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Purpose  The use of the 2009 H1N1 vaccine has generated much debate concerning safety issues among the general population and physicians. It was questioned if this is a safe vaccine. Therefore, we investigated the safety of an inactivated monovalent H1N1 pandemic influenza vaccine    Methods  We focused on the H1N1 pandemic influenza vaccine Pandemrix ®  and applied a self reporting questionnaire in a population of healthcare workers (HCWs) and medical students at a major university hospital.    Results  In total, 4337 individuals were vaccinated, consisting of 3808 HCWs and 529 medical students. The vaccination rate of the employees was higher than 40%. The majority of individuals were vaccinated in November 2009. In total, 291 of the 4337 vaccinations were reported to lead to one or more adverse reactions (6.7%). Local reactions were reported in 3.8%, myalgia and arthralgia in 3.7%, fatigue in 3.7%, headache in 3.1%.    Conclusions  Our data together with available data from several national and international institutions points to a safe pandemic influenza vaccine.

Self-reported adverse reactions in 4337 healthcare workers immunizations against novel H1N1 influenza