by Barbara Gehrett, MD; Joseph Gehrett, MD; Chris Flowers, MD; and Loree Britt, Daily Clout:
The War Room/DailyClout Pfizer Documents Analysis Project Post-Marketing Group (Team 1) – Barbara Gehrett, MD; Joseph Gehrett, MD; Chris Flowers, MD; and Loree Britt – wrote a shocking analysis of COVID-19 Adverse Events of Special Interest (AESIs) found in Pfizer document 5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received Through 28-FEB-2021 (a.k.a., “5.3.6“). This AESI category consists of 3,067 cases and 3,359 adverse events (AEs) among the reported cases related to COVID-19. Seven percent (,3067/42,086) of post-marketing surveillance cases were COVID-related.
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It is important to note that the AESIs in the 5.3.6 document were reported to Pfizer for only a 90-day period starting on December 1, 2020, the date of the United Kingdom’s public rollout of Pfizer’s COVID-19 experimental mRNA “vaccine” product.
Key points from this report:
- The COVID-19-related AESI descriptions in the post-marketing report show that at least 2,391 (71%) of the adverse events in this category were COVID-19 infection.
- One hundred and thirty-six patients (4.4%) with COVID-related adverse events died.
- The non-infection, COVID-related adverse events (AEs) were an assortment of COVID-19 exposures or COVID-19 test results, none of which can be considered serious adverse events (SAEs). Therefore, the 2,585 serious AEs, 77% of total AEs for this category, were related to COVID-19 infections.
- The FDA considers an adverse event as “serious” when a patient dies or had a life-threatening injury, is hospitalized, or has a pre-existing hospitalization prolonged, disability or permanent damage, experiences a birth defect, or requires medical or surgical intervention to prevent permanent impairment or damage.
- Fifty percent of the COVID-related adverse events began within five days of the injection, with a range of 247 hours to 374 days.
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Pfizer’s post-marketing report covered only the first 90 days of the vaccine rollout and was received by the FDA in late April, so the maximum range should have been under 150 days. How is 374 days possible given that?
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- There were 2,110 (63%) “unknown” adverse event outcomes, and at least 1,300 of those were serious adverse events.
- This is an unusually large number of unknown outcomes compared to other post-marketing categories. What happened to these patients?
- Ages across this post-marketing AESI category were: adult 1,315, elderly 560, two adolescent, two infant, and one child.
- Pfizer’s BNT162b2 COVID vaccine was not approved for infants and children at the time of the data collection for Pfizer’s post-marketing surveillance report.
- The gender breakdown for this category includes 1,650 females, 844 males, and 573 unknown. Among patients with their gender noted, women suffered almost twice as many adverse events as men.
- There were 505 adverse events that were positive COVID-19 tests, which included 31 patients who were reported to have “asymptomatic COVID-19.”
- COVID-19 cases are referenced in three places in 5.3.6: Table 2 reports 1,927 cases (4.6% of the 42,086 cases); Table 6 reports 2,211 cases (1,665 loss of efficacy cases and 546 COVID-19 cases excluded because they occurred so early after the first vaccine dose); and Table 7 with at least 2,391 cases. Which of those figures is correct? Or should the three be combined? The numbers don’t add up.
Please read the full report below.
https://dailyclout.io/wp-content/uploads/Post-Marketing-COVID-19-Micro-Report.pdf
