint, questioning whether there was a problem with the Infanrix lot number that was administered to the subject. The subject was treated with Bactrim. At the time of reporting (27 April 2007), the events were resolved. The healthcare professional considered the events were possibly related to vaccination with Infanrix. Comment: the event of ""localized cellulitis left arm"" was considered to be medically significant by manufacturer.". Salbutamol sulphate. The subject's medical history and concurrent medical conditions were not reported. The subject had experienced no adverse events following previous vaccinations. A0649108A was one of three cases reported by the same nurse of the occurrence. Patient recovered.

DTAP (INFANRIX) problem was reported from TN on May 21, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on May 21, 2007. "Reddened area approx 6"" x 5"". PVT. None. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on May 21, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on May 21, 2007. "+ Edema, erythema to LD (site of injection) post 24 hours after vaccination with Resp sx. 5/19/07 + purplish hue to site with increased edema extending pass L elbow, mom worried, seen at ER. Tx with Benadryl PO Q PM increasing itching.". None. None. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on May 21, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on May 17, 2007. "Mother brought patient in for PPD read with complaints of redness, swelling and fever at site of left deltoid. Patient has full ROM without complaint of joint stiffness. Patient evaluated by RN. Doctor appointment scheduled for 5/18/07.". None. None. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on May 22, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on May 22, 2007. "LT DELTOID REDNESS AND SWELLING, WARM TO TOUCH". PT ALSO HAD PPD PLACED SAME DATE. . Patient recovered.

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