COVID-19

Safety of COVID-19 vaccines

Safety information
How EMA monitors vaccine safety
Suspected side effects

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.

Safety information

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.

More information:

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.

Before their authorisation, the vaccines were tested in tens of thousands of clinical trial participants to confirm they met EMA’s scientific standards for safety, efficacy and quality.

As always, the benefits of these vaccines were weighed against the risks of side effects.

More information:

COVID-19 vaccines: development, evaluation, approval and monitoring

How EMA monitors vaccine safety

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:

Authorised COVID-19 vaccines

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:

Monitoring of COVID-19 medicines

List item

Report on pharmacovigilance tasks from EU Member States and the European Medicines Agency (EMA) 2019-2022 (PDF/1.68 MB)

First published: 22/06/2023
EMA/142695/2023

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

Suspected side effects

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:

Headache
Fever
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.

More information:

Authorised COVID-19 vaccines

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:

: Anaphylaxis is a sudden, severe allergic reaction.
Events of hypersensitivity and anaphylaxis have been reported following COVID-19 vaccination.
Appropriate medical treatment and supervision should always be readily available at a vaccination facility in case of an anaphylactic reaction to the vaccine.
Close observation for at least 15 minutes is recommended following vaccination.
No further dose of the same vaccine should be given to those who have experienced anaphylaxis after a prior dose.

: The Guillain-Barré syndrome (GBS) is a rare immune system disorder which can lead to pain, numbness, paralysis of the chest muscles, respiratory failure and death.
GBS has been reported as very rare side effect – less than 1 case in 10,000 people vaccinated – with the COVID-19 vaccines Jcovden (previously COVID-19 Vaccine Janssen) and Vaxzevria (previously COVID-19 Vaccine AstraZeneca).

Myocarditis and pericarditis are conditions that cause the inflammation of the heart muscle or outer lining of the heart.

Both have been observed in very rare cases – less than 1 in 10,000 people vaccinated – with Comirnaty and Spikevax (previously COVID-19 Vaccine Moderna). This happens more often after the second vaccination and in younger males.

Myocarditis and pericarditis usually occur within 14 days of vaccination.

They have also been reported as side effects of Jcovden (previously COVID-19 Vaccine Janssen) and Nuvaxovid, with unknown frequency.

The infection with SARS-CoV-2, the virus that causes COVID-19, is a risk factor for myocarditis and pericarditis, and some studies suggest that it comes with a substantially increased risk of hospitalisation or death.

For more information, read the scientific article below:

Nature: Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection

EMA continuously reviews data and studies likley to provide new relevant information.

The Agency also works with researchers from around the world to help shape the research agenda on numerous safety topics.

In January 2023, EMA hosted a workshop to review the understanding of the epidemiology, clinical manifestation and pathophysiology of myocarditis. For more information, see:

EMA virtual workshop on myocarditis post COVID-19 vaccination (16/01/2023)

Thrombosis with thrombocytopenia (TTS) is a rare syndrome, characterised by the formation of clots in the blood (thrombosis) combined with low blood platelets (thrombocytopenia) that can be fatal.

Blood clots can appear in different and unusual parts of the body, such as the brain or the abdomen.

Very rare events of TTS may occur after vaccination with COVID-19 vaccines Vaxzevria (previously COVID-19 Vaccine AstraZeneca) and Jcovden (previously COVID-19 Vaccine Janssen).

Up to May 2023, around 900 cases of TTS had been reported following vaccination with Vaxzevria and Jcovden, about 200 of which were associated with a fatal outcome.

Although the outcome is not necessarily linked to the vaccine’s side effect, it cannot be excluded that TTS caused death in some of these cases.

In June 2022, EMA hosted a workshop with regulators, medical experts and researchers to review the understanding of the TTS and to discuss the related research agenda.

EMA is following up with manufacturers and academic groups to ensure further research to investigate the pathophysiological mechanisms that cause these adverse reactions.

For more information on the workshop, see:

Safety of COVID-19 vaccines

Table of contents

Safety information

Largest vaccination programme in history

How EMA monitors vaccine safety

Report on pharmacovigilance tasks from EU Member States and the European Medicines Agency (EMA) 2019-2022 (PDF/1.68 MB)

Suspected side effects

Reports of suspected side effects

Common side effects

Particular side effects

Related content

External links

Topics

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