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

Reports of suspected side effects notified to the HPRA

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.

mRNA vaccines (Comirnaty® and Spikevax®)

13,641

Adenoviral vector vaccines (Vaxzevria® and Jcovden® [previously Janssen])

6,696

Recombinant adjuvanted spike protein vaccine (Nuvaxovid®)

6

Brand unknown/not specified

338


Note on table above:

  1. The number of reports received for different COVID-19 vaccines are not directly comparable, given differences in how vaccines have been used.

  2. Some reports involved vaccination with more than one brand of vaccine, therefore the sum of the number of reports per vaccine type is greater than the total number of reports received.

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.

Safety updates previously published by the HPRA

19 May 2022  Safety Update (#18): COVID-19 Vaccines

24 March 2022 Safety Update (#17): COVID-19 Vaccines

17 February 2022 Safety Update (#16): COVID-19 Vaccines
 
20 January 2022  Safety Update (#15): COVID-19 Vaccines

9 December 2021 Safety Update (#14): COVID-19 Vaccines
 
4 November 2021  Safety Update (#13): COVID-19 Vaccines
 
7 October 2021  Safety Update (#12): COVID-19 Vaccines
 
9 September 2021 Safety Update (#11): COVID-19 Vaccines
 
12 August 2021 Safety Update (#10): COVID-19 Vaccines
 
15 July 2021  Safety Update (#9): COVID-19 Vaccines
  
17 June 2021  Safety Update (#8): COVID-19 Vaccines

20 May 2021 Safety Update (#7): COVID-19 Vaccines 

22 April 2021

Safety Update (#6): COVID-19 Vaccines 

25 March 2021

Safety Update (#5): COVID-19 Vaccines

04 March 2021

Safety Update (#4): COVID-19 Vaccines

18 February 2021

Safety Update (#3): COVID-19 Vaccines 

04 February 2021

Safety Update (#2): COVID-19 Vaccines 

21 January 2021  Safety Update (#1): COVID-19 Vaccines