COVID-19 – MicroReport 19

Reporting Period and Background

Adverse events were reported to Pfizer during a 90-day period following the December 1, 2020, public rollout of its COVID-19 experimental “vaccine” product.

In the Pfizer 5.3.6 document, these AEs were categorized by System Organ Classes (SOC), in other words, by systems in the body.

Gender: 1,650 females and 844 males, with 573 unknown.

Age: Adult 1,315, elderly 560, two infants, two adolescents, and one child. (BNT162b2 was not approved for infants and children at the time of this report.)

COVID-19 Adverse Events of Special Interest

The COVID-related AESI category consists of 3,067 vaccinated cases (patients), including one child and two infants despite no authorized vaccine for those ages, who experienced a total of 3,359 adverse events (AEs).

This means that 7% (3,067/42,086) of all vaccinated patients of which Pfizer was notified during the post-marketing time frame suffered COVID-related AEs. Those include 2,585 serious adverse events (SAEs), all of which (77% of total AEs) appear to be COVID infections. The other adverse events (AEs) were COVID-19 exposures or COVID-19 test results.

Five hundred and five adverse events were positive COVID-19 tests, including 31 patients who were reported to have “asymptomatic COVID-19.” Pfizer did not clarify which test was used, other than 138 who had a SARS-CoV-2 antibody test.

FDA Definition of a Serious Adverse Event

The FDA definition of “serious” means patients died or had a life-threatening injury, were hospitalized, or had a pre-existing hospitalization prolonged, disability or permanent damage, experienced a birth defect, or required medical or surgical intervention to prevent permanent impairment or damage.

Time From Injection to Adverse Event

Fifty percent of the AEs began within five days of injection (after first or second shot is unknown), with an onset range of under 24 hours to 374 days.

This means that half of the AEs occurred before the vaccination was fully protective by Pfizer’s definition (i.e., starting day seven after the second shot). The other half, however, occurred more than five days post-injection, so at least some of them likely occurred seven or more days post-second injection.

An onset range of 374 days in this report does not make sense since it covers the first 90 days of public vaccine availability and was received by the FDA on April 30, 2021. The maximum onset range should have been 150 days or less.

Reported Outcomes

136 deaths

The number of unknown outcomes is disproportionately large compared to the other categories in Table 7. If one postulates that all the fatalities and all the “not resolved,” “resolved/resolving,” and “resolved with sequelae” AEs were serious, that leaves over 1,300 serious adverse events with unknown outcomes.

Why were so many outcomes unknown? What happened to those patients?

Discrepancies in Reported COVID-19 Cases

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).

• Table 7: Reports at least 2,391 cases.

Which figure is correct? Or should the three figures be combined? The numbers don’t add up.

Post-Marketing Team’s Conclusion

RECALL this unsafe “vaccine.”

Reference Information

5.3.6 AE Reporting Period

“Since the first temporary authorization for emergency supply under Regulation 174 in the UK (01 December 2020) and through 28 February 2021.”

5.3.6 AE Cases/Events

Abbreviations

• 5.3.6: Pfizer source document

• SOC: System Organ Class

• AE: Adverse Event

• AESI: Adverse Event of Special Interest

• EUA: Emergency Use Authorization by FDA

• PM: Post-Marketing

• BNT162b2: Pfizer’s mRNA COVID-19 vaccine

• Sequelae: An abnormal condition resulting from a previous disease, injury, or other trauma

Age Groups Defined in 5.3.6 (p. 25 footnote)