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 the event is believed to be linked to vaccination.
Reports of serious events are assessed first. The figures therefore do not give a true picture of the distribution between serious and non-serious events.
Click here to see an overview of reports of suspected adverse reactions (the adverse reactions report)
In December 2021, adverse reaction reports and news will be published in weeks 49 and 50. The first publication after New Year will be in week 1. We are still working hard to assess the reports that we receive. The change in the frequency of publication does not mean that we have reduced the amount of resources that are allocated to this task.
Please state the dose in adverse reaction reports
We distinguish between the third dose that is given to people with a severely weakened immune system in order to obtain the best possible protection against COVID-19, and the booster dose which is available to the entire population. The NIPH has recommended that everyone over the age of 18 receive a booster dose. As of December 5, more than 802,000 people have received a third or booster dose. See NIPH’s vaccination statistics.
“No other adverse reactions have yet been observed following the third or booster dose besides than those that we have seen after the first and second doses. It is very useful if health professionals and those who have been vaccinated state the dose that the adverse reaction report concerns,” says Senior Medical Consultant Ingrid Aas at the Norwegian Medicines Agency.
So far, over 7.1 million doses of Comirnaty (Pfizer/BioNtech) and over 1.6 million doses of Spikevax (Moderna) have been administered in Norway.
Common adverse reactions to vaccines can affect medical conditions
Infectious diseases and fever are known to affect existing medical conditions. For example, the risk of unstable blood sugar levels increases, blood pressure can rise, and the effect of blood-thinning medications such as Marevan can be affected. Similarly, common transient vaccine reactions such as fever, vomiting and diarrhoea can trigger symptoms or aggravate existing medical conditions. As a result, additional checks may be necessary, e.g. in order to measure blood pressure or blood sugar levels, and possibly adjust the dosage of medications.
How to report adverse reactions
Click here for a link to the report form for patients
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.
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.
