FDA Files: 26,000 ‘Nervous System Disorders’ From Pfizer Vaccine In First 2.5 Months

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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).”pfizer, covid vaccine

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.”

Whistleblower
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 adverse event. However, HHS also notes that VAERS is a “passive” system of reporting, and it “receives reports for only a small fraction of actual adverse events.” Many health care workers have disclosed they are instructed by their superiors not to report to VAERS any harm caused by COVID vaccines.

And the website OpenVAERS, which compiles summaries of the data on VAERS, points to an analysis known as the “Lazarus Report,” which concluded VAERS represents only 1% of vaccine injuries.

In early October, three Pfizer scientists were captured on hidden camera in a Project Veritas investigation admitting, contrary to the claims of Dr. Anthony Fauci and other public health officials, that natural immunity is superior to the immunity afforded from COVID vaccines.

Project Veritas interviewed an employee of the U.S. Department of Health and Human Services who secretly recorded colleagues voicing alarm about the safety of the vaccines. She alleged a cover-up of “evil at the highest level.” In another investigation by Project Veritas, two Johnson & Johnson officials said children don’t need the vaccine and it poses the risk of “unknown repercussions down the road.”

Pfizer scientist Rahul Khanke said employees are “bred and taught” to insist that the “vaccine is safer than actually getting COVID.” He said “we cannot talk about this” in public.

EDITOR’S NOTE: Last year, America’s doctors, nurses and paramedics were celebrated as frontline heroes battling a fearsome new pandemic. Today, under Joe Biden, tens of thousands of these same heroes are denounced as rebels, conspiracy theorists, extremists and potential terrorists. Along with massive numbers of police, firemen, Border Patrol agents, Navy SEALs, pilots, air-traffic controllers, and countless other truly essential Americans, they’re all considered so dangerous as to merit termination, their professional and personal lives turned upside down due to their decision not to be injected with the experimental COVID vaccines. Biden’s tyrannical mandate threatens to cripple American society – from law enforcement to airlines to commercial supply chains to hospitals. It’s already happening. But the good news is that huge numbers of “yesterday’s heroes” are now fighting back – bravely and boldly. The whole epic showdown is laid out as never before in the sensational October issue of WND’s monthly Whistleblower magazine, titled “THE GREAT AMERICAN REBELLION: ‘We will not comply!’ COVID-19 power grab ignites bold new era of national defiance.”

SOURCE


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Sheryl Hamlin

Big news…Pfizer loses in court….cannot take 75 years to disclose issues with vaccine…

https://aaronsiri.substack.com/p/instead-of-fdas-requested-500-pages

G.G.

Labeling information on Adverse Effects/Hazards of a medical product/drug, is the RESPONSIBILITY OF MANUFACTURER.
ADEQUATE WARNING
21 CPR Sec. 201.80 (e) – requires he MANUFACTURER to REVISE the label TO INCLUDE a warning AS SOON as there IS REASONABLE EVIDENCE of an association of a SERIOUS HAZARD with the drug.
21 CPR Sec. 314.80 (b)- Places RESPONSIBILITY for POST-MARKETING SURVEILLANCE on the MANUFACTURER.
73 FED. REG. 49605- MANUFACTURER continues to have a RESPONSIBILITY under Federal Law… TO maintain their labeling and update the label with NEW SAFETY INFORMATION.

ADEQUATE WARNING LAW- reasonable alerts the AVERAGE PRODUCT USE to a POTENTIAL HAZARD (s)- to include the NATURE & EXTENT OF DANGER…
AN ADEQUATE WARNING IS COMPRISED OF 4 ELEMENTS
1)Notice that hazard exisrs.
2)A discription of the nature of hazard.
3)A discription of thehazard’s POSSIBLE CONSEQUENCES
4)Guild lines on HOW TO AVOID the hazard.
MUST BE PROMINENTLY DISPLAYED.
PHOTOS THAT ILLUSTRATE THE NATURE AND SEVERITY OF THE HAZARD MUST BE INCLUDED.

STATE AND FEDERAL LAW REQUIRES WARNING LABEL TO BE PLACED ON POTENTIALLY DANGEROUS MATERIALS, SUCH AS DRUGS.

Murse

I don’t know what you’re trying to say here. You might want to look at the PREP Act though and how it has been applied recently.

Rex

My large visible vaccination injury showed up eight days after my first Pfizer jab attacking my muscular nervous system and spine growing larger and more painful every week since August 21. I’m not slipping through cracks at the VA. I’m being pushed through.

Mikailah Jensen

oh my goodness, I feel so bad for you.

Richard Noakes

Covid Crusher: Mix one heaped teaspoon of Iodine table or sea salt in a mug of clean warm water, cup a hand and sniff or snort the entire mugful up your nose, spitting out anything which comes down into your mouth. If sore, then you have a virus, so continue morning noon and night, or more often if you want, until the soreness goes away (2-3 minutes) then blow out your nose and flush away, washing your hands afterwards, until when you do my simple cure, you don’t have any soreness at all, when you flush – job done. Also swallow a couple of mouthfuls of salt water and if you have burning in your lungs, salt killing virus and pneumonia there too.
Gargling, using saline solution or tablets is a waste of time, because they deal with Covid in the body and not the virus in the head, where it is at its most vulnerable – how silly such an easy thing to destroy, is left to become the bio-weapon which kills you.
I have been doing this for over 27 years and not one person has died from this simple cure, or been injured from it from those I have been able to pass it on too, myself included – 100% Effective!!.
The Iodine in the salt kills Coronavirus or the Flu, in the nasal passages of the head and flushes out the escutcheon tubes to the ears, the brain stem and the brain bulb, so no long Covid either – dead Coronavirus = no Covid in the body ever and the salt water provides a protection over the surfaces where Coronavirus and the Flu like to breed – pour a bit of solution on a flat surface and see how it dries – what viruses hate, because it murders them, kills them dead.
Irrespective of if you have been vaccinated or not, do my simple, free cure and avoid further booster shots if you can – or better yet, don’t get vaccinated at all – the vaccines kill, one way or another and horribly too, sooner or later and then we get around to those Nanobots and other things in the vaccines (shudder).
If you think you have pcked up an infection, do my free salt water cure immediately and you will know instantly if you have picked up a Coronavirus – a sore or burning sensation – so you know what you have to do – above – to kill it dead quick, before it ever gets to be Covid anything.
Odd that a long swab up the nose to test for a Coronavirus, is later treated with vaccines in the body for Covid with ARR Efficiency rates of 1·3% for the AstraZeneca–Oxford, 1·2% for the Moderna–NIH, 1·2% for the J&J, 0·93% for the Gamaleya, and 0·84% for the Pfizer–BioNTech vaccines ACCORDING TO The Lancet and Doctors For Covid Ethics and booster shots now lasting for just 2 months, with Covid being at least 98% efficient in killing you?
I have to wonder how effective the ARR shots really are for kids – RRR 90.5% effective means less than ARR on the above efficiency rates?
Richard

Tommy

If I worked for Pfizer, I might have a nervous system disorder right about now, too.

Gloria

You have a conscious. The drug companies are off the hook courtesy of laws passed in the 1980s. Now think about how this President endangers our military and first responders, government and private employees, and our children. No conscience there.