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Fact Check-EudraVigilance does not say COVID-19 vaccines have killed tens of thousands of people

Social media users have claimed a European database of suspected adverse drug reactions has revealed tens of thousands of people have died as a result of COVID-19 vaccines. However, this is a misrepresentation of what the database is and what it shows.

Hundreds of people have engaged with memes online that claim to show results of a report on the Eudravigilance database, which covers the European Economic Area (EEA) – and is the European equivalent of Britain’s Yellow Card scheme.

One meme, posted to Facebook on Oct. 27, claims Eudravigilance shows COVID-19 vaccines caused 2.5 million “injuries”, more than 27,000 of which were fatal (here).

Another from Nov. 1 claimed COVID-19 vaccine injuries had risen to 2.6 million, while deaths climbed above 28,000 (here). A third from Nov. 11 said injuries rose another 100,000, while deaths topped 29,000 (here).

Many of these claims come from Health Impact News, a website that describes itself as publishing stories “the mainstream media seldom covers”. It regularly posts pieces that criticise COVID-19 vaccines, along with claims that figures provided by the EudraVigilance database are confirmed adverse reactions to the shots (here).

Reuters presented the claims to the European Medicines Agency (EMA), which said: “The data circulating in many articles and social media posts are incorrect.”

Medicines regulatory authorities and pharmaceutical companies across the EEA are required to submit reports of suspected adverse reactions to Eudravigilance from their respective member states (here).

The database emphasizes that each report describes an effect that happened either “following administration of, or treatment with, a medicine”. This is not confirmation of a causal link between the two (here and here).

“The collection of all reports of suspected adverse drug reactions is one of the pillars of the EU safety monitoring system,” the EMA told Reuters by email. “Spontaneous reporting serves as a tool to detect unusual or unexpected issues related to the use of a vaccine which may require further investigation and risk assessment.

“Reports of suspected adverse drug reactions (ADRs) alone are rarely sufficient to prove that a certain suspected reaction has been caused by a specific medicine, i.e. a COVID-19 vaccine. EMA’s detailed assessments take into account all available data from all sources (clinical trials, medical literature, observational studies, etc.) to draw a robust conclusion on the safety of the vaccine.

“For most medicines and vaccines, the vast majority of suspected side effects are not eventually confirmed as side effects. For cases with fatal outcome, it is difficult to state with certainty the real cause of death even if all data, including autopsy results, are available. Please note that it is not EMA’s role to adjudicate the cause of death.”

According to the EMA’s website, the safety of COVID-19 vaccines is continuously monitored and evaluated – and have been found to be “safe and effective”. It adds: “Serious safety problems are extremely rare” (here).

VERDICT

Missing context. Reports of suspected adverse reactions to the Eudravigilance database are not confirmed reactions.

This article was produced by the Reuters Fact Check team. Read more about our fact-checking work here.

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