title: Surveillance of adverse effects following vaccination and safety of immunization programs.
abstract: The aim of the review was to analyze conceptual and operational aspects of systems for surveillance of adverse events following immunization. Articles available in electronic format were included, published between 1985 and 2009, selected from the PubMed/Medline databases using the key words "adverse events following vaccine surveillance", "post-marketing surveillance", "safety vaccine" and "Phase IV clinical trials". Articles focusing on specific adverse events were excluded. The major aspects underlying the Public Health importance of adverse events following vaccination, the instruments aimed at ensuring vaccine safety, and the purpose, attributes, types, data interpretation issues, limitations, and further challenges in adverse events following immunization were describe, as well as strategies to improve sensitivity. The review was concluded by discussing the challenges to be faced in coming years with respect to ensuring the safety and reliability of vaccination programs.
authors.affiliation: Departamento de Epidemiologia, Faculdade de Saúde Pública, Universidade de São Paulo, São Paulo, Brasil. eawaldma@usp.br
authors.forename: Eliseu Alves
authors.initials: EA
authors.lastname: Waldman
authors.forename: Karin Regina
authors.initials: KR
authors.lastname: Luhm
authors.forename: Sandra Aparecida Moreira Gomes
authors.initials: SA
authors.lastname: Monteiro
authors.forename: Fabiana Ramos Martin de
authors.initials: FR
authors.lastname: Freitas
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D006801:Humans; D017589:Immunization Programs / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards; D014611:Vaccination / Q000009:adverse effects*