HPRA 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 include an overview of reports of suspected side effects notified to the HPRA safety monitoring system and are provided as an enhanced transparency measure for members of the public and healthcare professionals.
EMA Safety Updates
The European Medicines Agency publishes safety updates for authorised COVID-19 vaccines on its website.
Why is safety monitoring of COVID-19 vaccines important?
The scientific evaluation of a vaccine needs to show that a vaccine’s benefits in protecting people against diseases are far greater than any potential risk. Like any medicine, vaccines have benefits and risks. Although highly effective, no vaccine is 100% effective in preventing disease or 100% free from potential adverse reactions (side effects) in all vaccinated people.
At the time of approval, the main body of evidence for vaccine safety and efficacy comes from large controlled, randomised clinical trials. Selected volunteers are randomly allocated to receive the vaccine being tested and followed up under controlled conditions in line with strict protocols. After approval, a larger number of people will receive the vaccine. It is possible that certain adverse reactions, particularly those that rarely or very rarely occur, may only emerge during real life use in much larger and more diverse populations. It is therefore essential that the safe and effective use of authorised vaccines be continuously monitored.
How will the safety of COVID-19 vaccines be monitored?
The HPRA, together with the EMA and other EU medicines agencies, will continuously assess safety data emerging in relation to COVID-19 vaccine use, through well established safety monitoring systems. Any potential safety concerns identified will be addressed by taking appropriate regulatory action to safeguard individual and public health and communicating with the public in a transparent and timely manner. More information is available in the EU safety monitoring plan.
The HPRA strongly encourages healthcare professionals and members of the public, to report suspected adverse reactions (side effects) to COVID-19 vaccines to the HPRA.
What should I do if I feel unwell post-vaccination?
The HPRA encourages anyone who has experienced a suspected adverse reaction (side effect) to a COVID-19 vaccine or who feels unwell following vaccination to follow the advice given at the time of vaccination or to contact their doctor or healthcare professional, as necessary. It is very important to note that the HPRA cannot provide medical advice to individual patients, therefore if a person has any concerns about their medicines or medical conditions they should consult a healthcare professional involved in their care for advice. Suspected adverse reactions (side effects) may be reported to the HPRA by members of the public, carers, or healthcare professionals. To report a suspected adverse reaction (side effect) to a COVID-19 vaccine, please use the COVID-19 Vaccine Adverse Reaction Reporting Form.