HPRA Safety Update: COVID-19 Vaccines, Overview of National Reporting Experience: Publication date: 20 May 2021 (Update #7)
dc.contributor.author | Health Products Regulatory Authority (HPRA) | |
dc.date.accessioned | 2023-11-09T16:16:52Z | |
dc.date.available | 2023-11-09T16:16:52Z | |
dc.date.issued | 2021-05-20 | |
dc.identifier.uri | http://hdl.handle.net/10147/638317 | |
dc.description | This update includes an overview of reports of suspected side effects notified to the HPRA safety monitoring system and is provided as an enhanced transparency measure for members of the public and healthcare professionals. 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 expected benefits in preventing COVID-19 illness. Reports included in the overview are those notified to the HPRA on a voluntary basis by healthcare professionals and members of the public, with reporting of suspected side effects to COVID-19 vaccines (www.hpra.ie/report) encouraged. Any reports of Irish cases received by the HPRA from the company (i.e. the licence holder, to date, BioNTech, Moderna, AstraZeneca, Janssen) responsible for the vaccine are also included within this update. This overview provides an up-to-date summary of national reporting experience. However, it is important to understand that conclusions on the safety of a vaccine cannot be drawn based on the information provided, given well-established and known limitations in interpreting such data in isolation, examples of which are described below. | en_US |
dc.language.iso | en | en_US |
dc.publisher | Health Products Regulatory Authority (HPRA) | en_US |
dc.subject | REGULATION | en_US |
dc.subject | MEDICINES | en_US |
dc.subject | COVID-19 | en_US |
dc.subject | VACCINATION | en_US |
dc.subject | CORONAVIRUS | en_US |
dc.subject | SAFETY | en_US |
dc.title | HPRA Safety Update: COVID-19 Vaccines, Overview of National Reporting Experience: Publication date: 20 May 2021 (Update #7) | en_US |
dc.type | Report | en_US |
refterms.dateFOA | 2023-11-09T16:16:54Z |