Documents released by BioNTech to the European Medicines Agency (EMA) reveal tens of thousands of serious adverse events and thousands of deaths among people who received the Pfizer-BioNTech mRNA COVID-19 vaccine.
The documents, dated Aug. 18, 2022, and marked “confidential,” show that cumulatively, during the clinical trials and post-marketing period up to June 18, 2022, a total of 4,964,106 adverse events were recorded.
The documents included an appendix with further details about the specifics about the identified adverse events.
Among children under age 17, 189 deaths and thousands of serious adverse events were reported.
According to an analysis by commentator and author Daniel Horowitz, the percentage of adverse events classified as serious was “well above the standard for safety signals usually pegged at 15%,” and women reported adverse events at three times the rate of men.
Sixty percent of cases were reported with either “outcome unknown” or “not recovered,” suggesting many of the injuries “were not transient,” Horowitz said.
READ ALSO: FDA rejects request to add health risks to COVID vaccine labels
The highest number of cases occurred in the 31-50 age group, of which 92% did not have any comorbidities, making it very likely it was the vaccine causing “such widespread, sudden injury.”
There were 3,280 fatalities among vaccine recipients in the combined cumulative period including the clinical trials and post-marketing, up to July 18, 2022.
According to Horowitz, the documents “show that Pfizer knew about a sickening level of injury early on,” yet continued to distribute its COVID-19 vaccine.
The documents are not part of the ongoing court-ordered release of the so-called “Pfizer documents” in the U.S., but according to Horowitz, are pharmacovigilance documents requested by the EMA, the EU’s drug regulator.
The documents were made available to an Austrian science and politics blog, TKP, following “a FOIA [Freedom of Information Act] request from an anonymous reader.” They were subsequently published on March 4. However, once published, no European English-language media outlet appears to have reported on them.
The main Pfizer-BioNTech document revealed 9,605 adverse events (3,735 serious) during the PSUR #3 and 25 cases during the clinical trials among children ages 11 and younger. These included 20 fatalities, in children as young as 5 years old.
READ ALSO: COVID 19: NSCDC denies involvement in rift between security agencies in Edo
Causes of these fatalities included dyspnea, cardiac arrest, cardio-respiratory arrest, pyrexia and myocarditis, though “all events were assessed as unrelated” to the vaccine.
Pregnant and lactating women also were significantly affected. There were 3,642 post-authorization adverse events and 697 clinical trial adverse events in this population, including spontaneous abortion, fetal death, postpartum hemorrhage, premature separation of the placenta, premature labor or delivery, live birth with congenital anomalies and stillbirths.
A notable discrepancy appears in terms of reported cases of myocarditis in the clinical trials as compared to the post-marketing period — one myocarditis case (0.15% of all cases) is listed for the clinical trial period, while 5,422 cases (1.1% of all cases) and 5,458 serious events were reported in the PSUR #3 period.
Of these, 87 cases were fatal and 1,608 were listed as “not resolved.” Among children and young adults, 48 cases were reported for those between the ages of 5 and 11 (two deaths), 366 among 12-15-year-olds (three deaths), 345 among 16-17-year-olds and 968 among 18-24-year-olds (four deaths).
In one instance, an 11-year-old girl developed myocarditis two days after her first dose and subsequently died, with the listed causes of death including myocarditis, respiratory failure, acute cardiac failure and cardio-respiratory arrest.
READ ALSO: COVID 19: FG palliatives mainly for persons living with disability – Humanitarian minister
Separately, a 13-year-old boy developed myocarditis five days after his second dose, and subsequently died of myocarditis, cardiac arrest, multiple organ dysfunction syndrome, ventricular tachycardia and renal failure.
Similarly, while no cases of pericarditis were recorded during the clinical trial, 4,156 were recorded during the PSUR #3 period, including 4,164 serious adverse events and 19 fatalities. This included 30 cases among 5-11-year-olds, 118 cases among 12-15-year-olds, 106 cases among 16-17-year-olds, 479 cases among 18-24-year-olds (and one death), and 417 cases among 25-29-year-olds, again including one death.
Moreover, 204 fatalities (and 24,077 cases) of vaccination failure, 81 deaths from “vaccination stress,” 24 deaths (and 1,402 cases) of suspected vaccination failure, two deaths from glomerulonephritis and nephrotic syndrome, two deaths (1,326 cases) from “medication error” and 166 deaths from “other” adverse events — mostly pyrexia — were recorded.