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Monday, July 29, 2024

Exclusive: U.S. Government ‘Saddled’ With COVID Vaccine Injury ‘Mess’ — While Vaccine Makers Avoid Liability

 

July 18, 2024 Agency Capture COVID News

COVID

Exclusive: U.S. Government ‘Saddled’ With COVID Vaccine Injury ‘Mess’ — While Vaccine Makers Avoid Liability

As early as January 2022, NIH researchers were aware of at least 850 peer-reviewed case reports and/or research articles about COVID-19 vaccine reactions, according to emails obtained by Children’s Health Defense.

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As early as January 2022, National Institutes of Health (NIH) researchers were aware of at least 850 peer-reviewed case reports and/or research articles about COVID-19 vaccine reactions, according to emails obtained by Children’s Health Defense (CHD).

In one email (name and agency redacted), NIH researchers were told the federal government was “saddled” with the “mess” of dealing with those injured by the COVID-19 vaccines, due to the liability shield enjoyed by vaccine manufacturers.

The emails, part of a 309-page batch of documents released to CHD on June 21, originated from a U.S. Food and Drug Administration (FDA) request to NIH researchers for input on a report highlighting several injuries common among people who received the vaccines.

CHD requested the documents via a Freedom of Information Act (FOIA) request to the NIH in November 2022. When the NIH hadn’t responded by April 2023, CHD sued the agency.

In an October 2023 settlement, the NIH agreed to produce up to 7,500 pages of documents at a rate of 300 pages per month.

The batch of documents released in June — which include emails to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research — revealed that by fall 2021, key NIH researchers were aware of scientific studies on serious adverse events, including persistent neurological symptoms, following COVID-19 vaccines.

As with prior releases of the NIH documents, June’s tranche also included several emails from vaccine-injured individuals to NIH researchers, seeking help for their symptoms — with one person asking, “Why aren’t you studying vaccine injuries?”

‘Tinnitus … was a freight train in my head for the first four months’

On Jan. 10, 2022, NIH researcher Dr. Avindra Nath was forwarded an email from someone whose name is redacted, with the subject line: “Followup [sic] Jan 4th Meeting” (pages 281-289).

The original email, dated Jan. 9, 2022, was sent to FDA officials including Marks and Dr. Janet Woodcock, principal deputy commissioner of food and drugs, who apparently participated in a meeting on this topic on Jan. 4, 2022.

The Jan. 9, 2022 email included a list of “persistent symptoms following the Covid vaccines” and the names of researchers who were studying these conditions, which included dysautonomia, neuropathy, tinnitus, multisystem inflammatory syndrome (MIS), myocarditis, blood clots and parasthesias.

The email was accompanied by a spreadsheet listing approximately 850 “peer-reviewed case reports/research articles about Covid vaccine reactions.”

Regarding dysautonomia — a nervous system disorder that disrupts automatic bodily functions — the email stated that the condition is “grossly under diagnosed” and “is not diagnosed in ERs or ICUs” but in “autonomic specialty labs.”

The email noted that such labs are less likely than hospitals to file reports with the Vaccine Adverse Event Reporting System (VAERS) and added that there “likely are issues with identifying this syndrome if only looking through VAERS or similarly reported databases.”

As a result, the email suggested “it would be reasonable to approach autonomic specialists / long covid specialists about their observations.”

A 2011 Harvard study found that less than 1% of all adverse events are reported to VAERS.

The Jan. 9, 2022, email also noted unusual trends regarding diagnoses of neuropathy — a set of neurological symptoms that includes numbness and tingling in the hands or feet, and a burning, stabbing or shooting pain in affected areas.

According to the email, “Historically, neuropathy presents in the predominantly male population aged 59+. However as discussed previous [sic], neuropathy in our case is predominantly female, aged 29-40.”

As with dysautonomia, the email noted that neuropathy is “likely to be inadequately reported through the VAERS and BEST [Biologics Effectiveness and Safety] systems because of the circumstances previously mentioned for dysautonomia.”

The Jan. 9, 2022 email also acknowledged that tinnitus was a common post-vaccination injury, noting, “Our findings are that this is not just J&J [the Johnson & Johnson, or Janssen, COVID-19 vaccine] … not by a long shot.”

According to the email, “This symptom is more proportionate to the general neuro symptoms by brand as previously reported in our patient led survey of 500 participants.”

The email’s author also noted that, “in my case yes, I have tinnitus now and it was a freight train in my head for the first four months.”

‘Is it reasonable to dismiss … 20 new symptoms … in a single person post vaccine?’

According to the email, myocarditis and blood clots were already “acknowledged by the FDA and CDC” (Centers for Disease Control and Prevention).

“Every person in our groups that have one of these two conditions, also have accompanying neuro issues like those of us who are not currently acknowledged by the FDA and CDC,” the email said.

The conditions included postural orthostatic tachycardia syndrome (POTS), “brain fog/memory loss, and inflammation (MCAS)” — mast cell activation syndrome.

“Even the perfectly healthy very fit young males with the lasting myocarditis are struggling with the POTS and inflammation/brain fog/memory loss. Makes me suspect that somehow these all are a result of the same mechanism of action,” the email stated.

The Jan. 9, 2022, email also acknowledged parasthesia — a condition that causes a burning, prickling sensation — and MIS, a condition in which numerous organs become inflamed, as concerns.

The email openly questioned why more wasn’t being done to connect these conditions in the vaccinated, to the COVID-19 vaccines themselves, noting that vaccinated people were frequently demonstrating multiple rare symptoms:

“While we understand that correlation does not equal causation, we also find a strong correlation with the change in our blood that mirrors long-haul, and symptomology that mirrors long-haul.

“Because of this, I have to ask what is the process by which Covid PASC [post-acute sequelae of SARS-CoV-2 infection, or long COVID] symptoms have been so readily tied back to Covid, whereas the same symptoms due to the Covid vaccines have not?

“Also, while it may be coincidental to have one or maybe two strange symptoms pop up, is it reasonable to dismiss 10, 15, 20 new symptoms that occur in a single person post vaccine.”

‘Insanely challenging for these people suffering … to walk this path alone’

In the Jan. 10, 2022, email to Nath an NIH researcher wrote, “The FDA has asked once again for us to provide any input from those who have experience with this disease. Very prompt responses and more active engagement on their part lead me to believe they will now examine these problems with some effort.”

The author also asked Nath if he knew researchers “who could fill in the gaps” and asked him if he would “kindly be willing to discuss with Peter Marks?”

“The gov has conveniently absolved the drug companies of any liability, and the federal government is now saddled with the responsibility of figuring out this mess,” the email continued. “I am happy to orchestrate a meeting of the minds with NDR [non-disclosure] agreements if that would get the discussion started in a way that is similar to how previous new diseases have been investigated.”

The email also noted talks with public health officials in Germany and France.

“It has been insanely challenging for these people suffering to have to walk this path alone. They grow more and more desperate by the day. Knowing there is someone, somewhere looking into this makes a big difference for these people to just hang on.”

Even though public health agencies were aware of this information and were discussing vaccine injuries in early 2022, official government advice to the public continued to claim the COVID-19 vaccines were “safe and effective,” including statements by Dr. Anthony Fauci in November 2022.

And in testimony before Congress in February, Marks dismissed the COVID-19 vaccine injury reports filed with VAERS, stating that numerous false reports are submitted to the database — a claim some experts have disputed.

As of today, the CDC continues to recommend the COVID-19 vaccines “for everyone ages 6 months and older, including people who are pregnant, breastfeeding, or might become pregnant in the future.”

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NIH researchers aware of vaccine injury studies in fall of 2021

The June 2024 tranche of NIH documents also revealed that, at least as early as fall 2021, researchers with the agency were aware of scientific studies and surveys highlighting serious adverse events following COVID-19 vaccination.

In a Sept. 2, 2021, email (pages 109-121), Farinaz Safavi, M.D., Ph.D., of the NIH Division of Neuroimmunology and Neurovirology was sent the results of the “Covid Vaccine Persistent Symptoms Survey” conducted by React19, a group advocating on behalf of COVID-19 vaccine injury victims.

The version of the survey included in the email was accurate as of Aug. 31, 2021, and contained the results of 382 questionnaires submitted by people “suffering persistent neurological symptoms after receiving the Sars-CoV2 Vaccine in the United States.”

According to those results, 71% of respondents said they had no preexisting health conditions prior to the symptoms they developed following their COVID-19 vaccination, and 94% said they had never previously experienced a reaction to other vaccines.

The most commonly reported symptoms included paresthesia, tinnitus, heart palpitations, tachycardia, chest pain, visual disturbance or loss, muscle twitching, joint pain, muscle aches, brain fog, fatigue and anxiety attacks.

Almost all respondents said these symptoms began less than two weeks following vaccination.

In a Nov. 15, 2021, email (pages 300-305), Nath was sent a scientific paper, “Neurological side effects of SARS-CoV-2 vaccinations,” authored by Austrian researcher Josef Finsterer, M.D., Ph.D.

According to this paper, “The most frequent neurological side effects of SARS-CoV-2 vaccines are headache,” Guillain-Barré syndrome, venous sinus thrombosis and transverse myelitis.

“Safety concerns against SARS-CoV-2 vaccines are backed by an increasing number of studies reporting neurological side effects. … Healthcare professionals, particularly neurologists involved in the management of patients having undergone SARS-CoV-2 vaccinations, should be aware of these side effects and should stay vigilant to recognize them early and treat them adequately,” the paper concluded.

Nath received a review copy of this paper, which has since been published in Acta Neurologica Scandinavica.

And in a May 17, 2021, email (pages 292-299), Nath was sent a preprint of “Sudden Onset of Myelitis after COVID-19 Vaccination: An Under-Recognized Severe Rare Adverse Event,” co-authored by William E. Fitzsimmons, doctor of pharmacy, and Dr. Christopher S. Nance.

According to the preprint, “Myelitis has been reported as a complication of COVID-19 infection. However, it has rarely been reported as a complication of COVID-19 vaccination.”

The paper focused on the example of one of Fitzsimmons’ patients, a 63-year-old previously healthy male who developed myelitis after his second dose of the Moderna COVID-19 vaccine — and treatment that was effective in his case.

Other emails apparently sent by Fitzsimmons highlighted the injuries and the progression of treatment of this 63-year-old man (pages 145-150).

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‘A blood clot as a cause of your paralysis would make the most sense’

In an email chain to Nath beginning Sept. 20, 2021, (pages 228-233) with the subject “Paralyzed after J&J Covid Vaccine,” the author (whose name is redacted) said that less than 24 hours following vaccination, the patient “lost bladder control.” He later developed a blood clot and erectile dysfunction, before becoming paralyzed.

In a response that day, Nath told the patient, “The temporal association of the symptoms with the vaccine does make is [sic] suspect, but I do not know of any way how to sort it out.”

In a follow-up email that day, Nath said, “A blood clot as a cause of your paralysis would make the most sense, however, proving cause and effect related to the vaccine in a single patient is virtually impossible.”

In a Dec. 13, 2021, email to Nath (pages 234-236), another vaccine injury victim, who “was healthy prior to vaccination,” described injuries following both doses of the Pfizer-BioNTech COVID-19 vaccine, including paresthesia, tachycardia, severe tinnitus, intractable insomnia and “POTs-like symptoms.”

“I have been diligent and determined in seeking care near and far, but have continued to face skepticism, half-interest, and an inability to know how best to treat,” this person wrote.

And in a series of emails beginning Jan. 24, 2022, (pages 246-247), a “woman who was completely healthy before taking the Pfizer vaccines” told Nath about a series of neurological symptoms and inflammation she experienced following her second dose, in addition to symptoms like tinnitus, insomnia and brain fog.

“Why isn’t the NIH doing research on this?” she asked in a follow-up email on Jan. 25, 2022.

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