Newly released Pfizer documents list tens of thousands of vaccine injuries that occurred within three months of market approval..The most recent round of court-ordered Pfizer documents were made public on April 1, 2022..The document “BNT162b2, 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports,” provides descriptions of the 41,086 case reports containing 158,893 events..Though 41,086 cases arose, the events were concluded by Pfizer to be “theoretical risks” upon which “surveillance will continue.”.Adverse events after vaccination were recorded as vaccine-associated enhanced diseases (VAED)..The “safety concerns” section lists important identified risks, important potential risks and VAEDs, then vaccine-associated enhanced respiratory disease and anaphylaxis as important identified risks..This set of Pfizer documents explicitly says not enough data was known at the time of the trials to make conclusions on the safety of the vaccines..“An expected rate of VAED is difficult to establish, so a meaningful observed/expected analysis cannot be conducted at this point based on available data,” reads article 5.3.6 cumulative analysis..“The feasibility of conducting such an analysis will be re-evaluated on an ongoing basis as data on the virus grows and the vaccine safety data continues to accrue.”.Table 1 shows the age ranges and outcomes of participants who reported events after receiving the vaccine.. Screen-Shot-2022-04-07-at-12.57.52-PMCase descriptions and groups, courtesy of Pfizer .The largest group of reported cases occurred in those aged 31–50, 13,886 cases made up 33% of the adverse reactions..The document goes on to list many adverse events of special interest (AESI) that were found..Cardiovascular AESIs occurred in 1,403 cases, 3.3% of participants, of those, 136 were fatal cases..Cardiovascular AESIs listed were: acute myocardial infarction, arrhythmia, cardiac failure, cardiac failure acute, cardiogenic shock, coronary artery disease, myocardial infarction, postural orthostatic tachycardia syndrome, stress cardiomyopathy and tachycardia..Immune-mediated/autoimmune AESIs occurred in 1,050 cases, 2.5% of participants..Immune-mediated/autoimmune disorders listed were: autoimmune disorders, cytokine release syndrome, cytokine storm and hypersensitivity..Musculoskeletal AESIs occurred in 3,600 cases, 8.5% of participants..Musculoskeletal AESIs listed were: arthralgia, arthritis, arthritis bacterial, chronic fatigue syndrome, polyarthritis, polyneuropathy, post-viral fatigue syndrome and rheumatoid arthritis..The “other AESI” category has 8,152 cases, which represented 19.4% of patients..Other adverse events included neurological events (501 cases), liver injury (70), facial paralysis (449), dermatological events (20), stroke (275), vasculitis (32), thromboembolic events (151), respiratory events (130), haematological (932) and COVID-19 broad effects (3,067)..Other general events following immunization were identified by Pfizer as: herpes viral infections, inflammation, MERS-CoV test-negative, MERS-CoV test-positive, middle east respiratory syndrome, multiple-organ dysfunction syndrome, occupational exposure to communicable disease, patient isolation, product availability issue, product distribution issue, product supply issue, pyrexia, quarantine, SARS-CoV-1 test-negative and SARS-CoV-1 test-positive..Pregnant women were in a separate category of adverse effects..Pfizer reported 420 cases in pregnant women, of those, 274 serious cases were opened and 146 non-serious cases..Of the serious cases, 238 pregnancies recorded no outcome, 28 results of pregnancy-loss (including spontaneous abortion, premature birth and neonatal death, and intrauterine death), one normal outcome, and five outcomes pending..The Pfizer vaccine was approved in Canada on Dec. 9, 2020, before this research was conducted. Approval was granted in the UK and USA in early December, as well..Public Health Ontario’s overview of vaccine regulation in Canada says: “Health Canada’s review of a vaccine can often take several years. Given the urgency of the COVID-19 pandemic, the Government of Canada, including Health Canada, made revisions to expedite the regulatory review and approval process “without compromising safety, efficacy, and quality standards.”.Public Health Ontario outlines how a vaccine must display no significant safety concerns in the first three phases of human clinical trials..Phase III, the post-market pharmacovigilance phase, is described as using the vaccine on many thousands “to confirm it is both effective and safe by monitoring side effects and any adverse reactions.”.Ewa Sudyk is a reporter with the Western Standard.,.esudyk@westernstandard.news
Newly released Pfizer documents list tens of thousands of vaccine injuries that occurred within three months of market approval..The most recent round of court-ordered Pfizer documents were made public on April 1, 2022..The document “BNT162b2, 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports,” provides descriptions of the 41,086 case reports containing 158,893 events..Though 41,086 cases arose, the events were concluded by Pfizer to be “theoretical risks” upon which “surveillance will continue.”.Adverse events after vaccination were recorded as vaccine-associated enhanced diseases (VAED)..The “safety concerns” section lists important identified risks, important potential risks and VAEDs, then vaccine-associated enhanced respiratory disease and anaphylaxis as important identified risks..This set of Pfizer documents explicitly says not enough data was known at the time of the trials to make conclusions on the safety of the vaccines..“An expected rate of VAED is difficult to establish, so a meaningful observed/expected analysis cannot be conducted at this point based on available data,” reads article 5.3.6 cumulative analysis..“The feasibility of conducting such an analysis will be re-evaluated on an ongoing basis as data on the virus grows and the vaccine safety data continues to accrue.”.Table 1 shows the age ranges and outcomes of participants who reported events after receiving the vaccine.. Screen-Shot-2022-04-07-at-12.57.52-PMCase descriptions and groups, courtesy of Pfizer .The largest group of reported cases occurred in those aged 31–50, 13,886 cases made up 33% of the adverse reactions..The document goes on to list many adverse events of special interest (AESI) that were found..Cardiovascular AESIs occurred in 1,403 cases, 3.3% of participants, of those, 136 were fatal cases..Cardiovascular AESIs listed were: acute myocardial infarction, arrhythmia, cardiac failure, cardiac failure acute, cardiogenic shock, coronary artery disease, myocardial infarction, postural orthostatic tachycardia syndrome, stress cardiomyopathy and tachycardia..Immune-mediated/autoimmune AESIs occurred in 1,050 cases, 2.5% of participants..Immune-mediated/autoimmune disorders listed were: autoimmune disorders, cytokine release syndrome, cytokine storm and hypersensitivity..Musculoskeletal AESIs occurred in 3,600 cases, 8.5% of participants..Musculoskeletal AESIs listed were: arthralgia, arthritis, arthritis bacterial, chronic fatigue syndrome, polyarthritis, polyneuropathy, post-viral fatigue syndrome and rheumatoid arthritis..The “other AESI” category has 8,152 cases, which represented 19.4% of patients..Other adverse events included neurological events (501 cases), liver injury (70), facial paralysis (449), dermatological events (20), stroke (275), vasculitis (32), thromboembolic events (151), respiratory events (130), haematological (932) and COVID-19 broad effects (3,067)..Other general events following immunization were identified by Pfizer as: herpes viral infections, inflammation, MERS-CoV test-negative, MERS-CoV test-positive, middle east respiratory syndrome, multiple-organ dysfunction syndrome, occupational exposure to communicable disease, patient isolation, product availability issue, product distribution issue, product supply issue, pyrexia, quarantine, SARS-CoV-1 test-negative and SARS-CoV-1 test-positive..Pregnant women were in a separate category of adverse effects..Pfizer reported 420 cases in pregnant women, of those, 274 serious cases were opened and 146 non-serious cases..Of the serious cases, 238 pregnancies recorded no outcome, 28 results of pregnancy-loss (including spontaneous abortion, premature birth and neonatal death, and intrauterine death), one normal outcome, and five outcomes pending..The Pfizer vaccine was approved in Canada on Dec. 9, 2020, before this research was conducted. Approval was granted in the UK and USA in early December, as well..Public Health Ontario’s overview of vaccine regulation in Canada says: “Health Canada’s review of a vaccine can often take several years. Given the urgency of the COVID-19 pandemic, the Government of Canada, including Health Canada, made revisions to expedite the regulatory review and approval process “without compromising safety, efficacy, and quality standards.”.Public Health Ontario outlines how a vaccine must display no significant safety concerns in the first three phases of human clinical trials..Phase III, the post-market pharmacovigilance phase, is described as using the vaccine on many thousands “to confirm it is both effective and safe by monitoring side effects and any adverse reactions.”.Ewa Sudyk is a reporter with the Western Standard.,.esudyk@westernstandard.news
