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 go to an overview of reports of suspected adverse reactions (the adverse reactions report)
Booster doses for the elderly and nursing home residents
Elderly patients benefit greatly from vaccination, because they are at high risk of serious illness and death from COVID-19 infection. The Norwegian Institute of Public Health (NIPH) has therefore recently recommended booster doses for the elderly aged 65 upwards and nursing home residents. For most people in this group, the benefits of protection against severe COVID-19 disease will outweigh the risk of any side effects. However, for elderly people living with frailty, common adverse reactions to the vaccines, such as fever and nausea, can have serious consequences.
This winter, the Norwegian Medicines Agency ordered an independent assessment of deaths reported in frail elderly people from an expert group of geriatricians. The expert group concluded that, in the case of some of these frail patients, it was likely that common adverse reactions could have contributed to a more serious development of the disease.
- “It is important to reiterate that health professionals must carry out a thorough risk-benefit assessment before vaccinating very frail patients. For those with a short life expectancy, the benefits of a booster dose can be marginal. End of life patients should not be vaccinated,” says Senior Consultant Sigurd Hortemo.
NIPH recommends a one-week gap between vaccination with influenza vaccine and a booster COVID-19 vaccine dose. The booster COVID-19 dose must not be at the expense of influenza vaccination.
See the information on booster doses for the elderly and nursing home residents in NIPH’s vaccination guide
See the information on assessing frailty before giving a booster dose to the very elderly in NIPH’s information letter
Reports of suspected adverse reactions in the 12 to 17 age group
The monitoring of adverse reactions amongst children and adolescents is given a high priority. Adolescents normally experience the same common and transient adverse reactions as adults following vaccination. We are closely monitoring the situation and are particularly alert to reports of serious events following vaccination. Over 311,000 doses have so far been administered to children and adolescents aged between 12 and 17. During the period from December 2020 to 12 October 2021, we received and assessed 137 adverse reaction reports concerning this age group. Twenty of these are classified as serious.
Inflammation of the heart
Amongst the more rarely known adverse reactions are inflammation of the heart muscle (myocarditis) and inflammation of the heart lining (pericarditis). We have so far received one adverse reaction report concerning this age group. Anyone experiencing symptoms such as chest pain, wheezing or rapid or irregular heartbeat following vaccination should see a doctor.
Myocarditis occurs more often in boys and young men after vaccination with Spikevax (Moderna) than with Comirnaty (Pfizer/BioNTech). NIPH has underlined the recommendation that adolescents under the age of 18 who are to be vaccinated should be offered Comirnaty (Pfizer/BioNTech), regardless of which mRNA vaccine they received as their first dose.
Find out more about COVID-19 vaccines and inflammation of the heart
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
- whether the reaction occurred after the first or second dose
- whether a different type of vaccine was given as the second dose
- 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.
