PFIZER CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048

The Food and Drug Administration (“FDA”) has released Pfizer’s report on adverse events to its Covid injection for the first two-and-a-half months since post-emergency authorisation.  Over this period Pfizer had received more than 42,000 reports, mostly from the United States.  Almost 30,000 of these adverse event reports were from women and 26,000 related to nervous system disorders.

“Four days after the Pfizer vaccine was approved for ages 16+, we submitted a Freedom of Information Act Request to the FDA for all of the data within Pfizer’s Covid-19 vaccine biological product file. We have now sued the FDA for not releasing the data.” – Public Health and Medical Professionals for Transparency (“PHMPT”).

A few days ago, two months after PHMPT had sued, the FDA released the first round of documents it reviewed before licensing Pfizer’s Covid injection. One of the documents released was an analysis of adverse event reports for the two-and-a-half months, since Emergency Use Authorisation (“EUA”) was given, up to 28 February 2021.

“Pfizer received a total of 42,086 reports containing 158,893 ‘events’.  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’,” wrote Aaron Siri, a vaccine and civil rights attorney.

 

 

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PFIZER,5.3.6-postmarketing-experience

 

 

 

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