Did a COVID-19 safety update published by the European Medicines Agency (EMA) say that 8,368 people died in 2022 in the EU because of taking the Pfizer COVID vaccine? No, that's not true: the report contains data from EudraVigilance, an open database where anyone can file a report for suspected adverse reactions to the vaccine (and any drug), even if it's unclear whether the vaccine was the cause.
The claim originated from a video (archived here), published on TikTok on January 12, 2023, under the title "See what's happening to people with side effects! 🤔🤔 Why isn't anyone talking about this? 😫." It opened:
For 3 years, Terheș has been constantly warning us!
This is what the post looked like on TikTok at the time of writing:
(Source: TikTok screenshot taken on Tue May 16 06:10:27 2023 UTC)
In this clip, Romanian MEP Cristian Terheș is misinterpreting data from recent COVID-19 safety updates published by the European Medicines Agency (EMA). Since the first vaccines were authorized in December 2020, EMA's monthly safety updates have also provided high-level information on suspected adverse reaction reports.
The 8,368 alleged deaths are suspected unconfirmed cases, from a safety update published on Dec. 8, 2022, which mentions that, as of Nov. 23, 2022, EudraVigilance (the European database of suspected drug reaction reports) contained "a total of 967,351 cases of suspected side effects spontaneously reported from EU/EEA countries" related to the Comirnaty (Pfizer) vaccine and that "8,368 of these reported a fatal outcome."
The EMA specifically states in this report that "Health care 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's unclear whether the vaccine was the cause." The numbers in the EudraVigilance reports "don't tell the full story," as Lead Stories explained in a similar fact-check, because these reactions are "unverified, in a system open to anyone to submit a report."
It is not logical to assume that every post-vaccination death was vaccine-caused, since individuals may be suffering from a range of health conditions when they are vaccinated, including old age.
As Lead Stories pointed out in a January 27, 2021, fact check, assuming all post-vaccination deaths are vaccination caused is a prime example of a logical fallacy: Correlation (event B follows event A) is not the same as causation (event B was caused by event A). Establishing causation requires detailed follow-up on the reports stored in open public reporting lists such as the EudraVigilance system and those operated by other countries.
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