VAERS: how an essential safety program is being hijacked to falsely discredit vaccines

VAERS: how an essential safety program is being hijacked to falsely discredit vaccines

The Vaccine Adverse Event Reporting System (VAERS) has become a household name recently. Many misinformation campaigns have taken data from VAERS and have twisted it to discredit COVID-19 vaccines. This post will give an overview of what VAERS is, along with how it should (and should not) be used.

What is VAERS?

The Vaccine Adverse Event Reporting System (VAERS), which has been around since the 1990s, is managed by the CDC and the FDA. Its main goal is to monitor reports of vaccine adverse events, in order to serve as an early warning sign of potential emerging side effects or toxicities from vaccines used in the United States.

Many other similar programs exist around the world, such as the AEFI program in Canada or EudraVigilance in Europe.

All of these safety programs share the common goal of being an early detection system to identify potential new side effects from vaccines. Since VAERS is the most commonly cited, I will focus on that one in particular.


How are adverse events reported to VAERS?

VAERS is a passive reporting system that depends on people reporting adverse effects. In other words, if someone doesn’t think to report a side effect, then VAERS doesn’t hear about it. Here is the disclaimer that can be found on the VAERS website:

“VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases.”

VAERS Disclaimer

As you can see, the data from VAERS can come from literally anyone. Because of this, some very interesting reports can be found in the database.

Dr. James R. Laidler famously reported a very…unusual… side effect from a vaccine into VAERS just to prove a point. In his report, he claimed that his recent flu shot had turned him into the Incredible Hulk. The best part is that because of the way VAERS is set up, the report was actually filed into the system for all to see.

Vaccine side effect: Turned into the Incredible Hulk
Side effect: Turned into the Incredible Hulk

Because of how ridiculous his claim was, a representative of VAERS got in touch with him. They acknowledged that he had made his point, but asked if he could please take it down. Because he complied, this report was taken down. But it drives home the point that if he didn’t want to, this report would have stayed in the database.


Are VAERS side effect reports accurate?

While VAERS can offer an early glimpse into rare side effects emerging in the population, its shortcomings do not allow for it to determine if the effects reported were truly caused by a vaccine. Since so many things can happen by random chance, we cannot assume that everything in VAERS is cause and effect.

If a person receives a vaccine and then goes on to get hit by a bus the next day, someone could technically report this death as occurring after vaccination. Obviously the vaccine did not cause this person to get hit by a bus, but it could nonetheless be reported in VAERS as a vaccine-associated death.

Notice how I used the term “vaccine-associated”? That’s because an association is not the same as “vaccine-caused”. If you want a better review of why correlation/association is not the same as causation, check out my other post on how Nicholas Cage movies can correlate with pool drownings.

My earlier example of being hit by a bus may be a bit ridiculous; but there are many other events that can happen randomly that could unfortunately end up in VAERS. In the setting of the COVID-19 vaccines it’s particularly important, because of the sheer scale of the vaccination campaign.

Why the COVID-19 vaccines offer a unique opportunity to look at VAERS

Let’s review a couple statements before going any further:

  • With the COVID-19 vaccination campaign, we have seen billions of people vaccinated within the span of less than a year.
  • Everything has a background rate. This means that in the general population, we can have a general idea of what the chances are of a health event occurring.

So, because we are vaccinating a significant portion of the population in a relatively short timespan, it should be expected that all sorts of outcomes could occur after vaccination (by random chance). In this setting, we want to see if the rates reported in VAERS are higher than what would be expected in the general population.

VAERS is only meant to be an early warning sign. Its role has never been to determine a cause-effect relationship between the vaccine and a side effect.

After VAERS identifies something of interest, then further (separate) studies are undertaken to see if there truly is a cause-effect relationship between the vaccine and the specific side effect.

This is how myocarditis (heart inflammation) was first detected with the mRNA COVID-19 vaccines. After the first signals emerged in VAERS, more studies were done to assess if there truly were higher rates of heart inflammation after vaccination than what would be expected in the general population.

As a side note, heart inflammation is still much more likely to occur after COVID-19 infection than after vaccination (see my other post on COVID-19 vaccines and heart inflammation for more information).

Getting back to the fact that COVID-19 vaccines have been given to so many people, it makes the random appearance of adverse events even more likely.

Imagine if you had a Water Adverse Events Reporting System. “Did you know that many people die the day after they drank water? Maybe that means water isn’t safe!”. This is why it’s important to always ensure that proper studies are done to actually determine cause and effect (and not just assume that every correlation is cause and effect).


Does VAERS prove that COVID-19 vaccines are more dangerous than COVID-19 infection?

Reports of VAERS “proving” that COVID-19 vaccines are more dangerous than the infection are absolutely false and are also misleading. Due to its nature, VAERS cannot be used as proof of any side effect being causally linked to a vaccine.

Unfortunately, because VAERS is a publicly available government database, many will falsely assume that this means all the reported side effects have been determined to be caused by the vaccines. This is how anti-vaccine charlatans can prey on people who are predisposed to mistrust vaccines or government reporting.

Those with an agenda will often go scavenging in the VAERS database specifically looking for reports that match their preconceived notions. This dumpster diving for shock-value tidbits is both lazy and dishonest.

There is absolutely no evidence to support the false claim that COVID-19 vaccines are more dangerous than the infection. The available COVID-19 vaccines have been shown to be both very effective and safe to use.


The Bottom Line

VAERS is an essential program used to ensure continuous safety monitoring of vaccines. However, its shortcomings are often overlooked by those with an agenda to “prove” that vaccines are unsafe. VAERS does not have the ability to determine if there is a cause-effect association between vaccines and the reported events.

For years, people with an agenda have misinterpreted or misrepresented the data from the VAERS database in order to support their worldview. It’s essential to recognize the strengths of VAERS, but it’s even more essential to recognize its limitations.

If someone can claim in VAERS that a vaccine turned them into the Hulk, then it’s not much of a stretch to assume that other data in VAERS could be flawed.

Dan Landry

Daniel (Dan) Landry, founder of Rxplanation.com, is an infectious diseases pharmacist at the Dr-Georges-L.-Dumont University Hospital Centre in Moncton, NB, Canada.

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