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Reporting adverse effects of vaccines


Vaccines are administered to healthy persons to prevent diseases. This therefore requires an extra critical attitude regarding possible adverse effects. The scale and duration of pre-authorisation studies for vaccines are inevitably rather limited, which means that rare and late adverse effects are sometimes missed. In an attempt to identify adverse effects as soon as possible after authorisation, much effort and attention is spent on passive reporting systems and large databases of medical data that enable pharmaco-epidemiological research to be conducted. Generally speaking, the adverse effects of vaccines authorised in the past appear to be limited and mild.

  • The relatively limited scale of pre-authorisation studies means that rare adverse effects of vaccines may be missed.
  • Much attention is given to systems intended to identify adverse effects after authorisation, such as passive reporting systems and large databases of medical data for pharmaco-epidemiological research.
  • Adverse effects of vaccines authorised in the past generally appear to be limited and mild.

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Authors

  • Leo M.L. Stolk, dr