Adverse reaction reports summarise all reports of suspected adverse reactions that we have assessed. 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.
Click here to go to an overview of reports of suspected adverse reactions (the adverse reactions report)
How we process the reports
The Norwegian Medicines Agency has increased its staffing levels on a number of occasions in order to speed up the assessment of incoming adverse reaction reports. Reports of serious events are given priority and assessed first. The figures in the adverse reaction report therefore do not provide a complete picture of the distribution between serious and non-serious events.
“Every day, all new incoming reports are screened to give us an overview of the situation. This enables us to identify reports of possible adverse reactions which have not previously been reported or which must be assessed as a matter of priority. We read every report that we receive,” says Senior Medical Consultant Sigurd Hortemo.
Long-term adverse reactions
Little is currently known about possible long-term adverse reactions following COVID-19 vaccination. The Norwegian Medicines Agency has received reports of symptoms such as headaches that have lasted for several weeks.
Headaches following vaccination are common, and no causal relationship between vaccination and prolonged headaches has yet been confirmed. The adverse reaction reports provide a snapshot of the situation and we therefore do not know whether or not the patient’s symptoms are persistent. It may thus be necessary for the doctor to submit another report containing updated information.
“Anyone who experiences symptoms over many weeks after being vaccinated should contact their GP, who can then assess the causes of symptoms such as prolonged headaches. The doctor will have experience and a knowledge of the patient and be able to provide us with the supplementary information we need to assess a possible link to the vaccine," says Hortemo.
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
- other current medical conditions and medication
- if/when a COVID-19 test has been taken, 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
- the results of any blood tests or other medical investigations
- whether a doctor has been contacted (for those submitting a “patient report” via helsenorge.no)
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)
How to report adverse reactions
Click here to find out more about how to report adverse reactions (information in Norwegian)