KEYWORDS:
pneumococcal, vaccine safety, seizures

BACKGROUND:
In February 2000, PCV7 was licensed for use in infants and young children. In prelicensure trials, seizures were a rarely identified adverse event, although the finding was confounded by co-administration of DTP. Febrile seizures are a biologically plausible explanation, since PCV7 was associated with fever after each dose.

OBJECTIVE(S):
To examine VAERS reports involving PCV7 for signals indicating a possible association between PNC7 and seizures.

METHOD(S):
VAERS reports received from the time of PCV7 licensure through mid-April 2001 involving PCV7 and reported seizures were reviewed and categorized by age, onset interval, presence of fever, pre-existing conditions, and co-vaccination.

RESULT(S):
Twenty-two of the 100 reports involved PCV7 only; 78 reports included co-administration of other vaccines. About half of the vaccinees (51%) had intercurrent illness (otitis media, roseola, URI, etc) and 9% reported history of previous seizures. A majority of the reports involved vaccinees at least 7 months of age (69%), seizure onset within 3 days of vaccination (71%) and presence of fever (63%). 72% of the reports indicated the presence of fever and/or a previous history of seizures. Of the remaining cases, information on some reports indicated medical conditions which might explain the occurrence of seizures.

CONCLUSIONS(S):
Though subject to the limitations of VAERS, case series review of seizure reports involving PCV7 did not indicate any worrisome patterns indicating that PNC7 was associated with increased incidence of seizures compared with other vaccines. Most cases fit a profile consistent with fever associated seizures.

LEARNING OBJECTIVES:
To better understand VAERS reports involving PCV7 and seizures.