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Debunked: No, EU and US databases do not show that thousands of people have died from Covid-19 vaccines

Claims which rely on the EudraVigilance and VAERS databases are often misleading.

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A NUMBER OF claims have circulated recently suggesting that thousands of people in Europe and the US have died as a result of being given Covid-19 vaccines.

The claims often rely on statistics from the EudraVigilance database run by the European Medicines Agency (EMA) in an attempt to create fears around the use of vaccines.

Sometimes, they also misuse data from a similar database in the US – known as the VAERS database – to claim that adverse side-effects of vaccines are being under-reported.

False claims about vaccines, which rely on the EudraVigilance and VAERS databases, have appeared in social media posts, including on Facebook and Twitter, on TV and radio, and even in literature distributed by a candidate in the upcoming Dublin Bay South by-election. 

The claimants usually use the databases to suggest that a cover-up about the harm caused by Covid-19 vaccines is taking place, and often accompany their claims with images like these:

Eudravigilance

However, claims which rely on EudraVigilance and VAERS to suggest that thousands of people are dying from Covid-19 vaccines are misleading and often false.

The possible vaccine side-effects listed on the EMA and US databases have not been confirmed, and many posts which use EudraVigilance and VAERS data to heighten concerns about Covid-19 vaccines have taken figures out of context.

These posts often fail to specify how these databases collect their information, and contain no information outlining how safe vaccines actually are.

The posts have been circulating in numerous languages and across multiple social media platforms.

These claims are untrue and attempt to mislead people about vaccines through the misuse of statistics.

We have previously debunked suggestions that the vaccine is experimental and untested here.

Occasionally, the data used for these claims is based on the EudraVigilance system, which manages and analyses information on suspected adverse reactions to medicines approved by the EMA.

The data is regularly posted online and is collated similarly to other systems which contain data about possible Covid-19 vaccine side-effects.

The EudraVigilance database lists suspected side-effects from vaccines (for example, cardiac disorders) as well as suspected fatalities, and is refreshed every week.

However, like other systems, these are suspected adverse reactions which could relate to vaccination – but is not necessarily so. Often, the reported outcome and its link to vaccination has not been verified.

Ireland operates a similar system on a national basis, where any individual who has received a Covid-19 vaccine is encouraged to report any suspected side effects to the national reporting scheme, regardless of whether there is a definitive link to vaccines.

The Health Products Regulatory Authority receives these reports from individuals on a voluntary basis, based on a person’s suspicion that an adverse health effect they experience may be associated with them having received a Covid-19 vaccine.

The authority has emphasised that this does not mean vaccines caused the adverse effects, and says the reports it receives are only referred to as “suspected” side-effects.

A spokesperson for the EMA explained that the the EudraVigilance database works to The Journal in a similar way.

“The information on this website relates to suspected side effects, i.e. medical events that have been observed following the use of a medicine, but which are not necessarily related to or caused by the medicine,” a statement said.

Pharmaceutical companies are also required to have systems in place to collect any reports of suspected side-effects, both inside and outside the EU, and to submit this information to the EMA.

The information is then submitted to EudraVigilance, and regulators subsequently analyse the data.

But because side-effects listed on the database – including death – are only suspected to be related to vaccines, EudraVigilance statistics cannot be taken as a list of confirmed side-effects.

“Information on suspected side effects should not be interpreted as meaning that the medicine or the active substance causes the observed effect or is unsafe to use,” the EMA spokesperson continued.

“Only a detailed evaluation and scientific assessment of all available data allows for robust conclusions to be drawn on the benefits and risks of a medicine.”

But social media posts which share information from EudraVigilance do not mention that there has been no formal verification of the reported side-effects listed on the database.

Instead, they present the data without context, failing to mention that figures about suspected fatalities due to vaccines have not been confirmed.  

Other claims, similar to those which rely on EudraVigilance, are also misused in this way on social media.

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The US Centres for Disease Control and Prevention (CDC) runs a similar reporting scheme titled Vaccine Adverse Event Reporting System (VAERS), which also features in false and misleading claims about vaccines.

Anyone can report a suspected reaction to VAERS. “The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable,” the CDC warns.

A CDC spokesperson told The Journal that multiple factors could lead to potential adverse effects being reported – or not reported.

“Mild events, like a rash, tend to be reported less frequently than severe events (like a seizure),” the spokesperson said.

“Events that occur sooner after a vaccination (rather than later) tend to be reported more frequently. One potential explanation for low reporting of mild events might be that many are expected, and therefore people don’t feel the need to report them.”

In other words, suspected severe reactions will likely appear to be occurring more often than they are, because people are more likely to report them than milder ones.

VAERS itself has acknowledged the limitations with its system, including potential bias towards certain suspected side-effects.

And it has likewise said its data should be interpreted with caution because no “cause and effect relationship” between suspected side-effects and vaccination had been established within the reports.

“The event may have been related to an underlying disease or condition, to medications being taken concurrently, or may have occurred by chance,” a report reads.

Like posts using data from the EudraVigilance system, claims which rely on VAERS are often misleading and lacking key context.

Data from these sources which suggest that vaccines are dangerous should be treated with a high degree of scepticism.

Scientific evidence to date shows that vaccines against Covid-19 are overwhelmingly safe and that they reduce serious illness and rates of hospitalisation due to the virus.

You can read more about data supporting the use of vaccines here

The Journal’s FactCheck is a signatory to the International Fact-Checking Network’s Code of Principles. You can read it here. For information on how FactCheck works, what the verdicts mean, and how you can take part, check out our Reader’s Guide here. You can read about the team of editors and reporters who work on the factchecks here

Have you gotten a message on WhatsApp or Facebook or Twitter about coronavirus that you’re not sure about and want us to check it out? Message or mail us and we’ll look into debunking it. WhatsApp: 085 221 4696 or Email: answers@thejournal.ie

About the author:

Seana Davis

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