Monitoring vaccine safety and reporting side effects

Once a vaccine is approved for use, EU/EEA national authorities and the European Medicines Agency (EMA), continually monitor side effects in people who have received the vaccine.

This ensures that any possible risks are detected and managed as soon as possible.

EMA checks new information on the safety of all vaccines available in Europe. It analyses many sources of data, including:

  • reports from patients, parents and healthcare professionals;
  • clinical studies;
  • the medical literature;
  • information shared by other regulators.

EMA carefully assesses suspected side effects to determine if there is a causal link with the vaccine or not. This helps to rule out the possibility that it was a coincidence or that it was caused by factors unrelated to the vaccine itself. These could be due to an illness or anxiety over being given the vaccine.

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When needed, EMA and the other European regulators take action. For example, they can provide updated guidance to healthcare workers, or even restrict the use of a vaccine in certain groups.

Patients, healthcare professionals and pharmaceutical companies should report all suspected side effects to their national medicines regulatory authority. More information on how to report suspected side effects can be found in the prescribing information or package leaflet or the European database of suspected adverse drug reaction reports.

Information on these reported suspected side effects is publicly available on the European database of suspected adverse drug reaction reports

The process of monitoring the safety and managing the risks of medicines is called ‘pharmacovigilance’. For more information, see:

 

Benefits of vaccinating

Vaccines prevent diseases that could cause health problems, disabilities, or death. Many diseases are now rare due to vaccination.

Vaccine effectiveness

Approved vaccines are effective at preventing disease, serious symptoms, and decreasing transmission.

Page last updated 13 Mar 2020