In October, an intensive care unit (ICU) physician notified the CDC and FDA about severe injuries and illnesses that, in her expertise, were a result of her patients receiving one of the COVID-19 vaccines. Dr. Patricia Lee, who received the vaccine herself, has cared for patients at hospitals affiliated with Georgetown and Harvard. Despite the personal and professional price other doctors and researchers had paid for speaking out against the prevailing vaccine narrative, Lee sent the agencies a detailed letter outlining her clinical observations.
The injuries Lee attributes to COVID-19 vaccines are severe and result in death about half of the time. She let the agencies know about interactions with her colleagues as well:
On a related note, I work with a number of frontline workers that have seen these harms firsthand. They courageously worked through the pandemic and some have already had Covid‐ 19. Many of them have not received the Covid‐19 vaccines and these exce‖ent healthcare workers are desperately needed at my hospital but yet plan to quit or be fired rather than be mandated to receive this Covid‐19 vaccine.
The frontline medical workers I have spoken with are terrified to talk about their observations. Those who have licenses, primarily doctors and nurses, fear losing them. It is impossible to believe Lee did not feel similar trepidation. She did not receive a response until she engaged the legal firm Siri & Glimstad. Within hours, the attorneys received a response from the director of communications at the FDA directing Lee to the Vaccine Adverse Events Reporting System (VARES). The FDA representative essentially dismissed her concerns.
However, sometimes one courageous individual can inspire others. According to Lee’s attorney, Aaron Siri, over a dozen physicians have contacted him. Eleven felt compelled to sign declarations about patients’ injuries that they believe were directly caused by the COVID-19 vaccines. Some reported their own injuries from the vaccines, and other physicians dismissed them when they sought treatment. Siri compiled the declarations and sent them to Secretary of Health and Human Services Xavier Bacerra, CDC Director Rochelle Walensky, acting FDA Director Janet Woodcock, and vaccine experts from the FDA and the CDC.
Siri is an attorney who focuses on civil rights, class actions, and commercial litigation. The COVID-19 vaccine is not his first dance with the health bureaucracies. He has represented clients in cases concerning informed consent and mandated medical products. The CDC and the FDA know him from previous work. From the response Siri received, a dispassionate observer might deduce that the agencies prefer to avoid the issues he raises altogether.
The response to the declarations of the eleven additional physicians once again came from the communications department. However, Lorrie H. McNeill, director of the office of communication, outreach, and development, told Siri his clients should report any vaccine injuries in VAERS. However, Siri pointed out disparities between VAERS and rigorous studies on a single, immediate side effect:
As you are aware, an AHRQ-funded study by Harvard Medical School of 715,000 patients tracked reporting to VAERS over a three-year period at Harvard Pilgrim Health Care. It concluded that “fewer than 1% of vaccine adverse events are reported.”
This disturbingly low rate is confirmed by the rate at which anaphylaxis after COVID-19 vaccine is reported to VAERS. The CDC Director claims that “Anaphylaxis after COVID-19 vaccination is rare and occurred in approximately 2 to 5 people per million vaccinated in the United States based on events reported to VAERS.”
That claim is contradicted by a recent study at Mass General Brigham that assessed anaphylaxis in a clinical setting after the administration of COVID-19 vaccines and found “severe reactions consistent with anaphylaxis occurred at a rate of 2.47 per 10,000 vaccinations.” This is equivalent to 50 to 120 times more cases than what VAERS and the CDC are reporting.
Anaphylaxis is an immediate side effect that doctors are mandated to report in VAERS. A review in at least one large hospital indicates that is not happening. Further, the physicians’ declarations contain many instances where no one from the CDC followed up on a VAERS report. They also include a wide range of symptoms appearing within days or a few weeks of vaccination that sometimes get progressively worse. Many of them mimic autoimmune disorders that affect the gastrointestinal tract and the nervous system.
Comments made by Dr. Doran Fink, deputy director, FDA Vaccines and Related Biological Products Advisory Committee, during the committee meeting on Pfizer booster shots in September of 2021 support Siri’s assertion. Fink noted the occurrence of myocarditis according to VARES was approximately 1 in 10,000. However, he shared claims data that showed myocarditis occurred at a rate of 1 in 5,000. At most, VAERS was detecting half of the cases.
McNeill’s response to Siri also contained a dubious claim.
“In addition, our agency has been conducting and will continue to conduct rigorous active and passive safety surveillance on the FDA-authorized COVID-19 vaccines to ensure that we detect any safety signals of concern, and if we confirm any safety issues, please be assured that we will share the information with the public as rapidly as possible.”
Once again, information shared by Fink contradicts this assertion. According to the claims data Fink had, he said the following when asked when the risk from the vaccine was more significant than the risk from COVID-19:
“If you look at the healthcare claims data, you see that there is evidence of some attributable risk at all age groups, although, the older you get, the higher the risk of complications from COVID that offset the risk of myocarditis,” he said. “So, when you look at the balances of risk versus benefit, what we really start to see is risk of myocarditis being higher [than COVID-19] in males under age 40.”
In a sane world, that would mean healthy males under 40 would not be getting the vaccine. The standard medical practice would demand that a patient not be given a medical treatment where the known risks of the therapy outweigh the illness the treatment is supposed to prevent. Not only has the FDA not informed the public about this finding, but it is also allowing the president to mandate that millions of healthy young men in that age group take it.
Is this the agency you should trust to determine the safety and efficacy of a vaccine for your child? In an environment where physicians are scared to speak out for fear of catching the whirlwind personally and professionally? Perhaps Siri’s closing paragraph to the health agency leaders can provide some insight:
As a postscript, for reasons already addressed many times, VAERS and VSD [Vaccine Safety Datalink] are being utilized to confirm your biases about the products you promote. You repeatedly state that VAERS cannot confirm a safety issue yet simultaneously and incredibly claim it can confirm safety.
The VSD’s data, which you will not permit the public to access despite it being deidentified, are used to support the policies you have already implemented – a simple review of VSD studies makes that plain – and what bias could that introduce? If you were truly confident in the safety of these products and the data evidencing same, you would make the data within the VSD available to the public forthwith.
Fink obtained the data he referenced that found a 100% increase in myocarditis through the Vaccine Safety Datalink [VSD]. How much confidence do you have in the FDA and CDC now?