Do records from the Food and Drug Administration (FDA) subpoenaed by an attorney show over 158,000 adverse "events" in the first 2½ months of COVID-19 shot trials? Yes, but that number is misleading. While "158,000 adverse events" were noted in Pfizer documents released as part of a lawsuit, that doesn't mean there were 158,000 serious effects in people who received a COVID vaccine. The vast majority of the "adverse events" were expected, very short in duration and were not deadly. They included reactions like vomiting, fatigue and chills. Drugmakers, including Pfizer, are required by safety rules to collect all reports of possible negative effects but that doesn't automatically mean all these reports are equally serious or that the events were even caused by the vaccine.
The claim appeared in an article published by Red Voice Media on November 21, 2021, titled "FDA Records Subpoenaed By Attorney Shows Over 158,000 Adverse 'Events' In First 2.5 Months of COVID Shot Trials" (archived here). It opened:
Red Voice Media has previously reported on attorney Aaron Siri, who is at the front lines of fighting Big Pharma and the suppression of adverse effects of
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FDA Records Subpoenaed By Attorney Shows Over 158,000 Adverse "Events" In First 2.5 Months of COVID Shot Trials
Red Voice Media has previously reported on attorney Aaron Siri, who is at the front lines of fighting Big Pharma and the suppression of adverse effects of
The article says Siri received "91 pdf pages, one xpt file, and one txt file. One document received was the Cumulative Analysis of Post-Authorization Adverse Event Reports of [the Vaccine] Received Through 28-Feb-2021." It continued:
The report represents the first two-and-a-half months after the vaccine received emergency use authorization. During that time, the Vaccine Adverse Event Reporting System (VAERS) received 42,086 reports containing 158,893 'events,' according to the report. Additionally, 25,957 were said to be 'Nervous system disorders.'The report also showed that the 'events' disproportionately effected women, and those 31-50 years old. Most of these took place in the US.
VAERS represents approximately one percent of adverse vaccination events.
The document the article is referring to, called 5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021, was approved on April 30, 2021, according to the timestamp on the side of the PDF.
Lead Stories has previously debunked the baseless claims that the Pfizer documents reveal that thousands were killed by the COVID-19 vaccine in the first month here.
The numbers cited in the Red Voice Media article come from this paragraph on page 6 of the documents:
Cumulatively, through 28 February 2021, there was a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events. Most cases (34,762) were received from United States (13,739), United Kingdom (13,404) Italy (2,578), Germany (1913), France (1506), Portugal (866) and Spain (756); the remaining 7,324 were distributed among 56 other countries.
The 42,086 case reports include more than one event. An example would be if the COVID vaccine injection needle hurt a person's arm and there was slight swelling at the injection site, it itched and the person coughed. That would be four "events," not just one.
Table 2 on page 8 and 9 lists over 90,000 of the "events." Many are the simple side effects of any vaccination, such as chills, fever, rash and headache.
The article also claims, "VAERS represents approximately one percent of adverse vaccination events," as if to imply that the Vaccine Adverse Event Reporting System is not accurately reporting all the adverse events from a COVID vaccination. Lead Stories has published multiple articles debunking claims regarding VAERS.
Anyone with internet access can add a report to the VAERS list of reports. The public access link to it expressly warns against unwarranted conclusions based on VAERS material because it only provides a tally of unverified notes about any health event people experience after they are vaccinated.
VAERS website warnings include:
When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event."
On December 13, 2021, the FDA responded to Lead Stories' request for a response to a previous story that claimed the Pfizer document showed thousands of people around the world died from the company's COVID vaccine the first month it was available. In part, the agency said:
It's important to note that reports of adverse events to the Vaccine Adverse Event Reporting System (VAERS) following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. In fact, reviews by FDA and CDC have determined that the vast majority of the deaths reported are not directly attributable to the vaccines. FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it's unclear whether the vaccine was the cause. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem.
Reports of death after COVID-19 vaccination are rare. As reported on CDC's website, more than 459 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through November 29, 2021. During this time, VAERS received 10,128 reports of death (0.0022%) among people who received a COVID-19 vaccine.
