Age: 1.34
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL, DTAP, HIBV, MMR, VARCEL
Symptoms: Convulsion, Laboratory test abnormal
Clinical narrative: From correspondence received at manufacturer on 1/31/03 regarding a DAPTACEL phase IV study, it was reported that a 16 month old male child with a history of seizures with and without fever received a DAPTACEL, a PRP-T, MMR and a VZV vaccination on 9/5/02. The child had been previously vaccinated with a DTaP. Unspecified vaccine on 8/7/01 and an Infanrix vaccine on 11/16/01 and on 1/7/02. On the morning of 9/7/02 the child was taken to the ER after a 4-minute general seizure at home, which was witnessed by the pt's mother. Per the mother, the seizure occurred without post-ictal state. In ER a CT of the head was taken, which was negative. CBC was normal, except for the automated differential, which showed decreased Segs/Grans of 34% (range 50-70%) and elevated Eosinophils of 5% (range 0-4%). General chemistry was normal except for a decreased BUN of 7mg/dl (range 9-20mg/dl). Pt was discharged from ER only to return four hours later after another general seizure lasting 3 minutes, with post-ictal period of one hour. The pt was afebrile. Pt's mother had been giving Tylenol since immunizations. Pt had a low-grade fever the day before shots 9/4/02. Pt had a decreased appetite on 9/7/02. Pt was admitted to hospital for observation on 9/7/02, with a diagnosis of brief seizures. He experienced a third seizure just after he was transferred to the pediatric floor, which lasted five minutes and was relieved with rectal Valium. He was afebrile. Pt was discharged from the hospital on 9/8/02 with diagnosis of new-onset seizure disorder, however his has documented seizures to June 2001. An EEG was scheduled as an outpatient (no results available at this time). He was prescribed Diastat Rectal 5mg prn for seizure lasting longer than 10 minutes. The case is closed.   Reported on 03/04/2003: "Follow-up #1 (received date 02/27/2003) - During internal review it was determined that the PRP-T product name needed to be changed to the generalized Hib Vaccine with manufacturer unknown because the PRP-T vaccination could be the ActHIB product. From additional info received through call on 11/10/03, it was reported that there is no additional info for this case. No further info is anticipated, this case is considered closed. The event of seizures had been reported by the investigator as possibly related to the study vaccine. Follow up on 11/26/2003: "Information has been received through AP correspondence regarding a DTAP (Daptacel) phase IV study from a health professional regarding a 16 month old male w/a  history of seizures with and without fever and a low grade fever noted on 09/04/2002 who on 09/05/2002 was vaccinated with a dose of Haemophilus B conjugate vaccine (Lot # not reported).  Additional suspect therapies included vaccination on 09/05/2002 with a dose of MMRII (Lot # not reported) (MSD), vaccination on 09/05/2002 w/ a dose of varicella virus vaccine live (Lot # not reported) (MSD) (also reported as varicella zoster virus vaccine, manufacturer unknown) and vaccination on 09/05/2002 w/ a fourth dose of DTAP (Daptacel).  The child had been previously vaccinated w/ a dose of DTAP (manufacturer unknown) on 08/07/2001 and a dose of DTAP (Infanrix) on 11/16/2001 and on 01/07/2002.  On the morning of 09/07/2002 the child experienced a 4 minute general seizure at home, which was witnessed by the pt's mother, and the child was taken to the ER.  Per the mother, the seizure occurred w/out a post-iotal state.  In the ER a CAT of the head was taken, and was reported to be negative.  The CBC was normal, except for the automated differential, which showed decreased "Segs/Grans" of 34% (range 50-70%) and elevated Eosinophils of 5% (range 0-4%).  A general chemistry was normal except for a decreased BUN of 7mg/dl (range 9-20 mg/dl).  The patient was discharged from the ER and then returned 4 hours later after another general seizure lasting 3 minutes, w/a post-iotal period of 1 hour.  The pt was afebrile.  It was reported that the pt's mother had been giving the pt acetaminophen (Tylenol) since the child had rec'd the immunizations.  The pt had a decreased appetite on 09/07/2002.  The pt was admitted to the pediatric unit of the hospital for observation on 09/07/2002 w/a diagnosis of brief seizure.  Just after he was admitted to the unit he experienced a third seizure with lasted about 5 minutes and was relieved w/rectal diazepam (Valium).  It was noted the pt was afebrile.  The pt was discharged from the hospital on 09/08/2002 w/ a diagnosis of new-onset seizure disorder.  An EEG was scheduled as an outpt (no results available).  The pt was prescribed belladonna (+) choloroform (+) kaolin (+) morphine hydrochloride (+) pectin (+) phthalylsulfathiazole (+) streptomycine (Diastat) rectal 5mg prn for seizures lasting longer than 10 minutes.  The outcome of these events is unknown.  Follow up information indicated that the patient had developed a fever (dates and duration not reported).  The event of seizures was reported by the investigator as possibly related to the study vaccine.  The pt's outcome was not reported.  Seizures and fever were considered to be other important medical events (OMIC).  Other business partner numbers included F2003-00478, C2003-00045, U2003-00068, P3T0B and 37454020.  Additional information has been requested." Follow up on 11/26/2003: "From correspondence received at AP Inc on 01/31/2003 regarding a DAPTACEL phase IV study, it was reported that a 16 month old male child w/a history of seizures with and without fever received DAPTACEL a PRP-T, an MMR and a VZV vaccination on 09/05/2002.  The child had been previously vaccinated w/ a DTAP unspecified vaccine on 08/07/2001 and an Infanrix vaccine on 11/16/2001 and on 01/07/2002.  On the morning of 09/07/2002 the child was taken to the ER after a 4 minute general seizure at home, which was witnessed by the patient's mother.  Per the mother, the seizure occurred w/out post-ictal state.  In ER a CT of the head was taken, which was negative.  CBC was normal, except for the automated differential, which showed decreased Segs/Grans of 34% (range 50-70%) and elevated Eosinophils of 5% (range 0-4%).  General chemistry was normal except for a decreased BUN of 7 mg/dl (range 9-20 mg/dl).  Pt was discharged from ER only to return 4 hours later after another general seizure lasting 3 minutes, with post-ictal period of 1 hour.  The pt was afebrile.  Pt's mother had been giving Tylenol since immunizations.  Pt was admitted to the hospital (Pediatrics) for observation on 09/07/2002, w/a diagnosis of brief seizures.  He experienced a third seizure just after he was x-ferred to the pediatric floor, which lasted 5 minutes and was relieved with rectal Valium.   He was afebrile.  Pt was discharged from the hospital on 09/08/2002 w/diagnosis of new-onset seizure disorder, however he has documented seizures to June 2001.  An EEG was scheduled as an outpt (no results available at this time) .  He was prescribed Diastat Rectal 5mg. prn for seizure lasting longer than 10 minutes.  The case is closed.  Follow up #1 (received date 02/27/2003)-during internal review it was determined that the PRP-T product name needed to be changed to the generalized Hib VAccine with manufacturer unknown because the PRP-T vaccination could be the AP ActHIB product.  From additional information received through a telephone call from Medical Affairs on 11/10/2003, it was reported that there is no additional information for this case.  No further information is anticipated, this case is considered closed.  The event of seizures had been reported by the Investigator as possibly related to the study vaccine."  Follow up on 12/03/03: "Follow-up info indicated that the pt had developed a fever (dates and duration not reported).  The event of seizures was reported by the investigator as possibly related to the study vaccine.  The pt's outcome was not reported.  Seizures and fever were considered to be other important medical events (OMIC).  Other business partner numbers included F2003-00478, C2003-00045, U2003-00068, P3T08 and 37454020.  Additional info has been requested."  This is an amended report. Fever was deleted as an adverse event.  This is an amended report as corrected.