Main Finding

Death was the “relevant event outcome” for 96 individuals, which is 7.8% of 1,223 deaths from all causes reported in this 90-day report.

Main Findings

• 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.

• Of those with known age, 1,125 were elderly; 6,330 were non-elderly adult; nine were adolescents; nine were children; and six were infants.

• Of those whose gender was known (7,829), 5,969 (76%) were female and 1,860 (24%) were male with a ratio of 3.2:1 female to male.

Other Adverse Events of Special Interest

This category of AESIs is not related to a particular set of medical conditions or a specific organ of the body. The search criteria range from medical conditions (Herpes virus infections, Middle East Respiratory Syndrome, Multiple Organ Dysfunction Syndrome) to symptoms (fever, inflammation) to non-medical-related issues (manufacturing laboratory analytical testing issues, manufacturing production issues). The Pfizer report only specifically identified those conditions that had six or more occurrences.

This SOC included 8,152 patients, 19.4% of the total cases/patients in the 90-day period of this report. The cases were reported from 48 countries. In this total group of patients, there were 8,241 adverse events of which 3,674 (45%) were serious and 4,568 (55%) were non-serious.

Fever was the most common event (7,666). Herpes virus infection, including shingles, herpetic eye infections, and non-shingles herpes infections, comprised 391 events. Inflammation was listed with 132 events, but these were not defined further as to type or bodily location. Multiple organ dysfunction syndrome had 18 events.

Reported Outcomes

Death was the “relevant event outcome” for 96 individuals, which is 7.8% of 1,223 deaths from all causes reported in this 90-day report and for 1% of the patients in this SOC.

Of the 8,241 total events, outcomes of “resolved/resolving” were listed for 5,008 events (61%), “resolved with sequelae” for 84 (1%), “not resolved” for 1,429 (17%), and “unknown” for 1,685 (20%).

The time from injection to adverse event onset was from within 24 hours to 61 days with half occurring within one day.

Post-Marketing Team’s Assessment

To summarize this SOC, the search terms used seem to consist mainly of nonlethal conditions, yet there were 96 deaths. Herpes virus infections can cause a great deal of pain, which can be chronic and debilitating, and herpes eye infections have the potential to cause impaired vision or blindness. Yet, death other than from herpes encephalitis would be rare. However, encephalitis and encephalopathy are reported by Pfizer in different SOCs.

Certainly, multiple organ dysfunction syndrome can cause death in a significant number of cases, but only 18 were reported. If all 18 led to death, from where did the other 78 deaths come?

Inflammation types are not defined, but Pfizer has a separate SOC for Immune-Mediated/Autoimmune that would capture most of the purely inflammatory diseases. So, we are left with no clarity or explanation for at least 78 deaths.

Extremely high fevers can be lethal, and febrile seizures were reported by Pfizer in a separate SOC. Of the 8,241 events, 8,207 were presented because each occurred six or more times. What were the missing 34 events, and why were they not enumerated?

Finally, we are faced with the 15 individuals under 12 years of age (six of whom were infants), and nine adolescents (with an unknown number of these less than age 16). Pfizer’s drug was not approved for those under age 16 at the time of 5.3.6 data collection, and the dosage given to these children and young people had not been determined. We do not know how many deaths occurred in this underage group.

It is surprising that, in this SOC, non-elderly adults had almost six times the number of adverse events seen in elderly adults. In the first 90 days of rollout, priority for the vaccine was given to the elderly, high-risk patients, and health care workers. This distribution of adverse events is unexplained.

Pfizer’s Conclusion

Despite the incomplete and inconsistent reporting and 96 deaths, Pfizer’s conclusion remains the same:

“This cumulative case review does not raise new safety issues. Surveillance will continue.”

Note: As of the date of this team report, no follow-up, updated, and comprehensive safety report (comparable to 5.3.6) has been publicly released.

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)