New vaccine for influenza virus H1N1 : Pharmacosurveillance of adverse reactions in health staff at Hospital San Luis, Argentina

In March 2010, the Immunization Program of San Luis Province began a vaccination campaign against influenza A H1N1 with monovalent and trivalent vaccines. Being this the first year that this vaccine is used, and following the recommendations of WHO, we decided to develop pharmacovigilance actions in order to assess its safety. Our objective was to identify, describe and analyze adverse reactions associated with the vaccine against pandemic influenza occurring in health personnel of the Hospital San Luis, through active monitoring of vaccinated employees. An epidemiological descriptive and transversal study was carried out from March to June 2010. We found that 67 % (n = 809) reported adverse reactions associated with the vaccine. Main adverse reactions reported included: pain at injection site (54 %), fatigue, swelling and redness, malaise, headache and fever. The most frequent adverse reactions that have been reported were non-serious and within expectations. Colegio de Farmacéuticos de la Provincia de Buenos Aires