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Publication . Article . 2009

Safety of trivalent inactivated influenza vaccines in adults: Background for pandemic influenza vaccine safety monitoring

Claudia Vellozzi; Dale R. Burwen; Azra Dobardzic; Robert Ball; Kimp Walton; Penina Haber;
Open Access
Published: 01 Apr 2009 Journal: Vaccine, volume 27, pages 2,114-2,120 (issn: 0264-410X, Copyright policy )
Publisher: Elsevier BV

In preparation for pandemic vaccine safety monitoring, we assessed adverse events reported to the Vaccine Adverse Event Reporting System following receipt of trivalent inactivated influenza vaccines among adults from 1990 through 2005. We calculated reporting rates for nonserious, serious, and neurological adverse events. We reviewed reports of recurrent events and deaths, as well as reports identified through advanced signal detection. The most frequently reported events were local reactions and systemic symptoms. Guillain-Barré syndrome was the most frequently reported serious event (0.70 reports per million vaccinations). Adverse event reporting rates have been reasonably constant over time. No new safety concerns emerged after our review of 15 years of post-licensure surveillance data. These findings provide useful information if pandemic vaccine is rapidly distributed and pre-licensure data are limited.

Subjects by Vocabulary

Microsoft Academic Graph classification: Postmarketing surveillance Adverse effect Pharmacovigilance Pandemic Guillain-Barre syndrome medicine.disease medicine business.industry business Vaccination Emergency medicine medicine.medical_specialty Immunology Viral disease Adverse Event Reporting System


Infectious Diseases, Public Health, Environmental and Occupational Health, General Veterinary, General Immunology and Microbiology, Molecular Medicine