Surveillance of adverse effects following vaccination and safety of immunization programs

Authors

  • Eliseu Alves Waldman Universidade de São Paulo; Faculdade de Saúde Pública; Departamento de Epidemiologia
  • Karin Regina Luhm Universidade Federal do Paraná; Setor de Ciências da Saúde; Departamento de Saúde Comunitária
  • Sandra Aparecida Moreira Gomes Monteiro Universidade Federal de Mato Grosso; Instituto de Saúde Coletiva
  • Fabiana Ramos Martin de Freitas USP; FSP; Programa de Pós-Graduação em Saúde Pública

DOI:

https://doi.org/10.1590/S0034-89102011000100020

Keywords:

Vaccines^i2^sadverse effe, Immunization Programs, Clinical Trials^i2^sPhase IV as To, Product Surveillance, Postmarketing, Review

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.

Published

2011-02-01

Issue

Section

Reviews

How to Cite

Surveillance of adverse effects following vaccination and safety of immunization programs . (2011). Revista De Saúde Pública, 45(1), 173-184. https://doi.org/10.1590/S0034-89102011000100020