Mattie McGrath (Tipperary, Independent)
Link to this: Individually | In context | Oireachtas source

3179. To ask the Minister for Health the number of adverse reactions reported in Ireland following the roll-out of the Covid-19 vaccination programme; and if he will make a statement on the matter. [40583/21]

Catherine Connolly (Galway West, Independent)
Link to this: Individually | In context | Oireachtas source

3326. To ask the Minister for Health the number of persons who have reported serious cardiac related side effects via the HPRA Covid-19 Vaccine Adverse Reaction Reporting Form, after vaccination with the MRNA vaccines manufactured by companies (details supplied); the analysis that his Department has carried out into this matter; and if he will make a statement on the matter. [41349/21]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 3179 and 3326 together.

Up to 7 July, the Health Products Regulatory Authority (HPRA) received 11,445 reports describing suspected side effects in association with COVID-19 vaccines, of which 6,011 were in association with mRNA vaccines (Comirnaty and Spikevax (previously COVID-19 Vaccine Moderna)), 5,361 in association with Adenoviral vector vaccines (Vaxzevria and Covid-19 Vaccine Janssen) and 73 reports were in association with vaccines where the brand was not known or provided at the time of reporting.

The majority of regularly reported suspected side effects are consistent with the types of events typically observed following vaccination, including those described in the product information for the individual vaccines. Whilst not experienced by everyone, all vaccines have some side effects, the vast majority of which are mild to moderate in nature. These side effects need to be continuously balanced against the benefits in preventing COVID-19 illness. Overall, the national reporting experience continues to support the favourable assessment that the benefits of COVID-19 vaccines outweigh the risks.

The HPRA has been publishing regular public safety updates on reporting experience with the COVID-19 vaccines, including information on the numbers and nature of these reports. To date, nine such updates have been published and are accessible from the HPRA website (www.hpra.ie/homepage/medicines/covid-19-updates/covid-19-vaccine-communications) with the most recent publication issued on 15^thJuly.

Mattie McGrath (Tipperary, Independent)
Link to this: Individually | In context | Oireachtas source

3180. To ask 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]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

The 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.

Pa Daly (Kerry, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

3181. To ask the Minister for Health the estimated number of over 60s who have registered for but have yet to receive a second Covid-19 vaccine appointment. [40593/21]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

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 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.