RESUMO
Since Jenner and Pasteur, various vaccines have been developed and administered in immunization program conducted by WHO in order to diminish the circulation of pathogenic agents and eradicate some diseases. Risks associated with immunization are revealed by the collection and assessment of adverse events reported after the use of these drugs. They vary according to the type of vaccines. With high rates of immunization and a low incidence of infectious diseases, adverse events receive increasing attention. Frequent and mostly expected adverse events are reported in clinical trials. Unexpected rare adverse events are reported after marketing authorization by spontaneous reporting and post marketing surveillance studies. Post marketing surveillance should be adapted to vaccines (vaccino-vigilance) and should take into account the risk linked to the disease they may protect against. Adverse events are often temporally associated with vaccines, that does not mean they are causally related. Specific studies should be conducted to assess the causal relationship between vaccines and post immunization adverse events. In order to reduce the risk associated with immunization, a strict follow-up of recommendations, warnings and contraindications in addition to appropriate information being delivered to both vaccinees and physicians are required.