EMA and EU Member States continuously monitor the safety of COVID-19 vaccines to ensure any possible risks are detected and managed as early as possible. 

EMA continuously checks new information on the safety of all vaccines available in Europe from many data sources. These include: 

• Reports of suspected side effects 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 they were caused by a vaccine or by something else, such as an illness.  

If there is at least a reasonable possibility that a vaccine could have caused a suspected side effect, it is included in the vaccine’s product information. This ensures that healthcare professionals and patients have up-to-date information to hand.

The safety profiles of the COVID-19 vaccines authorised in the EU are very reassuring.

The vast majority of known side effects are mild and short-lived. Serious side effects may occur, but they are very rare. Fatal outcomes have been reported in very few of these rare cases. 

For more information, see: 

For a visual summary of how EMA monitors vaccine safety, watch the video below: