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Pfizer Cumulative Analysis of Post-Authorization Adverse Event Reports [pdf]

1 pointsby SQL2219over 3 years ago

2 comments

fasteoover 3 years ago
I did a minimal data QA and the numbers do not look good.<p>Where does the data come from ?<p>Pfizer’s safety database contains cases of AEs reported spontaneously to Pfizer, cases reported by the health authorities, cases published in the medical literature, cases from Pfizer-sponsored marketing programs, non-interventional studies, and cases of serious AEs reported from clinical studies regardless of causality assessment.<p>So, I went to the cases reported by Spanish health authorities [1]:<p>1. Data reported through Feb 28, 2021<p>2. For my country (Spain), Pfizer is reporting 756 cases.<p>3. However, the official data reported for Comirnaty (Pfizer) through Feb 21, 2021 is 5736<p>So, this report is only considering 756 out of 5736 (about 13%) cases.<p>[1] <a href="https:&#x2F;&#x2F;www.aemps.gob.es&#x2F;laAEMPS&#x2F;docs&#x2F;informe-farmacovigilancia-marzo-2021.pdf?x32797" rel="nofollow">https:&#x2F;&#x2F;www.aemps.gob.es&#x2F;laAEMPS&#x2F;docs&#x2F;informe-farmacovigilan...</a>
SQL2219over 3 years ago
Somebody help me discern the data table on page 7.<p>Relevant cases = 42,086<p>Fatal outcomes = 1,223<p>This can&#x27;t possibly be right, or I am seriously misinterpreting the table.