Vaccine Safety Updates and Communications 

The HPRA provides information and updates related to the regulation of COVID-19 vaccines. Please click on the links below to download relevant documents. 

Safety Updates (information on suspected side effects reported to the HPRA)

The HPRA is publishing regular safety updates which provide an overview of the national reporting experience for COVID-19 vaccines. These updates 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.

Reports included are those notified to the HPRA on a voluntary basis by healthcare professionals and members of the public. Reporting of all suspected side effects to COVID-19 vaccines (www.hpra.ie/report) is encouraged. Reports received by the HPRA from the companies (to date, BioNtech, Moderna, Astra Zeneca, Janssen) responsible for the vaccine are also included. 

The information provides an up-to-date summary of the 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.

Please click on the links below to download the documents. 

9 September 2021 Safety Update (#11): COVID-19 Vaccines
 
12 August 2021 Safety Update (#10): COVID-19 Vaccines
 
15 July 2021  Safety Update (#9): COVID-19 Vaccines
  
17 June 2021  Safety Update (#8): COVID-19 Vaccines

20 May 2021 Safety Update (#7): COVID-19 Vaccines 

22 April 2021

Safety Update (#6): COVID-19 Vaccines 

25 March 2021

Safety Update (#5): COVID-19 Vaccines

04 March 2021

Safety Update (#4): COVID-19 Vaccines

18 February 2021

Safety Update (#3): COVID-19 Vaccines 

04 February 2021

Safety Update (#2): COVID-19 Vaccines 

21 January 2021  Safety Update (#1): COVID-19 Vaccines 



HPRA Statements 

20 April 2021

EMA Review of COVID-19 Vaccine Janssen

07 April 2021

EMA Review of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca)

18 March 2021

EMA Review of COVID-19 Vaccine AstraZeneca 

14 March 2021

COVID-19 Vaccine AstraZeneca 

18 February 2021

Opening Statement Department of Health Press Briefing 

18 January 2021 Opening Statement Department of Health Press Briefing  



Drug Safety Newsletters

August 2021  Drug Safety Newsletter Issue 104: PRAC recommendations and advice on rare adverse reactions associated with COVID-19 vaccines

April 2021

Drug Safety Newsletter Issue 103: COVID-19 Vaccine Janssen – EMA review of very rare cases of thrombosis in combination with thrombocytopenia following vaccination

March 2021

 

Drug Safety Newsletter Issue 102: COVID-19 Vaccine AstraZeneca – conclusion of EMA review of thromboembolic events following vaccination

February 2021

Drug Safety Newsletter Issue 101: Special Edition on COVID-19 Vaccines Safety Monitoring Activities



Direct Healthcare Professional Communications

19 July 2021 COVID-19 Vaccine Janssen: Contraindication in individuals with previous capillary leak syndrome and update on thrombosis with thrombocytopenia syndrome 

16 July 2021   COVID-19 mRNA Vaccines Comirnaty and Spikevax: risk of myocarditis and pericarditis

21 June 2021 VAXZEVRIA/COVID-19 Vaccine AstraZeneca - Important Safety Information from AstraZeneca: Contraindication in individuals with previous capillary leak syndrome

02 June 2021  VAXZEVRIA/COVID-19 Vaccine AstraZeneca - Important Safety Information from AstraZeneca: Risk of thrombosis in combination with thrombocytopenia – Updated information  

26 April 2021

COVID-19 Vaccine Janssen: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia

13 April 2021

 

VAXZEVRIA / COVID-19 Vaccine AstraZeneca: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia

24 March 2021

 

COVID-19 Vaccine AstraZeneca: Risk of thrombocytopenia and coagulation disorders