COVID-19 vaccines – suspected side effects reported in Ireland and the EU/EEA
The HPRA has provided regular safety updates on COVID-19 vaccines since January 2021. In July 2022, we changed the format of the updates and the information is now provided directly on this webpage. Links to the latest EMA COVID-19 vaccine safety updates are also provided below. Healthcare professionals and members of the public are reminded to refer to the product information for COVID-19 vaccines for full details on the side effects.
The HPRA continues to monitor all reports received in relation to COVID-19 vaccines and will highlight any safety issues as necessary.
To report a suspected side effect to a COVID-19 vaccine, use our online reporting form.
Last update to HPRA data: 28 November 2022
Reports of suspected side effects are notified to the HPRA on a voluntary basis by healthcare professionals and members of the public. All COVID-19 vaccines have some side effects, the vast majority of which are mild to moderate in nature. These side effects need to be continuously balanced against the risk of COVID-19 illness and related complications, including hospitalisation and death.
As of 22 November 2022, the HPRA has received a total of 20,669 reports describing suspected side effects in association with COVID-19 vaccines, of which 2,750 were received in 2022. A breakdown of reports received by vaccine is provided in the table below.
Reports of suspected side effects notified in the EU/EEA
Anonymised data on reports of suspected side effects notified to the HPRA, as well as throughout the EU/EEA to other regulatory authorities, are publically available through the European database of suspected adverse drug reaction reports.
The safety of COVID-19 vaccines is continuously monitored by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), in which the HPRA participates. EMA safety updates for COVID-19 vaccines are published outlining the outcomes from assessments by the PRAC of emerging worldwide safety data. Please see links below to the latest publications:
EMA COVID-19 vaccine safety update: 10 November 2022
You can also view the COVID-19 vaccine safety updates previously published by the EMA.
Understanding the data
Conclusions on the safety of a vaccine cannot be drawn based on information from suspected side effect reports alone. The HPRA receives reports based on a suspicion that a side effect may be associated with vaccination. This does not mean that the vaccine caused the side effect. Reports may describe coincidental events, which have occurred post-vaccination, but would have occurred even if vaccination had not taken place (e.g. they may be due to an underlying medical condition, or be signs and symptoms of another illness). Only a detailed evaluation and scientific assessment of all available data allows for robust conclusions to be drawn on the benefits and risks of a vaccine. For more information, please see our information about understanding the data and background information on the evaluation of suspected side effect reports.