Misuse of the VAERS database: An old antivax deception repackaged to spread fear of COVID-19 vaccines

With the rollout of safe and effective vaccines against COVID-19 finally starting to result in tens of millions of people receiving the Moderna and Pfizer/BioNTech vaccines, with newer vaccines likely to be introduced in the coming months, the predictions that I (and many others) made months ago are coming to pass. I’m referring, of course, to antivaxxers resurrecting old antivaccine tropes, dusting them off, and updating them for the age of COVID. Examples abound, including antivaxxers claiming that COVID-19 vaccines cause female infertility, “reprogram your DNA“, are unnecessary because COVID-19 is not deadly, and even kill, particularly the elderly. Similarly, as expected, antivaxxers point to anecdotes of bad things happening to people after receiving the vaccine that are almost certainly coincidences and not related to the vaccine and are weaponizing them to spread fear. Certainly, it doesn’t help that there is at least one person who proclaims himself so very, very, very pro-vaccine is out there pointing to anecdotes and attacking critics to support his pet hypothesis that it’s dangerous to vaccinate people who have pre-existing COVID-19 antibodies. So I suppose I shouldn’t be surprised that antivaxxers are now weaponizing the Vaccine Adverse Events Reporting System (VAERS) database to try to blame all manner of adverse events on vaccines, whether there is evidence of causation or not.

It should therefore be no surprise that antivaxxers are now using VAERS to try to portray COVID-19 vaccines as harmful or even deadly. Consider this part 2 of my post from two weeks ago, the VAERS edition. Unsurprisingly, it’s one of the usual suspects responsible, Robert F. Kennedy, Jr. (RFK Jr.), in the form of a post in his antivaccine publication The Defender entitled “329 Deaths + 9,516 Other Injuries Reported Following COVID Vaccine, Latest CDC Data Show“. As I will show, antivaxxers are playing an old game with new vaccines.

VAERS and the antivaccine movement: A brief history

Those of you who’ve been reading this blog and my not-so-super-secret other blog should be familiar with VAERS, as it’s been discussed many times on both. Basically, VAERS is a passive reporting system, in which anyone can report suspected adverse events after any vaccination to be recorded in the database. Given that anyone can report any suspected adverse event, VAERS is intended to be an early warning system. Unfortunately, it is that very open nature of the system that has allowed it to be used and abused by antivaxxers to promote their false claims that vaccines cause so many adverse events and medical conditions.

Indeed, antivaxxers have long loved to portray VAERS as the be-all and end-all of the databases monitoring vaccine safety. The reason, to reiterate, is that VAERS is unique among US vaccine safety reporting systems in that it is a passive surveillance system. It relies on people to submit reports of adverse reactions to vaccines; it doesn’t actively look for them, as active surveillance systems do. Moreover, anyone can submit a report to VAERS, and they do, including parents of autistic children seeking compensation for their children’s autism as being due to “vaccine injury”. Indeed, I long ago discussed how lawyers have long gamed VAERS to support their litigation, reporting lots of cases of autism as supposedly an “adverse reaction” to vaccines. It’s not just vaccines and autism, either. The easily-abused nature of VAERS data is one huge reason why those of us who’ve been following the antivaccine movement a long time like to refer to the bad “scientific studies” published by antivaccine physicians and scientists that use VAERS as their data source as “dumpster diving“. Examples abound, including a study claiming to find a link between the H1N1 vaccine and miscarriages or one of the earliest examples that I ever encountered, Mark and David Geier’s epically bad study trying to link thimerosal-containing vaccines to autism. As an amusing aside, whenever I discuss VAERS, I like to recount the tale of how in 2006 Jim Laidler infamously reported to VAERS that the flu vaccine had turned him into The Incredible Hulk and VAERS accepted the report. True, someone did contact him to question it. If Laidler hadn’t been honest, he could have insisted that the report remain, and it would have.

You might wonder: Why would anyone set up a system like VAERS, which is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA)? First, you must understand that, as I alluded to above, VAERS isn’t intended to give an accurate estimate of the frequency of various adverse events after vaccination. Rather, it was always intended to serve as an early warning system, a “canary in the coalmine”, so to speak. Consequently, even though antivaxxers like to harp on how passive surveillance systems generally capture only a small fraction of adverse reactions, one thing VAERS does do is capture severe reactions. Practically no one is going to report an adverse reaction like a sore arm or transient fever to VAERS, but you know damned well they’ll report more serious ones, such as a seizure. The problem is that the natural human tendency to seek patterns, coupled with the way antivaccine lawyers game VAERS by having their clients report all sorts of spurious “adverse events” to the database after vaccination, means that VAERS is a very noisy, distorted, and unreliable database.

Even VAERS cautions people about how to interpret its data:

When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.

And:

A report to VAERS generally does not prove that the identified vaccine(s) caused the adverse event described. It only confirms that the reported event occurred sometime after vaccine was given. No proof that the event was caused by the vaccine is required in order for VAERS to accept the report. VAERS accepts all reports without judging whether the event was caused by the vaccine.

Except, apparently, when the claim is as outlandish as saying that the flu vaccine turned someone into The Incredible Hulk, but that is, of course, appropriate.

Still, its limitations aside, VAERS has its place if you understand its intended purpose. That purpose, contrary to what antivaxxers would have you believe, is not as the be-all and end-all of vaccine safety surveillance. It is primarily a hypothesis-generating, not hypothesis-testing, system when it comes to questions related to vaccine safety. To test the correlations found in VAERS requires different systems, systems such as the Vaccine Safety Datalink (VSD) or others, which are active safety monitoring databases in which investigators actively scan real medical records and insurance claims data to seek increases in frequencies of adverse events after vaccination and try to determine if there is a real association. So how are antivaxxers weaponizing VAERS? If you’ve been reading this blog a while, you can probably guess. Basically, in the age of the COVID-19 pandemic, everything old is new again, and antivaxxers have used the same old playbook to misuse VAERS reports in the age of COVID-19.

RFK Jr. dumpster dives in VAERS

So let’s get back to RFK Jr. and his deceptive article by the “Children’s Health Defense Team”. That is, of course, the generic author that RFK Jr.’s Children’s Health Defense gives to articles in The Defender that could include almost anyone on the team, all of whom are antivaccine to the core and the vast majority of whom are not scientists. If you look at the CHD scientific advisory board, you’ll soon see that it’s a who’s-who of antivaccine cranks, including Richard Deth (what a blast from the past!) and Nobel Prize winner turned homeopathy believer, antivaxxer, autism quack, and now COVID-19 crank, Luc Montagnier. Whoever wrote this article is clearly not an expert, and this article is clearly meant to be disinformation, not science. Here’s what I mean:

As of Jan. 22, 329 deaths — a subset of 9,845 total adverse events — had been reported to the Centers for Disease Control and Prevention’s (CDC) Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccinations. VAERS is the primary mechanism for reporting adverse vaccine reactions in the U.S. Reports submitted to VAERS require further investigation before confirmation can be made that an adverse event was linked to a vaccine.

The reports, filed on the VAERS website between Dec. 14, 2020 and Jan. 22, describe outcomes ranging from “foaming at the mouth” to “massive heart attacks” to “did not recover.”

First, one should note how CHD does note that a VAERS entry does not demonstrate causation. Of course, that disclaimer is included, so that RFK Jr. and his merry band of antivax ideologues can claim to have been literally honest while following up their recounting of VAERS numbers with all sorts of statements implying that vaccines were causative for the adverse events listed before.

Of course, whenever you see these sorts of numbers, two questions should come straight to you mind right away. The first is: What’s the denominator? The second is: What is the baseline rate for such adverse events in the population studied?

First, the denominator, which CHD provides without using it appropriately:

According to the Washington Post, as of Jan. 29, 22 million people in the U.S. had received one or both doses of a COVID vaccine. So far, only the Pfizer and Moderna vaccines have been granted Emergency Use Authorization in the U.S. by the U.S. Food and Drug Administration (FDA). By the FDA’s own definition, the vaccines are still considered experimental until fully licensed.

Noting further:

According to the VAERS data, of the 329 reported deaths, 285 were from the U.S., and 44 were from other countries. The average age of those who died was 76.5.

Later in the article, CHD starts listing all the anecdotes and other reports that antivaxxers have been flogging. The “Team” mentions Dr. Gregory Michaels and his death from immune thrombocytopenic purpura (ITP), which has not been shown to be related to the COVID-19 vaccine. They mention Dr. Jerry Spivak’s irresponsible quote in which he said that the thought “it is a medical certainty that the vaccine was related”. Then they invoke the “deaths in nursing homes in Norway” gambit. Never mind that, as I discussed, there was no evidence that these deaths, all of which were among very elderly nursing home residents, were caused by the vaccine and there was no evidence of an increase in the baseline mortality rate of nursing home residents in Norway, which averages around 400 per week.

The article then regurgitates RFK Jr.’s quote that he used to deny coincidence:

“Coincidence is turning out to be quite lethal to COVID vaccine recipients,” said Children’s Health Defense (CHD) Chairman Robert F. Kennedy, Jr. “If the clinical trials are good predictors, the rate of coincidence is likely to increase dramatically after the second shot.”

More on that last point in a moment.

First, let’s get back to the question of the denominator. What’s 285 divided by 22 million? (I realize that that 22 million figure includes an additional week of vaccinations and does not break down how many people had received one or both doses, but this is a “back-of-the-envelope”) calculation. The answer is 0.000015. That’s 1.3/100,000. The true number is likely slightly higher, given that the denominator includes one additional week of vaccinations administered compared to the VAERS figures, which only go until January 22, but, again, this is a back-of-the-envelope calculation, in which the orders of magnitude matter more than the precise figure.

This brings us to the second question: What’s the baseline rate?

Thanks to Dear Pandemic, who did similar “back-of-the-envelope” calculations, as did Mark Hoofnagle on Twitter, we can make a reasonable estimate for Norway:

What does that mean? Sadly, those over 80, especially those already frail enough to be a nursing home, already have high BASELINE mortality. A certain number of 80+ year old’s die every day. In “normal” times Norway typically sees 45 deaths among nursing residents each week.

More generally: The chance of dying in an average week for those over 80 is about 0.2%– or 1 in 500. Thus, if you vaccinated 40,000 80+ year old’s, you would expect about 80 deaths out of that group within one week *just by coincidence*. So even though 23 people dying shortly after a vaccine sounds scary, it’s not above what is expected.

This may sound similar to another argument that many COVID-19 deaths in older adults are deaths that would have happened anyway. This is true, and EXACTLY why scientists prefer to measure “EXCESS MORTALITY” to assess the true toll of the pandemic—which counts how many deaths from any cause there have been ABOVE AND BEYOND what is expected.

Spoiler alert: Excess mortality during the pandemic has been VERY high.

But that’s Norway. What about the US and VAERS? Here’s Seth Trueger:

So, roughly the baseline death rate is roughly 2.4/100,000 per day. Again, these are “back-of-the-envelope” calculations, but they’re close enough to make the point. What has been reported to VAERS is less than the expected baseline death rate in the US for any given day pre-pandemic (the death figures used were for the year 2019). The time period for the VAERS report runs from December 14, 2020 (the first day COVID-19 vaccines were generally available) to January 22, 2021. That’s 40 days, if you count December 14, 2020. so we’d expect 96/100,000 deaths during that period.

Now, add this to the mix, for comparison:

Now let’s bring Mark Hoofnagle into it:

The bottom line is that 285 deaths after COVID-19 vaccination reported to VAERS in a timeframe of 40 days is actually a very small number. Based on the law of large numbers, in which very small percentages translate into a large number of actual cases or people, we would expect a lot more deaths within a couple of weeks after vaccination by random chance alone. Indeed, even if, as is estimated, only 10% of actual deaths after vaccination were reported to VAERS (which is the commonly listed level of underreporting for passive surveillance systems so frequently harped on by antivaxxers themselves, including RFK Jr.), that would still be roughly in the range of what we would expect to observe due to random chance alone (i.e., coincidence).

Of course, in this article, RFK Jr. claims that it’s not just 10% of adverse reactions that are reported to VAERS but rather that only 1% of adverse reactions after vaccination are ever reported to VAERS:

The clinical trials suggested that almost all the benefits of COVID vaccination and the vast majority of injuries were associated with the second dose.

While the VAERS database numbers are sobering, according to a U.S. Department of Health and Human Services study, the actual number of adverse events is likely significantly higher. VAERS is a passive surveillance system that relies on the willingness of individuals and professionals to submit reports voluntarily.

In December, CHD and Kennedy wrote to former FDA director, Dr. David Kessler, co-chair of the COVID-19 Advisory Board and President Biden’s version of Operation Warp Speed. Kennedy told Kessler that VAERS has been an abject failure, with fewer than 1% of adverse events ever reported.

It might be true that such a small percentage of adverse events is reported for self-limited minor events, such as sore arms, fever, nausea, and the like. But death? Does anyone think that deaths after COVID-19 vaccination are going to be underreported by a factor of 100? Deaths definitely get one’s attention and are far more likely to be reported than any other AE. As is stated on the VAERS website:

“Underreporting” is one of the main limitations of passive surveillance systems, including VAERS. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. The degree of underreporting varies widely. As an example, a great many of the millions of vaccinations administered each year by injection cause soreness, but relatively few of these episodes lead to a VAERS report. Physicians and patients understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes.

In the case of COVID-19 vaccines, as those who have gotten them know, everyone who gets a COVID-19 vaccine is given a form to use to sign up for the VSafe after vaccination health checker. This is a system that sends regular text messages to those who’ve been vaccinated to ask them about side effects and in general how they feel. Links to VAERS are included. This, of course, is intended to increase reporting of adverse events to VAERS.

Unsurprisingly, RFK Jr. and CHD are full of…well, a brown stinky substance. As Dr. Vincent Iannelli points out:

Still, although reports to VAERS are underreported, they are almost certainly not underreported by as much as some folks believe.

Have you heard the claim that only 1% of serious vaccine reactions are reported to VAERS?

That’s not true.

That claim is based on an old study about drug reactions and was not specific to vaccines.

We also know that underreporting is less common for more severe adverse reactions than for those that are more mild. For example, one study found that up to 68% of cases of vaccine-associated poliomyelitis (a table injury) were reported to VAERS, while less than 1% of episodes of rash following the MMR vaccine were reported.

That’s not to say that only severe or serious adverse reactions should be reported.

But since VAERS watches “for unexpected or unusual patterns in adverse event reports,” it still works even if each and every side effect isn’t reported.

Basically, the “1% gambit” with respect to what percentage of adverse reactions are reported to VAERS has entered the realm of antivax talking points, as RFK Jr.’s article demonstrates. As with all antivax talking points, it’s meant to deceive.

As for that last part about VAERS having been an “abject failure,” to support that claim RFK Jr. cites this:

A critic familiar with VAERS’ shortcomings bluntly condemned VAERS in The BMJ as “nothing more than window dressing, and a part of U.S. authorities’ systematic effort to reassure/deceive us about vaccine safety.”

Unsurprisingly, RFK Jr. fails to mention that the BMJ “article” to which he refers is a BMJ Rapid Response, which is basically a comment section that is not peer-reviewed that cranks love to use to post their ramblings and then cite them as though they were legitimate articles in The BMJ. In this case, a retired pediatrician named Allan Cunningham rattled off a whole lot of antivaccine tropes about vaccines and autism and cites antivaccine-sympathetic BMJ editor Peter Doshi. In fact, the original article is by Peter Doshi and represents him falling for an antivaccine conspiracy theory that somehow VAERS was being made inaccessible to suppress reports. No, seriously, look at the stupidity on display here:

For over three weeks, the website of the US government Vaccination Adverse Reporting System (VAERS) has been inaccessible to most users. The website address, www.vaers.hhs.gov, is printed on the vaccine information statements (VISs), short documents listing the benefits and risks of vaccines that are required by law to be distributed with every vaccine dose administered in the US.¹

But the website link leads anybody using the web browsers Chrome, Firefox, and some versions of Internet Explorer to a warning page. “Your connection is not private,” it says in large font on my screen (fig 1⇓). “Attackers might be trying to steal your information from www.vaers.hhs.gov (for example, passwords, messages, or credit cards).” The only browser that seems to consistently connect properly is Safari, used by only around a quarter of people accessing …

As Skeptical Raptor notes, it was due to a certificate error:

The problem is the SSL certificate was generated for vaers.hhs.gov but he is going to http://www.vaers.hhs.gov.

Because of this mismatch, the browser is rejecting it. HHS needs a certificate that covers both vaers.hhs.gov and http://www.vaers.hhs.gov. It is indeed a misconfiguration but it’s relatively minor.

The government is making a sincere effort to make sure their web sites are more secure, but sometimes they mess up…SSL certificates facilitate encryption of traffic between the user and web site. They also allow users to verify that they are connected to the real web site, rather than a hacker’s web site. The mismatch is causing the browser to think that the user is not going to the genuine site.

That one earned a much belated Godzilla facepalm:

VAERS: Everything old is new again

One observation that I’ve made about how antivaxxers have joined the COVID-19 cranks and conspiracy theorists and started casting doubt on COVID-19 vaccines is that everything old is new again. The sorts of tactics antivaxxers are using now have surprised and befuddled a lot of pro-science advocates, mainly because so many of them have not been paying attention to the antivaccine movement, in particular its longstanding tactics and its basis in conspiracy theories. They also don’t understand how the antivaccine movement has always been about more than just vaccines. It’s basically against public health and any collective action to protect public health.

That’s why I’m going to take this opportunity to point out how, contrary to how one eminent academic oncologist like to put it, refuting antivaccine disinformation is anything but LeBron James “dunking on a 7′ hoop”. It’s a specific skill that requires deep knowledge of conspiracy theories and the specific tactic and tropes used by science denialists and conspiracy theorists like antivaxxers, coupled with a deep understanding of the scientific literature on vaccines. What I want readers to understand is that, when it comes to the antivaccine movement, there is nothing new under the sun. The misuse of VAERS to demonize COVID-19 vaccines is just another example of how old antivaccine tactics and tropes have been resurrected, dressed up, and updated to be deployed against COVID-19 vaccines.

The only old antivaccine lie or distortion that I haven’t seen used against COVID-19 vaccines yet is the claim that they cause autism or sudden infant death syndrome. I fully expect that, just as soon as a COVID-19 vaccine is approved for use in children, antivaxxers will start claiming that the vaccine causes autism and SIDS.

Then, with respect to antivaccine disinformation, truly everything old will be new again.