Safety of COVID-19 vaccines
The European Medicines Agency (EMA) monitors the safety of COVID-19 vaccines authorised in the European Union (EU) extremely carefully. With hundreds of millions of people already vaccinated in the EU, this enables the continued detection of any rare side effects.
- COVID-19 vaccines authorised for use in the EU and European Economic Area (EEA) are safe and effective.
- Close to 1 billion vaccine doses have been administered in the EU and EEA.
- EMA and the EU Member States continue to closely monitor the safety of COVID-19 vaccines.
COVID-19 vaccines continue to protect people from severe disease and death caused by infection with SARS-CoV-2, the virus that causes COVID-19.
Vaccination is the best tool to prevent the consequences of infection.
Infection can cause severe disease and long-term damage, including in healthy adults and children.
It remains particularly dangerous for older or sick people with low immunity and those with faulty immune systems.
Estimates indicate that millions of lives have been saved by COVID-19 vaccination.
- COVID-19 vaccines: key facts
- Global impact of the first year of COVID-19 vaccination: a mathematical modelling study
Largest vaccination programme in history
Since December 2020, people in the EU and EEA received almost 1 billion doses of COVID-19 vaccines, making it the largest vaccination programme in history.
Regulators have an unprecedented amount of data to confirm the safety and efficacy of COVID-19 vaccines.
As always, the benefits of these vaccines were weighed against the risks of side effects.
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.
Did you know..?
The full list of known side effects can be found in the product information for each COVID-19 vaccine, available in all languages:
At the peak of the pandemic, EMA also published monthly safety updates for all authorised COVID-19 vaccines, based on safety reporting by the marketing authorisation holders. Since August 2023, periodic safety update reports (PSURs) and their EMA assessments are made available for each vaccine.
For more information, see:
For a visual summary of how EMA monitors vaccine safety, watch the video below:
Reports of suspected side effects
Information on reports of suspected side effects and how to interpret them is available in the European suspected adverse drug reactions database.
By May 2023 there were:
- Almost 768 million vaccine doses administered in EU and EEA countries.
- Almost 1.7 million spontaneous reports of suspected side effects, which translates into about 0.2 spontaneous reports for every 100 administered vaccine doses.
- Almost 12,000 spontaneous reports of fatal outcomes in the EU and EEA, which translates into about 0.001 reported fatal outcomes for every 100 administered vaccine doses.
These reported side effects refer both to vaccines against the original SARS-CoV-2 strains and those adapted to target the Omicron virus variant.
Common side effects
As with all medicines, COVID-19 vaccines have side effects, but these are far outweighed by the benefits in terms of protection against severe disease and death.
The most common suspected side effects reported for these vaccines are:
- Fatigue (tiredness)
- Muscle pain
They are mostly mild and moderate and improve within a few days after vaccination.
Common side effects for COVID-19 vaccines are listed in each vaccine's product information.
Particular side effects
A number of side effects reported with COVID-19 vaccination have drawn public attention.
Some of these - such as anaphylaxis, Guillain-Barré syndrome and myocarditis and pericarditis - are adverse events of special interest.
These medical events or conditions have been identified as possible concerns based on previous experience with other vaccines, and are therefore closely monitored.
For more information, see the expandable menus below: