A post circulating on social media misleadingly claims that the pharmaceutical company Pfizer allegedly admitted that its COVID-19 vaccine causes dozens of serious health disorders – from blood clots and neurological diseases to cancer or death.
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To support these claims, a list of medical conditions taken from a company document is presented, but a crucial fact is omitted: it lists health events reported and further evaluated after vaccination, not confirmed adverse reactions caused by the vaccine.
By manipulating the document’s content, mere temporal coincidence is presented as proven causation. The post is also supplemented with other unfounded statements – that the vaccine does not protect against the disease, its spread, or severe forms of COVID-19, and that it killed more people than the infection itself.
What kind of list is this?
The list circulating on social media is not newly disclosed Pfizer information. It is an excerpt from a company document submitted to the U.S. Food and Drug Administration (FDA) in May 2021 (translated as “Summary analysis of reports of adverse events received post-authorization”).
This document has been publicly available online since 2022, but excerpts periodically resurface on social media, each time presented as newly released or previously hidden information.
This gives the old document a misleading impression of novelty and sensationalism, while omitting its purpose and the significance of the data presented.
Reactions monitored according to a pre-prepared list
The document’s appendix contains a list of so-called Adverse Events of Special Interest (AESI).
It does not list conditions diagnosed in unvaccinated people and recognized as vaccine side effects. It is a pre-compiled set of medical events and search terms monitored, according to which Pfizer’s safety database selected and analyzed reports received after vaccination.
It was prepared using AESI criteria established by the U.S. Centers for Disease Control and Prevention (CDC), the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), and other institutions.
The list itself is a broad set of monitored conditions, including health events possibly related to COVID-19 itself. It was used not only for this specific analysis but also for broader vaccine safety monitoring and other studies.
Therefore, the claim circulating on social media that Pfizer acknowledged dozens of vaccine side effects with this list misinterprets the document’s purpose.
Illness after vaccination can occur for reasons other than the vaccine
On August 23, 2021, the U.S. Food and Drug Administration (FDA) granted Pfizer and BioNTech the first approval for their COVID-19 vaccine. The information in the biological materials license application was confidential until the FDA released part of this data on March 1 of the following year.
Among other things, the mentioned 38-page safety monitoring report was published, prepared during the first three months after authorization, with a distributed 9-page appendix.
This text soon began to be shared on social media with comments claiming that the COVID-19 vaccine causes numerous side effects. At that time, the website Health Feedback wrote about it, and the falsehood was debunked by fact-checkers from Bosnia and Herzegovina’s Istinomer.
The document does not indicate vaccine side effects. The company simply collected data on adverse events reported after vaccination. Reports of these conditions did not prove that the vaccine caused an adverse effect or is unsafe.
According to Health Feedback, to understand why the list’s interpretations are incorrect, it is important to grasp the difference between an “adverse event” and a “side effect.”
The term “adverse event” describes any health problem occurring after vaccination. For example, a toothache in a vaccinated person would be such an event. However, it cannot be linked to vaccination.
In contrast, a “side effect” is an adverse event causally related to the vaccine, such as an allergic reaction to a vaccine component.
The Pfizer document is based on reports of any adverse events (not vaccine side effects, as internet users explain) recorded after vaccination. They were collected up to February 28, 2021.
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A total of 42,086 such reports were collected (the number of people who experienced them is not specified). Sources of information included spontaneous reports submitted directly to the company or health authorities in 63 countries, cases published in medical literature, or collected through studies.
Two-thirds of the reports came from the U.S. and the United Kingdom (13,739 and 13,404 respectively), mostly through monitoring systems (U.S. Vaccine Adverse Event Reporting System VAERS, UK Yellow Card Scheme).
However, the data collected in these systems cannot be relied upon without further analysis. Often, the information is provided not by specialists but by people who decided themselves that a particular ailment was caused by vaccines, although it may simply be an adverse event.
To prove that it was caused by the vaccine, additional analysis is required. The FDA document warns about this – noting incomplete clinical information and external factors.
“Reports do not necessarily indicate that a specific adverse event was caused by the drug; it may be due to an underlying disease or other factor(s), such as previous medical history or concomitant medications,” it states on page 6 of the document.
Vaccine effectiveness confirmed by studies
Data from clinical trials and real-world conditions refute the claim that the Pfizer-BioNTech vaccine provided no protection against COVID-19. Studies showed it significantly reduced the risk of severe illness and hospitalization.
Results of a retrospective cohort study published in the scientific journal The Lancet, conducted in the U.S. healthcare organization Kaiser Permanente Southern California, were reported. Researchers analyzed electronic health data of over 3.4 million individuals aged 12 and older and assessed the Pfizer-BioNTech vaccine’s effectiveness over six months after full vaccination.
It was found that the overall vaccine effectiveness against infection was 73%, and against COVID-19 hospitalization – 90%. However, protection against infection decreased over time: it was 88% in the first month and 47% after five months.
A similar trend was observed when evaluating protection against the delta variant: effectiveness against infection dropped from 93% in the first month to 53% in the fourth month.
However, protection against hospitalization due to this variant remained high throughout the six-month observation period, at 93%.
Another study conducted in Israel evaluated the effectiveness of a booster dose. Compared to people vaccinated with two doses, those who received a third dose had a 93% lower risk of hospitalization, 92% lower risk of severe illness, and 81% lower risk of death from coronavirus.
However, vaccine protection against infection and virus transmission decreased over time, and with the emergence of new virus variants, especially Omicron, this decline became even more pronounced.
For this reason, booster doses were recommended. But weaker protection against mild infection does not mean the vaccine was ineffective: protection against severe illness, hospitalization, and death remained much stronger.
15min verdict: false. The list circulating on social media is not newly recognized Pfizer COVID-19 vaccine side effects. It is an appendix to a document prepared in 2021, listing pre-identified medical events monitored to detect possible safety signals.
Inclusion of a condition on this list or its registration after vaccination does not by itself prove a causal relationship with the vaccine.
Research data also refute the claim that the vaccine provided no protection against COVID-19: although protection against infection waned over time, it significantly reduced the risk of severe illness, hospitalization, and death.
Publication prepared by 15min in cooperation with Meta, aiming to stop the spread of misleading news on social media. More about the program and its rules – here.
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