Files released by the Food and Drug Administration in a Freedom of Information lawsuit recorded 158,893 adverse events from the Pfizer vaccine in the first two and a half months of distribution, including 25,957 incidents of “nervous system disorders.”
The documentation was obtained in a Freedom of Information lawsuit filed a group called Public Health and Medical Professionals for Transparency, comprised of more than 30 professors and scientists from universities including Yale, Harvard, UCLA and Brown.
As WND reported, in court papers filed last week, the FDA proposed that it be given 55 years to release all 329,000 pages of documents related to the Pfizer COVID-19 vaccine requested by the group.
The plaintiffs want the records so they can be assured, amid significant public skepticism, that the Pfizer vaccine is indeed “safe and effective.”
Aaron Siri, an attorney for the plaintiffs, argued in court papers filed last week that it is “difficult to imagine a greater need for transparency than immediate disclosure of the documents relied upon by the FDA to license a product that is now being mandated to over 100 million Americans under penalty of losing their careers, their income, their military service status, and far worse.”
Siri, who wants the FDA to release all the material no later than March 3, 2022, wrote in a piece published on Substack that the adverse effects were reported in a document titled “Cumulative Analysis of Post-Authorization Adverse Event Reports of [the Vaccine] Received Through 28-Feb-2021.”
On page 6 of the document, Pfizer explains: “Due to the large numbers of spontaneous adverse event reports received for the product, [Pfizer] has prioritised the processing of serious cases.”
The document says Pfizer “has also taken a [sic] multiple actions to help alleviate the large increase of adverse event reports,” including “increasing the number of data entry and case processing colleagues” and “has onboarded approximately [REDACTED] additional fulltime employees (FTEs).”
Siri wants to know why Pfizer, or Justice Department lawyers, blacked out the number of people the pharmaceutical company had to hire “to track all of the adverse events being reported shortly after launching its product.”
The attorney said most of the reports of adverse events were from the U.S. and disproportionately involved women — 29,914 women compared to 9,182 men.
Most were between the ages of 31 and 50 years old, 13,886, compared to 21,325 for all other age groups combined. There were another 6,876 whose ages were unknown.
He noted the 25,957 events classified as “nervous system disorders,” with most affecting females between the ages of 30 and 51.
Siri pointed out that that description sounds similar to the vaccine injuries suffered by Brianne Dressen (Part 1, Part 2), Kellai Rodriguez and Suzanna Newell, who testified recently to Republican Sen. Ron Johnson’s panel in Washington, D.C.
The attorney noted that Pfizer assured the FDA there was no cause for alarm.
“The findings of these signal detection analyses are consistent with the known safety profile of the vaccine,” Pfizer said.
Siri asks: “So if they knew these issues were going to arise, then why didn’t they appear to have enough staff to process this expected volume of reports?”
Pfizer concluded: “The data do not reveal any novel safety concerns or risks requiring label changes and support a favorable benefit risk profile of to the BNT162b2 vaccine.”
Earlier this month, hours before a CDC panel’s approval of the Pfizer vaccine for children 5-11, the British Medical Journal published an article featuring a whistleblower’s charge that poor practices at a contract research company helping to carry out the crucial third phase of Pfizer’s COVID-19 vaccine trial last fall may have compromised data integrity and patient safety.
Members of FDA and CDC advisory panels, in fact, expressed concern that safety data for children regarding Pfizer’s COVID vaccine is lacking. Nevertheless, Pfizers CEO charged earlier this month that people are spreading “misinformation” about the vaccines, calling them “criminals” who have cost “millions of lives.”
The FDA approved the Pfizer shot for young children one week after an FDA advisory panel voted 17-0, with one abstention, to recommended it, despite acknowledging the lack of safety data and the nearly 100% survival rate for children from infection.
During the FDA advisory committee meeting, Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine, expressed the concern of many members about possible severe side effects that cannot yet be measured. He concluded, nevertheless, there was no other way forward.
“We’re never going to learn about how safe the vaccine is unless we start giving it,” he said. “That’s just the way it goes.”
More than 18,000 deaths attributed to COVID-19 vaccines have been reported to the CDC’s Vaccine Adverse Events Reporting System website.
Health and Human Services points out that a VAERS report is not documentation that a link has been established between a vaccine and an adv…