COVID-19 Medicines and Vaccines
COVID-19 vaccines: Reporting a suspected side effect
To report a suspected adverse reaction (side effect) of a COVID-19 vaccine, please use the COVID-19 Vaccine Adverse Reaction Reporting Form.
Adverse reactions (side effects) can be reported to the HPRA by members of the public, carers or healthcare professionals. Reporting adverse reactions (side effects) to the HPRA supports continuous monitoring of safe and effective use of COVID-19 vaccines. When reporting, as much information as is known should be provided, and where possible, the vaccine batch number should be included.
The HPRA cannot provide clinical advice on individual cases. Members of the public should contact their health care professional (their doctor or pharmacist) with any medical concerns they may have.
For information on data protection at the HPRA, please see our Privacy Notice .
The HPRA will provide information and updates on this section of the website related to COVID-19 and the regulation of medicines and vaccines. Please visit the webpages listed below for more information.
The HPRA is publishing regular safety updates which provide an overview of the national reporting experience for COVID-19 vaccines. These updates include an overview of reports of suspected side effects notified to the HPRA safety monitoring system and are provided as an enhanced transparency measure for members of the public and healthcare professionals.
Access the product information for vaccines. The product information includes the package leaflet, which provides information for members of the public, and the Summary of Product Characteristics (SPC), which contains information for healthcare professionals. These documents are updated regularly with the latest information on use and safety of each of the COVID-19 vaccines, including details of possible side effects.
Find links to communications issued by the HPRA, including safety updates, media statements, Drug Safety Newsletters and Direct Healthcare Professional Communications.
This page outlines the approval process for COVID-19 vaccines and medicines, providing a list of vaccines and medicines that have received conditional marketing authorisation and those that are currently undergoing rolling review.
Information about monitoring the safety of COVID-19 vaccines, including details about how to report adverse reactions (side effects).
This page provides responses to frequently asked questions about COVID-19 vaccines.
Find a list of useful links to resources providing further information.