FDA Deems Vaccine “Favorable” Despite Long List of Adverse Events

(Including Death)

A newly released FDA document concludes Pfizer’s Covid vaccine is “favorable” despite the document being loaded with bad reactions to the jab, including nervous system disorders, cardiac disorders, respiratory disorders, and even death.

The document is reportedly part of the data the FDA based its Emergency Use Authorization (EUA) on and specifically covers adverse events (AE) from Pfizer/BioNTech’s Covid vaccine (called BNT162b2) from December 1st, 2020 to February 28th, 2021.

During that time, 42,086 adverse events and 1,223 deaths were recorded, meaning roughly 1 out of every 34 adverse events was fatal.

As ordered by the courts the FDA must release the data it based it’s EUA for the Pfizer shot.

The FDA requested the courts to keep this information confidential for no oess than 55 YEARS!!

The court returned with an order to release 500 documents a month.— Gal Shalev 🎧 (@iGNORANTCHiMP) December 1, 2021

“Review of the available data for this cumulative PM experience, confirms a favorable benefit: risk balance for BNT162b2,” concludes the FDA document.

Interestingly, the document itself warns of the limitations of “post-marketing adverse drug event reporting” and even admits that “the magnitude of underreporting is unknown.”

Podcaster Gal Shalev describes what this could mean for the actual number of adverse events.

Looking at the amount of AE’s recorded for the 42,000+ is jaw dropping.

Whats worse, out of the recorded AE about 1:37 is death. That is isane.

The FDA admits these are onky recorded AE that are considered above mild. There was so much more that wasn’t released.— Gal Shalev 🎧 (@iGNORANTCHiMP) December 1, 2021

Please keep in mind these are AE that we’re recorded in the first 3 months alone from December 1st to February 28.

By all means and confirmed by Pfizer these are only “recorded AE” and there for it might be a small sample of the true number of AE’s that actually
Took place.— Gal Shalev 🎧 (@iGNORANTCHiMP) December 1, 2021

Unfortunately, the document only allows the reader to calculate the ratio of deaths to adverse events and not the ratio of deaths to doses administered or shipped.

This is because the FDA document redacted the number of doses shipped worldwide and did not mention the number of doses that were actually administered.

“It is estimated that approximately (b)(4) doses of BNT162b2 were shipped worldwide from the receipt of the first temporary authorisation for emergency supply on 01 December 2020 through 28 February 2021.”

According to the Administrative Conference’s website, exemption (b)(4) of FOIA permits agencies to withhold trade secrets and commercial or financial information considered privileged or confidential.

The entire FDA document, complete with a litany of other adverse events associated with the vaccine, can be read below:


This document became public after a nonprofit group sued the FDA for not releasing data from Pfizer’s COVID-19 vaccine biological product file.

The group, Public Health and Medical Professionals for Transparency, had earlier submitted a Freedom of Information Act (FOIA) request calling on the FDA to release all the data the federal government relied upon in licensing Pfizer’s COVID-19 vaccine.

Originally, the FDA wanted to wait 55 years to process the FOIA request.


FDA Document Deems Pfizer Vaccine “Favorable” Despite Long List of Adverse Events From Jab, Including Death:


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