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.

• 3,600 cases were reported, representing 8.5% of the post-marketing data set of 42,086 cases.

• Of the 3,600 individuals, 1,614 (44%) were classified as serious.

Musculoskeletal Adverse Events of Special Interest

The category of musculoskeletal adverse events of special interest (AESI) is made up of these different diagnoses: arthralgia (joint pain), arthritis (joint inflammation), arthritis/bacterial, chronic fatigue syndrome, polyarthritis (inflammation of multiple joints), post viral fatigue syndrome, and rheumatoid arthritis.

Fibromyalgia is not included in this report but was listed under the category of “Neurological AESIs.” Polyneuropathy (symmetrical damage to peripheral nerves) is included in this report rather than under “Neurological AESIs.”

3,600 cases were reported, 8.5% of the post-marketing data set of 42,086 cases. These 3,600 individuals reported 3,640 events. 1,614 (44%) were classified as serious. The most common adverse event was arthralgia (3,525 or 97%), followed by 70 arthritis (2%), 26 rheumatoid arthritis (less than 1%) and 5 (less than 1%) polyarthritis.

Time From Administration to Adverse Event

The time from administration to adverse event ranged from less than 24 hours to 32 days. 50% of the events started within the first 24 hours.

Of the cases where gender was reported, 2,760 individuals were female, and 711 were male. Once again, the pattern from 5.3.6 SOCs continues, with an almost 4:1 ratio of female to male.

Age Distribution

Age distribution was predominantly adult (2,850, 85%) with 515 (15%) elderly, two adolescents, four children, and one infant.

During these dates, BNT162b2 was not approved for use in children or infants. Approval was only for adolescents 16 and above (not clarified by Pfizer).

Reported Outcomes

Outcomes were reported for 3,662 events:

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 follow-up safety surveillance 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)