Following the FDA’s full approval of the Pfizer COVID-19 vaccine, social media lit up with posts questioning the decision with claims that thousands of people have died because of the vaccine.
The posts cite reports submitted to the Vaccine Adverse Event Reporting System (VAERS), a database managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA).
“How the hell can the FDA ‘approve’ the Pfizer COVID vaxx when they are blatantly aware of the VAERS data,” reads one tweet with a chart purporting to show more than 10,000 deaths in the U.S. caused by the vaccine.
Does the VAERS database show thousands of people have died because of the COVID-19 vaccine?
- Dr. Arnold Monto, epidemiologist at the University of Michigan
- Dr. Prathit Kulkarni, infectious disease specialist at Baylor College of Medicine
- Vaccine Adverse Event Reporting System (VAERS) database
- Centers for Disease Control and Prevention (CDC)
No, data on the VAERS database does not show thousands of people have died because of the COVID-19 vaccine. Any person can report any adverse event that occurs after vaccination to the site to be further investigated but it does not prove causation.
WHAT WE FOUND
Not included in many posts citing VAERS data are the numerous disclaimers on that same site warning reports alone submitted to the database cannot be used to determine if a vaccine contributed to an adverse event because reports can be incomplete, inaccurate, coincidental, or unverifiable.
The VAERS system has been used since 1990 as a sort of early warning system, allowing researchers to monitor reported, suspected side effects to detect potential unusual or rare patterns that might require further investigation or intervention.
Since mid-December, more than 357 million doses of COVID-19 vaccines have been administered, according to the CDC. As of August 16, VAERS received 6,789 reports of death (0.0019 percent) among people who received the COVID-19 vaccine.
The FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, according to the CDC, even if it’s unclear whether the vaccine was the cause.
Dr. Arnold Monto, a professor in epidemiology and public health at the University of Michigan and acting chair of the FDA's Vaccines and Related Biological Products Advisory Committee, further explains how the site is intended to be used.
He refers to it as “cries of alarm” because what’s reported isn’t necessarily causal or sometimes, frankly, even true.
An actual report found in the database submitted by someone after receiving the measles, mumps and rubella (MMR) vaccine claimed an adverse event was "turning green, super strength and rage attacks."
"The VAERS system is set up to be open-ended—in other words, you can report anything that occurs after vaccination,” Monto said.
But that’s only the first step.
“Then you have to figure out whether it’s really related to the vaccination or not,” Monto said. “You need the second step—doing the analysis.”
When it comes to reported deaths, Dr. Prathit Kulkarni, an infectious disease expert at Baylor College of Medicine, said it’s important to remember there’s always a certain number of deaths happening daily— regardless of a pandemic or vaccinations—so parsing out causality from coincidence becomes key.
“There’s a baseline rate of people passing away every day,” Kulkarni explained. “Now you’re suddenly giving millions of people the vaccine so there could be some idea that the vaccine caused it, but it might’ve happened anyway… because that was happening at a baseline rate in the population.”
COVID-19 vaccine-related deaths are rare, according to the CDC, but have occurred.
“A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines,” reads a statement on the CDC site.
“However, recent reports indicate a plausible causal relationship between the Johnson & Johnson/Janssen COVID-19 Vaccine and TTS, a rare and serious adverse event—blood clots with low platelets—which has caused deaths." the site continues.
There are three known deaths associated with vaccines, according to this Advisory Committee on Immunization Practices report.