Adverse events following pandemic influenza vaccine Pandemrix® reported in the French military forces-2009-2010

Background: In the face of the A(H1N1) 2009 influenza pandemic, in October 2009 the French military health service (SSA) initiated a large vaccination campaign with Pandemrix (R) vaccine in the military forces. The aim of this study was to describe vaccine adverse events (VAE) reported during this campaign. Methods: VAE and the number of people vaccinated were surveyed by the SSA Epidemiological network across all military forces during the campaign, from October 2009 to April 2010. For each case, a notification form was completed, providing patient and clinical information. Three types of VAE were considered: non-serious, serious and unexpected. Results: There were 315.4 reported VAE per 100,000 vaccinations. Vaccination and VAE incidence rate peaks coincided with influenza epidemic peak in early December. The number of injected doses was 49,138, corresponding to a 14.5% vaccination coverage among military personnel, and 155 VAE were reported, including 5 serious VAE (1 Guillain-Barre syndrome, 2 malaises and 1 convulsive episode). Most VAE were non-serious (97.1%). Among these, 6 cases of local, rapidly regressive paresthesia were observed. Discussion: The military VAE surveillance system constitutes the only observatory on benign VAE in France. The reporting rate was much higher after the pandemic vaccine than after the seasonal vaccine, which may be a reflection of stimulated reporting. This report provides a useful description of VAE among military personnel during a mass emergency vaccination program, showing that the tolerance of the pandemic vaccine appeared acceptable. (C) 2011 Elsevier Ltd. All rights reserved.