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.
scientist is working in a laboratory
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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.

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 otherwise cause serious health problems, permanent disability or even death.

Approval of vaccines in the European Union

Before a vaccine can be approved in the EU, it has to undergo rigorous testing by its developer...

Vaccine effectiveness

A vaccine's ability to prevent a specific disease determines its effectiveness.

How vaccines work

Each virus and bacterium triggers a unique response in the immune system involving a specific set of cells in the blood...

Decisions on vaccines in use in different European countries

Individual European countries decide which vaccines should be part of their national vaccination programmes and funded by their national health systems.

Page last updated 13 Mar 2020