Fact Check-VAERS and FAERS data shown does not prove COVID-19 vaccine adverse events and deaths – Reuters

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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).
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.
All quotes delayed a minimum of 15 minutes. See here for a complete list of exchanges and delays.


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