Frequently asked questions (COVID-19)

11 October 2021

Common known adverse effects of corona vaccines include fever, chills, headache, fatigue, muscle and joint pain, enlarged and painful lymph nodes, allergic reactions, nausea, nausea, diarrhoea and reactions at the vaccination site. It is not necessary to report these adverse reactions.

The known adverse reactions to corona vaccines are listed in the package leaflet for each product:

• Comirnaty’s summary of product characteristics and package leaflet (from page 28 onwards) (EMA)
• Spikevax summary of product characteristics and package leaflet (from page 26 onwards) (EMA)
• Vaxzevria's summary of product characteristics and package leaflet (from page 31 onwards) (EMA)

EudraVigilance is a EU database on reports of suspected adverse reactions to medicines. In the database, you can view the reports of adverse reactions to different vaccines more extensively. The vaccines used in Finland can be found in the database under the names of active substances:

• Active substance in Comirnaty: COVID-19 MRNA VACCINE PFIZER-BIONTECH (TOZINAMERAN)
• Active substance in Spikevax:D-19 MRNA  COVID-19 MRNA VACCINE MODERNA (CX-024414)
• Active substance in Vaxzevria: COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)

17 June 2021

The system for reporting adverse reactions is aimed at finding previously unrecognised rare adverse reactions. An adverse reaction should be reported especially when the reaction to a medicine or vaccine is severe or unexpected. An adverse reaction is severe if it has: 

• resulted in death
• endangered a life
• required hospitalisation or extended it (hospitalisation refers to treatment in a ward – not, for example, a visit to a health centre or emergency room)
• caused a permanent injury or significant loss of the ability to function (a significant loss of the ability to function refers to, for example, permanent or long-term incapacity to work, not a few days of sick leave)
• caused a birth defect or other congenital abnormality.

Adverse reactions are unexpected if they are not mentioned in the product summary and the package insert. For example, reactions caused by vaccines at the point of injection, fever, headache, and abdominal pains are known adverse reactions, so reporting them is not necessary. 

Reporting adverse reactions is voluntary, and the reports reflect the observations of those making the report, and their views on suspected harm. The reports that have been made do not disclose how common an adverse effect is among the users of a medicine or among those receiving a vaccine. Information on the frequency of adverse reactions is based on observations made in monitored pharmaceutical research and in studies using the registers of health care services.

11 October 2021

Adverse reaction reports are used to detect new and unexpected adverse reactions. The reports are not used to map out the prevalence of adverse reactions which can be determined through studies or the relevant information obtained from the health care registers.

Adverse reaction reports do not directly indicate that the vaccine has adverse effects. They reflect the observations and views of the submitter of the report and do not mean that a possible link between the vaccine and the observed effects is confirmed.

02 December 2021

Fimea publishes information on its website on suspected adverse reactions to coronavirus vaccines reported in Finland. The number of reports is updated once a month, and at the same time a summary of reports of adverse reactions to coronavirus vaccines is published (in Finnish).

Read more

Reports of adverse reactions to coronavirus vaccines (Fimea)

11 October 2021

In Finland, different amounts of corona vaccines from different manufacturers are used. Reporting adverse reactions is voluntary. The vaccines that are most administered are also most reported upon. Based on the number of adverse reaction reports, it is not possible to compare the safety of different vaccines.

From the viewpoint of the emergence of safety concerns, the main thing is the reported harm, i.e., the content of reports, not their number. If, based on reports of adverse reactions, a vaccine is suspected of causing safety concerns, its evaluation will be initiated. In connection with the evaluation, the whole medical problem will be investigated. In addition to the adverse effects reports, the relevant studies, medical literature and all other reliable sources of information will be reviewed. The study seeks to gain an understanding of the causal relationship between the vaccine and the adverse reaction, its severity, prevalence, and potential risk groups of the vaccine.

11 October 2021

All medicines may cause adverse effects. The presence of adverse reactions in itself does not automatically mean that the product is defective. Drug damage that may arise in connection with the use of medicines is a specific type of damage for which Finland also has a special insurance and compensation system known as pharmaceutical injury indemnities. The corona vaccines used in Finland are covered by this insurance scheme, and a person who has suffered a drug accident may apply for compensation through this scheme.

The Finnish Medicines Agency is not competent to deal with compensation issues related to possible drug accidents resulting from the use of vaccines. The Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities is responsible for processing claims, and its website contains comprehensive information on the number of claims received and the preconditions for granting compensation: The Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities

Updated on 11 January 2022

Pharmacotherapy options have been sought for COVID-19 disease from the outset. Most of the medicines being studied are already in use for other illnesses, which means that the research involves new targeting of pharmaceutical treatments.

Before a new pharmaceutical preparation is used for a new purpose (e.g., COVID-19 infection) sufficient scientific information needs to be available on the effectiveness and safety of the preparation.

Current information on preparations that have been authorised for use in the treatment of COVID-19-virus infections can be found on the European Medicines Agency EMA website. The same page also has information on medicines that have an application pending for a sales permit or for an expansion of the therapeutic indication for the treatment of coronavirus disease, or which are in a rolling review. 

The European Medicines Agency EMA has also come out in favour of giving dexamethasone to COVID-19 patients getting extra oxygen, or who are on a ventilator.

In addition to the abovementioned, there has been much media coverage during the COVID-19 pandemic of different types of information on claims that some medicines or drug combinations might show promise in fighting a coronavirus infection.

Examples of medicines that have been brought forward in public as possible treatments against coronavirus infections as drugs or drug combinations include:

• Hydroxychloroquine and chloroquine – no demonstrated effective benefit in the systemic treatment or prevention of coronavirus disease. EMA has warned about serious side-effects connected with large doses.
• Ivermectin – according to the EMA, available results of research so far do not support the use of ivermectin.