Reporting the adverse effects of vaccination
Fimea maintains a national adverse drug reaction register. Reports on the adverse effects of vaccines and vaccinations are also stored in the register.
Health care professionals have the right, notwithstanding confidentiality provisions, to notify Fimea of a diagnosed or suspected adverse reaction to a vaccine or vaccination (Communicable Diseases Act 1227/2016).
Why is reporting important?
The most common adverse reactions are usually already found in trials conducted before the issue of a marketing authorisation. The rarest adverse effects can only be detected once the vaccine has been widely used.
The main task of the notification system is to produce signals of possible rare adverse reactions that have not been previously identified for further examination. The frequency of adverse events cannot be calculated based on the notifications. Based on the number of notifications, it is also not possible to compare the safety of different products.
Fimea sends information about all adverse reaction reports it receives to the European Medicines Agency (EMA), which reports these to the marketing authorisation holder of the vaccine suspected to cause adverse effects and the World Health Organization (WHO). Fimea also submits information of the vaccine and vaccination reports included in the adverse reaction register to the Finnish Institute for Health and Welfare.
The risk-benefit balance of vaccines is continuously assessed for example, in the light of information gathered from adverse reaction reports. Adverse reaction registers are part of continuous safety monitoring.
When should I submit a report?
You should particularly submit a report if you suspect or find that vaccination has caused a serious adverse effect.
The adverse effect is serious if it has
- led to a person's death
- threatened a person’s life
- led to hospitalisation or prolonged hospitalisation
- led to permanent or significant disability or functional incapacity
- caused a congenital malformation.
You should also submit a report, if
- the adverse reaction is unexpected, i.e. it differs in quality or intensity from those mentioned in the vaccine's summary of product characteristics
- the adverse reaction is caused or suspected to have been caused by a new vaccine
- you believe that the frequency of the adverse reaction is increasing
- you become suspicious of a batch-specific problem
- the reaction affects a new or extended target group for the vaccine.
It is important that the vaccinated person or their guardian is in contact with the person who gave the vaccine if they suspect that the vaccination has caused a serious or unexpected adverse effect.
This allows a health care professional to
- provide guidance on how to treat possible symptoms
- to assess the situation, so that other possible causes of the symptoms can also be taken into account and treated
- consider possible further vaccinations in the aspect of vaccination safety.
If the situation leads to a notification of a suspected or confirmed adverse reaction, the notification will also provide all the necessary information about the given vaccine and event.
How do I submit a report?
Submit a report on an adverse reaction to Fimea electronically or using Fimea’s form: Report on a suspected adverse drug/vaccine reaction.
Provide the requested information as accurately and comprehensively as possible.
- Describe symptoms, findings and the progress of the reaction.
- Provide sufficient personal data. Reporting sufficient personal data is important for combining the reports concerning the same effect submitted by different sources.
- Provide the vaccine batch number. The vaccine batch number is required as it is the best way to identify the vaccine given.
Health professionals or vaccine recipients can submit reports. See the Fimea website for instructions on submitting a report.
Submitting a report on an adverse reaction (Fimea)
How to claim compensation for a vaccine adverse reaction in Finland
Information how to claim compensation for a vaccine adverse reaction:
Seeking compensation for an adverse reaction caused by vaccination
Legislation
The following acts and decrees lay down provisions on reporting adverse reactions of vaccines and vaccinations, and the Register for adverse drug reactions:
- Communicable Diseases Act (1227/2016)
- Medicines Act (395/1987)
- Act on National Personal Records Kept Under the Health Care System (556/1989)
- Decree on National Personal Records Kept Under the Health Care System (774/1989)
