From article:
“This month’s release of Pfizer COVID-19 vaccine documents by the U.S. Food and Drug Administration reveals three more reports of deaths among vaccine trial participants and more instances of Pfizer listing injuries as “not related” to the vaccine.
By Michael Nevradakis, Ph.D.
This month’s release of Pfizer-BioNTech COVID-19 vaccine documents by the U.S. Food and Drug Administration (FDA) reveals three more reports of deaths among vaccine trial participants and further instances of Pfizer downplaying serious adverse events sustained by participants and listing the injuries as “not related” to the vaccine.
Of the approximately 80,000 pages released this month, the most revelatory is a 3,611-page “confidential” document with no title — only the file name “fa_interim_narrative_sensitive.”
The document contains information about vaccine trial participants who died, who sustained adverse events during the trial or who contracted COVID-19 during the trial.
All participants listed in the document received the 30 μg dose of the BNT162b2 candidate vaccine, which the FDA in August 2021 granted Emergency Use Authorization.
The FDA on July 1 released the documents as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request filed in August 2021.
Public Health and Medical Professionals for Transparency, a group of doctors and public health professionals, initially submitted the FOIA request.
Document details deaths of three trial participants
The “interim narrative” document contains reports of three clinical trial participants who died — and in all cases, the investigator ruled out the possibility the deaths were related to Pfizer’s vaccines.
One instance pertains to a 56-year-old white female in the U.S. (unique Subject ID C4591001 1007 10071101), who suffered cardiac arrest on Oct. 18, 2021, and died three days later. She was vaccinated on July 30, 2020, and Aug. 20, 2020.
The “narrative comments” accompanying the report on the woman’s death stated her death could not have been related to the vaccine, due to the amount of time that had elapsed following her second dose:
“In the opinion of the investigator, there was no reasonable possibility that the cardiac arrest was related to the study intervention or clinical trial procedures, as the death occurred 2 months after receiving Dose 2.”
The woman’s medical history did not indicate any cardiovascular problems, although ongoing obesity, gastroesophageal reflux disease and sleep apnea syndrome were listed.
The second report of a death was that of a 60-year-old white male in the U.S. (unique Subject ID C4591001 1162 11621327), who received one dose of the vaccine (on Sept. 10, 2020) and died sometime in the following three days of atherosclerotic disease.
According to the document:
“The study site received a police report indicating that the police visited the subject’s home to perform a welfare check on 13 Sep 2020 (Day 4) and found him dead.”
The participant’s medical history indicated ongoing autoimmune thyroiditis, obesity and depression, and a prior craniocerebral injury and prior hip arthroplasty.
According to the report:
“It was reported that the subject’s body was cold and had visible lividity. According to the medical examiner, the probable cause of death was progression of atherosclerotic disease. Relevant tests were unknown. Autopsy results were not available at the time of this report.
“In the opinion of the investigator, there was no reasonable possibility that the arteriosclerosis was related to the study intervention, concomitant medications, or clinical trial procedures, but rather it was related to suspected [emphasis added] underlying disease. Pfizer concurred with the investigator’s causality assessment.”
In other words, the participant’s death was attributed to a “suspected” cause, while the possibility that it was vaccine-related in any way, was dismissed.
The third death listed in the “fa_interim_narrative_sensitive” documents was listed under the section in the document listing reports from trial participants who withdrew, not those who died.
The report pertained to a 72-year-old Hispanic/Latino male in the U.S. (unique Subject ID: C4591001 1152 11521497) who received one dose of the vaccine, on Oct. 7, 2020.
The subject sustained vasovagal syncope (a fainting incident) on Oct. 26, 2020, and was admitted to the hospital, causing him to miss his scheduled follow-up vaccination appointment on Oct. 28, 2020.”
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“This month’s release of Pfizer COVID-19 vaccine documents by the U.S. Food and Drug Administration reveals three more reports of deaths among vaccine trial participants and more instances of Pfizer listing injuries as “not related” to the vaccine.
By Michael Nevradakis, Ph.D.
This month’s release of Pfizer-BioNTech COVID-19 vaccine documents by the U.S. Food and Drug Administration (FDA) reveals three more reports of deaths among vaccine trial participants and further instances of Pfizer downplaying serious adverse events sustained by participants and listing the injuries as “not related” to the vaccine.
Of the approximately 80,000 pages released this month, the most revelatory is a 3,611-page “confidential” document with no title — only the file name “fa_interim_narrative_sensitive.”
The document contains information about vaccine trial participants who died, who sustained adverse events during the trial or who contracted COVID-19 during the trial.
All participants listed in the document received the 30 μg dose of the BNT162b2 candidate vaccine, which the FDA in August 2021 granted Emergency Use Authorization.
The FDA on July 1 released the documents as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request filed in August 2021.
Public Health and Medical Professionals for Transparency, a group of doctors and public health professionals, initially submitted the FOIA request.
Document details deaths of three trial participants
The “interim narrative” document contains reports of three clinical trial participants who died — and in all cases, the investigator ruled out the possibility the deaths were related to Pfizer’s vaccines.
One instance pertains to a 56-year-old white female in the U.S. (unique Subject ID C4591001 1007 10071101), who suffered cardiac arrest on Oct. 18, 2021, and died three days later. She was vaccinated on July 30, 2020, and Aug. 20, 2020.
The “narrative comments” accompanying the report on the woman’s death stated her death could not have been related to the vaccine, due to the amount of time that had elapsed following her second dose:
“In the opinion of the investigator, there was no reasonable possibility that the cardiac arrest was related to the study intervention or clinical trial procedures, as the death occurred 2 months after receiving Dose 2.”
The woman’s medical history did not indicate any cardiovascular problems, although ongoing obesity, gastroesophageal reflux disease and sleep apnea syndrome were listed.
The second report of a death was that of a 60-year-old white male in the U.S. (unique Subject ID C4591001 1162 11621327), who received one dose of the vaccine (on Sept. 10, 2020) and died sometime in the following three days of atherosclerotic disease.
According to the document:
“The study site received a police report indicating that the police visited the subject’s home to perform a welfare check on 13 Sep 2020 (Day 4) and found him dead.”
The participant’s medical history indicated ongoing autoimmune thyroiditis, obesity and depression, and a prior craniocerebral injury and prior hip arthroplasty.
According to the report:
“It was reported that the subject’s body was cold and had visible lividity. According to the medical examiner, the probable cause of death was progression of atherosclerotic disease. Relevant tests were unknown. Autopsy results were not available at the time of this report.
“In the opinion of the investigator, there was no reasonable possibility that the arteriosclerosis was related to the study intervention, concomitant medications, or clinical trial procedures, but rather it was related to suspected [emphasis added] underlying disease. Pfizer concurred with the investigator’s causality assessment.”
In other words, the participant’s death was attributed to a “suspected” cause, while the possibility that it was vaccine-related in any way, was dismissed.
The third death listed in the “fa_interim_narrative_sensitive” documents was listed under the section in the document listing reports from trial participants who withdrew, not those who died.
The report pertained to a 72-year-old Hispanic/Latino male in the U.S. (unique Subject ID: C4591001 1152 11521497) who received one dose of the vaccine, on Oct. 7, 2020.
The subject sustained vasovagal syncope (a fainting incident) on Oct. 26, 2020, and was admitted to the hospital, causing him to miss his scheduled follow-up vaccination appointment on Oct. 28, 2020.”
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