Human vaccines
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Systemic safety surveillance is an essential component of vaccination programmes to elucidate the full safety profile of a vaccine and to detect previously unrecognized adverse reactions that might be related to new vaccines. This article summarizes the spontaneous adverse drug reactions (ADR) from approximately 12 million administered doses of the pandemic MF59-adjuvanted H1N1v vaccine (Focetria®, Novartis Vaccines and Diagnostics) from the mass vaccination programmes in Europe. ⋯ The analyses of the spontaneously reported adverse events support the good safety profile of the MF59-adjuvanted H1N1v pandemic influenza vaccine.