The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland. The HPRA and the European Medicines Agency (EMA) continually monitor adverse events to vaccination.
The HPRA operates a national adverse reaction reporting system in which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions to vaccination. All reports received by the HPRA are routinely transmitted to the EMA's adverse reaction database for inclusion in global signal detection and monitoring activities.
The HPRA follows up on reports of suspected adverse reactions received from healthcare professionals and members of the public through the voluntary reporting system, including any deaths notified following vaccination.
The latest safety update from the HPRA regarding COVID-19 vaccinations is available here:
As of 9 June, 9,470 reports of suspected side effects were notified to the HPRA, in the context of 3.1 million doses of Covid-19 vaccine having been administered as of that date. It must be stressed that all vaccines have some side effects, the vast majority of which are mild to moderate in nature.
These side effects need to be balanced against the significant benefits of vaccination in preventing Covid-19 illness. The ongoing reporting conducted by the HPRA continues to provide a favourable assessment of the vaccines and that the benefits outweigh any associated risks.
As this Parliamentary Question relates to an operational issue, it is a matter for the HSE. However, members of the Oireachtas are advised that the HSE is currently unable to access the information to answer Parliamentary Questions due to the recent cyber-attack, which has required a temporary shut-down of HSE IT systems. The disruption to service is ongoing, and the HSE is working hard to restore its IT capacity and resume normal services. Members of the Oireachtas will be advised as soon as the HSE is again in a position to provide responses to PQs and are encouraged to resubmit their Parliamentary Questions at that point.