Case reports of suspected side effects
Collecting reports of medical events and problems that occur following the use of a medicine, and therefore might be side effects, is one of the pillars of the EU safety monitoring system. Healthcare professionals and vaccinated individuals are encouraged to report to their national competent authorities all suspected side effects individuals may have experienced after receiving a vaccine even if it is unclear whether the vaccine was the cause. For more informationon how to report, see Reporting suspected side effects. These spontaneous reports are collected in EudraVigilance, the EU database used for monitoring and analysing suspected side effects. Publicly available information can be accessed via EudraVigilance – European database of suspected drug reaction reports in all EU/EEA languages. Search for “COVID-19 MRNA VACCINE MODERNA (CX-024414)” to see all suspected side effect cases reported for Spikevax.
As of 29 July 2021, a total of 48,788 cases of suspected side effects with Spikevax were spontaneously reported to EudraVigilance from EU/EEA countries; 392 of these reported a fatal outcome3,4. By the same date, about 43.5 million doses of Spikevax had been given to people in the EU/EEA5.
These reports describe suspected side effects in individuals, i.e. medical events observed following the use of a vaccine. The fact that someone has had a medical issue or died after vaccination does not necessarily mean that this was caused by the vaccine. This may have been caused, for example, by health problems not related to the vaccination.
https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-update-spikevax-previously-covid-19-vaccine-moderna-11-august-2021_en.pdf
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