Journal Article

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

Burwen, Dale R., Ball, Robert, Vellozzi, Claudia, Walton, Kimp, Haber, Penina, Dobardzic, Azra

2009

Overview

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.

• Publisher: Elsevier Ltd,Elsevier,Elsevier Limited
• Subject: Adult / Adverse Drug Reaction Reporting Systems / Age / Allergy and Immunology / Applied microbiology / Ataxia / Biological and medical sciences / Codes / Female / Fever / Fundamental and applied biological sciences. Psychology / Guillain-Barre Syndrome - chemically induced / Guillain-Barre Syndrome - epidemiology / Headaches / Humans / Immunization / Influenza / Influenza vaccines / Influenza Vaccines - adverse effects / Influenza, Human - prevention & control / Male / Microbiology / Middle Aged / Pain / Pandemics / Post-marketing surveillance / Safety / Seasons / United States - epidemiology / Vaccine safety / Vaccines / Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)