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WHAT AMERICANS NEED TO KNOW ABOUT THE GOVERNMENT'S VAERS DATABASE: ANALYSIS

"This is truly a model of transparency."

ByDr. Karine Tawagi
24 April 2021, 13:00
• 5 min read
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Nearly 20 years ago, the federal government launched a massive crowdsourcing
project: A database filled by doctors and patients that could give an early
warning if problems arose with any of the millions of vaccines Americans take
every year.

The system, called VAERS, the Vaccine Adverse Event Reporting System, has now
been credited with identifying an extremely rare chance of a blood clot after
the Johnson & Johnson vaccine.



But with newfound attention on VAERS, this crucial public health system -- which
anyone can access -- is ripe for abuse, misuse and plain misunderstanding.

Key figures in the anti-vaccine movement have latched onto the public database,
incorrectly saying the vaccines directly caused numerous injuries listed in
VAERS. Meanwhile, concerned citizens are increasingly stumbling upon the
database and finding themselves alarmed by the reports.

MORE: CDC confirms more rare reactions following J&J vaccine

Although VAERS contains millions of reports of injuries following vaccinations,
the vast majority of those injuries are coincidental. The system accepts any
report of an adverse event following vaccination, even if it's not clear the
vaccine caused the problem.

For example, in the United States, someone has a heart attack every 40 seconds.
Some may have received a COVID-19 vaccine shortly prior to their heart attack
and that report may have been filed to VAERS. But it does not mean the vaccine
caused the problem.

"VAERS has been in place almost 20 years. It has been used as a radar system to
detect signals on vaccine safety issues ... and has been ramped up in response
to the COVID vaccine," said Dr. William Schaffner, a professor of preventative
medicine and infectious diseases at Vanderbilt University in Nashville.



Added Dr. John Brownstein, an epidemiologist at Boston Children's Hospital and
an ABC News contributor: "This is a frontline system which can quickly capture
data about what's happening in the population through self-report."

Anyone can use VAERS. All you need to do is download the app V-safe or enter
"vaccine reporting" in Google. It is very user-friendly and anyone can access
the data reported on VAERS.

"This is truly a model of transparency," Schaffner said.

MORE: The number of Americans getting vaccinated is on the decline

While abuse and misunderstanding are possible, a fully transparent system builds
confidence that the pharmaceutical industry and government can't hide cases of
adverse events during mass immunization campaigns.

And because it's a crowdsourced system, VAERS is the best way to detect
extremely rare side effects that may not otherwise have been identified.

"Think of how useful it has been. VAERS found a needle in a haystack," Schaffner
said. "These clotting events with [low platelets] occurred at a rate of 1 in
over 1 million doses of vaccine. It found a signal, which was investigated, and
health officials immediately convened an emergency meeting."

Federal and pharmaceutical authorities are alerted when the frequency of a side
effect is higher than would be expected in a large unvaccinated population,
explained Dr. Nabarun Dasgupta, an epidemiologist at the University of North
Carolina.

For public health experts, the expected frequency of health problems -- such as
one heart attack every 40 seconds -- is called the expected "background rate."
The VAERS system helps identify problems that exceed the expected background
rate.

One, however, must be cautious of misinformation entered on the site, including
false reports.

Government agencies look systemically for patterns related to the vaccine, and
when someone gets sick or dies shortly after the vaccine, this is investigated
in a very serious fashion to ensure there is no link or inaccurate reporting.

"It's funny because when you click submit, there is actually a big warning sign
... if misinformation is entered, it can actually result in legal action," said
Brownstein. "There is sort of a history for those who may want to perpetuate
misinformation about vaccines to use fear as a tool to do so."

Despite its limitations, VAERS has proven to be a valuable tool. Patients
receiving the vaccine are strongly encouraged to use the system so future
adverse events can be identified.

Karine Tawagi, M.D., is a hematology and oncology fellow at Ochsner Medical
Center in New Orleans and a contributor to the ABC News Medical Unit.

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