Two American doctors and a journalist say a 2021 Pfizer document suggests the company manipulated data and wrongly tabulated adverse events, which concealed them.The analysis was conducted by Barbara Gehrett, MD; Chris Flowers, MD; and Loree Britt and published in the DailyClout. The report is 93rd in a series that analyzes documents Pfizer and Moderna submitted to get the US Food and Drug Administration to approve the vaccine.The doctors said a close look at a February 28 2021 report by Pfizer intentionally minimized its representation of adverse events in System Organ Classes (SOCs) reports.“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,” the authors explained.The authors spent one year looking individually at the 42,086 patients (“cases”) and 158,893 adverse events. “Pfizer clearly did not expect this thorough analysis, which exposes data manipulation,” they wrote.The Stroke SOC buried a case of a post-vaccination stroke in a seven-year-old child “deep in a lengthy list of footnotes.” Pfizer listed 292 kinds of adverse events in strokes, leaving out eight cases, each with its own unique, concealed problem. A threshold of two adverse events was required for neurological incidents, which left 20 others excluded.Elsewhere, Pfizer admitted 1,080 hematological adverse events, including 34 fatalities. However, in its more specific list, Pfizer only listed 15 or more adverse events sharing the same diagnosis, leaving out 192 adverse events in this enumeration.“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,” the authors wrote.Another tactic was to only count occurrences in one category. The 25 cases of mycarditis and 32 cases of pericarditis were excluded from the “Cardiac and Cardiovascular” SOC list of 1,403 cases and counted only as “Immune-Mediated/Autoimmune.” “We found many examples of this type of soft-pedaling SOC assignment,” the authors wrote.“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.”In Table 7, “neurologic” diagnoses were split into 501 “neurological” cases (69% were seizures, 449 under “Facial Paralysis” and 275 under “Stroke.” In reality, these were all neurological, which should have had a total of 1,225. The sub-category of “neurological” had no further clarity. Similarly, the many cases of vaginal hemorrhage and heavy menstrual bleeding were listed without further clarity in the Hematological SOC, which the doctors say was wrong.Despite acknowleding 6,000 serious adverse events in a “Gastrointestinal” category, Pfizer did not create a Gastrointestinal SOC. Seventy of these cases were reported in the Hepatic (liver) SOC as a “liver injury.” This left details wanting, not only for what happened in the other cases, but also what test value results were counted as a “liver injury.”“Pfizer used all of the tools at its disposal to present adverse events’ data to its own benefit,” the authors said, including the Brighton Collaboration criteria created by a community of experts who aim to promote and improve vaccine safety.It appears Pfizer used the criteria 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, including nine deaths, in the Anaphylaxis SOC. Elsewhere in the document, it only counted 1,002 cases, however, because the Brighton criteria required a physical examination and laboratory results, neither of which were available in the reported anaphylaxis cases.“What happened to the excluded cases? Pfizer does not offer an explanation.”Pfizer also used the most strict Brighton criteria to assess possible signals of vaccine-associated enhanced disease. However, it did not follow through with investigating “breakthrough” cases of COVID-19, as the Brighton criteria would have called for. “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…also authored the primary report on Pfizer’s COVID vaccine Phase 2/3 clinical trial. This instrumental paper helped secure Pfizer’s COVID-19 vaccine’s emergency use authorization (EUA) from the FDA.”Doctors also asked why Table 2 reported 1,223 post-vaccination deaths in the first three months following the vaccine rollout, while Tables 4, 5, 6, and 7 documented 726 fatalities.“What caused the additional 497 deaths shown in Table 2?” the authors asked.Pfizer could not obscure how soon adverse effects followed vaccination, which is latency. Median latency means half the cases had the event onset within that time period.The median latency for adverse events in the cardiovascular and immune-related SOCs was less than 24 hours, compared to one day for hematological, musculoskeletal, neurological, “other,” and respiratory SOCs.“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’...However, that conclusion does not align with the EMA, WHO, or FDA’s definitions of safety signals,” the authors wrote.“[I]t 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…”The DailyClout authors believed its Report 50 on micro-strokes published Dec. 26, 2022, helped nudge the CDC and FDA to report on January 13, 2023 they were following a stroke signal in the elderly.“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.”The doctors reported the 90-day period was too short to manifest the possibility of reduced immunity or diseases, such as cancer and endocrine disorders. In March 2021, Pfizer unblinded its clinical trial with the FDA’s permission, vaccinating 90% of the placebo arm by March 2021, which “effectively terminated the clinical trial.”The doctors said Pfizer’s reported 51,000 “General disorders,” such as fever, fatigue, chills, pain, malaise, and vaccination site redness and swelling, included more 20,000 that were 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?” the doctors asked.“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….The end of Report 93 on DailyClout offers links to specific articles on each medical condtion outlined in Pfizer and Moderna documents.
Two American doctors and a journalist say a 2021 Pfizer document suggests the company manipulated data and wrongly tabulated adverse events, which concealed them.The analysis was conducted by Barbara Gehrett, MD; Chris Flowers, MD; and Loree Britt and published in the DailyClout. The report is 93rd in a series that analyzes documents Pfizer and Moderna submitted to get the US Food and Drug Administration to approve the vaccine.The doctors said a close look at a February 28 2021 report by Pfizer intentionally minimized its representation of adverse events in System Organ Classes (SOCs) reports.“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,” the authors explained.The authors spent one year looking individually at the 42,086 patients (“cases”) and 158,893 adverse events. “Pfizer clearly did not expect this thorough analysis, which exposes data manipulation,” they wrote.The Stroke SOC buried a case of a post-vaccination stroke in a seven-year-old child “deep in a lengthy list of footnotes.” Pfizer listed 292 kinds of adverse events in strokes, leaving out eight cases, each with its own unique, concealed problem. A threshold of two adverse events was required for neurological incidents, which left 20 others excluded.Elsewhere, Pfizer admitted 1,080 hematological adverse events, including 34 fatalities. However, in its more specific list, Pfizer only listed 15 or more adverse events sharing the same diagnosis, leaving out 192 adverse events in this enumeration.“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,” the authors wrote.Another tactic was to only count occurrences in one category. The 25 cases of mycarditis and 32 cases of pericarditis were excluded from the “Cardiac and Cardiovascular” SOC list of 1,403 cases and counted only as “Immune-Mediated/Autoimmune.” “We found many examples of this type of soft-pedaling SOC assignment,” the authors wrote.“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.”In Table 7, “neurologic” diagnoses were split into 501 “neurological” cases (69% were seizures, 449 under “Facial Paralysis” and 275 under “Stroke.” In reality, these were all neurological, which should have had a total of 1,225. The sub-category of “neurological” had no further clarity. Similarly, the many cases of vaginal hemorrhage and heavy menstrual bleeding were listed without further clarity in the Hematological SOC, which the doctors say was wrong.Despite acknowleding 6,000 serious adverse events in a “Gastrointestinal” category, Pfizer did not create a Gastrointestinal SOC. Seventy of these cases were reported in the Hepatic (liver) SOC as a “liver injury.” This left details wanting, not only for what happened in the other cases, but also what test value results were counted as a “liver injury.”“Pfizer used all of the tools at its disposal to present adverse events’ data to its own benefit,” the authors said, including the Brighton Collaboration criteria created by a community of experts who aim to promote and improve vaccine safety.It appears Pfizer used the criteria 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, including nine deaths, in the Anaphylaxis SOC. Elsewhere in the document, it only counted 1,002 cases, however, because the Brighton criteria required a physical examination and laboratory results, neither of which were available in the reported anaphylaxis cases.“What happened to the excluded cases? Pfizer does not offer an explanation.”Pfizer also used the most strict Brighton criteria to assess possible signals of vaccine-associated enhanced disease. However, it did not follow through with investigating “breakthrough” cases of COVID-19, as the Brighton criteria would have called for. “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…also authored the primary report on Pfizer’s COVID vaccine Phase 2/3 clinical trial. This instrumental paper helped secure Pfizer’s COVID-19 vaccine’s emergency use authorization (EUA) from the FDA.”Doctors also asked why Table 2 reported 1,223 post-vaccination deaths in the first three months following the vaccine rollout, while Tables 4, 5, 6, and 7 documented 726 fatalities.“What caused the additional 497 deaths shown in Table 2?” the authors asked.Pfizer could not obscure how soon adverse effects followed vaccination, which is latency. Median latency means half the cases had the event onset within that time period.The median latency for adverse events in the cardiovascular and immune-related SOCs was less than 24 hours, compared to one day for hematological, musculoskeletal, neurological, “other,” and respiratory SOCs.“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’...However, that conclusion does not align with the EMA, WHO, or FDA’s definitions of safety signals,” the authors wrote.“[I]t 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…”The DailyClout authors believed its Report 50 on micro-strokes published Dec. 26, 2022, helped nudge the CDC and FDA to report on January 13, 2023 they were following a stroke signal in the elderly.“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.”The doctors reported the 90-day period was too short to manifest the possibility of reduced immunity or diseases, such as cancer and endocrine disorders. In March 2021, Pfizer unblinded its clinical trial with the FDA’s permission, vaccinating 90% of the placebo arm by March 2021, which “effectively terminated the clinical trial.”The doctors said Pfizer’s reported 51,000 “General disorders,” such as fever, fatigue, chills, pain, malaise, and vaccination site redness and swelling, included more 20,000 that were 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?” the doctors asked.“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….The end of Report 93 on DailyClout offers links to specific articles on each medical condtion outlined in Pfizer and Moderna documents.
