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Reuters Fact Check
Invalid DateInvalid DateUpdated 4 months ago

FACT CHECK-VAERS AND FAERS DATA SHOWN DOES NOT PROVE COVID-19 VACCINE ADVERSE
EVENTS AND DEATHS

By Reuters Fact Check

6 Min Read

Posts are sharing an image comparing adverse events and deaths between
ivermectin, hydroxychloroquine, flu vaccines, dexamethasone, Tylenol and
COVID-19 vaccines, as reported by U.S. Centers for Disease control and
Prevention’s (CDC) Vaccine Adverse Event Reporting System (VAERS) and the U.S.
Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS).
This is missing context: both the VAERS and FAERS websites make clear that the
existence of a report in their system does not imply causation.

Examples can be seen here and here .

The image was taken from a presentation shown during a forum Senator Ron Johnson
held on June 28, 2021 with individuals who said they’d had an adverse reaction
to the COVID-19 vaccine. A video showing the entire forum can be seen here . The
image in the posts is visible at the 52:40 mark.

VAERS data is visible vaers.hhs.gov/ and FAERS here .

Anyone can report events to VAERS (www.vaers.hhs.gov/reportevent.html), with a
disclaimer on the website of the Centers for Disease Control and Prevention
(CDC) saying: “The reports may contain information that is incomplete,
inaccurate, coincidental, or unverifiable” (here).

When downloading the data, users are presented with a further disclaimer that
the data does not include information from investigations into reported cases.
The disclaimer also says “the inclusion of events in VAERS data does not imply
causality” (here).

The CDC here says COVID-19 vaccines are safe and effective, “under the most
intense safety monitoring in United States history,” and recommends receiving
the vaccine as soon as possible. It also explains that VAERS accepts reports of
any adverse event regardless of proof that it was caused by the vaccine. Reports
can be submitted by an individual.

A disclaimer on the FAERS website here , explains that the FDA receives over 1
million reports of adverse events with drug or biologic products each year.

The FDA explains that while the reports are a “valuable source of information”,
the system allows the potential submission of reports that are “incomplete,
inaccurate, untimely, unverified”. Due to this, the FDA says that this data
makes up only one part of its surveillance data and the data “does not confirm a
causal relationship between the drug product and the reported adverse event(s).”

Reuters explored this lack of causality in VAERS in other fact check articles
visible here , here , here and here .

In response to the posts, Martha Sharon from the CDC Vaccine Task Force, COVID
Response Public Affairs team shared a CDC page with Reuters (here) which reads,
in part, that, “When a serious adverse event is reported, like death, CDC
follows-up to get medical records, death certificates which specify the cause of
death, and autopsy reports. CDC reviews these records and verifies the certified
cause of death. Then does further analysis to see if there’s anything unusual or
unexpected happening.”

It goes on to establish this lack of causality: “A review of available clinical
information, including death certificates, autopsy, and medical records, has not
established a causal link to COVID-19 vaccines.” (A “plausible causal
relationship” has been found between the Janssen vaccine and rare, serious blood
clots that have caused deaths (here).

VERDICT

Misleading. The data shown for adverse events and deaths are from FAERS and
VAERS data, which does not provide information on verified, causal cases. The
information can be submitted by anyone and does not show causation.

This article was produced by the Reuters Fact Check team. Read more about our
fact-checking work here .

Our Standards: The Thomson Reuters Trust Principles.

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