Florida Department of Health misleads on COVID-19 vaccine safety with erroneous comparison of VAERS reports

Key takeaway

Multiple studies have shown that the benefits of COVID-19 vaccines outweigh their risks. One of the key reasons for the greater number of adverse event reports for COVID-19 vaccines is the mandatory requirement to report all serious adverse events regardless of causality. Other vaccines don’t carry this requirement.

Reviewed content

Verdict:

Misleading

Claim:

VAERS reports in Florida increased by 1,700% after COVID-19 vaccines became available, signaling safety concerns

Verdict detail

Misleading: It is mandatory for healthcare professionals to report all serious adverse events following COVID-19 vaccination, regardless of whether the vaccine was the cause. The same requirement isn’t imposed on other vaccines, therefore the greater number of reports associated with COVID-19 vaccines compared to other vaccines is expected even without any issues related to COVID-19 vaccine.
Misrepresents source: The study by Dag Berild et al. specifically stated that “No consistent associations were observed between the mRNA COVID-19 vaccines and coronary artery disease, coagulation disorders and cerebrovascular disease”. However, the Health Alert cited it to support the implication that COVID-19 mRNA vaccines are unsafe.

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Full Claim

“In Florida alone, there was a 1,700% increase in VAERS reports after the release of the COVID-19 vaccine, compared to an increase of 400% in overall vaccine administration for the same time period”; “The reporting of life-threatening conditions increased over 4,400%. This is a novel increase and was not seen during the 2009 H1N1 vaccination campaign.”

On 15 February 2023, the Florida Department of Health published a “Health Alert on mRNA COVID-19 Vaccine Safety”, stating that “In Florida alone, there was a 1,700% increase in VAERS reports after the release of the COVID-19 vaccine, compared to an increase of 400% in overall vaccine administration for the same time period” and also an increase in reports of life-threatening conditions by 400%, not seen during the 2009 H1N1 flu vaccination campaign.

Florida State Surgeon-General Joseph Ladapo also shared the Health Alert on Twitter and questioned the safety of COVID-19 vaccines: “Does that sound safe and effective? I didn’t think so either.”

The Health Alert also cited three studies, one by Fraiman et al., one by Sun et al., and another by Dag Berild et al., suggesting that these provided evidence of safety concerns with COVID-19 mRNA vaccines.

It’s not the first time that the Department, led by State Surgeon-General Joseph Ladapo, put out information alleging that COVID-19 vaccines are dangerous. In October 2022, the Department claimed that COVID-19 mRNA vaccines increased the risk of heart-related deaths in men. Health Feedback analyzed the claim and found it to be unsupported by the data presented by the Department. In fact, the analysis actually found lower all-cause mortality rates in vaccinated people across all ages.

Likewise, the Department’s notice about an increase in VAERS reports is highly misleading and the studies it cited don’t provide reliable evidence for the implication that there are safety concerns associated with the COVID-19 vaccines, as we will explain below.

A rise in VAERS reports likely reflects reporting requirements; it doesn’t mean that COVID-19 vaccines are dangerous

Firstly, the Vaccine Adverse Event Reporting System (VAERS) collects reports on adverse events after vaccination, regardless of causality. Therefore it cannot be used alone to imply a vaccine is unsafe.

Secondly, healthcare providers are required by law to report all serious adverse events following COVID-19 vaccination, regardless of whether they believe the vaccination caused the event, as the VAERS website states. The same requirement isn’t imposed on other vaccines like the flu vaccine.

Thirdly, the intense media attention on COVID-19 vaccines and their safety has likely produced a greater level of public awareness, which could plausibly also lead to more reports being submitted, as biostatistician Jeffrey Morris told FactCheck.org.

In other words, the reporting rate of adverse events for COVID-19 vaccines is much higher than that for other vaccines. Therefore, the much greater number of adverse events reported after COVID-19 vaccination is expected to reflect the higher reporting rate. This is why the number of reports for COVID-19 vaccines cannot be directly compared to those for other vaccines. Health Feedback encountered an earlier iteration of this narrative by Fox News host Tucker Carlson, documented here.

The studies cited don’t provide reliable evidence that COVID-19 vaccines present a safety concern

The first study cited is by Fraiman et al., which according to the Health Alert showed COVID-19 mRNA vaccines were associated with an excess risk of serious adverse events. However, the notice failed to also indicate the methodological problems with the study, which several scientists already pointed out in the middle of 2022. Health Feedback addressed the issues with this study at length in an earlier review.

One of the significant limitations of the study is its inconsistency in the kinds of serious adverse events that the authors chose to assess. For example, when counting events for gastroenteritis, the authors considered diarrhea as a relevant event, but not vomiting. Another example is the authors’ inclusion of arthritis as a serious adverse event, but not osteoarthritis (a form of arthritis).

The second study by Sun et al. was represented as showing “increased acute cardiac arrests and other acute cardiac events following mRNA COVID-19 vaccination”. This oversimplifies the study to the point of being misleading. The study reported a correlation between the number of calls made to the Israel National Emergency Medical Services for cardiac arrest and acute coronary syndrome with the number of COVID-19 vaccine doses administered.

Based on this correlation, the authors proposed COVID-19 vaccination as an explanation for these heart-related problems. The most significant problem with this conclusion is that the study didn’t have information on the vaccination status of the people who had heart problems. The first step towards assessing whether COVID-19 vaccination is involved is to see if these cases occurred more often in vaccinated people than in unvaccinated people. Without this information, it is impossible to determine that a causal relationship exists. Health Feedback discussed the study in greater detail here.

Therefore, neither of these two studies offer reliable evidence for the Health Alert’s implication that COVID-19 vaccines present a serious health concern.

As for the third study by Dag Berild et al., the authors reported an association between the AstraZeneca-Oxford COVID-19 vaccine and blood clotting disorders^[1]. This vaccine is a viral vector vaccine and not an mRNA vaccine, and it isn’t used in the U.S, so one cannot claim it as evidence for mRNA vaccines causing health issues in the U.S. The authors also clearly stated that “No consistent associations were observed between the mRNA COVID-19 vaccines and coronary artery disease, coagulation disorders and cerebrovascular disease” [emphasis added].

Therefore, on top of making unsubstantiated claims with flawed studies, the Health Alert also misrepresented the research findings from the study by Dag Berild et al.

The benefits of COVID-19 vaccines outweigh their risks

Multiple studies have shown that COVID-19 vaccines are safer than getting COVID-19. For example, while heart inflammation is associated with COVID-19 vaccination, COVID-19 itself is associated with a much greater risk of heart problems^[2], among others, and this risk persists for at least a year after infection^[3].

Figure 1. There is a favorable benefit-to-risk ratio for COVID-19 mRNA vaccine recipients at highest risk for postvaccination myocarditis^[4]. 

Scientific studies also show that mortality rates aren’t higher in vaccinated people than in unvaccinated people^[5-7].

Overall, the Health Alert’s implication that there are grave safety concerns with COVID-19 mRNA vaccines isn’t substantiated by the data it presents and is contradicted by published studies showing that the vaccines’ benefits outweigh their risks.

REFERENCES

• 1 – Dag Berild et al. (2022) Analysis of Thromboembolic and Thrombocytopenic Events After the AZD1222, BNT162b2, and MRNA-1273 COVID-19 Vaccines in 3 Nordic Countries. JAMA Network.
• 2 – Writing Committee. (2022) 2022 ACC Expert Consensus Decision Pathway on Cardiovascular Sequelae of COVID-19 in Adults: Myocarditis and Other Myocardial Involvement, Post-Acute Sequelae of SARS-CoV-2 Infection, and Return to Play: A Report of the American College of Cardiology Solution Set Oversight Committee. Journal of the American College of Cardiology.
• 3 – Xie et al. (2022) Long-term cardiovascular outcomes of COVID-19. Nature Medicine.
• 4 – Bozkurt et al. (2021) Myocarditis With COVID-19 mRNA Vaccines. Circulation.
• 5 – 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.
• 6 – Bilinski et al. (2023) COVID-19 and Excess All-Cause Mortality in the US and 20 Comparison Countries, June 2021-March 2022. JAMA Network.
• 7 – 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.