Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Convulsion, Dyskinesia, Eye disorder, Sleep disorder
Clinical narrative: This report was received on 5/16/01 from the mother of a 12 month old male who was vaccinated with Prevnar (dose 3), Varivax (MSD) and MMR on 1/10/01. Two days later, on 1/12/01, the infant experienced a seizure described by his mother as, "his eyes shut, his head jerks to the right and his right shoulder pulls up". No fever was associated with the seizure. The mother reports he has had at least 75 seizures, which last less than 5 seconds, since 1/12/01. The infant was referred to a pediatric neurologist and "benign seizure disorder" was dx'd. The mother states the neurologist could not determine a cause and she was told he would "probably out grow" the seizures. No medications were prescribed and the infant was to return if the seizures continued for 6 months. The mother reported the seizures were subsiding. Follow-up information was received from the pt's pediatrician on 6/8/01. The physician indicated that the pt had "possible seizures", but referred to them as "spells" rather than "seizures". He noted that a dx of "stereotypic spells" was made, rather than "benign seizure disorder" that was originally reported by the pt's mother. Also, the pt was reevaluated by neurologists. He also noted that "it is clear that the spells began soon after the vaccine". NOTE: The follow-up information received on 6/8/01 has upgraded this report to a "15-day", serious/unexpected report. F/U states that information was received from a consumer concerning her 12 month old son with a history of a viral illness of an upper respiratory infection with a loose cough (1/2/01) who on 1/10/01 was vaccinated with a 1st dose of varicella (lot 636569/0926K), a 3rd dose IM in the thigh of Prevnar and a 1st dose of MMRII (lot 637255/1380K). There were no other concomitant medications, illnesses or fever at the time of vaccination. On 7/12/01, the pt experienced a seizure described by the mother as "his eyes shut, his head jerks to the right and his right shoulder pulls up". There was no fever associated with the seizure. It was reported at the time of the report by the child's mother that the child has had "at least 75 seizures" since 1/12/01, each of which lasted less than 5 seconds. On 1/23/01, the mother reported to the pediatrician that the child "had stopped sleeping, was not napping and had a twitch of his right arm that had been occurring for the past week and a half". The pt was referred to a pediatric neurologist on 1/30/01 and a rule out seizure disorder. The pt was seen by a pediatric neurologist on 1/30/01 and a dx of "benign seizure disorder" was made. It was noted that the neurologist could not find a cause and that the child would "probably outgrow" the seizures. The pt was not prescribed medications and is to return to the doctor if the seizures contined for 6 months. On 2/4/01, the pt's mother reported that the seizures were occurring less frequently. On 7/5/01, it was noted that no seizures had been noted in the past month. The reporter felt that benign seizure disorder was not related to the therapy with varicella, Prevnar or MMRII. Upon internal review, the pt's benign seizure disorder was considered to be an "Other Important Medical Event". F/U has been received from a physician and indicated that on 7/5/01, at the pt's last check-up, there had been no spells of seizures since 5/01. As of 8/30/01, it was unknown if the pt recovered from his experience. Additional information has been requested.