Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2352. To ask the Minister for Health to set out the current pathway by which a person in Ireland who suffers a serious adverse reaction following vaccination may obtain compensation, including whether any ex-gratia or statutory routes exists; the number of cases compensated by the State since 2000; the total amounts paid, itemised by year and vaccine, if available; and if she will make a statement on the matter. [45666/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Where an individual alleges that they have suffered a personal injury related to a vaccine, they may pursue a claim through the courts.

The State Claims Agency (SCA) has a statutory remit to manage personal injury claims on behalf of State authorities, as delegated by Government.

The SCA has provided me with the following information.

The vaccine types categorised on NIMS are Pandemrix (H1N1), Gardasil (HPV), and COVID-19.

The following table contains the transactional amounts paid in damages (including VAT where applicable) by the SCA on behalf of State authorities where they occurred in the period, and the unique number of healthcare claims that these payments relate to, where the vaccine type is categorised on NIMS.

There were no transactional amounts paid in damages by the SCA in the period relating to Gardasil (HPV).

Due to the low number of claims across a number of years, the information has not been broken down by year and the vaccine types have been merged.

As the Deputy may be aware significant work has been completed by my Department to develop a model for a vaccine damage scheme. It is my intention to bring the model to Cabinet for discussion and consideration in due course. Until the model has been considered and approved by Government, it is not possible to provide any further information in relation to the scheme's implementation.

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2353. To ask the Minister for Health the timeline for the establishment of a State vaccine injury compensation scheme; the target go-live date; the proposed administrator; whether the scheme will be statutory or administrative; whether it will be retrospective to vaccinations administered since 2020; and if she will make a statement on the matter. [45667/25]

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2354. To ask the Minister for Health the proposed standard of proof for eligibility under any State vaccine injury compensation scheme; whether determinations will operate on the balance of probabilities; whether presumptive conditions will be listed on a “vaccine injury table” with defined time-to-onset criteria, as used in comparable international schemes; and if she will make a statement on the matter. [45668/25]

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2355. To ask the Minister for Health if she will publish draft heads of bill or scheme rules for public consultation before commencement of a State vaccine injury compensation scheme; the planned appeals mechanism; whether appeals will lie to an independent tribunal; the expected average decision time; and if she will make a statement on the matter. [45669/25]

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2356. To ask the Minister for Health whether legal costs in any State vaccine injury compensation scheme will be borne by the scheme for unsuccessful as well as successful applicants subject to basic merit thresholds, in line with international comparators; the projected annual budget impact and contingency provision for the first five years; and if she will make a statement on the matter. [45670/25]

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2358. To ask the Minister for Health whether any planned State vaccine injury compensation scheme will cover non-COVID vaccines in the National Immunisation Programme; how childhood, HPV, influenza, and adult booster vaccines will be treated; whether coverage will extend to off-schedule but HSE-administered vaccines; and if she will make a statement on the matter. [45672/25]

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2359. To ask the Minister for Health whether a State vaccine injury compensation scheme will include a tax-free lump-sum model, periodic payments, or both; the proposed award calibration for death, severe disability, loss of earnings, care, medical costs, and rehabilitation; whether indexation will apply; and if she will make a statement on the matter. [45673/25]

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2458. To ask the Minister for Health if the scheme will recognise injuries following mixed-brand or heterologous schedules where causation apportionment is complex; the approach to multi-dose temporal associations; if a proportional liability model will apply; and if she will make a statement on the matter. [46190/25]

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2462. To ask the Minister for Health if adverse events following vaccination administered outside HSE settings but within the State, or administered abroad to Irish residents, will be eligible; the way in which domicile and jurisdiction will be assessed; and if she will make a statement on the matter. [46194/25]

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2463. To ask the Minister for Health if deaths temporally associated with vaccination will be eligible where a coroner's verdict is inconclusive but medical evidence supports probability; the evidentiary threshold; the role of independent medical experts; and if she will make a statement on the matter. [46195/25]

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2464. To ask the Minister for Health to provide a legal analysis of the way in which the proposed scheme will interact with existing tort remedies; if acceptance of an award will bar subsequent civil action; if structured settlements will be available; and if she will make a statement on the matter. [46196/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 2353 to 2356, inclusive, 2358, 2359, 2458 and 2462 to 2464, inclusive, together.

As the Deputy may be aware significant work has been completed by my Department to develop a model for a vaccine damage scheme. It is my intention to bring the model to Cabinet for discussion and consideration in due course. Until the model has been considered and approved by Government, it is not possible to provide any further information in relation to the scheme's implementation.

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2357. To ask the Minister for Health to provide the number of suspected adverse reaction reports for vaccines received by HPRA in each year from 2019 to 2025, disaggregated by vaccine, seriousness, age band and outcome; and to confirm the number of these cases that proceeded to any form of compensation or settlement. [45671/25]

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2360. To ask the Minister for Health to publish an annual report on vaccine adverse events and compensation, integrating HPRA pharmacovigilance data with scheme outcomes; to include rates per million doses administered by vaccine and year; and to benchmark Ireland against the EU and the UK. [45674/25]

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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2455. To ask the Minister for Health to publish an annual report on vaccine adverse events and compensation, integrating HPRA pharmacovigilance data with scheme outcomes; to include rates per million doses administered by vaccine and year; and to benchmark Ireland against the EU and the UK. [46187/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 2357, 2360 and 2455 together.

The Health Products Regulatory Authority (HPRA) is the competent authority for pharmacovigilance in Ireland. Among its responsibilities, it operates a national reporting scheme for suspected adverse reactions (i.e. side effects) associated with the use of medicines, including vaccines.

Reports may be notified through the scheme on a voluntary basis and can be submitted by healthcare professionals or members of the public. Reports are notified based on a suspicion of an association between the medicine/vaccine and the suspected adverse reaction. Reports collected through the scheme are a key component of the safety monitoring of medicines. They can contribute to increasing knowledge about known adverse reactions and act as an early warning system for the identification of previously unrecognised adverse reactions.

The HPRA participates in the EU’s pharmacovigilance system, together with competent authorities in other EU/EEA Member States and the European Medicines Agency (EMA). In compliance with statutory and legal reporting requirements, suspected adverse reaction reports (excluding personal identifiers such as name and contact details) received by the HPRA are submitted to the European database of suspected adverse reaction reports, known as EudraVigilance. This database is operated and managed by the EMA. The public can access information from this database through adrreports.eu, where as much information as possible is provided on suspected adverse reaction reports, while meeting data protection obligations. This is the official source for suspected adverse reaction data on medicines and vaccines in the EU, including reports notified to the HPRA, and is referred to in response to your request. In addition, to complement the information accessible via adrreports.eu, additional information on reports notified to the HPRA is provided below.

It is important to highlight that while reports are a highly valuable source of information, they are often not sufficient alone to confirm a causal association between a vaccine and a particular event. Reports submitted to the HPRA in many instances arise from suspicions occurring during observation of an unexpected and/or unwanted event. This does not necessarily mean that the medicine has caused the observed effect. Many factors have to be taken into account in assessing a causal relationship including a temporal association, the possible contribution of concomitant medication, and the underlying disease. Interpretation of reactions/events in cases where a combination or multiple other therapies have been administered around the same time requires special care. This may be particularly relevant for vaccines, as more than one vaccine may be administered in combination. Oftentimes, the information provided in reports may be limited. The report may describe signs and symptoms or a suspected diagnosis. The diagnosis may not yet be clinically confirmed. Certain reported reactions/events are conditions which often occur spontaneously. In these cases, a temporal relationship may exist between the medicine and the reaction/event, but it is not necessarily causal. Suspected adverse reaction reports need to be considered in the broader context of additional data, such as from clinical trials, epidemiological studies, and global safety monitoring experience.

The EMA’s safety committee (the Pharmacovigilance Risk Assessment Committee, or PRAC) has a legal mandate for the ongoing safety monitoring and risk management of all medicines in the EU, including vaccines. The PRAC includes members appointed by each EU Member State, including Ireland, through representatives from the HPRA. It also includes independent experts appointed by the European Commission, as well as representatives of healthcare professionals and patients. Where information arises about a new or known adverse reaction that may be caused by a medicine, including a vaccine, and requires further investigation, the data in EudraVigilance, as well as that from any other available data source, is further considered by PRAC, together with the EU competent authorities, to ensure evidence-based conclusions are drawn.

If a new adverse reaction is identified as having a causal relationship, the appropriate regulatory action is taken, including updates to the official approved vaccine product information. This includes the Package Leaflet (for members of the public) and Summary of Product Characteristics (for healthcare professionals), which are also publicly available via the EMA website and the HPRA website. The official approved vaccine product information includes details of adverse reactions that are considered to have at least a reasonable possibility of a causal relationship to the vaccine, together with any appropriate advice for healthcare professionals and those receiving vaccines. This is a trusted source of evidence-based information on vaccine safety.

As noted above, additional information on suspected adverse reaction reports received through the national reporting scheme by the HPRA and associated with a vaccine(s) is provided below for the period from 2019 to 2025 (data lock of 31 July), and as a complement to the publicly accessible information from EudraVigilance and official vaccine product information.

- The total number of suspected adverse reaction reports received in the period from 2019 to 2025 is 22,412. Of these, 21,008 relate to COVID-19 vaccines, reflecting the large-scale immunisation campaigns against COVID-19 infection and the promotion of the national reporting scheme to the public and healthcare professionals to report adverse experiences. The remaining 1,404 reports relate to other vaccines authorised for use in Ireland; the majority of which relate to vaccines included as part of childhood immunisation campaigns and annual influenza campaigns.

- Per year, the number of suspected adverse reaction reports received across all vaccines is, as follows: 2019: 350 reports, 2020: 365 reports; 2021: 17,917 reports; 2022: 2,790 reports; 2023: 510 reports, 2024: 353 reports, 2025: 127 reports (to 31 July 2025).

- Per year, the number of suspected adverse reaction reports received for COVID-19 vaccines is, as follows: 2019: not applicable; 2020: not applicable; 2021: 17,734 reports; 2022: 2,643 reports; 2023: 382 reports, 2024: 196 reports, 2025: 53 reports (to 31 July 2025).

Note: Some suspected adverse reaction reports list more than one vaccine (e.g., in cases where more than one vaccine was administered to the individual).

- In relation to age, this information is available for 20,509 reports, of which 93% describe an adult, and 7% describe a person younger than 18 years of age. The majority of these reports (19,296) are associated with a COVID-19 vaccine.

- In relation to outcome and seriousness, information is provided on reports received across all vaccines which describe a fatality and/or hospitalisation. In total, 135 reports were received which describe a fatal outcome and 1581 reports involved hospitalisation or prolonged hospitalisation. Whilst the reports were temporally associated (i.e. occurred following a vaccination), as described earlier, this does not mean that the vaccine caused the outcome.

- All reports received by the HPRA are carefully reviewed, and as noted above, are evaluated as part of the EU’s pharmacovigilance system to identify those that may be causally related. The HPRA is happy to furnish additional data on any specific vaccine or safety issue on request through medsafety@hpra.ie.

Guidance on the interpretation of suspected adverse reaction data from the national reporting scheme

Interpretation of the data provided should take into account the following:

- Data provided on suspected adverse reactions received through the national reporting scheme are subject to change if/when updated report information becomes available, or information is received that allows identification of duplicate reports (i.e. submission of the same case from more than one source over time). Identification of duplicate reports may lead to the consolidation of reports.

- Reports submitted to the HPRA come from a variety of sources, including healthcare professionals and patients/consumers.

- Adverse reaction/event reporting rates are influenced by many factors, such as the seriousness of the reaction/event, its ease of recognition and the extent of use of a particular medicine. Report rates may also be stimulated by promotion and publicity about a medicine, and reporting rates tend to be highest for newly authorised medicines.

- The number of reports received should not be used as a basis for determining the incidence of a reaction/event as neither the total number of reactions/events occurring nor the number of patients using a medicine is known.

There are no plans for publication of annual reports on vaccine compensation scheme outcomes.

The State Claims Agency (SCA)

In relation to the number of these cases proceeded to any form of compensation or settlement from 2019 to 2025:

- The State Claims Agency (SCA) has a statutory remit to manage personal injury claims on behalf of State authorities, as delegated by Government. The SCA does not collect data from the HPRA, and vice versa. While there may be some overlap between the HPRA's pharmacovigilance data and the SCA claims data, there is no means of linking the two.