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)
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
So far, over 7.3 million doses of Comirnaty (Pfizer/BioNtech) and over 1.6 million doses of Spikevax (Moderna) have been administered in Norway. As of December 14, more than 1 million 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.
See also: Have your booster dose when you’re offered it (fhi.no)
Menstrual disorders
We have so far assessed 2,379 reports of menstrual disorders. Most of these reports concern women between the ages of 20 and 49. 215 of these reports are classified as serious.
We have also received 178 reports concerning women who have suffered unexpected vaginal bleeding after menopausal age. 172 of these are classified as serious. Unexpected vaginal bleeding after menopausal age is always classified as severe if it occurs more than a year after the last menstruation.
“We do not yet know whether women who have experienced menstrual disorders in connection with their first or second dose are at greater risk of experiencing such disorders again when they receive their third dose or booster dose. The Norwegian Institute of Public Health’s major ongoing study will tell us more, and we are currently awaiting the results of this study," says Aas.
Reports of suspected adverse reactions in adolescents aged 12-17
The assessment of adverse reaction reports from the 12-17 age group is given a high priority. 16- and 17-year-olds are now receiving their second vaccine dose. We are closely monitoring the situation and are particularly alert to reports of serious events following vaccination.
Adolescents normally experience the same common and transient adverse reactions as adults following vaccination. As of 14 December 2021, more than 417,000 doses have been administered to children and adolescents aged between 12 and 17 years. During the period from December 2020 to 14 December 2021, we received and assessed 328 reports of suspected adverse reactions in this age group. 43 of these are classified as serious. We have so far received one report of pericarditis and one report of myocarditis.
Over 75% of the adverse reaction reports in this age group are from girls. A high proportion of the reports relate to menstrual disorders and headaches. The majority of these are classified as non-serious.
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.
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.
