The Health Products Regulatory Authority (HPRA), as the regulatory authority in Ireland for medicines, medical devices and other healthcare products is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland.
As part of its remit, the HPRA operates the national adverse reaction database, to which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions to. All suspected adverse reaction reports received by the HPRA are entered into the national database for national monitoring and subsequently submitted to the European Medicines Agency’s (EMA's) adverse reaction database for inclusion in global signal detection and monitoring activities.
All reports of a suspected adverse reaction (side effect) to a COVID-19 vaccine should be referred to the HPRA. This can be done using the COVID-19 Vaccine adverse reaction reporting form at: www.hpra.ie/homepage/about-us/report-an-issue/covid-19-vaccine-adverse-reaction.
Adverse reactions can be reported to the HPRA by members of the public, carers or healthcare professionals. Reporting adverse reactions to the HPRA supports continuous monitoring of the 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.
The HPRA publishes 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.
The most recent vaccine safety updates & communication (update 15) from the HPRA can be found at the following link, along with previous safety updates: safety-update-covid-19-vaccines-overview-of-national-reporting-experience-(20012022).pdf (hpra.ie).
As the administration of Covid 19 Vaccines is a service matter, I have asked the Health Service Executive to respond on this element to the deputy directly, as soon as possible.
