Report 87: In Early 2021, Pfizer Documented Significant Harms and Deaths Following Vaccination with Its mRNA COVID Vaccine. The FDA Did Not Inform the Public.
“5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162b2) Received Through 28-Feb-2021,” Pfizer’s post-marketing report, a required U.S. Food and Drug Administration (FDA) compliance document, is one of the ways in which the FDA assessed patients’ risks associated with Pfizer’s COVID-19 vaccine, BNT162b2. The data within the Pfizer’s 5.3.6 analysis are not indicative of a safe-for-humans biologic. (Worldwide Safety Pfizer. “5.3.6 Cumulative Analysis of POST-AUTHORIZATION ADVERSE Event Reports of PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021”. Public Health and Medical Professionals for Transparency, 1 Apr. 2022, www.phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf.)
This Post-Marketing Experience (PME) Team’s summary analysis describes adverse events (AEs) with percentages representing proportions of case reports received during Pfizer’s BNT162b2 post-marketing period. Percentages should not be taken as incidence occurrence rates as these are observational data, not clinical trial data. The Pfizer post-marketing report is built from case submissions to Pfizer in the first 90 days, starting on December 1, 2020, of its vaccine being publicly available. Within this short time frame, there were 1,223 deaths reported. Categories within Pfizer’s report have a combination of medically confirmed and non-medically confirmed adverse events (AEs).
An European Union (EU) Periodic Safety Update Report (PSUR #1), covering December 19, 2020, through June 18, 2021, confirms the PME Team summary showing alarming safety signals caused by the Pfizer COVID-19 vaccine. PSUR #3 was released August 18, 2022, covering December 19, 2021, to June 18, 2022, which as discussed below also confirms the findings of the PME Team summary. As of early August 2023, no publicly available follow-up reporting to FDA regulators regarding Pfizer’s post-marketing report exists.
The PME Team will state arguments made by Pfizer within its 5.3.6 post-marketing report followed by the team’s conclusions and key findings.
The 90-day, post-vaccine-rollout 5.3.6 post-marketing experience report, required by the FDA from Pfizer, is touted as showing that the BNT162b2 “vaccine” is safe. However, Pfizer’s own data do not back up that claim.
There are multiple Serious Adverse Events (SAEs) reported across all age groups. Age groups were divided as follows: Adult = 18 to 64 years; Elderly = greater than or equal to 65 years; child = two (2) to 11 years; Adolescent = 12 to less than 18 years (defined in 5.3.6) [https://www.phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf, p. 16]. Many of the adverse events occurred within days of receiving the injection and include permanent harms and fatalities.
- It is important to note that the adverse events in the 5.3.6 document were reported to Pfizer for only a 90-day period starting on December 1, 2020. There were 1,223 deaths, and Pfizer’s concluded, “This cumulative case review does not raise new safety issues.” (Emphasis added.) That conclusion was repeated 15 times within the document. [pp. 17, 18, 19, 20, 21, 22, 23, and 24]
- Pfizer states, “Reports are submitted voluntarily, and the magnitude of underreporting is unknown.” (Emphasis added) [p. 5]
- Pfizer planned to increase personnel for data entry and case reporting to 2,400 additional full-time employees to handle the large increase of adverse event reports. [p. 6] It is unknown how many persons were already employed for data entry purposes.
- Latency, the period of time between when the drug was given and an adverse event occurred, was often short, typically zero (0) to four (4) days. There were four deaths on the same day of vaccination.
- Of the 42,086 “cases” (i.e., patients), AEs for women (29,914 or 71%) were reported more than three times that of men (9,182 or 21.8%).
- Age demographics show that 54% of the cases were less than or equal to 50 years old; the highest number of cases were in the age bracket of 31- to 50-years-old. The range of years among the age brackets was variable. For example: less than 17 years old (a 17-year range), 18 to 30 years old (a 13-year range), 31 to 50 years old (a 20-year range), 51 to 64 years old (a 14-year range), 65 to 74 years old (a 10-year range), and greater than or equal to 75 years old.
- One hundred and seventy-five (175) cases were under 17 years of age. Unknown dosages were given to children under the age of 12 as there was no authorization for children under 12 during this period. Harms to children included Bell’s palsy in a one-year-old, stroke in a seven-year-old, and renal failure in an infant less than 23 months of age.
- The Pregnancy category reveals 56 fetuses and infants died. There were 54 pregnancy cases in which the baby was not carried to a live birth. It should be noted that BNT162b2 was not approved for use in pregnancy or during lactation at the time of the post-marketing data collection.
- Full informed consent was NOT provided. Before the public rollout, the FDA and similar agencies in other countries knew about adverse events related to Pfizer’s vaccine and yet did not provide that information to the general public. [https://www.phmpt.org/wp-content/uploads/2022/04/125742_S1_M5_5351_c4591001-interim-mth6-adverse-events-sensitive.pdf, https://www.phmpt.org/wp-content/uploads/2022/05/125742_S1_M5_5351_bnt162-01-interim3-adverse-events.pdf, https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/060122/125742_S1_M5_5351_c4591001-fa-interim-adverse-events.pdf, and https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/070122/125742_S1_M5_5351_c4591001-interim-mth6-adverse-events.zip]
- Outcomes were separated into the following categories: Unknown, Recovered/Recovering (inconsistent categories combined), Not Recovered at time of report, Recovered with sequelae (meaning, there is a pathological condition as a result of the initial adverse event), and Fatal.
- Pfizer reported that surveillance would continue, yet no information on subsequent surveillance has been released to U.S. regulatory authorities. Periodic Safety Update Report (PSUR) #1 and #3 have been PARTIALLY released to the European Union. A brief summary of the PSUR reports and reference links appear in this summary.
SAFETY: FATALITIES AND LACK OF INFORMED CONSENT
This PME summary is a comprehensive review of Pfizer document “5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021.” (https://www.phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf) The Pfizer report findings represent adverse events (AEs) submitted voluntarily to Pfizer’s safety database from various sources worldwide, including medical providers and clinical studies. In just three months, 42,086 case (or patient) reports were submitted to Pfizer representing 158,895 adverse events [p. 6] among them. That averages to 3.78 adverse events per case/patient. Adverse events are broken into System Organ Classes (SOC) with each System Organ Class containing conditions found in the field.
Post-marketing represents the results of the first 90 days following the rollout of a drug to the public. Although not a scientific data set, this Pfizer analysis includes critical harms, reported to Pfizer by providers in the field, that were not relayed to the public until the post-marketing document was released under court order on November 17, 2021, and then again in an unredacted version on April 1, 2022. [https://www.phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf and https://www.phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf]
Review Team Conclusion:
Key Finding: Full informed consent was not provided. Informed consent must list all potential harms, one of which is death.
“5.3.6 Cumulative Analysis of Post-Authorization Adverse Events Reports of PF-07302048 (BNT162b2) Received Through 28-FEB-2021” does not represent a safety report. Pfizer repeatedly concluded “no new safety issues” despite an analysis showing significant injuries and even fatalities.
With different risks and rates of risk noted, the singular issue at hand is informed consent. By the end of February 2021, the adverse events reported across several System Organ Classes show serious damages including deaths. Pfizer detected harms through its data collection that were not included in the original December 11, 2020, emergency use authorization (EUA) [https://www.fda.gov/media/144959] As such, the detection of these potential harmful side effects necessitates an updated list of potential risks as part of patient consent. The detection of adverse events and subsequent omission of them in printed or online package inserts and/or fact sheets represents a violation of truth in medical ethics. Most importantly, the concerning and, in many cases, potentially long-term adverse events listed within the Pfizer post-marketing report do not support assertions of product safety.
Informed consent requires the disclosure of known potential for adverse events on the package inserts. Patients should be given the opportunity to fully understand potential harmful side effects before receiving the drug. [https://www.verywellhealth.com/understanding-informed-consent-2615507]
Sufficient concerns are documented from review of Pfizer’s post-marketing analysis to conclude its COVID-19 vaccine (BNT162b2) raises important safety concerns.
Key finding: Mandating the administration of the experimental COVID-19 vaccine without offering full informed consent to the public should be viewed as unacceptable. The FDA was negligent in its duty to protect the public when it allowed Pfizer to leave its package inserts blank, without written warnings or links to those known warnings, rather than listing the known adverse events found through post-marketing surveillance in its printed or online package inserts and/or fact sheets. [https://www.fda.gov/media/72139/download]
Pfizer claimed [p.6] that the reported cases could be used to look for signals, and yet Pfizer disregarded the signal of 1,223 deaths in a 90-day period, during the early rollout of the “vaccine.”
Key Finding: Fatalities were seemingly obscured in the analysis by Pfizer spreading the deaths across many different System Organ Classes. The total reported deaths were 1,223, yet this important figure is not readily apparent in the post-marketing report.
The fatalities noted during this review are spread across all but three System Organ Classes. Though there were many routes to death, when it is viewed as a singular result, the fatality rate of cases observed in the post-marketing patient population is 2.9% of the cases reported. Pfizer analysis Table 2 [pp. 8-9] claimed to identify adverse events equal to or above a two percent threshold. However, Pfizer failed to include fatalities as a separate adverse event category even though it met Pfizer’s criterion for equal to or greater than two percent. Deaths would have stood out as a significant issue in the Pfizer report Table 2 [pp. 8-9] if included as its own category.
In Pfizer’s own words [p. 6], post-marketing data should be used for “signal detection.” The Post-Marketing Experience Team authors of this summary suggest that 1,223 deaths and the level of other adverse events present large signals that should have triggered, at minimum, a pause in the vaccine rollout. Distribution and injection of Pfizer’s mRNA vaccine should be suspended based on known, severe adverse events to date.
After a review with the Post-Marketing Experience Team, several points emerged as both relevant conclusions and possible larger questions moving forward. This summary acknowledges the fact that the data are not a scientific data set. It is unknown what number of injections were administered during the 90-day post-marketing timeframe and, thus, how that relates to the 42,086 cases reported.
Every System Organ Class had fatalities except for Dermatological adverse events, Facial Paralysis adverse events and Musculoskeletal (dealing with muscles, bones, and joints) adverse events.
How do Pfizer and the FDA consider 1,223 deaths — a 2.9% death rate — “safe?”
Who (which individuals or groups) made the determination of safety?
Why does the FDA agree with Pfizer’s assessment and continue to allow this drug to be given to patients?
FEMALE PREPONDERANCE OF ADVERSE EVENTS
Gender is a demographic tracked throughout the analysis. Adverse event female cases number 29,914 (71%), and male cases number 9,182 (21.8%); and the remaining 2,990 cases listed the gender as “unknown.” Pfizer does not offer an explanation for this difference.
Review Team Conclusion:
Key Finding: The number of adverse events reported for women is more than three times that reported for men. While it is possible that the large number of female adverse events may be due to sampling bias and not related to gender-specific effects, the disparity in the number of events women suffer is evident. This large discrepancy is a signal that females are likely at greater risk of an adverse event than males, and the signal should be investigated further.
The ratio of women to men receiving injections is unknown. It is also unknown whether the persons reported in post-marketing, as receiving injections, were otherwise healthy individuals at the time of inoculation. The adverse events represent reports from the field alone without standardization.
What does Pfizer know about gender-related risk of adverse events from its COVID vaccine?
What was the number of women versus men vaccinated during the timeframe of December 1, 2020, through February 28, 2021?
Why did Pfizer and the FDA seemingly ignore the signal indicating that women were much more likely to be harmed by this vaccine?
WHY WERE AGE GROUPINGS IRREGULAR?
Pfizer [p. 7] displays the events/age group categories as: less than or equal to 17, 18 to 30, 31 to 50, 51 to 64, 65 to 74, greater than or equal to 75, and unknown.
The age demographic showing the most adverse events is 31 to 50. This segment encompasses 20 years. Other age categories are 14 or fewer years in span except for the under 17-year-old group.
Review Team Conclusion:
Key Finding: Irregular age groupings obfuscate relevant risks. Age groups of standard intervals would show age-related side effects if they exist. If there are no age-related effects, the risk of adverse events would be constant at all ages.
Pfizer reports adverse events by age brackets that are not standardized in age range, leading to potential issues in understanding age-related side effects. There are groupings of 13 years, 20 years, 14 years, and 10 years. The bookend ranges are under-17 years and over-75 years. This unbalanced grouping approach obscures possible age-related relationships to adverse events. Most adverse events occurred in the 31- to 50-year age range, but this age range is also the broadest (encompassing 20 years). The large proportion of adverse events in the age group of 31 to 50 years, combined with the larger number of reports involving females, could suggest that women of childbearing age are greatly affected. This age-based analysis cannot be linked to adverse events without clear, high-quality data. As such, statistical conclusions are impossible to make based on the post-marketing analysis.
The number of reported adverse events for patients in their 30s or 40s may be similar or different, but it cannot be determined. If there are adverse events more commonly seen in patients in their 30s, the events would not be detectable due to the irregular interval of a combined age range of 31 to 50.
Ideally, Pfizer would have reported adverse events by standardized age intervals, for instance, five-year or 10-year intervals. It is, thus, more difficult to conclude the potential relationship between reported adverse events and age. There are an additional 6,876 adverse event reports that list age as “Unknown.” This unknown set may also skew the data.
Mean age was calculated by Pfizer [p. 7] from an age range of 0.01 to 107 years to yield a mean age of 50.9 years. If the range were one year to 78 years (life expectancy) the median age would be 39.5 years. Of the number of cases where the age of the recipient is known, 54% are less than or equal to 50-years-old.
How many persons aged 31 to 40 had adverse events?
How many women of childbearing age were negatively affected or permanently harmed?
WHY DID PFIZER SEEMINGLY HIDE 97% OF THE OUTCOMES?
Table 1 is found on page seven of the Pfizer post-marketing report. Pfizer grouped the results into categories of “unknown,” “fatal,” “not recovered at the time of the report,” “recovered with sequelae,” and “recovered/recovering.” Table 1 lists 1,223 fatalities or deaths (2.9% of cases). “Recovered/Recovering” is a combined category (19,582 cases). Additional outcome categories include “Recovered with Sequelae” (which includes 520 events), “Not Recovered at the time of report” (11,361 cases), and “Unknown” (9,400 cases).
Review Team Conclusion:
Key Finding: The proportion of cases with permanent harms (death) is 2.9 percent. The true proportion of harms that may become chronic conditions is unknown.
Table 1 data [p. 7] are important as they describe deaths in almost three percent of patients.
- “Not Recovered at the time of report” and “Recovered with Sequelae” were 11,361 cases and 520 cases respectively of the 42,086 total cases, or 27%.
- By February 28, 2021, 27% of case reports from a 90-day period were not resolved.
- “Recovered/Recovering” is 19,582 or 47% of cases.
- The “Unknown” population for outcomes is 9,400, which represents 22% of case reports.
The category of “Recovered/Recovering” involves two different outcomes since “Recovering,” as a term, does not represent “Recovered.” However, they are combined as a single outcome in the Pfizer report. It is unknown if the “recovering” group is a small or large proportion of that 47%. Proportions of “unknown” cases (22%) and “recovering” cases (47%) may also represent unresolved side effects. The listing of outcomes in Table 1 represents harms that are permanent, temporary, or unknown.
“Recovered with sequelae” means that the patient may have recovered from the original ailment but now has a different, lingering health problem that was not present prior to being injected with Pfizer’s drug. When totaled, the “unknown,” “not recovered at the time of the report,” “recovered with sequelae,” and “recovered/recovering,” relevant cases come to 97%.
We do NOT know the outcome of almost 97% or 40,863 of the total 42,086 relevant cases.
We do know 2.9% died.
Why did the FDA attempt to conceal this data, along with other Pfizer clinical trial data, for 75 years?
Why were “Recovered/Recovering” combined? It seems Pfizer would want to highlight the number of recovered persons if this outcome category were favorable.
How is “Recovering” different from “Not recovered at time of report”?
CONFUSING REPRESENTATION OF PEDIATRIC DATA
Pediatric individuals were considered less than 12-years-old, and cases reported ranged in age from two months to nine years [p. 13]. There were 34 cases included in the report, 24 (71%) of which were listed as “Serious” [p. 13]. There were two cases of facial paralysis in the young; one was a child, and one was an infant. The System Organ Class for Pediatric lists 34 cases, but Pfizer acknowledged that 28 additional cases were excluded due to height and/or weight. Forty-six cases were listed as under 16 years old, which leaves the remaining cases (out of 175) as 67 cases between 16- and 17-years-old.
Review Team Conclusion:
At the time of the Pfizer 5.3.6 report, there was no emergency use authorization for a COVID vaccine for individuals under the age of 16. However, there were post-marketing cases reported for individuals younger than 16. It is unclear if individuals who were 12- to 17-years-old were inoculated during Phase 3 of the trial and if these cases were reported after a trial inoculation rather than being separated into “trial related data.”
In the Pfizer report [p. 7], the age category lists 175 cases as less than 17 years with 46 cases less than 16 years, and 34 cases less than 12 years. The Under 12 category is misleading since page 13 shows 62 total cases under the age of 12.
After the Pfizer post-marketing report was released, Pfizer presented Phase 3 data to the FDA regarding 12- to 17-year-olds, https://www.pfizer.com/science/coronavirus/vaccine/about-our-landmark-trial. Pfizer and BioNTech announced positive topline results of the pivotal COVID-19 vaccine study in 2,260 adolescents ages 12 to 15. A claim is made by Pfizer and BioNTech that all participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose. On April 9, 2021, the companies submitted these data to the FDA and requested an amendment to the BNT162b2 emergency use authorization to expand use to adolescents 12 to 15 years of age. The 16-to-17 age group is not addressed separately, and no public data has been released regarding this data from the FDA.
Key Finding: Do fatalities occur in the young? The Pfizer post-marketing report does not address this clearly.
Although the Pfizer report section for the Pediatric System Organ Class listed 34 adverse event cases, there were 62 case reports with ages listed as under 12-years-old. Pfizer excluded 28 cases of patients under 12-years-old due to their height and/or weight. [p.15] Since this category was age related only and the drug was not administered based on body weight, these additional 28 cases seemingly should not have been excluded.
During the timeframe of these adverse event cases (December 1, 2020, through February 28, 2021), the emergency use authorization (EUA) dosage publicly available was only for persons older than 16. There was no EUA for a pediatric dose. It is possible that these children received adult doses of the Pfizer product. The dosing of these children warrants further investigation.
A one-year-old suffered Bell’s palsy one day following vaccination, and it had not resolved at the conclusion of the post-marketing report.
A seven-year-old suffered a stroke, outcome unknown.
Children under 12 should not have received the Pfizer vaccine as the trial for the 5 to 11 age group did not begin until late March 2021.
Cases for those younger than 18 are scattered within the listed sections of System Organ Classes for Adverse Events of Special Interest (Anaphylaxis, Cardiovascular, COVID-19, Hematologic, Facial Paralysis, Immune-Mediated/Autoimmune, Musculoskeletal, Renal, Respiratory, Stroke, Other).
What dose or doses were children under age 12 given since there was no emergency use authorization for children that age during this the time?
SELECTIVE REPORTING OF DEATHS
Pfizer claimed [p. 8] that any adverse events that occurred in greater than or equal to (≥) two percent of adverse event reports would be listed in Table 2 [pp. 8-9]. Table 2 includes 93,473 events grouped by System Organ Class. Conditions listed are milder symptoms such as pain, malaise, fever, and/or nausea. Also, it is important to note that there were COVID-19 infections (4.6%); Paraesthesia (paresthesia), which is an abnormal sensation of tingling or prickling caused chiefly by pressure on or damage to peripheral nerves (3.6%); and Hypoaesthesia (hypoesthesia) or numbness (2.4%).
Review Team Conclusion:
Key Finding: Unresolved adverse event cases and fatalities are not included in Pfizer’s Table 2 even though they exceed the two percent threshold required for adverse events’ inclusion.
Why did Pfizer not list the deaths in the table and only listed them in the body of the text?
In the strict sense of the wording, there were 1,223 “cases” resulting in death out of 42,086 total cases; this is 2.9% of the cases and should have been included in the Table 2 per Pfizer’s own criteria.
“SERIOUS” VERSUS “NON-SERIOUS” ADVERSE EVENTS
Pfizer provided adverse event groupings of “Serious” and “Non-Serious.” When aggregated, there are 16,147 “Serious” adverse events and 11,617 “Non-Serious” adverse events.
Review Team Conclusion:
Key Finding: On page 26 of the Pfizer report, the “non-serious” event category included deaths related to medication errors. Pfizer footnoted, “All the medication errors reported in these cases were assessed as non-serious occurrences with an unknown outcome; based on the available information including the causes of death, the relationship between the medication error and the death is weak.” Is it left only to Pfizer to determine if the link between a medication error and death is “weak”? Pfizer still concluded product safety despite significant “Serious Adverse Events.”
The FDA defines a Serious Adverse Event as: any untoward medical occurrence that: 1) results in death; 2) is life threatening; 3) requires inpatient hospitalization or causes prolongation of existing hospitalization; 4) results in persistent or significant disability/incapacity; 5) may have caused a congenital anomaly/birth defect; 6) requires intervention to prevent permanent impairment or damage. (Emphasis added.)
[https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event and https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.32]
According to Pfizer [p. 6], the company planned to hire an additional 2,400 full-time personnel for data entry and case processing. Pfizer indicated, “Pfizer has also taken multiple actions to help alleviate the large increase of Adverse Event reports.” [p. 6] By its own admission, Pfizer expected to have large numbers of cases and adverse events reported. This expectation of increased adverse event reports supports a conclusion that Pfizer’s vaccine is not as safe as was communicated to the general public. Pfizer also indicated, “Reports are submitted voluntarily, and the magnitude of underreporting is unknown.” [p. 5]
A truly safe vaccine should not lead to a post-marketing report with large numbers of “Serious Adverse Events.”
The scope of this PME Team summary will not document all individual findings within each System Organ Class. The Post-Marketing Team micro-reports are available for a more detailed investigation into some of the System Organ Class evidence, such as stroke, thromboembolic (clotting) and hematologic (blood), liver, cardiovascular, neurologic events and more [https://dailyclout.io/category/pfizer-reports/] (Also see references below).
PFIZER CONCLUDES ITS COVID-19 VACCINE IS “SAFE”
At the end of each System Organ Class section, Pfizer drew a conclusion — “Conclusion: this cumulative case review does not raise new safety issues.”
Review Team Conclusion:
Key Finding: Incredibly, Pfizer’s conclusion of “no new safety issues” is repeated 15 times including for System Organ Class categories that included deaths. The conclusion for pediatrics is, “No new significant safety information was identified based on a review of these cases compared with the non-pediatric population.” Based on the evidence in the report, the PME Team strongly disagrees with Pfizer’s conclusion.
How can a 2.9% fatality rate among reported cases in just 90 days lead to a conclusion of drug safety?
There are three Safety Concern Categories (SCC) in the Pfizer report [p. 9] which lead to the data included in Table 3. The first safety concern, Anaphylaxis, is considered an “Identified Risk.” Anaphylaxis is a severe, potentially life-threatening allergic reaction. The second, Vaccine-Associated Enhanced Disease (VAED), is considered a “Potential Risk.” The third category of “Missing Information” concerns: “Pregnancy and Lactation,” “Use in Pediatric Individuals,” and “Vaccine Effectiveness.”
As detailed above, sufficient concerns are documented from the review of the Pfizer post-marketing data to conclude the Pfizer COVID-19 vaccine (BNT162b2) is not safe. Additional data and follow-up on the reported cases identified as “unknown” would be required to clarify significant unanswered questions about safety.
The only follow-up data for the remaining adverse event reporting to date are the Periodic Safety Update Reports (PSURs) #1 and #3 issued in the European Union (EU), as mentioned above. These two reports confirm the PME Team findings in this report, though it is unclear why the data appears to have not also been released to the FDA. That follow-up data is needed to begin to understand the scope of the harms to the human population. PSUR #3 states, “There were no marketing authorization (sic) withdrawal for safety reasons during the reporting interval.” In their own words, “According to the European Risk Management Plan (EU-RMP) version 4.0 adopted 26 November 2021, in effect the beginning of the reporting period, safety concerns for BNT162b2 are:…”.
Then, Pfizer proceeds to list serious safety concerns such as vaccine-associated enhanced respiratory disease (VAERD), anaphylaxis, myocarditis, and pericarditis, all of which affirm the findings in 5.3.6. Use in pregnancy and breastfeeding and use in immunocompromised patients is incomplete and noted as “missing information” in PSUR #3. A more comprehensive report comparing this PME Team summary and PSUR#3 data will be forthcoming. The EU PSURs beg the question of why no similar U.S. reports have been released to meet the stated reporting requirements.
Table 1: System Organ Class and “Serious” Versus “Non-Serious” Adverse Events According to Pfizer’s Post-Marketing Report
|System Organ Class||Page||Number, %||Serious||Non-Serious||Death/ Unknown||Female/Male/ Unknown||Notations|
|Anaphylaxis (Safety Concern Category)||10||2,958
|Vaccine-Associated Enhanced Disease
|–||–||38/8||73/57/8||75 potential cases. Pfizer suggested: “None of the 75 cases could be definitively considered as VAED/VAERD.”|
|Pregnancy and Lactation (SCC)||12-13||413
|84||329||(Baby2 =28)/242||Babies not listed||Spontaneous abortions and neonatal deaths reported; alterations to breastfeeding|
(2 mo. – 9 yr.)
|24||10||0/5||25/7/2||Two Facial Paralysis; one Stroke|
|Vaccine Effectiveness (SCC)||13-15||1,665
|1625||21||65/1230||Not listed||Contracting COVID is considered “Serious”; no immunity conferred; 16 cases of vaccine failure per Pfizer criteria|
|946||495||136/380||1076/291/36||130 myocardial infarctions, 91 cardiac failures|
|2,585||774||136/2110||1650/844/573||Unremarkable; deals with positive cases|
|681||399||34/371||676/222/34||Numerous examples of spontaneous bleeding from mucous membranes|
|53||41||5/47||43/26/1||Metabolic alterations within the liver|
|399||54||0/97||295/133/21||One infant; one child|
|Immune-Mediated and Autoimmune||20||1,050
|780||297||12/312||526/156/368||32 Pericarditis, 25 Myocarditis|
|1,614||2,026||0/853||2760/711/129||3,525 Arthralgia (joint pain)|
|515||27||16/161||328/150/23||204 Seizure, 83 Epilepsy|
|70||0||23/22||46/23/0||All serious: 40 acute kidney injury, 30 renal failure, includes one infant|
|126||11||41/31||72/58/0||44 respiratory failure 1|
|165||3||18/42||89/55/7||60 Pulmonary Embolism, 39 thrombosis, 35 DVT|
|300||0||61/83||182/91/2||All serious; Ischaemic and Haemorrhagic conditions reported|
|25||9||1/8||26/6/0||Specific condition leading to one fatality not noted|
|124||1932||7/1498||Not disclosed||7 fatalities not categorized as “Serious.” Pfizer lack information leading to fatalities, considered noncontributory|
- Note: 10 cases of ARDS (Acute Respiratory Distress Syndrome).
- Twenty-eight (28) deaths in babies/infants. The outcome for 242 of the pregnant mothers/babies was listed as “unknown.”
As stated previously, the period of this set of adverse events reporting to Pfizer was 90 days from December 1, 2020, ending on February 28, 2021. Interestingly, Pfizer changed the coding convention related to Vaccine Effectiveness (VE) on February 15, 2021. [https://www.phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf, p. 13] This change, less than two weeks before the end of the report’s data cycle as well as a month and a half months after public rollout, allowed the company to shift at least three cases from the Vaccine Failure category to the Drug Ineffective category. That shift in category was enabled due to the addition of requiring a “confirmed laboratory test” to qualify a case as Vaccine Failure [p. 13].
HOW MANY FETUSES/INFANTS ACTUALLY DIED?
Argument: The numbers for the Pregnancy category are found in the Pfizer report on pages 12 and 13. The first bullet point lists 270 mother-related cases and “4 foetus/baby cases”. Pfizer lists that “no outcome was provided for 238 pregnancies…”, which is over 88% of the pregnancies [p12].
Review Team Conclusion:
The Pregnancy category enumerates 56 cases of dead babies/infants as follows: 48 spontaneous abortions; two premature births with neonatal death; two spontaneous abortions with intrauterine death; one spontaneous abortion with neonatal death, one abortion, one abortion missed, and one fetal death. 238 pregnancies were listed as “no outcome reported.”
There was one “normal outcome” and, sadly, that was one baby from a set of twins in which the other twin died. Upon counting the numbers, woven through the report’s text, there were 56 dead fetuses/infants among the classifications.
Why is the first bullet point listed as only four foetus/baby cases when many more than were affected?
How do 56 dead fetuses/babies lead to a conclusion of a “safe and effective” drug for pregnant women?
What happened to the 238 pregnancy cases where there was “no outcome reported”?
LATENCY: WHY WERE SO MANY ADVERSE EVENTS OCCURRING SO QUICKLY?
Latency is the time span between vaccine dose and the emergence of an adverse event. Pfizer concluded, “The data do not reveal any novel safety concerns or risks requiring label changes and support a favorable benefit risk profile of to [sic] the BNT162b2 vaccine.” Pfizer continued, “Review of available data for this cumulative PM experience, confirms a favorable benefit: risk balance for BNT162b2.” [p. 28]
Review Team Conclusion:
Key Finding: Short latency suggests a dose-response relationship between Pfizer’s COVID-19 “vaccine” (BNT162b2) and reported adverse events.
The occurrence of harms soon after doses, a temporal relationship, suggests the product causes harms. There are four instances of patient deaths the same day as the patient received Pfizer’s COVID-19 vaccine (BNT162b2). In the first emergency use authorization (EUA), the FDA considered that any adverse events within six weeks of product use could be plausibly related to the product itself. [https://www.fda.gov/media/144416/download] Within the 5.3.6 Pfizer report, some adverse events occurred within zero to four days after product administration, and most occurred within six weeks. That pattern is consistent across all System Organ Classes. The 5.3.6 report data do not speak to any long-term adverse events which may be present beyond 90 days. After cataloguing events from clinicians in the field who made the connection between product use and adverse events, Pfizer repeatedly concluded, “This cumulative case review does not raise safety issues.” The use of this vaccine product led to a large number of adverse event reports that included significant harms and even fatalities. Pfizer dismissed its own data to make that safety conclusion.
Below, the PME Team reports median time, which is the midpoint value, for adverse event occurrences in each System Organ Class. When this value is within the immediate days after the vaccination, most adverse events develop quickly. These categories show there is a wide range of onset, with some adverse events not developing for over a month. Latencies for System Organ Classes are listed in PME Team summary Table 2 below.
Table 2: Latency; Time from dose to emergence of an Adverse Event (AE)
|System Organ Class||AE Development Range||AE Development Median|
|Cardiovascular||<24 hours – 21 days||<24 hours|
|COVID-19||<24 hours – 50 days||5 days|
|Dermatological||<24 hours – 17 days||3 days|
|Hematological||<24 hours – 33 days||1 day|
|Hepatic||<24 hours – 20 days||3 days|
|Facial Paralysis||<24 hours – 46 days||2 days|
|Immune-Mediated and Autoimmune||<24 hours – 30 days||<24 hours|
|Musculoskeletal||<24 hours – 32 days||1 day|
|Neurological||<24 hours – 48 days||1 day|
|Other||<24 hours – 61 days||1 day|
|Renal||<24 hours – 15 days||4 days|
|Respiratory||<24 hours – 18 days||1 day|
|Thromboembolic||<24 hours – 28 days||4 days|
|Stroke||<24 hours – 41 days||2 days|
|Vasculitic||<24 hours – 19 days||3 days|
- Pfizer report, “5.3.6 Cumulative Analysis of Post-Authorization Adverse Events Reports of PF-07302048 (BNT162b2) Received Through 28-FEB-2021.”
- Report 47: Blood System-Related Adverse Events Following Pfizer COVID-10 mRNA Vaccination – DailyClout
- Report 49: Clotting System-Related Adverse Events Following Pfizer COVID-19 mRNA Vaccination – DailyClout
- Report 50: 20% of Post-Jab Strokes Fatal in the 90 Days 03Following Pfizer COVID mRNA Vaccine Rollout – DailyClout
- Report 51: Liver Adverse Events – Five Deaths Within 20 Days of Pfizer’s mRNA COVID Injection. 50% of Adverse Events Occurred Within Three Days. – DailyClout
- Report 53: 77% of Cardiovascular Adverse Events from Pfizer’s mRNA COVID Shot Occurred in Women, as Well as in People Under Age 65. Two Minors Suffered Cardiac Events. – DailyClout
- Report 54: Infants and Children Under 12 Given the Pfizer mRNA COVID “Vaccine” Seven Months Before the Product Was Approved for Children – DailyClout
- Report 57: 542 Neurological Adverse Events, 95% Serious, in First 90 Days of Pfizer mRNA Vaccine Rollout 16 Deaths Females Suffered AEs More Than Twice as Often as Males – DailyClout
- Report 60: 449 Patients Suffer Bell’s Palsy Following Pfizer – DailyClout
- Report 62: Acute Kidney Injury and Acute Renal Failure – DailyClout
- Report 65: In the First Three Months of Pfizer’s mRNA “Vaccine” Rollout, Nine Patients Died of Anaphylaxis – DailyClout
- Report 66: 1,077 Immune-Mediated/Autoimmune Adverse Events in First 90 Days of Pfizer mRNA “Vaccine” Rollout, Including 12 Fatalities. Pfizer Undercounted This Category of Adverse Events by 270 Occurrences. – DailyClout
- Report 68: 34 Blood Vessel Inflammation, Vasculitis, Adverse Events Occurred in First 90 Days After Pfizer mRNA “Vaccine” Rollout, Including One Fatality. Half Had Onset Within Three Days of Injection. 81% of Sufferers Were Women. – DailyClout
- Report 71: Musculoskeletal Adverse Events of Special Interest Afflicted 8.5% of Patients in Pfizer’s Post-Marketing Data Set, Including Four Children and One Infant. Women Affected at a Ratio of Almost 4:1 Over Men. – DailyClout
- Report 72: “Other AESIs” Included MERS, Multiple Organ Dysfunction Syndrome (MODS), Herpes Infections, and 96 DEATHS. 15 Patients Were Under Age 12, Including Six Infants. – DailyClout
- Report 77: Women Suffered 94% of Dermatological Adverse Events Reported in First 90 Days of Pfizer COVID “Vaccine” Rollout. 80% of These Adverse Events Were Categorized As “Serious.”
- Report 78: Thirty-Two Percent of Pfizer’s Post-Marketing Respiratory Adverse Event Patients Died, Yet Pfizer Found No New Safety Signals.
- Report 83: 23% of Vaccinated Mothers’ Fetuses or Neonates Died. Suppressed Lactation and Breast Milk Discoloration Reported.
APPENDIX 1: REPORT AUTHORS
The Post-Marketing Experience Team
- LD LaLonde, M.S.
- Lora Hammill BSMT, ASCP
- David Shaw
- Dr. Chris Flowers M.D.
- Loree Britt
- Dr. Joseph Gehrett M.D.
- Dr. Barbara Gehrett M.D.
- Michelle Cibelli RN, BSN
- Margaret Turoski, RPh
- Cassie B. Papillon
- Tony Damian