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.
The Norwegian Institute of Public Health has suspended use of the Vaxzevria (AstraZeneca) vaccine following suspicions of a possible link between the vaccine and cases of rare and very serious adverse reactions involving a combination of blood clotting, bleeding and low platelet counts. As of 6 April 2021, no further reports of cases involving this rare combination have been received in Norway. According to the European Medicines Agency (EMA), a total of 169 cases of blood clotting in the brain (cerebral venous sinus thrombosis) and 53 cases of blood clotting in the digestive system had been registered as of 4 April 2021. A total of 34 million people have been vaccinated with the AstraZeneca vaccine in the EU/EEA and UK.
Read more: The EMA has concluded: Link between the AstraZeneca vaccine and the rare cases
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)
Most of the reports concern common adverse and expected reactions, such as pain at the injection site, headache, general malaise with fever, fatigue, nausea and pain in the body. These adverse reactions last around 2-3 days and are known from the studies which formed the basis for the vaccine authorisations.
What suspected adverse reactions should be reported?
Any suspicion that a COVID-19 vaccine has triggered an adverse reaction is sufficient to report the reaction. Health professionals are obliged to report suspected serious adverse reactions to vaccines. The causal relationship need not be known. 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 (lack of effect based on what the vaccine is expected to provide protection against)
Breakthrough infection
The COVID-19 vaccines provide people who have been vaccinated with good protection against serious illness. Full protection is achieved 1-2 weeks after the final dose of the vaccine. The degree of protection may vary between the different vaccines, and some people may experience different immune responses to the same vaccine, depending on their age and health. If a vaccinated person becomes seriously ill with COVID-19 more than 14 days after being fully vaccinated, this is considered to be a breakthrough infection and constitutes a possible vaccine failure.
In the case of severe illness in a fully vaccinated person with a verified positive COVID-19 test result, it is important to investigate the cause of the vaccine failure more thoroughly. These events must be reported via melde.no.
This makes it possible to determine whether there are any risk groups which may have an inadequate immune response, whether any changes have occurred in the pathogenic microbe, rendering the vaccine no longer effective, or whether any changes need to be made to the vaccination regime.
In addition, the Norwegian Institute of Public Health monitors breakthrough infection after vaccination by regularly linking information on COVID-19 vaccination in the Norwegian Immunisation Registry (SYSVAK) with positive COVID-19 test results reported to the Norwegian Surveillance System for Communicable Diseases (MSIS). Positive cases in fully vaccinated persons are followed up by obtaining information about any mutations in the samples.
How to report adverse reactions
Health professionals should report adverse reactions 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.
