COVID-19 important messages

Important information to consider before looking at ADR reports for the COVID-19 vaccines

  • The information on this website relates to suspected side effects, i.e. medical events that have been observed following the administration of the COVID-19 vaccines, but which are not necessarily related to or caused by the vaccine. These events may have been caused by another illness or be associated with another medicine taken by the patient at the same time.
  • The EMA’s scientific assessment takes into account many other factors, such as the patient’s medical history, the frequency of the suspected adverse reaction in the vaccinated population compared to the frequency in the general population and whether it is biologically plausible that the vaccine could have caused the event.
  • Only a detailed assessment of all available data allows for robust conclusions to be drawn on the benefits and risks of the COVID-19 vaccines.
  • Each individual case generally refers to a single patient; however, more than one side effect may have been included in a single report. Therefore, the number of side effects will not be the same as the number of individual cases.
  • The data included in this website reflects the reports submitted by national competent authorities and pharmaceutical companies. They may contain duplicated information. EMA checks the reports as part of its scientific assessment and that also includes the identification of duplicates.

Warning for cases with a fatal outcome

  • This website does not provide the total number of cases reported with a fatal outcome. It provides the number of cases reported as fatal for specific reactions groups (e.g. cardiac disorders) and for specific reactions (e.g. myocardial infarction). Since one individual case may contain more than one suspected side effect, the sum of the number of fatal cases per reaction group will always be higher than the total number of fatal cases.
  • The number of cases in the website, including those reported with fatal outcome, which may have a variety of different causes, should be put in the context of the different vaccines’ exposure (numbers of given doses may vary significantly from one vaccine to another). Data about exposure is published by the European Centre for Disease Prevention and Control (https://www.ecdc.europa.eu/en).

What information does this website provide?

  • The information on this website relates to suspected side effects reported to EudraVigilance, the EU pharmacovigilance database designed for collecting reports of suspected side effects.
  • The spontaneous cases reported to EudraVigilance come from patients and healthcare professionals and are submitted electronically by national medicines regulatory authorities and pharmaceutical companies.
  • These reports are used for evaluating the benefits and risks of medicines during their development and monitoring their safety following their authorisation in the European Economic Area (EEA).
  • The information on this website may include known side effects already listed in the summary of product characteristics (SmPC) and the package leaflet.
  • The EMA must comply with the EU Data Protection legislation and therefore, certain data elements (e.g. country where a specific reaction occurred) are not disclosed to safeguard the identity of individuals.

More information

 

 EMA
EudraVigilance