Neurological – MicroReport 7

Main Finding

Of the 542 neurological adverse events, 95% were defined as serious. 16 were fatal.

• 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.

• In the neurologic SOC, of those patients whose sex was reported, 69% were female and 31% were male.

• Of the 478 subjects with age reported, 329 were adult and 149 were elderly.

Within each SOC, the adverse events are further classified as either “serious” or “non-serious.” Given the extremely high rate of “serious” neurological adverse events, an understanding of the FDA’s definition of this term is important. Below are excerpts from the official FDA website. Provided with this context, the full impact of the information presented in this report can be realized.

What Is a Serious Adverse Event?

An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is:

• Death

• Life-threatening

• Hospitalization (initial or prolonged)

• Disability or Permanent Damage

• Congenital Anomaly/Birth Defect

• Required Intervention to Prevent Permanent Impairment or Damage (Devices)

• Other Serious (Important Medical Events)

Source: FDA: What Is a Serious Adverse Event?

Neurological Adverse Events

This category includes conditions of altered function of the brain, spinal cord, or peripheral nerves (nerves that connect to the spinal cord and extend to the rest of the body). Also included are conditions resulting from direct damage to nerve tissue. Pfizer chose to report fibromyalgia in this category. However, those conditions categorized by Pfizer under the general term peripheral neuropathy (abnormal nerve function) are reported separately in the SOC of “Immune-related/Autoimmune” adverse events. “Polyneuropathy” (multiple nerve dysfunction) is categorized under the SOC “Musculoskeletal” adverse events. The distribution of these diagnoses into various other SOCs is medically debatable. Bell’s palsy with facial nerve damage is summarized in its own report.

To recap, 95% of the adverse events were considered serious. 16 resulted in death. Our review found the largest number of diagnoses were seizures including generalized, petit mal and febrile. There are 376 (69%) events of these types though notably 12 (3%) were status epilepticus (sustained seizures). This particular diagnosis deserves a full explanation here.

What Is Status Epilepticus?

A seizure that lasts longer than 5 minutes, or having more than 1 seizure within a 5 minutes period, without returning to a normal level of consciousness between episodes is called status epilepticus. This is a medical emergency that may lead to permanent brain damage or death.

Source: Johns Hopkins Medicine: Status Epilepticus

Additional Neurological Findings

Pfizer reports 15 febrile seizures. These are considered a pediatric event, but Pfizer reported no children in this SOC. Were these seizures erroneously listed as febrile seizures or did Pfizer not report ages properly?

Another 29 events (5%) include disturbances of sensation or function including aura, narcolepsy, and “bad sensation.” Three meningitis cases and seven cases of encephalopathy (disordered brain function often resulting in confusion or disturbance of mental clarity) were diagnosed.

Guillain-Barré syndrome, often described as immune attack on nerves with paralysis starting in the legs and ascending at times to the chest with inability to breathe, was diagnosed in 24 (4%). There were eight (1.5%) with disturbances of walking. Seventeen (3%) had trigeminal neuralgia, an extremely painful facial condition. Multiple sclerosis and other cases of damage to the sheath surrounding some nerve cells, typically found to be from an immune system attack, comprised 38 (7%) of the events. Seventeen (3%) cases of fibromyalgia were reported. Clinical diagnoses were specified only if there were two or more reports, so 20 diagnoses or syndromes were not given to us. What were they?

Post-Marketing Team’s Assessment

The neurologic adverse events above are in addition to the strokes reported in a separate report. This set of patients has suffered an equally serious group of lethal or potentially disabling disorders. We see double-digit fatalities in the first 90 days with a litany of dreaded new diagnoses among which are multiple sclerosis, seizures, Guillain-Barré, meningitis, and encephalopathy. And half of the total events occurred within 24 hours of receiving the injection. In addition, at least 250 of the non-fatal events have no documented recovery.

Pfizer’s Conclusion

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

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

Reported Outcomes

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)