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 an event is believed to be linked to vaccination.
Reports of serious events are given priority and 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).
Confirmed COVID-19 in vaccinated persons
No vaccine provides 100% protection against either infection or serious illness. The COVID-19 vaccines provide excellent protection against serious illness and death from COVID-19, as well as good protection against infection amongst those who have been fully vaccinated. The degree of protection may vary between the different vaccines, and some people may experience different immune responses to the same vaccine, depending on their age and health.
If a vaccinated person becomes seriously ill with COVID-19 more than 1-2 weeks after being fully vaccinated, this is considered to be a breakthrough infection and a possible case of vaccine failure. A total of 32 cases have so far been reported by health professionals where fully vaccinated persons have been confirmed as having COVID-19 between two weeks and seven months after receiving their last dose. Less than half of the reports concerned patients who were seriously ill, with nine reports concerning deaths. The average age of those who died was 89.
Mandatory reporting
The Norwegian Institute of Public Health monitors hospital admissions and deaths with COVID-19 amongst those who have been fully vaccinated. The number of fully vaccinated people admitted to hospital due to COVID-19 is low, but still higher than the number of adverse reaction reports of breakthrough infections and suspected vaccine failure received from health professionals.
- Suspected cases of vaccine failure and breakthrough infections amongst fully vaccinated persons appears to be being underreported. It is important to note that health professionals are obliged to report such events. It is also important that adverse reaction reports include a detailed description of the patient's condition and the development of the symptoms,” says Steinar Madsen, Medical Director at the Norwegian Medicines Agency.
Monitored
It is important to investigate the cause of inadequate protection following vaccination, so that we can identify the risk groups that could have a poor immune response. The Norwegian Institute of Public Health monitors COVID-19 disease in vaccinated persons by regularly linking information on COVID-19 vaccination in the Norwegian Immunisation Registry (SYSVAK) with positive COVID-19 test results reported to the Norwegian Surveillance System for Communicable Diseases (MSIS). These figures are published in the Norwegian Institute of Public Health's weekly reports.
Rare but known adverse reactions concerning the heart
Amongst the rarer adverse reactions are inflammation of the heart muscle (myocarditis) and inflammation of the heart lining (pericarditis). These are rare, but known adverse reactions listed in the product information for the Comirnaty (Pfizer/BioNtech) and Spikevax (Moderna) COVID-19 vaccines. Symptoms of pericarditis and myocarditis are: Chest pain, wheezing or rapid or irregular heart rate in those who have been vaccinated. Fever and cough may also occur. Persons of all ages have been affected, but most cases have occurred in men under the age of 30. Of those affected, most symptoms develop 1-2 weeks after vaccination.
The mechanism behind pericarditis and myocarditis following vaccination is currently unknown. Health professionals are urged to report cases which occur following vaccination via melde.no.
How to report adverse reactions
Click here for a link to the report form and more information on how to report adverse reactions (information in Norwegian).
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:
- 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)
Report adverse reactions on behalf of children
Contact a health professional, such as a public health nurse or a doctor, for an assessment and advice if a child or adolescent is experiencing troublesome adverse reactions. Health professionals are obliged to report serious, new and unexpected reactions which they suspect may be caused by a vaccine.
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.
