The adverse reaction report summarises all reports of suspected adverse reactions that we have assessed following the administration of more than 5.8 million doses. 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 provide a complete picture of the distribution between serious and non-serious events.
New advice concerning the second dose for vaccinated persons who have developed heart inflammation
A number of cases of pericarditis (inflammation of the lining around the heart) and myocarditis (inflammation of the heart muscle) have been observed in persons who have been vaccinated with Comirnaty or Spikevax . Persons of all ages have been affected, but most cases have occurred in men under the age of 30. It is not yet known whether those who have developed pericarditis or myocarditis after their first dose are at risk of recurrence after their second dose and, as a precaution, the Norwegian Institute of Public Health therefore recommends that persons who have developed these inflammatory conditions after having their first dose should not have a second dose.
“The mechanism behind pericarditis and myocarditis following vaccination is currently unknown. Most people recover quickly, but we have seen cases where complications have occurred. It is important to contact your doctor if you experience chest pain, shortness of breath or irregular heartbeat,” says Steinar Madsen, Medical Director of the Norwegian Medicines Agency.
As of 10 August 2021, 90 cases of pericarditis and 30 cases of myocarditis have been reported in Norway.
Pericarditis and myocarditis are mentioned as rare adverse reactions in the product information for Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna).
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
• results of any blood tests
• 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)