Unsubstantiated claim that COVID-19 vaccines have caused hundreds of severe reactions in military veterans misuses VAERS reports

FULL CLAIM: “Judicial Watch announced today that it has received 75 pages of documents from the Department of Veterans Affairs detailing the adverse reactions of veterans to COVID-19 vaccines. In April 2021, Veterans Health Services reported 895 serious reactions, including: 20 cardiac arrests, 36 strokes, 15 cases of deep vein thrombosis, 10 heart attacks and 19 pulmonary embolisms. ”

MEET AGAIN

On July 14, 2021, the organization Judicial Watch said in this statement to have files “detailing the adverse reactions of veterans to COVID-19 vaccines”. These suspected reactions included cardiac arrests, stroke, deep vein thrombosis, heart attacks, and pulmonary embolisms. The organization shared the press release on its Facebook, Instagram and Twitter accounts, receiving more than 132,000 interactions on these platforms.

The claim is based on a 75-page document that the Department of Veterans Affairs (VA) sent in response to a request from Sean Dunagan, a senior investigator for Judicial Watch. Although the press release suggests otherwise, the main part of the document is unrelated to vaccine-related adverse events. Instead, the first 65 pages provide interim guidance for COVID-19 vaccination and prioritization in the Veterans Health Administration.

All adverse event information appears in a nine page overview set attached at the end of the VA document. This section includes a graph showing the frequency of the most common side effects, such as muscle pain, headache, fever, and fatigue. Finally, three tables list the adverse events that the remaining five slides break down based on their severity, timing, and whether they happened to veterans or staff. The document states that the VA reported all of these adverse events to the US Adverse Reaction Reporting System (VAERS), which means the information is publicly available in the VAERS database.

Since the start of COVID-19 vaccination campaigns, VAERS reports have been repeatedly misused to claim that COVID-19 vaccines are harmful. Another example is the Judicial Watch press release, as it incorrectly used VAERS reports to suggest that COVID-19 vaccines caused 895 serious adverse effects in military veterans. Such claims are unsubstantiated and are misleading because VAERS reports alone cannot prove that a vaccine caused an adverse event, as Health Feedback previously explained here, here, and here.

VAERS is a vaccine safety reporting system that collects information on adverse events that occur after receiving a vaccine. These safety monitoring systems aim to identify potential rare side effects, that is, those that occur in less than 0.1% of the population. As their frequency is very low, such effects may go unnoticed in clinical trials and only appear in very large populations. Therefore, VAERS serves as a “national early warning system for detecting possible safety issues in licensed vaccines.

Anyone can voluntarily report any health problem resulting from vaccination to VAERS, even if it is clearly unrelated to the vaccine, such as a broken arm. This means that the VAERS database contains “incomplete, inaccurate, incidental or unverifiable” information, as the United States Centers for Disease Control and Prevention clearly warns. In other words, VAERS reports show that an adverse event occurred after vaccination. However, this temporal association alone is insufficient to prove that the vaccine caused the event.

Demonstrating causation, i.e. showing that the vaccine caused an adverse event, is not so straightforward and requires further investigation. This Health Feedback informational article discussed the multiple aspects to be taken into account in deducing the causality of adverse events. These include the baseline rate of the adverse event in the general population and the size of the population considered.

As of July 22, 2021, nearly half of the American population was already fully vaccinated with one of the three COVID-19 vaccines currently authorized by the United States Food and Drug Administration (FDA). In addition, 186 million people in the United States have received at least one dose of the vaccine. Accidental illnesses are expected to occur in such a large population, which doesn’t mean COVID-19 vaccines cause them. Likewise, VAERS reports from the VA do not show that vaccines caused 895 serious adverse events in military veterans.

FDA-cleared COVID-19 vaccines have been shown to be safe and effective at several stages of clinical trials, which is a prerequisite for obtaining emergency use clearance. While COVID-19 vaccines can have side effects, like all medications, these are usually mild and only last a few days. On the other hand, serious health problems after vaccination are rare.

Real-world safety monitoring data is reassuring, showing that COVID-19 vaccines are highly effective against disease and have a high safety profile^[1-3]. In July 2021, a large study published in Annals of Internal Medicine showed COVID-19 mRNA vaccines to be over 95% effective in preventing infection in military veterans[4]. This group is at greater risk for severe COVID-19 than the general population due to their age and the prevalence of underlying health conditions. Therefore, COVID-19 vaccines are an extremely effective tool to protect them from the risks associated with the disease.

THE REFERENCES