Increase in reported adverse events following seasonal influenza vaccination among the French armed forces, 2008-2009: possible role of stimulated reporting and background cases of influenza-like infection.

Summary Objectives In September 2009, an increase in seasonal influenza vaccine adverse events (VAE), compared with reports for previous years, was detected among the French armed forces in the setting of an extended immunization campaign. This work presents the results of this investigation. Study design VAE were surveyed among all French military personnel from 2008 to 2009 by Epidemiological Departments of the French Military Health Service. For each case, a notification form was completed, providing patient and clinical information. Methods Case definitions were derived from the French drug vigilance guidelines. Three types of VAE were considered: non-serious, serious and unexpected. Incidence rates were calculated by relating VAE to the number of vaccine doses injected. Results Forty-seven seasonal influenza VAE were reported in continental France: 18 in 2008 and 29 in 2009. The annual reporting rate was higher in 2009 (31.6 vs 16.6 VAE per 100,000 injections, respectively). The highest monthly incidence was observed in September 2009 (60.8 events per 100,000 injections). Two other peaks were observed in February 2008 and March 2009. The incidence in September 2009 was not significantly different from the incidences in February 2008 and March 2009. It was observed that incidence peaks occurred during influenza epidemic periods. One serious neurological VAE was observed. Conclusions The increase in seasonal influenza VAE in late 2009 mainly involved non-serious events, and could reflect stimulated reporting in the context of the A(H1N1)pdm09 pandemic. VAE reporting rates were highest during influenza epidemic periods, which could be explained by VAE being wrongly attributed to the vaccine when symptoms could reflect coincident background cases of viral infection.