Medicines and Vaccines: COVID-19 Updates
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.
Approval of COVID-19 vaccines
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.
Product information for COVID-19 vaccines
This page contains links to product information for authorised vaccines, including the Summary of Product Characteristics and the Package Leaflet.
Reporting side effects of COVID-19 vaccines
The information on this page provides information about monitoring the safety of COVID-19 vaccines, including information about reporting adverse reactions (side effects).
COVID-19 vaccines: FAQs
The information on this page provides responses to frequently asked questions about COVID-19 vaccines.
Maintaining medicines on the EU market during COVID-19
See details in relation to the regulatory expectations and flexibilities available to MAHs to maintain medicines on the EU market during the COVID-19 pandemic.