ST. PETERSBURG, Fla. — Florida Surgeon General Dr. Joseph Ladapo is warning of an increase in instances of adverse side effects he says are linked to the mRNA COVID-19 vaccines, citing unverified reports from a government database.
In a letter this week addressed to the Centers for Disease Control and Prevention and the Food and Drug Administration, Ladapo wrote, “researchers throughout our country and around the globe have seen troubling safety signals of adverse events surrounding this vaccine.” He went on to write that those concerns are “corroborated by the substantial increase in VAERS reports from Florida, including life-threatening conditions.”
VAERS is the Vaccine Adverse Event Reporting System, a database managed by the CDC and the FDA.
Any person can report any adverse event that occurs after vaccination to the VAERS site to be further investigated. It does not prove causation, University of Michigan epidemiologist Dr. Arnold Monto previously explained to 10 Tampa Bay.
"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.”
He refers to it as “cries of alarm” because what’s reported isn’t necessarily causal or sometimes, frankly, even true.
An actual report 10 Tampa Bay 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 website says any report submitted to the database is “not documentation that a vaccine caused the event.”
A disclaimer on the VAERS website warns submissions “may include incomplete, inaccurate, coincidental and unverified information.”
Ladapo said the increased reports to the site show there is a "need for additional assessments and research regarding safety of all mRNA COVID-19 vaccines." He argues in his letter that the increase in reported adverse events exceeds what would typically be expected.
The increase in reports is not unique to Florida, an FDA spokesperson told 10 Tampa Bay in an email, adding an increase in VAERS reports does not indicate that the COVID-19 vaccines are unsafe.
There are several key reasons reporting to VAERS after COVID-19 vaccinations are higher than for other vaccines, according to the FDA, including more stringent reporting requirements, more doses of the COVID-19 vaccine being given than other vaccines, and heightened public awareness of the reporting system.
According to the CDC, nearly 42 million COVID-19 vaccine doses have been administered in Florida.
The CDC told our VERIFY team the agency is aware of some reports of long-term illnesses that have been submitted to VAERS after immunization, but those accounts are “variable and no specific medical cause for symptoms has been found.”
“Currently, there are no epidemiologic [scientific] data from safety monitoring to suggest that COVID-19 vaccines are causing these types of health problems,” the CDC told our VERIFY team.
Last year, under Ladapo’s direction, Florida became the first state to recommend against the COVID vaccine for “healthy” kids, despite studies cited by the state concluding vaccines are safe and effective.
The state has also recommended against the vaccine for some men due to cardiac complications, according to their analysis, but scientists said it lacks evidence.
VERIFY's Kelly Jones contributed to this report.