The adverse reaction report summarises all reports of suspected adverse reactions that we have assessed to date following the vaccination of more than 2.8 million people. Events following vaccination are reported on the basis of suspicions, which means that there is not necessarily any causal relationship. The challenge is to distinguish symptoms and medical conditions which occur randomly from those which could be linked to vaccination. All reports are included in the report, regardless of whether or not an event is believed to be linked to vaccination.
Reports of serious events are given priority and assessed first. The figures therefore do not give a true picture of the distribution between serious and non-serious events.
Click here to go to an overview of reports of suspected adverse reactions (the adverse reactions report)
Known adverse reactions
The Norwegian Medicines Agency receives reports concerning all types of reactions and events following vaccination, with the majority relating to known and non-serious adverse reactions. The most common are transient adverse reactions, such as headache, fatigue, malaise, fever, nausea and pain in the body. These usually appear on the first or second day after vaccination and last around two to three days. These adverse reactions are described in the product information. This will be updated if new adverse reactions are reported which the European Medicines Agency (EMA) believes are probably linked to the vaccine.
Please provide supplementary information when reporting adverse reactions
It is particularly important that any suspected cases of new, unexpected and/or serious adverse reactions are reported. We are working systematically to identify signals concerning new and unknown adverse reactions and are therefore prioritising the serious reports for assessment. To make it easier for us to assess the reports, we urge anyone who submits a report to provide as much detailed information as possible.
Please remember to include the following information when reporting adverse reactions:
- name of the vaccine and date of vaccination
- detailed description of the sequence of events
- when the adverse reaction first started
- whether the reaction is persistent or has passed
- any previous medical conditions and the taking of medication
- if/when you have taken a COVID-19 test, and the result
- whether the reaction occurred after the first or second dose
- whether a different type of vaccine was given as the second dose
- results of any blood tests
- whether a doctor has been contacted
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)
Vaccine failure
If a fully vaccinated person becomes seriously ill with COVID-19, this is considered to constitute a possible vaccine failure. This is considered to be an adverse reaction and must be reported via melde.no. Reports of possible vaccine failure are followed up by obtaining information about which virus variant has been detected, whether the patient has underlying medical conditions or other factors which could explain a lower than expected response to the vaccine.
The Norwegian Institute of Public Health monitors cases of positive tests for COVID-19 (Sars-Cov-2) in fully vaccinated persons.
