Name Change Needed for Vaccine Adverse Event Reporting System to Reduce Misinformation, Says Penn’s Annenberg Center

Hardly anyone except researchers, drug regulators and pharmaceutical companies had heard of the Vaccine Adverse Event Reporting System until COVID-19 vaccination began. Then a lot of people suddenly did as anti-vaccination groups and the far right manipulated the publicly available reports to falsely claim that immunizations to protect against the coronavirus were killing tens of thousands of people.

Those claims, which likely stopped unknown numbers of people from getting vaccinated, putting their own lives at risk, were made easier by a single attribute of the reporting system, according to a new report: its name.

The Vaccine Adverse Event Reporting System is a database where anyone — health provider, patient, manufacturer, neighbor — can report any event, confirmed or not, that they think might be related to vaccination. Events range from redness and soreness around an injection site to serious disease — and even to death),

A report released earlier this week by the Annenberg Public Policy Center of the University of Pennsylvania, examines how the name of the monitoring system, as well as descriptions and caveats about its contents that are less visible than they might be, allowed anti-vaxxers and politicians to more easily mislead the general public about the safety of COVID-19 vaccines. The vaccines have proven to be extraordinarily safe and effective.

The 30-page document, produced in partnership with Critica, a nonprofit that develops and tests ways to counteract scientific misinformation and promote the use of research evidence in policymaking, also recommends ways to fix the problem.

VAERS, which is jointly managed by the CDC and FDA, was created in 1990 as an early warning system for rare problems with U.S.-licensed vaccines, including how they are administered and persistent clerical errors, that might emerge from patterns of reports when the numbers of people getting vaccinated are far larger than even the biggest clinical trials.

Drug manufacturers are required to report all adverse events that come to their attention following vaccination, regardless of whether they are related to the vaccine. Healthcare providers must report certain adverse events. But the system is open to anyone, and anything can reported. The data are fully available to the public regardless of confirmation.

Indeed, several years before the pandemic, in order to prove a point, an anesthesiologist named James R. Laidler reported to VAERS that after receiving an influenza vaccination “his skin turned green, his muscles grew and he started having rage problems,” a la the Hulk. The claim was so unusual that a representative of the reporting system contacted him and then sought his permission to remove the entry, which he granted. Had he not, Laidler later wrote on the neurodiversity weblog, the claim would have remained in the system.

This level of uncorrected transparency has allowed the data to be misused in the past, for example in claims that the MMR vaccine caused autism. But that was nothing compared to what happened when COVID-19 vaccines first came on the market under FDA emergency use authorizations in late 2020 and early 2021.

The Annenberg report cites data showing an immediate spike in web content that referenced VAERS. There were nearly 45,000 public interactions with that content in March 2021, up from essentially zero two months before. An analysis of a subset of the web content that mentioned VAERS between March 1, 2020, and April 1, 2023 found that 84% of the items assumed or asserted that the vaccines were unsafe compared with 16% that said they were safe.

The public interactions with related content have remained elevated, varying from a few thousand to up to 30,000 a month, with the numbers gradually declining -- until spiking again to more than 40,000 in January 2023after social media that a COVID-19 vaccine had caused Buffalo Bills safety Damar Hamlin to collapse on the field. (Doctors later diagnosed the cause as commotio cordis, a condition in which something hitting someone’s chest directly over the heart can cause cardiac arrest.

Polling data, meanwhile, shows that the public is confused about what VAERS contains, with 63% saying in an August 2022 survey that they weren’t sure whether deaths following COVID-19 vaccination in the database had been confirmed to be related to the vaccine compared 27% correctly saying that they were not confirmed and 10% incorrectly saying they were.

That confusion has allowed misinformation to proliferate.

On May 5, 2021, for example, Tucker Carlson said on his top-rated Fox News show: “Between late December 2020 and last month, a total of 3,362 people died after getting the COVID vaccine in the United States, 3,362. … The actual number is almost certainly higher than that, perhaps vastly higher than that. The data we just cited come from the Vaccine Adverse Events Reporting System, VAERS.”

In fact, a CDC review of VAERS reports one week earlier had found no evidence at that point that vaccination had contributed to any deaths.

On Jan. 3, 2021, Sen. Ron Johnson (R-Wis.) tweeted, citing VAERS, that 21,002 people had died worldwide following COVID-19 vaccination.

The CDC, which regularly reviews VAERS data, said on March 7, 2023, that the raw data included 19,476 reported deaths following vaccination immunization. The agency said that it had identified “nine deaths causally associated with J&J/Janssen COVID-19 vaccination,” and zero from the Pfizer and Moderna mRNA vaccines received by the vast majority of vaccinated Americans).

To reduce misunderstanding and misuse of the Vaccine Adverse Event Reporting System, the Annenberg/Critica report makes several recommendations:

• In the name: Replace the current adverse event with some combination of “safety monitor,” “safety watch” of “safety sentinel.” For example: “Vaccine Safety Watch: Incident Reporting System.”
• Until the name is changed: Routinely point to the current clarifying subtitle -- A National Program for Monitoring Vaccine Safety -- whenever mentioning VAERS.”
• In guides and descriptions of VAERS: Preface mentions of death or adverse events in the database with “unconfirmed,” and preface the word data with “raw.”
• In all public statements: Reiterate that VAERS data are unverified (perhaps abbreviating it as “uVAERS”).