Ref, vaers the yellow card?

Observers, especially on social media, may have noticed that the Qonion movement is engaging in scare tactics around adverse reactions to the covid-19 vaccine. Essentially, they are arguing that there are major adverse reactions to the covid-19 vaccine, including mass deaths, and they are using this to discourage those still on the fence from taking the vaccine. Their motives for this vary, but for the purposes of this post are not relevant.

One particular tactic they are using to bolster their position on this – and to flesh out their scare tactic – is relying on the USA’s Vaccine Adverse Event Reporting System (VAERS), as well as more recently the UK’s Yellow Card Scheme (essentially the UK equivalent to VAERS). In this they are citing the various adverse reactions to the covid-19 vaccine that are being reported in VAERS and the Yellow Card as gospel and evidence of adverse reactions, are extrapolating them to Bermuda, often embellishing with stories from Bermuda along the lines of Nicki Minaj.

Screenshot from the Bermuda Freedom Alliance Facebook page demonstrating their use of this scare tactic.

So, let’s take a look at VAERS and the Yellow Card and see if there’s anything in them that those sitting on the fence about the covid-19 vaccine need to consider – and this applies to those who have taken one shot of the vaccine but are hesitant now to take their second shot.

What is VAERS and the Yellow Card Scheme?

VAERS is a US national vaccine safety surveillance program overseen by the CDC and FDA. At the most basic, it collects and analyses reports of adverse reactions after vaccination. It is not new, established in 1990, and generally receives about 30,000 reports a year. The vast majority of reports describe known and mild side effects, such as fever. The scientists at both the CDC and FDA monitor VAERS to identify those events that require further studies to identify if the reported effect is genuinely due to the vaccine in question, and, if so, the probability of the event occurring.

Importantly, anyone can submit a report to VAERS. It is not solely healthcare professionals or vaccine manufactures that make submissions into it. Anyone can. It is essentially raw data that requires analysis and should not be taken as definite. What the scientists do is they look for unusually high numbers of reports of an adverse event after a particular vaccine or a new pattern of adverse events. If these are identified, then scientists conduct focused studies to determine if the adverse event in question is or is not a side effect of the vaccine.

If a new side-effect is identified, information about the side-effect is added to the package insert that lists safety information and accompanies the vaccine. If the side-effect is determined to be serious, and the risks of it outweigh the benefits, then the recommendation to use the vaccine is withdrawn.

What’s important to stress here is that an adverse event reported to VAERS does not necessarily mean they are side-effects caused by the vaccine in question. It may or may not be – thus the need for further investigation to determine if they are. A side-effect is when the adverse event has been shown to be linked to the vaccination by scientific studies.

I can’t stress this enough – just because something is reported to VAERS does not mean it is caused by the vaccine in question. Quite often they are chance events with no medical/causal link between the vaccine and the adverse event reported. Also, there is the risk of certain persons weaponising VAERS for ideological reasons – such as anti-vaxxers deliberately reporting false adverse events for the purpose of undermining confidence in vaccines.

The UK’s Yellow Card Scheme is essentially the same as the USA’s VAERS, with the exception that it has a wider scope. While VAERS is focused solely on vaccines, the Yellow Card applies to all medicines and medical devices, including vaccines (and even herbal remedies). Similar to VAERS, anyone can report an adverse reaction to a vaccine, and scientists study these to determine which require further studies to determine the veracity of the reported adverse reaction. As with VAERS, if, after further studies, a side-effect is identified, this is added to the safety profile for the vaccine. Similarly, if the risk of the identified side-effect is determined to outweigh the benefits of the vaccine, the vaccine can be withdrawn.

Importantly, as with VAERS, the adverse effects reported to Yellow Card are pure unverified raw data and do not mean that the adverse effect reported is indeed caused by the vaccine as opposed to chance.

Correlation Does Not Imply Causation

This really cannot be stressed enough. Humans are great at identifying patterns, and while this has been vital to the success of human evolution and civilisation through the development of technology, it isn’t perfect. It’s not unusual at all for our brains to make a connection that actually isn’t there. That’s why humans sometimes see images in clouds, faces in inanimate objects or generally add the proverbial two and two together and get five – such as this classic case about nigh lights and short-sightedness.

The raw data provided by VAERS and the Yellow Card do potentially provide a useful scientific tool ONLY in terms of identifying patterns that merit further research. The raw data itself is essentially meaningless. It is only the focused studies that are conducted based on patterns found from the raw data which are of use in determining whether the reported adverse effect is real (and if so, how common) or unrelated to the vaccine in question.

A very useful article for readers (especially the discussion of the Weber effect) interested is this one that looked at deaths reported to VAERS between 1997-2013; basically, over 2,149 deaths from vaccines were reported to VAERS in that time-period, but by researching the individual deaths recorded, zero were found to be actually attributable to any vaccine. There may have been a correlation, but there was no actual causation.

Give Qonion A Yellow Card!

There is no denying that databases such as VAERS and the Yellow Card Scheme are valuable tools for researchers. They provide a potential early warning system to detect adverse reactions, especially those that are too rare to show up in standard clinical trials.

However, like any tool, it can be misused.

They are vulnerable to weaponisation – both by anti-vaxxers submitting false reports to them, and by anti-vaxxers cherry picking unverified raw data and presenting the scary reports as proof that a vaccine (in this case covid-19 vaccines) cause serious harm and/or death.

This latter is the most common amongst the Qonion community, and it deserves being given a yellow card and being called out for what it is – a scare tactic based on cherry picking and logical fallacies.

If you’re worried about taking the covid-19 vaccine, please discuss with an actual doctor, including your concerns about reports of adverse reactions. But please, don’t give in to the Qonion scare tactic and take the unverified data as gospel.

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