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 whose sex was specified, 526 (77%) were female, and 156 (23%) were male (a ratio of 3.4 to 1).

• Age was listed as elderly 196 (19%), adult 746 (71%), adolescent 2 (less than 1%), and not reported 106 (10%).

There were 1,077 events reported with 780 (72%) serious and 297 (28%) non-serious.

12 (1.1%) AEs were fatal.

Immune-Mediated and Autoimmune Adverse Events

This category comprises the numerous diseases resulting from disordered immune attacks against tissues of any of the body’s organs. Pfizer has grouped some conditions in a very general way, such as “hypersensitivity.” This is defined as an exaggerated response of the normal immune system. However, anaphylaxis, another hypersensitivity reaction, has its own separate SOC report.

Autoimmune diseases attacking nerve tissue (Guillain-Barré, multiple sclerosis, polyneuropathy, and others) are not in this SOC but are found under the Neurological and Musculoskeletal SOC reports. However, dermatitis (skin hypersensitivity) is listed here.

Only diseases or conditions with over 10 cases are described with a diagnosis or symptom. Hypersensitivity had 596 (55%) of the adverse events. The conditions in this large grouping are not further defined in the report. Peripheral neuropathy had 49 events (5%) though, and, as discussed above, other neuropathies are separately listed and presumably different patients. There are 32 diagnosed pericarditis events (3%) with inflammation of the lining around the heart. Myocarditis (immune attack against the heart muscle itself) had 25 events (2%).

Reported Outcomes

The time from vaccination to adverse event onset was defined in 807 (75%) of the 1,077 events with a range of within 24 hours to 30 days. Half of the adverse events started within 24 hours of the injection.

517 (48%) had outcomes reported as “resolved” or “resolving.” 215 events (20%) were not resolved, 22 (2%) resolved with sequelae, and 312 (29%) had unknown outcome.

Further Observations Regarding Autoimmune Events

There was no mention of immune rejection of transplanted organs. It is unknown whether Pfizer found none, or whether there were 10 or fewer and thus not listed explicitly.

There is a VAERS report of a 17-year-old male who was vaccinated 1/19/2021 and was hospitalized mid-May 2021 with heart transplant rejection and heart failure.

Additional Autoimmune Conditions

Encephalitis (brain inflammatory disorders) occurred 16 times (1.5%). There were 16 cases (1.5%) of diabetes reported though not specified as insulin dependent or non-insulin dependent.

Skin disorders listed were psoriasis 14 events (1.3%), dermatitis 24 events (2%) and blistering skin disorder 13 events (1.2%). Autoimmune disorder, a broad group rather than a specific disease, had 11 events (1%). Raynaud’s phenomenon (spasm of the small arteries in the extremities) also had 11 events (1%).

Pfizer, by excluding those conditions with fewer than 11 events, has therefore left out explanations of 270 adverse events. Were there instances of Crohn’s disease, ulcerative colitis, or glomerulonephritis?

Pfizer’s Conclusion

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

Note: As of the date of this team report, no additional safety data have 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)