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DTAP (INFANRIX) Safety Reports

Total DTAP (INFANRIX) reports: 971.

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DTAP (INFANRIX) problem was reported from CA on Apr 02, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 30, 2007. "DTap given at left thigh- 3-29-07. 3-30-07 Today appt- with Dr left thigh swollen, warm to touch. Played last night and had scrapes on the site.". . None. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Apr 03, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 23, 2007. "Right arm large (13x9 cm) red, hot, painful area. No fever. Tx: Keflex 250/5ml 1 tsp PO 96 hours x 7 days, Benadryl 12.5/5ml 1/2 tsp PO q4-6 PRN itching PRN ice/ Tylenol. Follow-up 4-5 days.". . None. Patient recovered.

DTAP (INFANRIX) problem was reported from IA on Apr 03, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 28, 2007. "Left arm red, swollen from elbow to upper arm. Central blanding (4 cm diameter) at injection site. Low grade fever 24 hours after shot. Arm is swollen significantly now 2 days after shot.". None. None. Patient recovered.

DTAP (INFANRIX) problem was reported from WI on Apr 03, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 22, 2007. "Wed March 21, 2007 at 6:55pm. His whole arm around the injection site is swollen. No fever, no streaking. Using cool compresses and Benadryl 12.5 mg 1 tsp q4-6 hours.". "ALBUTEROL 90 mcg 2 puffs QID for 1 week then prn - Inhalation, Zithromax 6ml po today then 3 ml daily for 4 days - Oral, Robusstin chest congestion or 1/2 tsp last night, Amoxicillin 250 mg/5ml 1 teaspoonful every 8 hours - Oral, Tylenol co". None. Patient recovered.

DTAP (INFANRIX) problem was reported from KS on Apr 03, 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 4 cm.. . None. Patient recovered.

DTAP (INFANRIX) problem was reported from FL on Apr 03, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Apr 03, 2007. "Received 4 year old vaccinations left upper arm has some swelling. No fever, pain, here for shots only today 3/22/07". None. NKA. Patient recovered.

DTAP (INFANRIX) problem was reported from NJ on Apr 04, 2007. Female patient , child 1.2 years of age, was vaccinated with DTAP (INFANRIX) on Apr 04, 2007. Local site reaction on Rt.thigh. Hydrocortisone cream 2.5% as directed.. Has local burn on arm- on eflex250/5 1tsp.BIDX10days and Silvadene locally to burn.. None. Patient recovered.

DTAP (INFANRIX) problem was reported from RI on Apr 05, 2007. Male patient , child 1.5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 29, 2007. "Localized redness and swelling, heat with Atarax 10mg TOD and Keflex 20 - BID x 10 days.". . None. Patient recovered.

DTAP (INFANRIX) problem was reported from MD on Apr 06, 2007. Male patient , child 0.5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 05, 2007. "This case was reported by a lawyer and described the occurrence of nerve injury in a male subject who was vaccinated with Engerix, Infanrix, Hib, OPV, Ipv, MMR and Varivax for prophylaxis. The subject was vaccinated with hepatitis B vaccine on 22 June 1997, and with Engerix B on 22 August 1997 and 05 January 1998. The subject was vaccinated with Infanrix on 22 August 1997, 22 October 1997, and 05 January 1998. On 5 January 1998 the subject received the third dose of Engerix B and the third dose of Infanrix. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced ""serious and permanent neurological injuries"". . NKA. Patient recovered.

DTAP (INFANRIX) problem was reported from IN on Apr 09, 2007. Male patient , child 0.5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 09, 2007. "High fever up to 106.2 degrees rectally that occurred Saturday night, 04/07/2007,(about 2.5 days after vaccinations). Vomitted 1 time during 1st night after receiving vaccinations. Took to ER on Saturday night when fever got so high. ER docs did thorough exam, including chest film and U/A and found nothing wrong. Sent home with instructions to give alternating Tylenol and Motrin. Fever finally got down to 101 rectally after this regimen begun. Fever did not completely go away until Monday morning at about 3:00. No residual problems after this.". p.r.n. nebulizer at home (unknown medication used in nebulizer).. Allergies - is on as-needed nebulizer at home per pediatrician for wheezing.. Patient recovered.

DTAP (INFANRIX) problem was reported from CT on Apr 09, 2007. Male patient , child 1.5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 05, 2007. Rash noted on cheeks and arms (flushing in appearance) went away in 2 minutes. Gave Benadryl and Tylenol and observed pt for 30 mins still had normal exam No rash 4/5/07. . . Patient recovered.

DTAP (INFANRIX) problem was reported from MI on Apr 09, 2007. Male patient , child 0.5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 05, 2007. "After receiving 5 pediatric vaccines at 11:00, client stopped breathing, color bright red, then at. Went pale, and had weak cry. Client did not regain normal color or cry, 911 called, at hospital. Upon vasovagal s/s, nurse placed on back to promote circulation abd stimulated client by rubbing soles, undressing and changing positions keeping supine.". None given. None. Patient recovered.

DTAP (INFANRIX) problem was reported from WI on Apr 10, 2007. Male patient , child 6 years of age, was vaccinated with DTAP (INFANRIX) on Apr 06, 2007. "PT after injection at home mother states child fever 100, 10 cm x 8 cm welt and child had wheezing, lethargy and malaise per mother.". "Albuterol inhaler PRN,". Asthma. Patient recovered.

DTAP (INFANRIX) problem was reported from IA on Apr 10, 2007. Female patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 04, 2007. "4-3-07 mom reported by phone, localized redness of L deltoid area, warm to touch. 4-4-07 mom called stated redness and warmth from deltoid to elbow. Recommend child to be seen. Child was going out of town - mom refused appt.". None. . Patient recovered.

DTAP (INFANRIX) problem was reported from AL on Apr 10, 2007. Female patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 03, 2007. "Swelling around injection site left leg tenderness, splotchy rash". . eczema. Patient recovered.

DTAP (INFANRIX) problem was reported from KS on Apr 10, 2007. Male patient , child 2.3 years of age, was vaccinated with DTAP (INFANRIX) on Mar 30, 2007. "Warmth, Erythema and swelling to injection site Left upper arm from shoulder to approx. 2 inches above elbow. Dr 11:30 on 3/30/07 treated with Amoxicillin x 7 days and Zyrtec. Spoke with parent on 4/2/07 and stated childs arm was no longer swollen, red or warm". None. None. Patient recovered.

DTAP (INFANRIX) problem was reported from IN on Apr 10, 2007. Female patient , child 1.5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 02, 2007. "Dtap and HIB given on 3/28/07. On 3/29/07 Left thigh (Dtap) had 9 cm Red, Raised warm area with tenderness. Right thigh (HIB) had 4 cm Red, Raised warm area. Prescription of Cephalex in 250 mg given". . . Patient recovered.

DTAP (INFANRIX) problem was reported from VT on Apr 11, 2007. Female patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 29, 2007. "DTap + IPV administered in Left arm. on 3-26-07. Seen today 3-29-07-Large local reaction= 8x8cm in area of DTap. Arm, red, painful and itchy prescribed Zyrtec 10 mg; cold compresses.". . Asthma. Patient recovered.

DTAP (INFANRIX) problem was reported from CT on Apr 11, 2007. Male patient , child 1.3 years of age, was vaccinated with DTAP (INFANRIX) on Apr 06, 2007. Developed approx 20-30 varicella lesions on 4/6/07. Amoxicillin 400 mg po bid. 31 wk premie. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Apr 11, 2007. Male patient , child 0.5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 02, 2007. pt came in with rash all over body caregiver stated she introduced pt to egg as well the next day. First time pt had immunizations (pt foster child). . . Patient recovered.

DTAP (INFANRIX) problem was reported from IN on Apr 11, 2007. Female patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 11, 2007. "4/10/07 - 8:00 A.M. PT REC'D VACCINATIONS. 9 P.M. MOTHER NOTICED THAT THE AREAS OF VACCINATIONS WERE HOT AND ""HARDENED"". TYLENOL WAS GIVEN PRIOR TO VACCINATIONS BUT NONE GIVEN AFTER THE VACCINATIONS ON 4/10/07. THIS MORNING AT 6:45 A.M. AREAS OF VACCINATIONS NOTICIABLE WORSE, LEFT ARM WAS HOT, RED, SWOLLEN FROM SHOULDER TO ELBOW COVERING AT LEAST 1/2 OF WIDTH OF ARM. RIGHT ARM WAS HOT, SWOLLEN 47MM IN CIRCUM. WITH AN INNER CIRCLE 32MM THAT HAD A DARKER COLORATION, WITH MORE TYLENOL WAS GIVEN AT 7:00 A.M. AND ANOTHER DOSE (1 1/2 TSP.) GIVEN AT 12:00 P.M. MOTHER FELT THAT HER DOCTOR SHOULD SEE THE CHILD AND CHILD WAS SEEN BY DR. AT 1 P.M. ANTIBIOTIC AND ANTIHISTAMINE PRESCRIPTIONS GIVEN. MOTHER UNSURE WHAT THE PRESCRIPTIONS". NONE. NONE KNOWN. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Apr 11, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 11, 2007. PT'S LEFT ARM IS SWOLLEN AND RED AROUND THE AREA WHERE VACCINATION WAS ADMIISTERED.. . NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from NJ on Apr 11, 2007. Female patient , child 0.2 years of age, was vaccinated with DTAP (INFANRIX) on Apr 05, 2007. Patient received vaccines 3-21-07 at around 11:30 AM later that day around 6:00PM she started to present shaking of upper and lower extremities: eyes were rolled up lasting approx 5 seconds.. None. None. Patient was hospitalized Patient recovered.

DTAP (INFANRIX) problem was reported from OK on Apr 12, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Apr 11, 2007. "Fever, pain, limb swelling started within 16 hours of injection. Patient taking ibuprofen for pain and swelling.". . None. Patient recovered.

DTAP (INFANRIX) problem was reported from KY on Apr 12, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Apr 09, 2007. "3/26/07 Dtap, IPV et MMRV given. Ran fever per mother day of vaccine. No fever since. Rash started on hands and spread to rest of body by 3/29/07, TX: Benadryl 12.5mg/5ml Elixir 3/4 tsp Q 4.6 hrs and Prelone 5mg/5ml. Syrup 1 tsp BID x 2 days 1 tsp x 2 days 1/2 tsp x 2 days.". . None. Patient recovered.

DTAP (INFANRIX) problem was reported from KY on Apr 12, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Apr 09, 2007. 2/2/07 R upper arm swollen 2 1/2 inches mildly raised with tiny small papules. TX: none. None. None. Patient recovered.

DTAP (INFANRIX) problem was reported from IA on Apr 12, 2007. Male patient , child 1.6 years of age, was vaccinated with DTAP (INFANRIX) on Apr 12, 2007. NONE KNOWN. NONE/UNKNOWN. NONE. Patient recovered.

DTAP (INFANRIX) problem was reported from NV on Apr 12, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Apr 12, 2007. Patient had localized redness and swelling. Mother advised to apply warm compresses and to notify Dr. of any further selling or pain. Mother has not called us back. Two messages left for Mother to call back with update on status of child.. . none. Patient recovered.

DTAP (INFANRIX) problem was reported from TN on Apr 12, 2007. Female patient , child 1.7 years of age, was vaccinated with DTAP (INFANRIX) on Apr 12, 2007. Reddened area at site of Prevnar inj R deltoid and failure of child to want to walk Hib inj in L thigh IM. Advised warm compress 15 minutes Q 4-5 hours. Tylenol. . Unknown. Patient recovered.

DTAP (INFANRIX) problem was reported from PA on Apr 13, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Mar 30, 2007. "Mom reports via telephone that pt received Hep A vaccine on 3/28/07 and last night (3/29) started vomiting. This am diarrhea began. Child very weak and pale. T 96, clammy. Also received DTap and IPV. Mom denies poss. that symptoms are caused by GI virus. Right arm was red and swollen but is better now. Hep a given in LA.". . none. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Apr 13, 2007. Female patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 13, 2007. "Right arm Redness, arm hot to the touch, itching". . . Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Apr 13, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Apr 13, 2007. L arm red and swollen. . none. Patient recovered.

DTAP (INFANRIX) problem was reported from AZ on Apr 13, 2007. Female patient , child 0.3 years of age, was vaccinated with DTAP (INFANRIX) on Apr 13, 2007. Screaming RxN on 2/12/07 after immun. Mom states lasted 1 hr and 45 mins. . None. Patient recovered.

DTAP (INFANRIX) problem was reported from TN on Apr 16, 2007. Female patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 10, 2007. "3 days after vaccine administered, pt presented to the office with area of cellulitis surrounding injections site. Patient c/o pain since receiving shot than began to turn red and swollen. Presented with 13x13 cm area surrounding site with decreased ROM of elbow.". . . Patient recovered.

DTAP (INFANRIX) problem was reported from LA on Apr 16, 2007. Female patient , child 01 years of age, was vaccinated with DTAP (INFANRIX) on Mar 29, 2007. "March 16, 2007-Mom called and stated child had been running fever since Wednesday 03-14-07 as high as 103.9. Instructed to contact MD and I would follow up with her on Monday March 19, 2007. March 19, 2007-Phoned mother back and she spoke with MD and he said it was o.k. to give future immunizations. Mother went on to report that child was still running fever since 03-14-07 ranging from 100.5-103.9. She was the child Tylenol & Ibuprofen. The child also has a loss of appetite. She also reported that she noted a red bump on the child's right buttock near anus the day she received immunizations but the child wasn't running fever then and today the bump was now formed into a boil and the child is unable to sit down. She was waiting for the MD's office to call her back with an appointment for the child. March 21, 2007-Spoke with mother and child is not on antibiotics by mouth and topical for boil on right buttock and MD said it is not related to immunizations.". None. None. Patient recovered.

DTAP (INFANRIX) problem was reported from IL on Apr 16, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Apr 16, 2007. "On 4/11/07 Client came to Immunization Clinic for Routine 4y/o vaccinations. Mom states that day did not seem to have ill effcts, just a small bruise at the area of the shot. The next day Mom noted redness approx. size of 2"" on the right leg where the DTaP had been given. On Friday 4/13/07 Mom noted in the AM that the redness had increased to approx. 4"" and she then made an appointment for the child to see his Family Physician for that afternoon. His appointment was at 2:45 PM and by that time the redness had gone around his entire upper thigh. He complained of itching at this time and it was ""very red slightly swollen and ""hot"" to touch. Mom staes he was examined by Dr. Clyde Dayhoff and was given a Rocephin injection (she did not know the dose he was given). He was also given a presciption for Omnicef 250mg/ml 6ml daily for 10 days, which he is presently taking. When questioned Mom on his condition following his appointment, she stated that by 4/14/07, the redness was gone and he wasn't complaining of any other symtoms.". None. "Mom states child ""at 9 months of age had some type of allergic reation where his whole body became red over a course of hours for an unknown reason and was taken to the ER where he was given Benadryl and kept for Observation in the Hospital". Patient recovered.

DTAP (INFANRIX) problem was reported from TX on Apr 16, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Apr 16, 2007. Developed cellulitis/rash at injection site on left thigh with some blistering. Seen at acute care center day after vaccines given and given keflex; then seen at our office the next day for continued spread and given ceftriaxone with resolution of the rash over the next 2 days.. multivitamin. none. Patient recovered.

DTAP (INFANRIX) problem was reported from NM on Apr 16, 2007. Male patient , child 0.3 years of age, was vaccinated with DTAP (INFANRIX) on Apr 16, 2007. "Pt well at time of administration of immunizations. Began vomiting approx 4 hrs after imm. given, then not feeding well, then became somewhat irritable. Taken to ER by parents about 14 hrs after imm. given. No fever. Diagnosed with Paroxysmal atrial tachycardia, and shock. Adenosine IV administered in ER as directed per Ped cardiologist. Transported via air to another medical center.". None. None Known. Patient was hospitalized Patient recovered.

DTAP (INFANRIX) problem was reported from TN on Apr 16, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Apr 16, 2007. Local redness and swelling around site. Concern caused mom to seek treatment from local clinic on Sunday. . none. Patient recovered.

DTAP (INFANRIX) problem was reported from LA on Apr 17, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Apr 12, 2007. "DTaP given (L) IM and Proquad given (L) sub 4/7/07. Pt came in 4/4/07 w/local reaction, red hot and hard, no itching, no fever. Dr said do warm compresses mother did. Pt came back 4/12/07 and reaction was bigger, harder, same redness w/blisters and itches now. Dr pres. Atarax and Prednisolone". Clinda 300 mg po TID floxin. "AR, RAD, Chronic OM". Patient recovered.

DTAP (INFANRIX) problem was reported from IA on Apr 17, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 04, 2007. Leg pain began 4/2/07. Fever also occurred on that date. Limping on 4/3/07 swelling of leg on 4/3/07 with redness. Swelling at redness continue today but no longer limping.. . none. Patient recovered.

DTAP (INFANRIX) problem was reported from MI on Apr 17, 2007. Male patient , child 1.5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 12, 2007. "fever, tender swelling of thigh (L) Motrin (sites DTaP given)". . . Patient recovered.

DTAP (INFANRIX) problem was reported from MS on Apr 17, 2007. Male patient , child 3 years of age, was vaccinated with DTAP (INFANRIX) on Apr 09, 2007. "Child presented to clinic on 4-9-07, 4 days following vaccination with redness, itching & welting at site of injection". None. Asthmatic. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Apr 17, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Mar 30, 2007. "Warm, redness and swollen left deltoid, small bruises at the site of IPV injection.". . . Patient recovered.

DTAP (INFANRIX) problem was reported from NV on Apr 17, 2007. Female patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 17, 2007. Mother stated childs arm started swelling in the evening - the next morning it was trippled in size and spreading to her chest and neck. Went to the Hospital and was admitted on 4/12/07. She was told patient had a staff infection from receiving the shot. She was put on antibiotics and discharged on 4/15/2007. 04/23/2007 MR received for an ER visit for c/o Left arm swelling s/p immunizations. PMH: none. NKDA. PE: Swelling and tenderness of LUE. Pain 6/10. DX: Cellulitis S/P immunizations. Transfered to Pediatric facility for IV antibiotics.. . NONE PMH: none. NKDA.. Patient was hospitalized Patient recovered.

DTAP (INFANRIX) problem was reported from FL on Apr 17, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Apr 17, 2007. Mother reported redness/pain and swelling 4/14/07 10am; went to Night Lite Pediatrics - diagnosed with local immunization reaction with cellulitis - treated with Rocephin 750mg IM/Benadryl po/Motrin po and sent home with Omnicef po bid/Benadryl po bid; parents returned 4/15 with c/o worsening - treated with Rocephin 1gm IV/Solumedrol IV/ Benadryl IV and admitted to hospital.. Bactrim. Hx prematurity/VCUG Reflux. Patient was hospitalized Patient recovered.

DTAP (INFANRIX) problem was reported from MI on Apr 17, 2007. Female patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Apr 17, 2007. "2"" area of swelling, redness, tenderness, warmth. Gave Keflex 2 weeks later area better.". . None. Patient recovered.

DTAP (INFANRIX) problem was reported from MS on Apr 18, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 11, 2007. "In Health Dept 4/11/07 @ 4:30 p.m. Right arm red, hot to touch from elbot to clavicle. Swollen and Tight. Painful and Itching. Splotchy redness notedto arm pit area. Dr. notified; Instructed given for cool and warm compresses, ibuprofen, benadryl, check radial pulses; If s/s worsen or persist to take child to ER. To TC 4/12/07 for recheck; Returned 4/12/07...Resolving.". . NKA. Patient recovered.

DTAP (INFANRIX) problem was reported from CA on Apr 18, 2007. Male patient , child 5 years of age, was vaccinated with DTAP (INFANRIX) on Apr 18, 2007. area over right deltoid muscle became red swollen and firm to touch and minimally painful on the evening the vaccine was given. did not resolve so mom returned to clinic.. none. none. Patient recovered.

DTAP (INFANRIX) problem was reported from AZ on Apr 19, 2007. Male patient , child 4 years of age, was vaccinated with DTAP (INFANRIX) on Apr 19, 2007. L upper arm swelling around injection siteApply cold compress to area and take Benadryl. . none. Patient recovered.

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