- Health
VAERS death reports don’t prove COVID-19 vaccines killed hundreds of thousands, contrary to claim by Steve Kirsch
Key takeaway
The COVID-19 vaccines were initially issued in the U.S. under Emergency Use Authorization by the FDA, which requires every serious adverse event that occurred post-COVID-19 vaccination to be reported, regardless of whether healthcare providers believe the vaccine was the cause. This led to an increase in the number of deaths reported in VAERS following the rollout of the COVID-19 vaccines in 2021. However, studies have shown that vaccinated people don’t experience a higher risk of mortality compared to unvaccinated people.
Reviewed content
Verdict:
Claim:
Verdict detail
Flawed reasoning: The claim that vaccine-related deaths are being underreported by a factor of 41 is based on a flawed analysis co-authored by Kirsch, using assumptions that aren’t supported by evidence. Inadequate support: An adverse event reported to VAERS doesn’t necessarily mean that the vaccine caused the issue. The VAERS database is a tool that helps identify unusual patterns that could indicate rare side effects. Determining whether the vaccine caused the event requires a much more detailed investigation beyond the total number of reports. Lack of context: The COVID-19 vaccines initially received Emergency Use Authorization by the FDA to speed up the rollout, which came with stricter reporting requirements to VAERS. Therefore, the number of VAERS reports associated with the COVID-19 vaccines is higher than for previous vaccines.
Full Claim
Review
A Facebook video posted on 6 August 2022 showed Steve Kirsch, a known spreader of COVID-19 misinformation, claiming that the COVID-19 vaccines caused higher rates of death than previously reported. Specifically, he claimed that these deaths were underreported by a factor of 41, which translated into 410,000 deaths post-vaccination as the VAERS database contains 10,000 deaths reported.
Kirsch further claimed that the vaccines caused essentially a blood-clotting epidemic, stating that an embalmer he spoke to said that blood clots were present in 93% of the people who died following vaccination, something which has “never been seen before the vaccine rolled out”.
The video is an excerpt of the “Expert Panel Discussion on COVID-19 and Medical Freedom”, hosted by Pennsylvania State Senator Doug Mastriano on 4 March 2022. Multiple copies of the video still circulate online, like the Facebook video.
Kirsch later made similar allegations in a blog post, where he claimed that the U.S. Vaccine Adverse Event Reporting System (VAERS) reports prove that COVID-19 vaccines killed thousands of people. Health Feedback previously debunked a similar claim from Kirsch.
The headline of his blog post read: “VAERS data is crystal clear: The COVID vaccines are killing an estimated 1 person per 1,000 doses (676,000 dead Americans)”.
These types of allegations against COVID-19 vaccines have been rife in the media, with many claims that COVID-19 vaccines are responsible for deaths. But Kirsch’s claim is rooted in very old vaccine misinformation, as we will explain below.
VAERS reports of deaths alone don’t prove that COVID-19 vaccines killed people
VAERS is a passive reporting system where individuals can voluntarily report any adverse event they experience after receiving a vaccine. These reports are all publicly available and are then assessed by the U.S. Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) to determine whether there is a genuine safety concern. The CDC and FDA don’t restrict what people can report, as long as it happened following vaccination.
The site contains a disclaimer, stating that “a report to VAERS does not mean that the vaccine caused the adverse event, only that the adverse event occurred sometime after vaccination”.
This is because VAERS isn’t designed to establish that a vaccine caused any specific health problem, although it’s useful for detecting patterns of adverse events reported by the public, which can be further investigated by scientists. For example, VAERS data first surfaced reports of myocarditis following the second dose of COVID-19 mRNA vaccine.
Because people can report any event post-vaccination, VAERS reports cannot be taken at face value and it’s critical to first assess reports to determine if a vaccine-related cause is plausible. For example, in 2021, the CDC had to remove a false report of a 2-year-old who supposedly had died after receiving the Pfizer vaccine. One report even claimed someone turned into the Incredible Hulk.
Kawsar Talaat, a vaccine scientist and associate professor at the Johns Hopkins Bloomberg School of Public Health, said that “the COVID vaccine especially is where VAERS has gotten so misused. Eighty percent of people in this country have gotten at least one dose. Well, a lot of things have happened to 80% of people in the last two years that are unrelated to the vaccine”.
Alongside the fact that more people reported adverse events due to the high vaccination rates, the reporting rules were different for COVID-19 vaccines. This is because all manufacturers and healthcare providers administering the vaccines had to report all serious adverse events regardless of the cause.
This more stringent and comprehensive reporting requirement doesn’t apply to earlier vaccines, such as childhood vaccines. For these, only deaths that are linked to known vaccine side effects need to be reported by those administering them.
Since the COVID-19 vaccines were released, only nine deaths to date have been linked to them, specifically the Janssen vaccine in all cases.
Health Feedback previously debunked many similar claims of increased adverse event reports to VAERS, including increases in deaths and miscarriages.
Analysis claiming to show an underreporting factor of 41 is highly flawed
Kirsch’s multiplying VAERS reports of death by a figure of 41 is likely derived from an analysis that he co-authored, which alleged that genuine vaccine adverse events are underreported by a factor of 41. Briefly, Kirsch had arrived at this number by comparing one hospital’s reporting rates of post-vaccination anaphylaxis[1] and VAERS reporting rates of anaphylaxis as of March 2021.
Jeffrey Morris, a biostatistician and professor at the University of Pennsylvania, explained in an article why Kirsch’s assumption of an underreporting factor of 41 is baseless.
He pointed to a study which also examined the issue of vaccine adverse event underreporting. This study looked at adverse event reports for seven vaccines in the Vaccine Safety Datalink, a database that aggregates reports from healthcare institutions across the U.S. The study concluded that anaphylaxis was underreported by a factor of 1.3 to eight times, depending on the vaccine.
Morris also looked at studies that estimated the rate of myocarditis and pericarditis following mRNA vaccination[2,3], and when combined with Kirsch’s own figure for VAERS reporting of myocarditis and pericarditis, Morris found that the underreporting factor ranged between two to 2.7 times.
Morris concluded by pointing out that “it is difficult to see the plausibility of Kirsch’s [underreporting rate] estimate of 41x”, given how far out of range Kirsch’s figure is. He also highlighted that since death is a more serious adverse event compared to anaphylaxis, its underreporting rate should actually be lower than that of anaphylaxis.
In brief, Kirsch’s claim that post-vaccine deaths are underreported by a factor of 41 is based on a highly flawed analysis and baseless assumptions.
Studies haven’t found that vaccinated people are more likely to die compared to unvaccinated people. One such example is a CDC study examining the period between December 2020 and July 2021[4], which found that COVID-19 vaccine recipients had lower rates of non–COVID-19 mortality.
Another study in the state of Indiana, which included more than 520,000 people, compared vaccinated people with unvaccinated, previously infected people. The study found that all-cause mortality was 37% lower in the vaccinated group[5].
Blood clots after death don’t demonstrate COVID-19 vaccines caused the deaths
Kirsch’s claim that 93% of people who died after COVID-19 vaccines became available had blood clots is likewise unsubstantiated, but even if true, wouldn’t necessarily be a sign that COVID-19 vaccines caused the blood clots. Blood clotting can naturally occur after death due to blood settling in the body. Health Feedback addressed similar claims in an earlier review.
Certain COVID-19 vaccines like the Janssen COVID-19 vaccines have indeed been associated with a slightly elevated risk of a particular blood clotting disorder. However, COVID-19 itself actually increases the risk of blood clots and other cardiovascular complications, and this risk is greater than that from the vaccines[6,7]. On the other hand, COVID-19 vaccines may reduce the likelihood of clotting by preventing severe COVID-19, a major risk factor for developing blood clots[2,8].
Patients with moderate and even mild COVID-19 have also been found to be at a higher risk of blood clots compared to the general population[6,9,10]. One study that analyzed English and Welsh medical records also found that this risk remained increased for nearly a year following infection with SARS-CoV-2[10]. Overall, the scientific evidence indicates that not getting vaccinated leaves individuals at a higher risk of blood clots from COVID-19.
Conclusion
In summary, it’s incorrect to claim that increased reports of death in VAERS is due to the COVID-19 vaccines. The increase in deaths reported to VAERS after the rollout of the COVID-19 vaccines was due to the heightened reporting requirements for these vaccines. Published studies didn’t find that vaccinated people are more likely to die compared to unvaccinated people. It is COVID-19 itself that poses a greater risk of causing blood clots, not COVID-19 vaccination.
REFERENCES
- 1 – Blumenthal et al. (2021) Acute Allergic Reactions to mRNA COVID-19 Vaccines. JAMA.
- 2 – Barda et al. (2021) Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. New England Journal of Medicine.
- 3 – Diaz et al. (2021) Myocarditis and Pericarditis After Vaccination for COVID-19. JAMA.
- 4 – Xu et al. (2021) COVID-19 Vaccination and Non–COVID-19 Mortality Risk — Seven Integrated Health Care Organizations, United States, December 14, 2020–July 31, 2021. Morbidity and Mortality Weekly Report.
- 5 – Tu et al. (2023) SARS-CoV-2 Infection, Hospitalization, and Death in Vaccinated and Infected Individuals by Age Groups in Indiana, 2021‒2022. American Journal of Public Health.
- 6 – Hippisley-Cox et al. (2021) Risk of thrombocytopenia and thromboembolism after covid-19 vaccination and SARS-CoV-2 positive testing: self-controlled case series study. BMJ.
- 7 – Taquet et al. (2021) Cerebral venous thrombosis and portal vein thrombosis: A retrospective cohort study of 537,913 COVID-19 cases. eClinicalMedicine.
- 8 – Wichmann et al. (2020) Autopsy Findings and Venous Thromboembolism in Patients With COVID-19: A Prospective Cohort Study. Annals of Internal Medicine.
- 9 – Douillet et al. (2021) Risk of symptomatic venous thromboembolism in mild and moderate COVID-19: A comparison of two prospective European cohorts. Thrombosis Research.
- 10 – Raisi-Estabragh et al. (2022) Cardiovascular disease and mortality sequelae of COVID-19 in the UK Biobank. Heart.
- 11 – Knight et al. (2022) Association of COVID-19 With Major Arterial and Venous Thrombotic Diseases: A Population-Wide Cohort Study of 48 Million Adults in England and Wales. Circulation.