Dáil Éireann Debate, Tuesday - 27 July 2021
3180. Deputy Mattie McGrath asked the Minister for Health the number of patients that have been hospitalised or who have had a suspected adverse reaction following vaccination; if hospitals and general practitioners are legally obliged to report all suspected adverse reactions to the HPRA; and if he will make a statement on the matter. [40584/21]
View answerThe Health Products Regulatory Authority (HPRA) operates the national adverse reaction reporting system, through which healthcare professionals and members of the public can notify a report of a suspected adverse reaction (ADR) on a voluntary basis. Up to 7 July, the HPRA had received 11,445 reports describing suspected adverse reactions in association with COVID-19 vaccines, of which less than 1% described a hospital attendance.
It is important to note that the HPRA receives reports based on suspicion that an adverse experience may be associated with vaccination. This does not mean the vaccine caused the adverse experience. The information received by the HPRA may also be limited at the time of initial reporting (for example the report may or may not specify whether the patient has been hospitalised), and more information about individual reports may become available through follow-up.
The HPRA has and continues to engage with healthcare professionals, for example, via the HPRA Drug Safety Newsletter, to emphasise the importance of and to encourage reporting. A safety update is published monthly, which sets out an overview of the national reporting experience associated with COVID-19 vaccines.
The HSE may also have further information with respect to hospitalisations that may have occurred following vaccination but where no ADR report was sent to the HPRA. 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 on-going, 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.
