by Barbara Gehrett, MD; Chris Flowers, MD; and Loree Britt, Daily Clout:
We evaluated Pfizer’s 38-page “5.3.6 Cumulative Analysis of Post-Authorization Adverse Events Reports of PF-07302048 (BNT162b2) received through 28-Feb-2021,” commonly known as “5.3.6,” starting in September of 2022. Patterns emerged across the System Organ Classes (SOCs). These patterns included Pfizer’s apparent concealment of various cases of adverse events, as well as unexplained causes of death.
Because we saw these patterns, we shifted our attention from Pfizer’s descriptions of adverse events and reviewed each SOC on its own. Thus, we found many data discrepancies. We saw that Pfizer manipulated data by setting various different “thresholds” for counting adverse events in each SOC. In addition, Pfizer frequently assigned adverse events to SOCs that were inappropriate, which obscured adverse event signals. We dedicated a year to this intensive analysis of this report, which contains 42,086 patients (“cases”) and 158,893 adverse events. Pfizer clearly did not expect this thoroughgoing analysis, which exposes data manipulation.
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Pfizer Manipulated Data by Using Different “Thresholds” for Events.
After preparing several reports based on Table 7, “AESIs Evaluation for BNT162b2,” (p. 16) of 5.3.6, we realized that the “threshold” for reporting adverse events, or the number of times an adverse event had to occur prior to it being named as an adverse event diagnosis, varied significantly across different SOCs. Why, for instance, did the Hematological SOC have a threshold of 15 adverse events occurring before a diagnosis was named (which allowed Pfizer to leave out 192 related adverse events) even as the Neurological SOC had a threshold of only two adverse events, which allowed Pfizer to leave out 20 adverse events’ diagnoses? Such a large difference in the number of adverse events required for them to be assigned a diagnosis seems inexplicable — unless Pfizer was attempting to lessen the number of vaccine-related medically significant outcomes. These threshold variations were clearly not due to space constraints, as the report was 38 pages long. Its final eight pages, “Appendix 1. List of Adverse Events of Special Interest,” being a single-spaced compilation of 1,290 routine and obscure adverse event terms.
Consider the Stroke SOC. The Stroke SOC managed to bury a case of a post-vaccination stroke in a seven-year-old child by disclosing deep in a lengthy list of footnotes. All 300 adverse events in the Stroke SOC were serious; but again, because of the threshold of greater than one occurrence, only 292 adverse events were listed, leaving eight serious adverse events undisclosed. We know there were a total of 300 stroke adverse events, because we added up the total number of stroke-specified diagnoses (p. 24). For example, the Stroke SOC states, “Number of relevant events: 300, all serious” and, then, directly under that states:
- PTs indicative of Ischaemic stroke: Cerebrovascular accident (160), Ischaemic stroke (41), Cerebral infarction (15), Cerebral ischaemia, Cerebral thrombosis, Cerebral venous sinus thrombosis, Ischaemic cerebral infarction and Lacunal infarction (3 each) Basal ganglia stroke, Cerebellar infarction and Thrombotic stroke (2 each);
- PTs indicative of Haemorrhagic stroke: Cerebral haemorrhage (26), Haemorrhagic stroke (11), Haemorrhage intracranical and Subarachnoid haemorrhage (5 each), Cerebral haematoma (4), Basal ganglia haemorrhage and Cerebellar haemorrhage (2 each);”
In the Hematological SOC, for its part, there were 1,080 adverse events. Within this SOC, 34 fatalities were recorded. It is possible that some of the listed diagnoses could have been fatal (for instance, thrombocytopenia or low platelet count, neutropenia or low white blood cell count, various forms of hemorrhage or bleeding). However, due to the threshold criteria of 15 or more adverse events sharing the same diagnosis, 192 adverse events were not included in this SOC’s enumeration of adverse events. Deaths may have been concealed among those 192 patients whose diagnoses were not numerous enough to be mentioned. There is no way to know, which means the public remains not fully informed about Pfizer’s post-marketing findings.
No definitive conclusions can be reached about the true causes of the 34 hematological deaths, as well as most of the other deaths in Table 7, since there is no linkage between fatalities and other outcomes to specific diagnoses. Indeed, the more we examined 5.3.6, the less clarity emerged. Who at Pfizer set the seemingly arbitrary SOC thresholds and, thus, decided which conditions and diseases “qualified” to be listed as adverse events in Pfizer’s post-marketing report? How many conditions and diseases were excluded due to those thresholds?
Pfizer Attempted to Hide Some Diagnostic Trends.
In 5.3.6, we saw that diagnoses were either combined or split apart in ways that obscure the total number of adverse events. For instance, in Table 7, “neurologic” diagnoses are split apart into three separate classes:
- “Neurological”: 501 cases (69% of adverse events were seizures).
- “Facial Paralysis” (or “Bell’s Palsy”), with 449 cases.
- “Stroke,” with 275 cases.
Of course, this amounts to a total of 1,225 neurological cases. However, that is not apparent if one reviews the “Neurological” SOC alone, which contains only 41% of the total. Similar trends arose with other diagnostic categories, such as cardiovascular disease.
In the first three months of Pfizer’s vaccine rollout, 1,403 suffered from post-vaccination cardiovascular disease adverse events. However, the Cardiovascular SOC excluded 25 cases of myocarditis and 32 cases of pericarditis, which are inherently cardiac events, and Pfizer instead reported them in the Immune-Mediated/Autoimmune SOC. By reporting those in a seemingly unrelated SOC, Pfizer decreased the cardiovascular disease signal and prevented quick review of all cardiac-related adverse events.
Despite approximately 6,000 serious adverse events (SAEs) under Figure 1’s (p. 8) “Gastrointestinal” category, Pfizer did not create a Gastrointestinal SOC. Seventy gastrointestinal cases (about 1%) were reported in the Hepatic (liver) SOC. While the liver is, indeed, part of the overall gastrointestinal system, where are the thousands of other gastrointestinal serious adverse events? The Hepatic SOC is also an anomaly because it only includes one diagnosis, “liver injury.” The other hepatic adverse events are primarily abnormal liver tests. Pfizer does not explain what test result value results in a liver test being counted as adverse event. Such irregularities appeared elsewhere as we reviewed other System Organ Classes, such as the Hematological SOC.
The Hematological SOC contains conditions such as vaginal hemorrhage and menorrhagia (heavy menstrual bleeding), which are more typically associated with gynecology than with bleeding disorders. Even though Figure 1 lists reproductive disorders in addition to those in the Hematological SOC, Pfizer did not create a Gynecology or Reproductive SOC. The frequency of post-vaccination menstrual irregularities and miscarriages necessitates a comprehensive gynecological or reproductive adverse events and diagnoses presentation. You will see that Pfizer used all of the tools at its disposal to present adverse events’ data to its own benefit.
