and disproportionately involved women (29,914 vs. Pfizer explains, on page 6, that “Due to the large numbers of spontaneous adverse event reports received for the product, has prioritised the processing of serious cases…” and that Pfizer “has also taken a multiple actions to help alleviate the large increase of adverse event reports” including “increasing the number of data entry and case processing colleagues” and “has onboarded approximately additional fulltime employees (FTEs).” Query why it is proprietary to share how many people Pfizer had to hire to track all of the adverse events being reported shortly after launching its product.Īs for the volume of reports, in the 2 ½ months following EUA, Pfizer received a total of 42,086 reports containing 158,893 “events.” Most of these reports were from the U.S. This 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. One of the documents produced is a Cumulative Analysis of Post-Authorization Adverse Event Reports of Received Through 2, which is a mere 2 ½ months after the vaccine received emergency use authorization (EUA).
While it is for the scientists to properly analyze, let me share one observation.
#ORCAFLEX BATCH POST PROCESSING PDF#
The production consisted of 91 pdf pages, one xpt file, and one txt file. Two months and one day after it was sued, and close to 3 months since it licensed Pfizer’s Covid-19 vaccine, the FDA released the first round of documents it reviewed before licensing this product.