Improving public understanding of the vaccine adverse event reporting system

The Vaccine Adverse Event Reporting System (VAERS) is an open, national surveillance system used by medical professionals as well as the public at large to self-report potential adverse medical events following vaccination. These events are entered as unconfirmed reports to VAERS, which is managed by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). As the CDC notes, “Reports sent to VAERS may include incomplete, inaccurate, coincidental, and unverified information.”

Pre-pandemic, there was little public attention paid to VAERS. Since the pandemic and the development of vaccines against Covid-19, however, vaccination-related information has flooded social media around the globe. The result has been an “infodemic” fueled by mis- and disinformation about vaccination, some of which is based on a misreading, misunderstanding, or misrepresentation of what VAERS is and what its reports show.

In a new Viewpoint piece in the Journal of the American Medical Association (JAMA), “Misinformation and the Vaccine Adverse Event Reporting System,” three University of Pennsylvania scholars examine how VAERS reports have been misrepresented during the pandemic. Drawing on data first published in an Annenberg Public Policy Center white paper, the researchers argue that the VAERS system has been misused by vaccine skeptics to fuel vaccine hesitancy. They urge public health agencies to improve public understanding of the vaccine surveillance reports and their significance – or lack thereof.

The paper is written by Kathleen Hall Jamieson, Ph.D., director of the Annenberg Public Policy Center (APPC) of the University of Pennsylvania and a professor of communication at Penn’s Annenberg School for Communication; Kevin B. Johnson, M.D., M.S., a professor of pediatrics, biomedical informatics, and science communication at the University of Pennsylvania; and Anne R. Cappola, M.C., Sc.M., a professor of medicine and executive director of the Penn Medical Communication Research Institute.

Public uncertainty about VAERS

Americans are not sure whether VAERS verifies that vaccines cause the events reported in the system, according to APPC survey data. A survey of U.S. adults found that from January to August 2022, the percentage of U.S. adults who incorrectly said that VAERS does present vaccine-caused deaths increased significantly – as did the percentage who correctly said it does not. “Worrisomely,” the researchers wrote, “more than 6 out of 10 respondents reported being unsure.”

APPC survey data also showed that just about a third of the public (34%) knows that an “adverse event” in the VAERS name can refer to either a serious or non-serious medical event. These findings were previously reported in the APPC white paper “Minimizing public susceptibility to misconceptions about the effects of vaccination: Vaccine Adverse Event Reporting System.”

Penn professors urge rebranding VAERS

The researchers propose renaming VAERS as the “Vaccine Safety Sentinel,” which “would remind audiences that the incidents of concern are unverified, related to safety, and part of a monitoring or early-warning system.” They also propose improving the system by providing additional details to the public, including summary information linked to raw data, coupled with expanded public education about the vaccination reporting system.

“The false inference that the events reported in VAERS are necessarily caused by vaccination is seeded by the name Vaccine Adverse Event Reporting System,” said Jamieson, who also advanced this case in a March 2022 presentation to the President’s Council of Advisors on Science and Technology, an October 2022 keynote lecture at the CDC’s Shepard Award ceremony, and a May 2023 session at the Nobel Prize Summit. “Changing the name could reduce the public’s susceptibility to deceptive users of VAERS data. In the meantime, we should treat VAERS and ‘unverified’ as synonyms.”

Cappola said, “Names matter. We want to encourage transparency and accessibility, but not at the expense of misinterpretation.”

Johnson added: “I’ve had some success working with the FDA to change their policies on blood donations from men who have sex with men. Thanks to our collective efforts, I hope the FDA and CDC receive pressure to address the role VAERS plays in supporting misinformation.”