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Pfizer Cumulative Analysis of Post-Authorization Adverse Event Reports [pdf]
- SQL2219 5y agoSomebody help me discern the data table on page 7. Relevant cases = 42,086 Fatal outcomes = 1,223 This can't possibly be right, or I am seriously misinterpreting the table.
- fasteo 5y agoI did a minimal data QA and the numbers do not look good. Where does the data come from ? 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. So, I went to the cases reported by Spanish health authorities [1]: 1. Data reported through Feb 28, 2021 2. For my country (Spain), Pfizer is reporting 756 cases. 3. However, the official data reported for Comirnaty (Pfizer) through Feb 21, 2021 is 5736 So, this report is only considering 756 out of 5736 (about 13%) cases. [1] https://www.aemps.gob.es/laAEMPS/docs/informe-farmacovigilancia-marzo-2021.pdf?x32797 https://www.aemps.gob.es/laAEMPS/docs/informe-farmacovigilan...