The FDA released documents it reviewed before licensing the Pfizer jab showing a “large increase of adverse event reports.”
QUICK FACTS:
- Siri & Glimstad Lawyer Aaron Siri shared the first round of documents the U.S. Food and Drug Administration reviewed before licensing Pfizer’s Covisd-19 vaccine on his Substack account.
- The document “reflects adverse events following vaccination that have completed Pfizer’s ‘workflow cycle,’ both in and outside the U.S., up to February 28, 2021,” Siri explains.
- The documents also indicate that Pfizer had to take “multiple actions” to help “alleviate the large increase of adverse event reports,” including hiring more data entry and case processing staff.
- In order to process the excess data of adverse reactions among recipients of Pfizer’s vaccine, the pharmaceutical company had “onboarded approximately [REDACTED] additional fulltime employees (FTEs),” according to the documents.
- Nevertheless, Pfizer told the FDA that the data “do not reveal any novel safety concerns or risks requiring label changes and support a favorable benefit risk profile of to the BNT162b2 vaccine.”
- “Nothing to see here,” Siri quipped.
ADVERSE REACTIONS REPORTED IN THE DOCUMENT:
- “As for the volume of reports, in the 2 ½ months following EUA, Pfizer received a total of 42,086 reports containing 158,893 ‘events,'” Siri explained.
- “Most of these reports were from the U.S. and disproportionately involved women (29,914 vs. 9,182 provided by men) and those between 31 and 50 years old (13,886 vs 21,325 for all other age groups combined, with another 6,876 whose ages were unknown).”
- “Also, 25,957 of the events were classified as ‘Nervous system disorders,'” Siri added.
