False: The Pfizer ‘Cumulative Analysis of Post-authorization Adverse Event Reports’ proves that the COVID-19 vaccine is dangerous.

Context

A recent film titled by vaccine skeptic and conspiracy theorist Stew Peters has captured the conspiracy theory community's attention. The film, titled "Died Suddenly," claims that the COVID-19 vaccines were created as part of a global depopulation agenda and draws together and reiterates various claims made by the online anti-vaccine community since the introduction of the COVID-19 vaccine. In one segment, the film claims that adverse events reported by Pfizer from sources such as the Vaccine Adverse Event Reporting System (VAERS) and the Yellow Card system in the U.K. prove that the COVID-19 vaccine is harmful to human health. 

In Fact

Data from adverse event databases has been misused by vaccine skeptics and anti-vaccine activists throughout the pandemic to support their claims. An article by Health Feedback explains that it is important to distinguish between the terms "adverse event" and "side effect": “The term 'adverse event' describes any health problem that occurs after vaccination, regardless of whether the vaccine caused it. For example, a toothache in someone who received a vaccine would be considered an adverse event. However, a toothache can’t be attributed to vaccination. In contrast, the term 'side effect' refers only to adverse events causally linked to the vaccine, such as an allergic reaction to a vaccine ingredient.”

The data from Pfizer referred to in "Died Suddenly" is drawn from adverse event databases. VAERS, in particular, is an early warning system that aims to "detect unusual or unexpected patterns of adverse events, also known as safety signals." VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) and functions as a self-reporting platform. This means that anyone can report an adverse event on VAERS. Healthcare professionals are required to report certain adverse events, and vaccine manufacturers are required to report all adverse events that come to their attention. Raw data on VAERS' database is unconfirmed and unassessed. 

As the CDC does not verify the reported symptoms to VAERS, the figures are not an accurate representation of post-vaccination adverse events and fatalities. The CDC states on its website that a causal relationship between reported symptoms to VAERS and the vaccine "cannot be established." This is because VAERS is not designed to determine if a vaccine caused a health problem, but is intended to collect data on unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. Despite this, the Pfizer report has been used by vaccine skeptics to stoke fear in people around COVID-19 vaccines. 

Similarly, the U.K.’s Yellow Card scheme is the system for collecting and monitoring information on safety concerns such as suspected side effects or adverse incidents involving medicines. The scheme is run by the Medicines and Healthcare Products Regulatory Agency and, like VAERS, it relies on voluntary reports made by health professionals and the public, including patients, carers, and parents. The purpose of the scheme is to provide an early warning that the safety of a drug may require further investigation.

Verdict

The Pfizer report analyses data on adverse events following the COVID-19 vaccine. Adverse events are not confirmed side effects. The claim that the report proves that the vaccine is dangerous has been repeated by anti-vaccine activists during the COVID-19 pandemic ever since the vaccine’s introduction, and it has been debunked numerous times. This claim is therefore false.