The latest release of documents from the Pfizer-BioNTech COVID-19 injection raises questions about the frequency with which adverse events experienced by clinical trial participants were reported as “unrelated” to the injection.
The 80,000-page cache of documents released on 2 May by the US Food and Drug Administration (FDA) includes an extensive set of Case Report Forms CRFs from Pfizer trials conducted at various sites in the US.
The documents also include the “third interim report” from BioNTech 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 injection’s Emergency Use Authorisation (EUA), 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 physicians and public health professionals, filed the FOIA request.
Adverse events during Pfizer’s injection trials in the US are generally reported as “unrelated” to vaccination
Pfizer conducted a number of injection trials at several sites in the US, including New York University Langone Health Center, Rochester Clinical Research and Rochester General Hospital (Rochester, New York) and J. Lewis Research, Inc. Foothill Family Clinic (Salt Lake City, Utah).
The Pfizer documents released this month by the FDA included a series of Case Report Forms, CRFs for patients who experienced some type of adverse event during their participation in the COVID-19 injection trials.
As the documents reveal, despite the occurrence of a wide range of symptoms, including serious cardiovascular events, almost none were identified as “related” to the injection.
Such serious but “unrelated” adverse events included:
Acute exacerbation of asthma
Aortic aneurysm (listed as a pre-existing condition)
Appendicitis (requiring hospitalisation)
Cardiac arrest and acute respiratory failure, requiring hospitalisation, sustained by a patient who was then ‘lost’ (could not be located for continued participation in the trial)
Chest pain (requiring hospitalisation, later categorised as cardiac ischaemia)
Coronary artery occlusion (listed as severe and life-threatening)
Injuries sustained from a fall
Intermittent non-cardiac chest pain (requiring hospitalisation)
Left breast cancer (listed as a pre-existing occult malignancy)
Neuritis (peripheral nerve injury), listed as “unrelated” to injection but related to blood draw during vaccination
Pulmonary embolism and bilateral deep venous thrombosis
Respiratory failure (requiring hospitalisation)
Right ureteropelvic junction obstruction (requiring hospitalisation, 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 vaccine-related adverse event is clearly specified: a participant suffering from psoriatic arthritis, with no previous history of the condition.
In addition, several CRF case report forms indicated exposure during pregnancy, or during a partner’s pregnancy. However, the documents provided do not appear to have provided any follow-up regarding outcomes or possible adverse events for participants, their partners or their newborn babies once born.
In some cases, while the CRF case report forms stated that adverse events suffered by patients were unrelated to the injection, their cause was not specified, simply stated as “other”, while in another case, a participant’s small bowel obstruction and “unplanned” panic attacks were listed as unrelated to vaccination despite having no relevant medical history related to the SAEs (serious adverse events) in question.
Did Pfizer withhold critical information from regulators?
It is difficult to draw concrete conclusions about any specific case from the data provided by case report forms, CRFs and injection trial summaries.
What is surprising, however, is the large number of adverse events, often serious and often requiring hospitalisation of the patients involved, that were determined to be “unrelated” to the administration of the COVID injection.
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, in reality, were far from healthy.
SAE numbers were left blank.
Barcodes were missing from samples collected from trial participants.
The second dose of the injection was administered outside the three-week protocol window.
New health problems were dismissed as “unrelated” to vaccination.
A remarkable number of patients with an observation period of exactly the same length: 30 minutes, with very little variety in observation times and raising questions about whether patients were adequately observed or put at risk.
Oddities related to EDC start and end dates: for example, a “healthy” diabetic suffered a “severe” heart attack on 27 October 2020, but the “end” date of this EDC is listed as the following day, even though the patient was diagnosed with pneumonia on the same day.
Impossible dating: in the above example of the patient who suffered a heart attack and pneumonia, the individual in question died later, but the date of death is listed as the day before the patient was recorded as having gone for a “COVID sick” visit.
Unblinded teams, who knew which patients received the actual injection or a placebo, were responsible for reviewing adverse event reports, which could generate pressure to minimise COVID-related events in vaccinees, or to indicate that adverse events were related to the injection.
Other adverse events were indicated as “not serious” despite prolonged hospital stays of up to at least 26 days in the case of one patient who suffered a fall that was classified as “not serious”, but facial lacerations suffered as a result of the fall were attributed to hypotension (low blood pressure).
Many of these practices appear to appear in documents related to the trial released this month.
Medical and scientific experts expressed similar concerns about what this month’s series of documents reveals and addressed cases of adverse events that “disappear”.
Brian Hooker, Ph.D commented:
“What concerns me most are the patients who ‘disappear’. You can’t run a valid trial and just omit the results they don’t like!
“With the stories about Maddie de Garay and Augusto Roux coming out, I have to wonder how many other participants were eliminated to hide the adverse effects/events of the injection.
“If you look at the data in VAERS [Vaccine Adverse Event Reporting System], the COVID-19 injections are the most dangerous ever introduced into the population.”
Dr Madhava Setty, a board-certified anaesthesiologist Ph.D said:
“The ‘unrelated’ label that researchers use to deflect attention away from AEs [adverse events] is a powerful point that stands on its own. We haven’t pushed this hard enough.
“Equivalently, we can say that the meagre and short-lived benefit of these injections is also not ‘related’ to their ‘standards’. On what basis can they say that their product prevents infection (which it no longer does) or death (marginally)?
“They can’t have it both ways. They can’t claim a benefit through short-term results while denying that side effects of any kind are related to their product.
“That’s the whole point of doing a trial. You can’t prove causation, only statistically significant correlation.”
Setty provided more context for his comments in an April 2022 article and in a March 2022 presentation , in which he discussed the number of these adverse events and how Pfizer eliminated them (timestamp 24:00).
In Setty’s opinion:
“There is a high likelihood of criminal acts occurring. [Pfizer whistleblower] Brook Jackson says the PIs [lead investigators] were not blinded. If true, it would be very easy for the researchers to increase AEs in the placebo group while ignoring some of the AEs in the injection group.
“Pfizer claims that 0.5% of those who received placebo suffered a serious adverse event compared to 0.6% in the injection group. This is how these events were obscured”.
The existing body of evidence indicates that Pfizer “is withholding critical information from regulators,” Setty said:
“The clincher is in the VRBPAC [Vaccines and Related Biological Products Advisory Committee] memo (Table 2, efficacy populations), where they show us that five times as many people in the injection group were withdrawn from the trial as the placebo group within seven days of their second injection for ‘major protocol deviations’.
“In such a large trial, the chances that a coincidence could have occurred are infinitesimally small (less than 1 in 100,000).
“Moreover, months later, the same thing happened in the paediatric trial (Table 12). This time, six times as many children were withdrawn from the trial after the second dose.
“There are, of course, procedural differences when placebo versus mRNA injection is given, but why didn’t this also happen after the first dose?
“Mathematically, that’s as close as you can get to eliminating any ‘shadow of doubt’. With a formal accusation from a trial coordinator claiming the same thing [referring to whistleblower Brook Jackson], we can be sure that Pfizer is withholding critical information from regulators.”
BioNTech trials in Germany claim few ‘injection-related’ adverse events
The BioNTech trial in Germany tested several doses of two injection formulations against COVID-19, labelled BNT162b1 and BNT162b2, the latter of which is licensed by the FDA as EUA.
Pfizer’s latest cache of documents suggests a pattern, similar to the US trials, of reporting no injection-related adverse events.
According to the third interim report, dated 20 March 2021, among trial participants administered the BNT162b2 injection candidate that was granted EUA in the US, 87% of younger participants reported no adverse events:
87 % of younger participants reported solicited local reactions and 88 % reported solicited systemic reactions, and 10 % reported solicited systemic reactions of grade 3 or higher.
Eighty-seven percent of the youngest participants experienced ‘mild’ solicited local reactions and 35% experienced ‘moderate’ solicited local reactions.
88% of younger participants experienced ‘mild’ requested systemic reactions and 38% experienced ‘moderate’ requested systemic reactions. As stated in the report:
“The most frequently reported solicited systemic reactions of any severity were fatigue (n=40, 67 %), followed by headache (n=32, 53 %), malaise (n=24, 40 %) and myalgia (n=23 , 38 %). The remaining symptom terms were less frequent.
“For nausea, headache, fatigue, myalgia, chills, arthralgia and malaise, each symptom was assessed as severe in <10 % of the participants”.
Forty-three percent of the younger participants reported a total of 51 unsolicited treatment-emergent adverse events (TEAEs referring to conditions that were not present before treatment or worsened in intensity after treatment) within 28 days after the first or second dose, nine of which were considered to be “related” to vaccination. One participant in this category suffered a treatment-emergent adverse event TEAE assessed as Grade 3 or higher, but “assessed by the investigator as unrelated”.
Treatment-emergent adverse events,TEAE among younger participants included hypoaesthesia, lymphadenopathy, heart palpitations, external ear inflammation, blepharitis, toothache, non-cardiac chest pain, cestode infection, oral herpes, tonsillitis, neck pain, insomnia, anosmia and dysmenorrhoea.
No unsolicited treatment-emergent serious adverse events (TESAEs) or deaths were reported among the younger participants, but one discontinued participation due to moderate nasopharyngitis.
One younger participant “discontinued due to a moderate TESAE (nasopharyngitis).
86% of the older participants reported requested local reactions, with 6% reporting grade 3 or higher requested local reactions, 78% reporting “mild” requested local reactions and 36% reporting “moderate” requested local reactions.
Seventy-two percent of older participants reported requested systemic reactions, with 11% of these participants sustaining requested systemic reactions of Grade 3 or higher, 69% sustaining “mild” requested reactions and 36% sustaining “moderate” requested reactions.
Thirty-three percent of older participants reported a total of 20 unsolicited TESAEs, four of which were determined to be “related” to vaccination. Among the older participants, 8% reported a TESAE of grade 3 or higher, with “an event assessed as related by the investigator”.
One older participant was reported to have an “unrelated TESAE” emergent serious adverse event (an ankle fracture).
TESAEs among older participants included back pain, chest pain, facial injuries, increased lipase, increased amylase, muscle spasms, musculoskeletal pain, tendon pain, orthostatic intolerance, renal colic, seborrheic dermatitis, and “painful breathing”.
Among trial participants who received the candidate injection BNT162b1 (not given in the US):
86 % of “younger participants” reported localised solicited (expected) reactions (remaining in one part of the body), with 18 % reporting localised solicited reactions of Grade 3 or higher, 86 % of younger participants reporting “mild” localised solicited reactions and 54 % reporting “moderate” localised solicited reactions.
Ninety-two percent of younger participants reported requested systemic reactions (extending to other parts of the body), with 44% reporting Grade 3 or higher requested systemic reactions, 90% reporting ‘mild’ requested systemic reactions and 74% experiencing ‘moderate’ requested systemic reactions. .
The report states:
“The most frequently reported requested systemic reactions of any severity were fatigue (n=68, 81 %), headache (n=66, 79 %), myalgia (n=51, 61 %), malaise (n=50, 60 % ), and chills (n=47, 56 %). The remaining symptom terms were less frequent.
“For nausea, vomiting, diarrhoea, myalgia, arthralgia and fever, each symptom was assessed as severe in ≤10 % of participants.”
Forty-five percent of the younger participants reported a total of 83 unsolicited (unexpected) TEAEs within 28 days of receiving the first or second dose.
A total of 51 of these unsolicited TEAEs were reported as “related” to vaccination, while 2% of participants experienced grade 3 or higher TEAEs (four in total), “of which three events were assessed as related by the investigator”.
No TESAEs or unsolicited deaths were reported in this category.
According to the report, among younger participants, TESAEs included:
“‘General disorders and administration site conditions’ reported by 9 participants (11%),” including influenza-like illness and injection site haematoma.
“Nervous system disorders’ reported by 10 participants (12%)”, including presyncope, hyperesthesia, paraesthesia and headache.
“Respiratory, thoracic and mediastinal disorders’ reported by 9 participants (11%)”, including cough and oropharyngeal pain.
Other symptoms included back pain, musculoskeletal chest pain, cervicobrachial syndrome, taste disorder, sleep disorder, depression, hallucinations, dysmenorrhoea, pruritus and pityriasis rosea, while one participant required excision (removal) of a papilloma.
One younger participant discontinued participation in the trial, “due to moderate AE”, while another participant discontinued participation “due to dose-limiting toxicity”.
Eighty-three percent of the ‘older participants’ reported requested local reactions, but none were grade 3 or higher, while 83% of the requested local reactions were ‘mild’ and 42% were ‘moderate’.
Ninety-two percent of older participants reported solicited systemic reactions, with 28% of participants experiencing solicited systemic reactions of Grade 3 or higher, 89% experienced ‘mild’ solicited systemic reactions and 61% experienced ‘moderate’ solicited systemic reactions.
According to the report:
“The most frequently reported requested systemic reactions of any severity were headache (n=29, 81 %), fatigue (n=27, 75 %), myalgia (n=18, 50 %) and malaise (n=18, 50 %). The remaining symptom terms were less frequent”.
Thirty-six percent of participants reported a total of 24 unsolicited TEAEs within 28 days after the first or second dose, nine of which were assessed as “related” to vaccination.
Of the participants in this category, 11% reported TEAEs of grade 3 or higher (four events in total), and one of these events was assessed as “related” to vaccination.
TESAEs reported by older participants included oropharyngeal pain, nasopharyngitis, bladder dysfunction, sleep disturbance, musculoskeletal pain and musculoskeletal chest pain, pollakiuria, migraine, syncope and alopecia.
One older participant who received candidate TNB162b1 suffered a TESAE (syncope) and there were no deaths in this category.
Notably, none of the participants in any of the candidate injections were pregnant, raising questions about the recommendation and administration of the vaccine to pregnant women despite the absence of clinical trial data.
As the papers show, a wide range of adverse effects were reported, including cardiovascular and nervous system conditions, most of which were found to be unrelated to the vaccination itself.