Adverse reactions are reported on the basis of suspicions. The fact that an adverse reaction has been reported does not necessarily mean that there is a causal link with the vaccine. The purpose of the reporting system is to determine what we should investigate further. The reports often concern symptoms and conditions which are relatively common amongst the population. At a time when so many people are being vaccinated, the challenge is to separate out conditions or symptoms which occur coincidentally following vaccination from genuine adverse reactions.
All reports are included in the report of possible adverse reactions to Covid-19 vaccines, regardless of whether or not the event is believed to be linked to vaccination. As a result, the figures cannot be used to assess causalities or determine how often an adverse reaction occurs.
The report summarises all reports of suspected adverse reactions that we have assessed. Reports of serious events are assessed first. The figures therefore do not give a true picture of the distribution between serious and non-serious reports.
Click here to see a report containing an overview of reports of suspected adverse reactions
Submit another report if the symptoms persist
As of 1 February 2022, over 2.7 million people had received a third or booster dose. We have so far not observed any adverse reactions following the third or booster dose other than those that we have seen after the first and second doses. Health professionals are obliged to submit reports if they suspect new, unexpected or serious adverse reactions following vaccination.
The adverse reaction reports provide a snapshot of the situation at the time of reporting, and we therefore do not always know how long the symptoms persist. As a result, it may be necessary for the doctor or vaccinated person to submit another report with updated information.
“Anyone who experiences symptoms such as headaches over many weeks after being vaccinated should contact their GP, who can then assess the causes of symptoms. The doctor has knowledge of the patient and can provide useful information which is important in our assessment," says Senior Medical Consultant Ingrid Aas of the Norwegian Medicines Agency.
Being monitored in surveys
In Norway, large population surveys (cohort studies) are carried out to identify symptoms and conditions that are not necessarily being reported as suspected adverse reactions. Participants in the Norwegian Institute of Public Health's population surveys regularly answer questions about symptoms or adverse reactions following vaccination. Questions concerning prolonged headaches and other persistent symptoms are included in the questionnaire in these cohort studies.
"We review all reports that we receive to ensure we have an overview at all times and can identify those that should be prioritised in our assessment. We look for combinations of symptoms and severe or unusual symptoms. If we identify something that could be a signal of a possible adverse reaction, we investigate it in more detail in collaboration with NIPH. They have excellent analysis tools and can conduct follow-up research, as they are doing in the case of menstrual disorders," says Ingrid Aas.
The Norwegian Institute of Public Health is monitoring a wide range of diseases using data from the Preparedness Register to compare incidences amongst vaccinated and unvaccinated persons. Amongst the diseases being monitored are blood clots in the lungs, deep vein thrombosis, cardiac infarction and stroke. No link has so far been confirmed between the vaccines used in the Norwegian vaccination programme and the risk of any of these conditions.
What do we know about delayed adverse reactions?
So far, no delayed adverse reactions to COVID-19 vaccines have been identified, i.e. adverse reactions which occur long after vaccination. Globally, over 10 billion vaccine doses were administered during 2021, and it is believed that over 60% of the world's population has now received at least one dose. We therefore have a good understanding of the adverse effect profile of the COVID-19 vaccines. We have never learned so much about any other vaccine in such a short period of time before.
“In most cases, adverse reactions occur during the first few weeks following vaccination, and it is very rare that symptoms that occur more than six weeks after vaccination can be linked to vaccines. Nevertheless, we are monitoring the situation closely to identify signals of possible late adverse reactions," says Aas.
Find out more about what we know about rare adverse reactions and how long after vaccination adverse reactions can be expected to occur in NIPH's vaccination guide (in Norwegian).
See the latest figures in the report: Menstrual disorders, inflammation of the heart and reports concerning young people under the age of 18.
Report adverse reactions on behalf of children
Children under 16: Parents and guardians can report adverse reactions on behalf of their children.
Children over 16: Young people over the age of 16 can report adverse reactions themselves, but they will need an electronic ID, such as Bank-ID. Parents can report adverse reactions if a power of attorney has been set up. Power of attorney can be set up digitally at helsenorge.no.
Find out more about representing other people at helsenorge.no.
How to report adverse reactions
Click here for a link to the report form and more information on how to report adverse reactions.
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
- the dose after which the adverse reaction occurred
- whether a different type of vaccine was given as subsequent doses
- 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:
- adverse reactions not referred to in the patient information leaflet
- unexpected adverse reactions
- serious adverse reactions
- vaccine failure (severe COVID-19 following full vaccination)
Health professionals are obliged to report serious, new and unexpected reactions which they suspect may be caused by a vaccine.