Report 90: Pfizer’s ‘Post-Marketing Surveillance’ Shows mRNA-Vaccinated Suffered 1000s of COVID Cases in 1st 90 Days of Vaccine Rollout. Most Infections in the Vaccinated Categorized as ‘Serious Adverse Events.’
Though spokespeople assured us that the COVID-19 injection stops — well — COVID, Pfizer and the Food and Drug Administration (FDA) both knew that during the first three months of Pfizer’s mRNA COVID-19 vaccine rollout, thousands of COVID cases were reported to Pfizer — among vaccinated people. The ‘COVID-19 Adverse Events of Special Interest’ (AESI) category in Pfizer’s internal report includes 3,067 cases of vaccinated patients infected with COVID. Two of these were infants, and one which was a child, though at that time no Pfizer COVID vaccine was yet authorized for children or infants.
Among those 3,067 cases of vaccinated people infected with COVID, there were 3,359 COVID-19-related adverse events (AEs); that is to say, there was more than one adverse event related to COVID per vaccinated patient in this category. Of the 42,086 total cases of which Pfizer was notified during that period, seven percent (or 3,067 out of 42,086) were COVID-related adverse events.
The WarRoom/DailyClout researchers’ analysis of the shockingly high levels of COVID-19-related AESIs is based on 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“).
The AESIs in the 5.3.6 document were reported to Pfizer for 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 — alone. So many more thousands, or hundreds of thousands if not millions, of vaccinated people can be expected to have suffered serious adverse events (SAEs) related to COVID in the months that followed.
Key points from this report:
- The COVID-19-related AESIs 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%) experiencing COVID-related adverse events died.
- The non-infection COVID-related adverse events (AEs) were either COVID-19 exposures or COVID-19 test results, neither of which can be considered SAEs.
- All 2,585 AEs categorized as “serious,” 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 onset between 24 hours and 374 days.
Pfizer’s post-marketing report covered only the first 90 days of the vaccine availability, and the report was received by the FDA in late April; therefore, the maximum range should have been 150 days or less (December 1, 2020, through April 30, 2021). Given that, how is an onset of 374 days captured in the post-marketing surveillance report? It does not make sense.
- 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 in Table 7. What happened to these patients experiencing COVID-related AEs?
- Ages across this post-marketing AESI category were: 1,315 adults, 560 elderly individuals, two adolescents, two infants, 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.