Report 93: Pfizer’s ‘Post-Marketing Surveillance Report’ Reveals That Pfizer Manipulated Data and Wrongly Tabulated Adverse Events, Which Concealed Them.

By Barbara Gehrett, MD; Chris Flowers, MD; and Loree Britt

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.

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:

“Most frequently reported relevant PTs [Preferred Terms] (>1 occurrence) included:

• 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);"

The total of the specified diagnoses in the above two bullet points is 292, not the 300 previously stated. Therefore, Pfizer excluded eight serious stroke adverse event cases and diluted the stroke signal. This pattern continued across other SOCs.

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?

We also observed that Pfizer used various diagnostic terms to describe the same disease. This practice reduced the apparent number of occurrences below the threshold of reporting. For example, "myocarditis" was assigned to the "Immune-Mediated/Autoimmune SOC," which excluded those cases from being counted in the "Cardiac and Cardiovascular SOCs." We found many examples of this type of soft-pedaling SOC assignment.

The public deserves to know all of the post-vaccination adverse events and related diagnoses, not just the ones Pfizer included by playing "threshold" and SOC misassignment games.

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:

1. "Neurological": 501 cases (69% of adverse events were seizures).

2. "Facial Paralysis" (or "Bell’s Palsy"), with 449 cases.

3. "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.

Pfizer Manipulated Data Using a Special Tool, the "Brighton Collaboration Criteria."

Brighton Collaboration is a community of experts who aim to promote and improve vaccine safety. The group enhances the science of vaccine research by providing standardized, validated, and objective methods for monitoring vaccine safety and benefit-risk profiles. (https://brightoncollaboration.org/) It appears Pfizer used the "Brighton Collaboration criteria" (https://brightoncollaboration.org/case-definitions-table-view/) when it served the company’s desired outcomes -- such as excluding clinically diagnosed anaphylaxis cases and possible vaccine-associated enhanced disease (VAED) cases -- but ignored the expert criteria for other disease categories.

Pfizer recorded 1,833 clinical anaphylaxis cases in the Anaphylaxis SOC (Table 4, “Important Identified Risk,” p. 10). Those diagnoses reported to Pfizer contain synopses of medical information but not complete medical charts. Pfizer applied a set of strict criteria, known as "Brighton Collaboration criteria," to these clinical diagnoses of anaphylaxis. However, the Brighton criteria require a complete clinical history, including a physical examination and laboratory results, neither of which are available in the reported anaphylaxis cases. The use of the Brighton Collaboration criteria for diagnostic certainty, as seen on page 10 of 5.3.6, led to the exclusion of 831 anaphylaxis cases from this SOC, resulting in the cases’ not being included in 5.3.6. That left 1,002 anaphylaxis cases, among which there were nine deaths. What happened to the excluded cases? Pfizer does not offer an explanation.

Pfizer also applied the Brighton Collaboration criteria to vaccine-associated enhanced disease (VAED), as detailed in Table 5, "Important Potential Risk" (p. 11). VAED is characterized as an instance of infection, notably COVID-19, following vaccination that is either unusual or more severe than a typical infection. The Brighton Collaboration published its VAED criteria on February 23, 2021.  (Vaccine-associated enhanced disease: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data - PMC (nih.gov)) The Brighton Collaboration article pointed out the challenge in distinguishing between vaccine failure, also known as breakthrough disease, and VAED in vaccinated individuals, advising that all cases of vaccine failure should be scrutinized for VAED. While cases of COVID-19 in vaccinated patients were quickly labeled “breakthrough” cases in 2021, there was no indication that Pfizer or the FDA followed the Brighton recommendation to investigate those cases as instances of VAED. Whether or not the “breakthrough” cases were unusual or more severe cases of COVID-19 remains unknown.

Did the Brighton Collaboration experts have any conflicts of interest related to the COVID pandemic and Pfizer's COVID vaccine? It is worth noting that Fernando Polack, a member of the Brighton Collaboration Vaccine-associated Enhanced Disease Working Group (https://pubmed.ncbi.nlm.nih.gov/33637387/), also authored the primary report on Pfizer's COVID vaccine Phase 2/3 clinical trial. (N Engl J Med 2020;383:2603-15. DOI: 10.1056/NEJMoa2034577, https://www.nejm.org/doi/full/10.1056/NEJMoa2034577) This instrumental paper helped secure Pfizer’s COVID-19 vaccine’s emergency use authorization (EUA) from the FDA.

Why Are There Obvious Discrepancies in Death Totals?

Where did 497 deaths go? Different tables reveal different death totals. Tables 4, 5, 6, and 7 document 726 fatalities during the first three months of the vaccine rollout. However, Table 2, in contrast, reports 1,223 deaths within the same 90-day period.

What caused the additional 497 deaths shown in Table 2? Why were they left out of Tables 4, 5, 6, and 7? We speculate that some of those deaths may be among the 831 “non-anaphylaxis” cases, which, because they did not meet the Brighton Collaboration criteria, were excluded. However, there is no way to know with certainty.

Striking Findings About the Speed of Symptoms Onset After Injection.

Even though Pfizer appears to have tried to conceal adverse events and deaths by recategorizing them, what it could not hide is how soon after injection people got sick or died. One of the most striking findings from the 5.3.6 document was the median latency for each SOC in Table 7.

The median latency for adverse events in the Cardiovascular and Immune-Mediated/Autoimmune SOCs was less than 24 hours. That means that half the cardiovascular events and half the immune-mediated/autoimmune events began within 24 hours of receiving a BNT162b2 injection. The median latency for adverse events in the Hematological, Musculoskeletal, Neurological, Other, and Respiratory SOCs was one day.  For example, the 376 seizure events in the Neurological SOC made up 69% of the total neurological adverse events, and half of the neurological adverse events occurred within one day post-injection. The longest median latency in Table 7 was five days.

Yet, After Each SOC, Pfizer Concluded: “This cumulative case review does not raise new safety issues.”

What is a safety issue or signal? The European Medicines Agency (EMA) says that a safety signal is “information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature.” The World Health Organization (WHO) defines a safety signal as “information on a new or known side effect that may be caused by a medicine and is typically generated from more than a single report of a suspected side effect.” Additionally, the FDA offers this information on safety signals:

https://www.fda.gov/media/96408/download, p. 32.

Pfizer’s post-marketing surveillance report captured adverse events related to its new drug that were reported from multiple sources (i.e., multiple case reports) and that had more than a single report, yet the company repeatedly communicated that no new safety issues were raised by those findings. However, that conclusion does not align with the EMA, WHO, or FDA’s definitions of safety signals seen above.

Did Pfizer, for example, consider what the rate of seizures is within a day of receiving other vaccines, or how often strokes occur within two days of receiving another vaccine? Such comparisons would give meaning and context to Pfizer’s “does not raise new safety issues” conclusion. However, it seems the company did not give such consideration to the myriad of adverse events happening after vaccination with its novel drug. Rather, it appears Pfizer was left to its own devices to make a call on the safety of its own drug. What would it have taken to convince Pfizer of a relationship between its shot and an adverse event? Apparently not even deaths post-vaccination gave Pfizer pause to consider such a relationship.

In addition to deaths, adverse event outcomes following vaccination were reported in four categories: "resolved/resolving," "resolved with sequelae," "not resolved," and "unknown." Table 7 does not present ratios of ‘resolved’ versus ‘resolving,’ and we do not know whether the ‘resolving’ ever completely resolved. How many adverse events never fully resolved? Table 7 does not provide the details of reported ‘sequelae,’ a condition which is the consequence of a previous disease or injury. Such outcomes may not resolve and could lead to disability or even death. Pfizer's post-marketing report offers only a partial view of adverse event outcomes and leaves one with more questions than answers.

Did the DailyClout Micro-Reports have an impact on the FDA or CDC?

The Post-Marketing Team’s micro-report on strokes (WarRoom/DailyClout Pfizer Report 50) was posted to Dr. Naomi Wolf’s DailyClout.io website on December 26, 2022.  On January 13, 2023, the CDC and FDA announced that they had been following a stroke signal in individuals aged 65 and over. (https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cdc-and-fda-identify-preliminary-covid-19-vaccine-safety-signal-persons-aged-65-years-and-older)  Coincidence? Perhaps; or maybe the agencies felt the need to get in front of Pfizer’s own information that was finally being highlighted publicly.  What other signals have the CDC and FDA been following related to the Pfizer vaccine’s adverse effects? The Post-Marketing Team covered 19 SOCs, in addition to the Stroke SOC, all of which deserve the CDC and FDA’s close attention.

Closing Thoughts

1. Based on the information in and time frame of 5.3.6, it is not possible to make statements about possible long-term reduction of immunity or about risk of diseases that have a longer latency period than 90 days, such as cancer and endocrine disorders.

2. Despite committing in its Phase 2/3 C4591001 clinical trial protocol to follow trial participants for 24 months, Pfizer unblinded its clinical trial in December 2020, with the FDA's permission, and vaccinated over 90% of the study's placebo arm by March 2021, thus making it impossible to fully investigate and report on long-term adverse events and vaccine safety. This effectively terminated the clinical trial.

Where does this leave us? Our review of the first 90 days of use of BNT162b2, as reported by Pfizer to the FDA, reveals serious safety concerns.  5.3.6's Figure 1 and Table 1 report 51,000 “General disorders,” such as fever, fatigue, chills, pain, malaise, and vaccination site redness and swelling. Over 20,000 of these adverse events were classified as serious (i.e., death, life-threatening, hospitalization, disability, or congenital disorder). What happened to the patients who suffered those 20,000+ serious adverse events? Why was such suffering hidden until a court order forced the public release of this document?

Administering a novel vaccine that uses new technology and an untested lipid nanoparticle (LNP) carrier -- one which crosses every natural cellular barrier -- to billions of people worldwide is a bold venture into unknown territory.  It is critical to continually analyze and reanalyze the risk-benefit ratios of such a drug based on current viral mutations, but that has not been done. Flexibility in response and recommendations is particularly important because these products are being used on pregnant and breastfeeding women, children, and infants. Instead of learning about risks and benefits during a traditional clinical trial, we are now learning about those lessons in real-time across much of humanity.

Our analysis of 5.3.6 suggests that the FDA and CDC failed to protect Americans from serious adverse events related to Pfizer’s mRNA COVID vaccine product.  The 5.3.6 report should be of concern to every BNT162b2-vaccinated individual; however, due to a media blackout, most people do not know it exists. It is important to share these findings with others so that the public may be more fully informed. You can read about every 5.3.6 system organ class on DailyClout’s website.

Ignore these issues at your peril. Pfizer’s own documentation shows that they are real.

Appendix

WarRoom/DailyClout Pfizer Document Analysis Project

Team One Reports on 5.3.6

5.3.6 Micro-Reports

Hematological: Report 47

Thromboembolic: Report 49

Stroke: Report 50

Hepatic: Report 51

Cardiovascular: Report 53

Pediatrics: Report 54

Neurological: Report 57

Facial Paralysis: Report 60

Renal: Report 62

Anaphylaxis: Report 65

Immune-Mediated/Autoimmune: Report 66

Vasculitis: Report 68

Musculoskeletal: Report 71

Other AESIs: Report 72

Dermatological: Report 77

Respiratory: Report 78

Pregnancy and Lactation: Report 83

Vaccine Effectiveness: Report 88

COVID-19: Report 90

VAED: Report 92

5.3.6 Micro-Reports Retrospective: Report 93

Review of 5.3.6 and Pharmacovigilance Plan: Report 73

5.3.6 Comprehensive Overview”: Report 87