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.
Safety updates providing an overview of the national reporting experience of COVID-19 vaccines are available on our Safety Notices page.
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.
On 7 April 2021, the European Medicines Agency concluded a review of cases of unusual blood clots, combined with low blood platelets, which have occurred in people vaccinated with Vaxzevria (formerly known as COVID-19 AstraZeneca). The information on this page contains a statement from the HPRA, highlighting key aspects of the EMA conclusion.
The information on this page outlines the approval (authorisation) process for COVID-19 vaccines and provides updates on the progress of specific vaccines through the various stages of the approval process.
Find links to product information for authorised vaccines, including the Summary of Product Characteristics and the Package Leaflet.
Information about monitoring the safety of COVID-19 vaccines, including details about how to report adverse reactions (side effects).
Our Safety Notices page contains safety updates providing an overview of the national reporting experience of COVID-19 vaccines.
This page provides responses to frequently asked questions about COVID-19 vaccines.
Find a list of useful links to resources providing further information.