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Home » VAERS facts — contradicting anti-vaccine claims and beliefs

VAERS facts — contradicting anti-vaccine claims and beliefs

Last updated on August 18th, 2022 at 11:25 am

This article about VAERS facts, literally a FAQ, was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about vaccination’s social and legal policies. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

Some of the new generation of anti-vaccine activists appear to have built their careers on misrepresentation of VAERS. One example is Dr. Jessica Rose, who apparently started her career as a legitimate young scientist, but at some point became a devoted anti-vaccine activist. Dr. Rose’s background is described by Orac thus:

Her background is more in the sort of computational biology that looks at protein structures and bioinformatics related to DNA sequences than it is to the sort of mathematical and statistical skill set necessary to delve into VAERS with any credibility. A perusal of her curriculum vitae, which is included on the profile, confirms my assessment, particularly her publication record, which includes a lot of molecular biology and virology, but nothing in the way of epidemiology.

In 2021, Dr. Rose joined the anti-vaccine organization IPAK as a research fellow, and she has published several papers in IPAK’s own publication, named Science, Public Health Policy, and the Law, whose editorial board is comprised of leading anti-vaccine activists.

Dr. Rose’s specialty appears to be doing bad analyses of VAERS and claiming, based on them, that COVID-19 vaccines are dangerous.

On August 9, 2022, Dr. Rose published a “Question and Answer” “facts” about VAERS, titled “A question and answer document on the subject of VAERS as a pharmacovigilance tool”. It is highly misleading. But it gave me an opportunity to provide information based on actual facts about VAERS.

If you want to see how it’s misleading, jump ahead to question 3 (and I hope you then go back and read the long discussion in questions 1 and 2).

I will repeat each question, answer it, shortly summarize Dr. Rose’s claims, and explain why they are misleading. Note that this discussion is limited to the mRNA vaccines and the J&J vaccine, which are the ones used in the United States and subject to reporting to VAERS – Novavax is newer and is not the subject of most of the misinformation from the anti-vaccine activists misleading people about VAERS. 

What is VAERS – the facts

The Vaccine Adverse Events Reporting System – VAERS – is a passive database of vaccine adverse events to which anyone can report a problem they claim happened after vaccines. VAERS is an important part of our vaccine safety monitoring system (though it’s certainly not all of it) because it is actually very good at detecting signals – things that might be problems with vaccines – early on. For example, VAERS alerted us early to a potentially dangerous type of blood clots after JNJ vaccines.

However, by its nature VAERS is vulnerable to abuse – and has been abused – by anti-vaccine activists and those sympathetic to the goal of deterring and misleading parents, for example, not to vaccinate.

This post takes advantage of an anti-vaccine and misleading set of answers to questions about VAERS to provide accurate facts. It’s long, and I hope people feel free to jump to the question that they are interested in.

1. “Are the COVID vaccines causing injuries, what kinds, and how do we know?”

Yes, but serious harms are rare, and the vaccines’ risks are smaller than the risks of COVID-19.

The harms include severe allergic reactions after any vaccine – which are possible, but rare. Because of the risk of these reactions, you should stay at the vaccination area for 15 minutes after vaccinating.

They also include blood clots after JNJ vaccines – a specific, very severe, but rare syndrome, which led CDC to recommend that the mRNA vaccines are preferred. 

They include Guillain-Barre Syndrome after JNJ vaccines, rarely, and myocarditis – especially in young men or boys – after mRNA vaccines.

Although myocarditis is a serious condition, most people who get it after vaccines recover well, so far, and the risks of it from vaccines are still lower than the risks of COVID-19.

There are also cases of tinnitus reported after the vaccine, though it is still hard to be sure if there’s a causal connection there (it’s possible).

In addition, the vaccines can and do cause local reactions, and can and do cause a day or two of unpleasant symptoms in many recipients – fever, aches, nausea. 

How do we know? 

We know because there are multiple monitoring systems across the world that look at COVID-19 vaccine safety. Some are passive, like VAERS; some are active. In a post addressing this, Ed Nierenberg goes into detail about the different systems.

We know these systems work because they have caught things as rare as anaphylactic reactions that are few per million for mRNA vaccines, and they caught them fast – for example, an analysis was already published in a scientific journal, having undergone peer review, on February 12, 2021, for the vaccines authorized in December 2020. They caught the rare clots from J&J.

Further, we have a history of catching quickly other issues, like intussusception from a rotavirus vaccine in 1999.  

For COVID-19 vaccines, data is not coming just from the United States, though. It’s coming from all around the world – from Israel, Canada, Europe, and Japan, for example. Specific issues are also studied – like the safety of vaccines during pregnancy, or myocarditis in young people.  

The safety of COVID-19 vaccines is something looked at through many mechanisms throughout the world. There is a lot of data about it, and we do not need to rely on an analysis of raw VAERS reports – which, as discussed below, do not show causation – to know what the vaccine risk and safety profile is.

What does Dr. Rose say? 

Dr. Rose alleges that the number of VAERS reports shows that the vaccine affects “[a]ny human physiological system that you can name” in an injurious way, based on raw VAERS reports – because there is a large number of them. The problem with using VAERS reports this way is that this is a misuse. As the VAERS site itself explains

VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. 

Vaccine providers are encouraged to report any clinically significant health problem following vaccination to VAERS even if they are not sure if the vaccine was the cause. In some situations, reporting to VAERS is required of healthcare providers and vaccine manufacturers.

The number of reports alone cannot be interpreted as evidence of a causal association between a vaccine and an adverse event, or as evidence about the existence, severity, frequency, or rates of problems associated with vaccines.

Reports may include incomplete, inaccurate, coincidental and unverified information.

Implying that VAERS reports show the vaccines cause harm is a misuse of the data. 

She also mentions two other databases that have reports. She mentions the UK Yellow Card, (though she links to another site, not the actual site – I link to the actual website) which like VAERS, allows anyone to report anything (and has a special portal to report things about coronavirus-related products, vaccines, and medicines). The Yellow Card site explains:

The Yellow Card scheme is a mechanism by which anybody can voluntarily report any suspected adverse reactions or side effects to the vaccine. It is very important to note that a Yellow Card report does not necessarily mean the vaccine caused that reaction or event. We ask for any suspicions to be reported, even if the reporter isn’t sure if it was caused by the vaccine. Reports to the scheme are known as suspected adverse drug reactions (ADRs).

So here, too, it is a misuse to allege that the sites show injuries. The other database she mentions is EUDRA – a European database, but the link she provided lists no adverse events. I suspect she meant EudraVigilance – which is another database that does not show causation.

This site, too, explains to us that “The information on the databases relate to suspected adverse reactions – for instance, the effects that have been observed following the administration of, or treatment with, a medicine. However, these suspected adverse reactions may not be related to, or caused by, the medicine.

So basically, Dr. Rose is misleading her readers by referring them to databases that do not show causation and claiming they show that COVID-19 vaccines cause harm, instead of referring them to the actual studies on the topic. 

2. An introduction to VAERS: what is it, who runs it, what is its history?

VAERS was created in 1990, as part of the reform that also created the National Vaccine Injury Compensation program we discussed before. The site explains that VAERS:

…is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.

VAERS is used primarily to identify a problem early. The problem may or may turn out to be a risk associated with a vaccine. Edward Nierenberg gives the example that “when the MCV4 vaccine was introduced in 2005, there was a spike in reported cases of Guillain-Barré syndrome. A subsequent investigation showed no increased risk.”

CDC routinely monitors VAERS data to detect patterns. For COVID-19 vaccines, CDC also engaged in enhanced surveillance for adverse events of special interest, including “death, COVID- 19 disease, Guillain-Barre Syndrome (GBS), seizure, stroke, narcolepsy/cataplexy, anaphylaxis, vaccination during pregnancy, acute myocardial infarction, myopericarditis, coagulopathy (including thrombocytopenia, disseminated intravascular coagulopathy [DIC], and deep venous thrombosis [DVT]), Kawasaki’s disease, a multisystemic inflammatory syndrome in children (MIS-C), a multisystemic inflammatory syndrome in adults (MIS-A), transverse myelitis, Bells Palsy, and appendicitis.”

The results of the CDC’s monitoring of VAERS were presented to the CDC’s Advisory Committee on Immunization Practices in meetings discussing covid-19 vaccines, like here and here, and are used in detailed studies by CDC officials, like this in-depth analysis.

Dr. Rose covered some of this in less detail, but then added that “under-reporting is a known imperfection of the VAERS system.” 

This is true but incomplete. It is true that underreporting is a feature of VAERS —like all databases that depend on reporting, VAERS will tend to have underreporting. That’s because not everyone may report a problem. But this needs to be qualified in three ways.

  1. Mild side effects tend to be more under-reported than serious ones.  
  2. Because VAERS is designed to detect signals, not identify rates, underreporting should not prevent it from doing its job: it can raise a signal, that then can be studied more in-depth in other ways.
  3. While anti-vaccine activists like to emphasize under-reporting, they ignore reporting VAERS events that are not related to it. This happens all the time — anything that happens after vaccines can be reported. In a study from 2012 of VAERS reports, only 3% of reports were “definitely casually related” to any vaccine, and 22% more were “probably” related.   53% were “unlikely or unrelated” to a vaccine. So there are a lot of reports that are not related to the vaccine, and anyone addressing the numbers without considering over-reporting is as wrong as anyone ignoring under-reporting. The bottom line is that the number of cases in VAERS cannot be used, by itself, without a lot of caution.

3. In fairness to the “other side”, what is the distinction between reported injury and confirmed injury?

An injury reported to VAERS only tells us that someone filed a VAERS report. It does not tell us whether the event actually happened, whether it happened as described and whether it’s linked to the vaccine. The site tells us that “[R]eports may include incomplete, inaccurate, coincidental and unverified information.” It also tells us that “VAERS does not obtain follow-up records on every report.”

As a reminder, VAERS’ goal is there to detect signals; so it’s not actually crucial to examine every report.

Further, we know that some reports do not reflect actual events. For example, Edward Nierenberg documented coding errors for congenital anomalies in COVID-19 vaccines. A congenital anomaly would require that a pregnant woman got the COVID-19 vaccine. Nierenberg pointed out:

at the time of writing this, 11 congenital anomalies were reported for COVID-19 vaccines into VAERS. Of these: 

• Two involved a pregnant patient (957368-1, 932107-1; these reports may in fact be describing the same individual based on how similar they are) 

• one involved a seventy-year-old patient who expired (932787-1) 

• one involved a male who described an eye infection (927415-1) 

• one involved a 57-year-old female who apparently stated the vaccine caused a congenital anomaly while she was not pregnant (907175-1) (yeah I don’t know what this is about)

etc. None of the reports of congenital anomalies associated with these vaccines were reporting an infant born to a vaccinated mother…

Treating these reports as “confirmed” would, obviously, be an error. Before COVID-19, a science blogger looked at reports of death from HPV vaccines. Two of the deaths were suicides. Out of 11 reports, several were anecdotes that people heard – for example, VAERS #0425680 said that:

A consumer reported that he/she obtained the information from internet concerning a 17 years old woman who in June 2007 was vaccinated the first dose of GARDASIL. In the afternoon of the same day, in June 2007, the patient was found unconscious (without signs of life) by her mother. The doctor from the emergency crew attempted resuscitation, but without success. The cause of death was unspecified. This is one of several reports received from the same source. No further information is available.

Similarly, #0425598 said that:

A consumer reported that he/she read an internet concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot # , dose and route not reported). On an unspecified date, the patient died of “”clot blood”” eight hours after vaccination. This is one of several reports from the same source. No further information is available.

Treating these second-hand reports as “verified” is problematic. 

In a list with VAERS reports (you can check on them – add a 0 before numbers with six digits), the organization Start Mandatory Vaccination gives a list of VAERS reports submitted. They include “child abuse by caregiver” and “Dog has fleas which bit the patient.” In what sense are these “confirmed”?

Anti-vaccine activists reasonably point out that filing a false VAERS report can be a crime. The VAERS site says: “Knowingly filing a false VAERS report is a violation of Federal law (18 U.S. Code § 1001) punishable by fine and imprisonment.” This is a catch-all provision to penalize people for “knowingly and willfully” making false statements or submitting false documents to the government.

In theory, that would be a deterrent to fake reports. In practice, it’s not going to prevent VAERS from having a lot of noise. First, a report can be completely true and yet unrelated to vaccines. As a reminder, providers are required to report any death after vaccines – even if unrelated. Second, the provision requires intent: knowing and willing. Someone who thinks something happened, sincerely, will not be liable under it. Finally, you can comply with this and still file a report by, sincerely, as above, saying you read it on the internet. 

I know of no – zero – prosecutions of anyone for filing a false VAERS report, and I’ll be surprised if we see one. First, it will be hard to prove the intent to lie. People just have to believe what they write (or the error is a negligent one). Second, it’s likely not going to be considered worth it; prosecutors always have limited time and resources, and unless there’s a large, systematic effort, it’s not going to be worth prosecuting. So this provision doesn’t change things. 

Dr. Rose’s claim

Dr. Rose said this, “A reported injury that gets into the front-end downloadable database IS a confirmed injury” and provides as reference this link.

This is obviously, as explained above, incorrect. At best, this is a gross error. At worst, a misrepresentation. If Dr. Rose understands VAERS so poorly that she thinks this is true, she is not qualified to work with VAERS data: her understanding of the system is simply too poor.

If she does not and is intentionally lying, she is an untrustworthy source. In either case, her VAERS work cannot be relied on. Although her initial link does not support her claim, I wonder if she meant to link here — where VAERS say it says a “confirmation letter” to individuals. If that was her thought – that this means the event is “confirmed” – it’s highly misleading.

People who read “confirmed,” think it means that the event was verified. This confirmation letter – before any step to verify the report has been taken – clearly only refers to confirming that the report was submitted. Her readers are unlikely to understand it that way, and her other statements – treating VAERS reports as proven, vaccine-related events – also suggest that she is not treating this way: that she, too, sees “confirmed” as “verified” and likely also “vaccine-related.” A VAERS report in the database, by itself, is neither. 

4. What is the reality of submitting an adverse event report to the VAERS system?

I will actually start with Dr. Rose’s comment here. Dr. Rose said:

It takes 30 minutes – at least – to file a VAERS report online. It requires a multi-electronic page submission of detailed information and each electronic page is time-restricted. This means that if one does not complete the electronic form fast enough, one must begin the submission process again. The vetting process is long and dealt with by a handful of contracted employees.[10] There is a massive backlog of data in VAERS.[11]

VAERS facts

As before, this can be true or misleading. The actual form for VAERS is a four-page form with many parts. But look at this report above. The event description sayspt recvd vax; 8aug95 devel fever & a few lesions on lower extremities;by 15aug95 devel 50 gen vesicular lesions;pt was seen by MD who thought lesions were flea bites;f/u: lesions resolved p/ family’s pet dog was removed from home;pt fine.” 

Would this really take 30 minutes to write? Or this, with the description above of an internet myth.

This report of an unlikely, unverified claim was, apparently, filed by an anti-vaccine nurse.

VAERS facts

It’s short, has minimal details, and there is no good reason to assume it took 30 minutes to fill. The system accepts reports that do not include all the details. As with online comments, you can write a detailed report – that might be time-consuming – or a short partial one. 

What about follow-up? Because of the anticipated VAERS workload – with a massive vaccination effort like COVID-19 was always bound to be, CDC and FDA prepared a planning document. The plan was for a contractor to review each report and ask for medical records for each serious report, including death. The CDC appears to have overestimated its capacity here because, in its Lancet analysis, the authors explained that “[a]lthough VAERS death reports were individually reviewed by CDC physicians and follow-up is ongoing to obtain additional and missing records, other reports of serious adverse events were not individually reviewed.”

So death reports are followed with a request for records, at least, but other reports may not be, and at any rate, it can take time. In the analysis of VAERS published in the Lancet, all deaths  reported were reviewed thus:

VAERS staff requested death certificates and autopsy reports for reports of death. CDC physicians reviewed VAERS reports and available death certificates for each death to form an impression about cause of death. Impressions were assigned to one of the following categories: one of the 15 most common diagnostic categories from the International Classification of Disease, Tenth Revision, reported on US death certificates,

COVID-19 related, other (ie, impression was not included in prespecified categories), or unknown or unclear if not enough information were available to determine a cause of death.

In addition, when questions about the relationships between potential risk and the vaccine come up, CDC scientists review the data and address the report. The Advisory Committee on Immunization Practices gets detailed presentations on this in its meetings. On July 19, 2022, for example, the CDC team presented on myocarditis following mRNA vaccines.

5. What percentage of actual incidents is reflected by the number of reports – and how are we making that guess?

The short answer to this one is that you cannot use VAERS reports alone to assess the number of events, not without a lot more investigation, and anyone who does that is either not knowledgeable or dishonest. The numbers are going to have issues both ways, as discussed in more detail in the previous answers: some reports may be wrong, or unrelated to vaccines, and some actual events are not going to be reported. 

Dr. Rose said:

“The under-reporting factor represents the percentage of individuals who actually experienced an adverse event in contrast with how many individuals reported an event. Studies have shown that the percentage of incidents reported can be quite low (1–10%). My own study showed an under-reporting factor of 31, which means that each stand-alone adverse event count must be multiplied by a factor of 31.[12],[13],[14] Steve Kirsch also estimated the under-reporting factor to be 41 based on Anaphylaxis data.1

What Dr. Rose is doing here is a double misrepresentation. Maybe a triple.

First, she claims that only 1-10% of actual harms are reported to VAERS. This is an old anti-vaccine trope, and in its latest form, the one quoted in Dr. Rose’s reference 12, draws on an electronic, unpublished report by a group that examined VAERS in 2006-2009. The report did conclude that only one percent of issues were reported, but –

  1. It never provided a basis for that number, so we cannot check it.
  2. That number included all adverse events, not serious ones. I’m willing to assume sore arms after covid-19 vaccines are extremely under-reported to VAERS. Hey, my arm hurt for a day or two after the first two doses, and I did not report that. But we know that serious events are reported at substantially higher rates because studies have looked at that. By the way, a later report, found that the VAERS system’s reporting substantially improved after the report anti-vaccine activists like to cite – but the anti-vaccine activists won’t tell you that. 

Second, Dr. Rose makes up an underreporting factor. Data does not support her claim that serious harms are underreported by a rate of 30 or 40. She has no good basis for that number, nor the training to calculate it. So she makes up a number and wants her audience to use it as fact.

Third, Dr. Rose completely ignores overreporting – reporting of things not related to vaccines. It just does not figure in her book. In her book, fleabites after the vaccine are vaccine-related. That is problematic. 

6. What are the top injuries reported with percentages?

As mentioned already, the number of VAERS reports does not give you an indication of the rate of a problem or whether it’s connected to the vaccine. So the answer to this is meaningless. But Dr. Rose’s response here is also wrong. Dr. Rose alleges that “Cardiovascular and neurological injuries remain highest with regard to grouped adverse event reporting frequency.”

She refers to her own analysis published in IPAK’s home publication. 

What the actual scientists at CDC that analyzed the report found were:

“The most common MedDRA preferred terms assigned to non-serious reports were headache (64 064 [20·4%] of 313 499), fatigue (52 048 [16·6%]), pyrexia (51 023 [16·3%]), chills (49 234 [15·7%]), and pain (47 745 [15·2%]; table 1). The most common MedDRA preferred terms assigned to serious reports were dyspnoea (4175 [15·4%] of 27 023), death (3802 [14·1%]), pyrexia (2986 [11·0%]), fatigue (2608 [9·7%]), and headache (2567 [9·5%]; table 1).”

They also found that “313 499 (92·1%) were classified as non-serious; 22 527 (6·6%) were serious, not resulting in death, and 4496 (1·3%) were deaths (table 1).”

From the serious events, dyspnoea is shortness of breath. Pyrexia means fever. (In case, like me, you’re a lay person). So the most common serious reports are breathing issues, death, fever, fatigue, and headache. Heart diseases were leading among the death reports, but that pattern matched what is usual in the population – there was no concerning pattern – and aside from myocarditis, there is no link between covid-19 mRNA vaccines and heart problems in studies. Myocarditis is a serious issue and deserves attention, but is well known and monitored. 

7. How does this injury rate compare to all other vaccines recorded by VAERS?

Dr. Rose correctly points out that the rate of reporting to VAERS is much higher after COVID-19. But that’s not surprising.

First, the COVID-19 vaccines were an unusually large vaccination effort; over 78% of the United States population has received at least one dose of them, over 260 million people. That is a lot of people, and we would expect more things to happen after vaccines, if only by coincidence. Further, VAERS received attention during the COVID-19 pandemic in part due to the increased attention to vaccines, and in part due to the growing link between anti-vaccine groups and right-wing media. For example, Tucker Carlson mentioned VAERS on several shows, giving the database unprecedented exposure – and leading to coverage in major news outlets giving the database even more attention. 

Unusually large vaccination drive lots of attention – it’s not surprising there are more reports. That alone does not justify ignoring the analysis of the reports (most of which are non-serious) or the analysis of the deaths reported to VAERS and whether they are, in fact, linked to COVID-19 vaccines. Aside from the deaths linked to a specific type of clots related to J&J vaccines, the answer is that the deaths are, so far, not linked to the vaccines 

8. That amazing CDC ad looking for analysts to cover the 770,000 incidents related to COVID alone.

This refers to a previous article Dr. Rose wrote that described an email she got for a job opportunity with CDC helping process VAERS reports. This is a reiteration of the claim that “hey, there are many more reports now.” Again, we have an unprecedented effort to vaccinate most of the population, with unusually broad coverage with multiple causes for vaccines. Of course, there are more reports – most of them, by the way, non-serious.

If the complaint is “the CDC should not hire people to review the reports,” well, I think it’s a good thing that CDC takes the reports seriously and investigates them. This is not the gotcha anti-vaccine activists think it is. 

Conclusion about VAERS facts

VAERS is a very, very useful tool to detect problems with vaccines by providing a fast operating system that can quickly detect safety signals that can then be investigated, to see if they’re linked to vaccines. It’s also very vulnerable to misrepresentation and abuse by anti-vaccine activists. Anti-vaccine activists have been abusing it for years, and Dr. Rose appears to have built a new career by misrepresenting it to claim COVID-19 vaccines have risks not supported by the actual data. 

VAERS reports do not show causation. They cannot be taken at face value without investigation. The Q&A set by Dr. Rose assumes the opposite and therefore provides readers with incorrect, misleading answers that can lead them to unnecessary risks from COVID-19. Her readers deserve better. 

Dorit Rubinstein Reiss

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