COVID-19 vaccines – suspected side effects reported in Ireland and the EU/EEA
The HPRA continues to provide regular safety updates on the national reporting experience with COVID-19 vaccines. We are currently providing summary data directly on this webpage. This page is updated regularly.
On 17 February 2023, in addition to updating the webpage, we also published our safety update (#19), providing a more detailed overview of reports received to 31 January 2023.
Links to the 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: 06 March 2023
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.
Up to 28 February 2023, the HPRA has received a total of 20,917 reports describing suspected side effects in association with COVID-19 vaccines, of which 2,852 were received in 2022 and 158 were received in 2023. 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 publicly available through the European database of suspected adverse drug reaction reports. Please note that the number of reports available in the European database for Ireland can be less than the number of reports cited above. The number of HPRA reports includes some which do not meet the criteria for reporting to the European database, for example reports where the vaccine brand is unknown, or reports which describe a medication error with no side effect. At any given time, there are also a number of reports which remain under processing by the HPRA, following which they are submitted to the European database in accordance with regulatory reporting timelines.
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. From January 2021 to December 2022, the EMA published safety updates for COVID-19 vaccines, outlining the outcomes from assessments by the PRAC of emerging worldwide safety data.
From December 2022, the EMA is no longer publishing monthly updates. However, the EMA will continue publishing high-level information on reports of suspected side effects. You can view the most up to date information and safety updates previously published on the EMA’s COVID-19 vaccines safety webpage.
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.