KEYWORDS:
vaccine safety, influenza, pneumococcal, postmarketing surveillance

BACKGROUND:
Influenza (TIV) and pneumococcal (PPV) vaccination levels in adults have lagged behind childhood vaccine coverage; concern about potential adverse events may be one contributing factor. VAERS is the national spontaneous reporting system for adverse events occurring after vaccination. Reports concerning TIV and/or PPV are received on a voluntary basis.

OBJECTIVE(S):
To describe the safety profile of TIV and PPV based on reports to the Vaccine Adverse Event Reporting System (VAERS)

METHOD(S):
Reports received from 1991 through mid-July 2001for persons 18 and older involving TIV or PPV vaccines (both alone and in combination with others) were reviewed. Reports involving coadministration of TIV and PPV were analyzed as a separate subset. Reports were considered serious if they involved either hospitalization, death, life threatening illness, or permanent disability. An overall safety profile and most frequently reported outcomes were summarized for each group.

RESULT(S):
Among 9420 TIV, 2171 PPV and 1516 TIV + PPV reports, 16, 11 and 9% of reports respectively were serious. Injection site reactions were more commonly reported with PPV alone than with TIV alone (43 vs 16%) as was fever (20 vs 15.5%). Guillan Barre syndrome was a reported outcome in less than 5% of TIV only reports, with the diagnosis often unconfirmed.

CONCLUSIONS(S):
Though causality should not be inferred from case reports, minor and expected adverse events were most common for both TIV and PPV. The data is consistent with PPV’s known greater reactogenicity when compared with TIV. Serious neurologic events are reported rarely after influenza vaccine. VAERS is subject to temporal and other reporting biases. Indications for TIV and PPV are also confounding risk factors for numerous adverse health outcomes.

LEARNING OBJECTIVES:
Appreciate the postmarketing safety profile of influenza and pneumococcal vaccines in adults