The reports of adverse reactions that we have received do not provide a basis for revising the current recommendations regarding vaccination with the Comirnaty (BioNTech/Pfizer) and Moderna COVID-19 vaccines.
Click here to go to an overview of reports of suspected adverse reactions (the adverse reactions report)
Reports of serious events are assessed first. The figures therefore do not give a true picture of the distribution between serious and non-serious events.
Reported deaths amongst the frail elderly following vaccination
As of 18 of May 2021, a total of 155 deaths have been reported following vaccination with the Comirnaty vaccine. Most reports concern elderly and very frail nursing home residents. As the mortality rate in nursing homes is generally very high, it was expected that there would be deaths following vaccination. Nevertheless, the Norwegian Medicines Agency wanted an independent assessment of the deaths from geriatric specialists.
"Frail patients can benefit from vaccination because they are at great risk of serious illness and even death if they become infected with the COVID-19 virus. Nevertheless, the expert group believes that, for some of these frail patients, common adverse reactions may have contributed to a more serious course of their disease", says senior medical consultant Sigurd Hortemo.
Read more: Expert group has assessed deaths amongst the frail elderly following COVID-19 vaccination
Reporting of suspected adverse reactions improves patient safety
In Norway, healthcare professionals readily report suspected adverse reactions and events which occur with a temporal link to vaccination. These reports are important in our work to monitor the safety and use of newly developed vaccines.
It was a combination of observant doctors at Oslo University Hospital, a robust and well-functioning monitoring system which enabled Norway to help reveal that, in rare cases, Vaxzevria can give rise to a serious combination of symptoms involving blood clotting and low blood platelet counts.
Read more: Vigilant doctors ensure better vaccine safety
Common and expected adverse reactions
Most adverse reactions following COVID-19 vaccination, regardless of the type of vaccine used, concern known and transient adverse reactions such as:
- headache
- fatigue
- malaise
- fever
- nausea
- pain in the body
These usually appear on the first or second day after vaccination and last around 2-3 days. Most people tolerate these transient adverse reactions well, while others experience significant discomfort during the first few days after vaccination. These suspected adverse reactions are in line with what is described in the product information.
How to report adverse reactions
Health professionals are obliged to report suspected serious adverse reactions following vaccination. It is not necessary for the causal relationship to be known; suspicion is sufficient to report an incident.
It is particularly important to report reactions where any of the following are suspected:
- new adverse reactions not referred to in the patient information leaflet
- unexpected adverse reactions
- serious adverse reactions
- vaccine failure (severe COVID-19 following full vaccination)
If a person becomes seriously ill with COVID-19 one to two weeks following the completion of vaccination, this is considered to constitute a possible vaccine failure. Severe or critical cases (COVID-19 symptoms and disease) in persons who have been fully vaccinated must be reported as a suspected adverse reaction via melde.no
The general population can report adverse reactions via helsenorge.no, but you should consult a doctor or other health professional in the case of suspected serious or unexpected adverse reactions following vaccination. You do not need to report a possible adverse reaction yourself if a health professional has already reported the reaction.
International cooperation
Reports of adverse reactions following vaccination are followed up by the Norwegian Medicines Agency in partnership with the Norwegian Institute of Public Health and the regional medicines information and pharmacovigilance centres (RELIS). The Norwegian Medicines Agency is responsible for the National ADR Register, and exchanges adverse reaction data with the European Medicines Agency (EMA) and the World Health Organization (WHO). This provides us with a better basis for assessing causation, identifying new adverse reactions and implementing measures to safeguard patient safety.
