The adverse reaction report summarises all reports of suspected adverse reactions that we have assessed following the vaccination of more than three 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 provide a complete 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)
A vital tool
The reporting scheme is a vital tool in the monitoring of vaccines. The reports submitted by health professionals and members of the general public give us signals of events which we should investigate further. It is not known with any certainty what proportion of events are actually being reported, and the submission of a report does not necessarily mean that there is a causal relationship. As a result, the number of reports submitted to the Norwegian Medicines Agency cannot normally be used to determine how often or how many adverse reactions a vaccine could give rise to, or to compare the adverse reaction profiles of different vaccines.
Adverse reaction reports with comprehensive information are of greatest value
The Norwegian Medicines Agency receives many reports of suspected adverse reactions linked to the COVID-19 vaccines. When a report is to be assessed, it is very important that the information it contains is as detailed as possible. We receive many inadequate adverse reaction reports from both health professionals and patients. These reports are difficult to assess and are of little value. The Norwegian Medicines Agency and the Norwegian Institute of Public Health (NIPH) devote a lot of resources to requesting more information in order to assess and process adverse reaction reports, but as resources are limited, this is only possible for reports we consider to be serious.
Doctors play an important role in the monitoring of adverse reactions
Experience has shown that reports from doctors are particularly important. Doctors normally possess valuable information about the clinical picture and are able to provide clear and objective descriptions of symptoms or diagnoses. The doctor's experience and knowledge of the patient can provide us with the information we need to assess whether the event could be linked to the vaccine.
"During the pandemic, we have seen how important it is for doctors to report suspected adverse reactions and focus on submitting high-quality adverse reaction reports. This enables us to act quickly in the event of suspected adverse reactions, and it also benefits those who are receiving the vaccines," says Sigurd Hortemo, Senior Consultant at the Norwegian Medicines Agency.
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
- it is important that the correct medical terms are used
- 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
- results of any blood tests
- 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
