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)
Long-term adverse reactions
We currently know little about possible long-term adverse reactions following COVID-19 vaccination. This makes it particularly important that the reports we receive are as complete as possible. These reports provide us with a basis for assessing the events in cooperation with other European countries.
The Norwegian Medicines Agency have received reports of symptoms that have lasted several weeks following COVID-19 vaccination, such as reports of prolonged fatigue or headaches. The reports only provide a snapshot and we often have little or no information regarding the duration of symptoms.
Patients who experience long-term ailments should contact a doctor who can assess their condition and submit an adverse reaction report if necessary. Healthcare professionals are obliged to report suspected unknown and/or serious adverse reactions. Doctors normally possess valuable information about the clinical picture and are able to provide objective descriptions of symptoms and diagnoses.
“We need supplementary information from those who have previously reported ailments that have lasted for several weeks. It would be very useful for us if a second report could be submitted stating whether the symptoms are persistent or whether they have passed. You should ideally state that you have previously submitted a report,” says senior medical consultant Sigurd 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
- 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)
