By Michael Nevradikis, Ph.D.
The latest release of Pfizer-BioNTech COVID-19 vaccine documents raises questions about how frequently adverse events experienced by clinical trial participants were reported as “unrelated” to the vaccine.
The 80,000-page document cache released May 2 by the U.S. Food and Drug Administration (FDA) includes an extensive set of Case Report Forms (CRFs) from Pfizer trials conducted at various locations in the U.S.
The documents also include the “third interim report” from BioNTech’s trials conducted in Germany (accompanied by a synopsis of this report and a database of adverse events from this particular set of trials).
The FDA released the documents, which pertain to the Emergency Use Authorization (EUA) of the vaccine, 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, submitted the FOIA request.
Adverse events during Pfizer vaccine trials in the U.S. usually reported as ‘unrelated’ to vaccination
Pfizer conducted a series of vaccine trials at various locations in the U.S., including the New York University Langone Health Center, Rochester Clinical Research and Rochester General Hospital (Rochester, New York) and the J. Lewis Research, Inc. Foothill Family Clinic (Salt Lake City, Utah).
The Pfizer documents released this month by the FDA included a series of CRFs for patients who suffered some type of adverse event during their participation in the COVID-19 vaccine trials.
As the documents reveal, despite the occurrence of a wide range of symptoms, including serious cardiovascular events, almost none were identified as being “related” to the vaccine.
Such serious yet “unrelated” adverse events included:
- Acute asthma exacerbation
- Aortic aneurysm (listed as a pre-existing condition)
- Appendicitis (requiring hospitalization)
- Atrial defibrillation
- Cardiac arrest and acute respiratory failure, requiring hospitalization, sustained by a patient who then was “lost” (could not be located for continued participation in the trial)
- Chest pain (requiring hospitalization, later listed as cardiac ischemia)
- Coronary artery occlusion (listed as both serious and life-threatening)
- Injuries sustained from a fall
- Intermittent non-cardiac chest pain (requiring hospitalization)
- Left breast cancer (listed as a pre-existing occult malignancy)
- Neuritis (peripheral nerve Injury), listed as “unrelated” to the vaccine but related to the blood draw during vaccination
- Pulmonary embolism and bilateral deep venous thrombosis
- Respiratory failure (requiring hospitalization)
- Right ureteropelvic junction obstruction (requiring hospitalization, listed as congenital)
- Small bowel obstruction, listed as “unplanned,” and a panic attack
Of the CRFs found in the documents released this month, only one adverse event is clearly specified as being related to the vaccination: a participant who suffered from psoriatic arthritis, with no prior history of the condition.
In addition, several CRFs indicated exposure during pregnancy (see here and here), or during a partner’s pregnancy (see here and here). However, the documents provided do not appear to have provided any follow-ups regarding any outcomes or potential adverse events for the participants, their partners or their newborn babies once born.
In some instances, while the CRFs claimed the adverse events suffered by patients were not related to the vaccine, their cause was unspecified, simply indicated as “other,” while in another case, a participant’s “unplanned” small bowel obstruction and panic attacks were listed as being unrelated to the vaccination despite no relevant medical history pertaining to the SAEs (severe adverse events) in question.
Did Pfizer hide critical information from regulators?
It is difficult to draw concrete conclusions about any specific case from the data provided by CRFs and vaccine trial summaries.
However, what raises eyebrows is the very large number of adverse events — often serious and often requiring the hospitalization of the patients involved — that were determined to be “unrelated” to the administration of the COVID vaccine.
Previously released Pfizer documents also included discrepancies in the recording of adverse events.
According to investigative journalist Sonia Elijah, these discrepancies include:
- Trial participants were entered into the “healthy population” but were, in actuality, far from healthy.
- SAE numbers were left blank.
- Barcodes were missing from samples collected from trial participants.
- The second vaccine dose was administered outside the three-week protocol window.
- New health problems were dismissed as “unrelated” to the vaccination.
- A remarkable number of patients with an observation period of exactly the same duration — 30 minutes, with very little variety in observation times and raising questions as to whether patients were adequately observed or were put at risk.
- Oddities pertaining to the start and end dates of SAEs – for instance, a “healthy” diabetic suffered a “serious” heart attack on October 27, 2020, but the “end” date for this SAE is listed as the very next day, even though the patient was diagnosed with pneumonia that same day.
- Impossible dating: in the aforementioned example of the patient who sustained a heart attack and pneumonia, the individual in question later died, but the date of death is indicated as the day before the patient was recorded as having gone to a “COVID ill” visit.
- Unblinded teams, who were aware of which patients received the actual vaccine or a placebo, were responsible for reviewing adverse event reports, potentially leading to pressure to downplay COVID-related events in the vaccinated, or to indicate that adverse events were related to the vaccine.
- Other adverse events were indicated as “not serious” despite extensive hospital stays, of up to at least 26 days in the case of one patient who suffered a fall which was classified as “not serious,” yet facial lacerations sustained as a result of the fall were attributed to hypotension (low blood pressure).
Many of these practices seem to appear in the trial-related documents released this month.
Medical and scientific experts who spoke to The Defender expressed similar concerns about what this month’s tranche of documents reveals, and addressed cases of “disappearing” adverse events.
Brian Hooker, chief scientific officer for Children’s Health Defense, remarked:
“I’m most concerned about ‘disappearing’ patients. One cannot conduct a valid trial and simply omit the results that they don’t like!
“With the stories about Maddie de Garay and Augusto Roux surfacing, I have to wonder how many other participants were dropped in order to hide vaccine adverse events/effects.
“If you look at the data in VAERS [Vaccine Adverse Event Reporting System], COVID-19 vaccines are the most dangerous ever introduced into the population.”
Dr. Madhava Setty, a board-certified anesthesiologist and senior science editor for The Defender, said:
“The ‘unrelated’ label the investigators use to divert attention from AEs [adverse events] is a powerful point that stands on its own. We haven’t pushed back on this enough.
“Equivalently, we can say that the meager and short-lived benefit of these shots is also ‘unrelated’ using their ‘standards.’ On what grounds can they say that their product is preventing infection (which it isn’t anymore), or death (marginally)?
“They cannot have it both ways. They cannot claim a benefit through short-term outcomes while denying that side effects of any kind are related to their product.
“That’s the whole point of doing a trial. You cannot prove causation, only statistically significant correlation.”
Setty provided further context for his remarks in an April 2022 article for The Defender and in a March 2022 presentation, in which he discussed the number of these adverse events and how Pfizer swept them away (timestamp 24:00).
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I’m so upset, they my adverse vaccine report of blue hair and penus enlargement from the stats. Make sure you report any symptoms you got from the vaccine. Vaers.hhs.gov