First ever NIH study on vaccine injury presents erroneous data, says study participant
NIH’s observational study ended before it was finished…
Questions are being raised about a landmark observational study that evaluated 23 patients who reported new neuropathic symptoms within one month of SARS-CoV-2 vaccination.1 The first study of its kind by the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health (NIH)—published on a preprint server—concluded that “a variety of neuropathic symptoms may manifest after SARS-CoV-2 vaccinations and in some patients might be an immune-mediated process.” 2
Purporting to evaluate patients’ responses to immunotherapy with corticosteroids or intravenous immunoglobulin (IVIg), the authors claimed that at five to nine months post-symptom onset, “three non-recovering patients received intravenous immunoglobulin with symptom resolution within two weeks.” In other words, all study participants experienced a full recovery by the end of the study period.
But if you ask Brianne Dressen, a patient who participated in the study, this claim couldn’t be further from the truth.
Dr. Mobeen Syed interviews Brianne Dressen about her experience as a participant in the landmark NINDS/NIH vaccine injury study.
‘I'm still not working and my body feels like glass’
In early November 2020, Dressen, a physically fit and active pre-school teacher and mother of two children, participated in the “Phase 3” clinical trial for the AstraZeneca COVID-19 vaccine. “I enlisted in the fight against COVID,” she explains. Within an hour of receiving her first shot she felt a “tingling” down her arm and later the same day she had blurry and double vision. Her hearing also changed: “It sounded like I had seashells over both of my ears.”
AstraZeneca did not allow Dressen to get the second shot and once unblinded, Dressen learned she had received the vaccine (not the placebo).3
In an interview with Dr. Mobeen Syed, Dressen describes the harrowing onslaught that followed. The morning after her vaccination, the sensory issues persisted and at the preschool she was unable to function, with extreme sensitivities to light and sound. It would be Dressen’s last day of teaching.
My symptoms cascaded from there. Over the next two and a half weeks, I ended up with severe tachycardia, temperature fluctuations, strange tremors, the adrenaline dumps, the impending doom. I lost control of my legs. I lost control of my bladder, had to retrain my legs. I landed in the hospital two and a half weeks in, and had this horrific internal vibration sensation that still is the one thing that plagues me and is my least favorite thing, and the tinnitus…I am better, but I'm still totally dependent on my physicians and my medical team to help me. I have to go and get IVIg every two weeks and that's just to stave things off so I can function and can try to have somewhat of a normal life. I'm still not working and my body feels like glass but I am hopeful that things will improve.4
In January 2021—three months after the onset of her symptoms—Dressen reported her injury to the NIH in an email to Dr. Avindra Nath, a senior scientist at the NINDS. Within 24 hours she received a response. The correspondence would initiate the study, with Dr. Nath as the study’s principal investigator, and Dressen its first participant.
They took it very seriously. I had a telehealth appointment within a couple of days and before I knew it, I was sending [blood] samples across the country and they were trying to figure out when I could come out for further evaluation.
Dressen says that she initially thought her reaction to the vaccine was an isolated one, but “it turned into a cascade of patients… so, they [the NIH] got bombarded by people after me.”
In mid-May, after receiving word from Dressen that her condition was not improving, Dr. Nath invited her for further testing at the NIH hospital in Maryland. About a month later she spent eight days there, which included five days of IVIg treatment. For several weeks she was monitored over telehealth and her symptoms were tracked on a weekly basis.
We [the study participants] were supposed to go back out [to Maryland] in September, but our follow up appointments all got cancelled.
Dr. Avindra Nath, principal investigator in vaccine injury observational study and senior scientist at the National Institute of Neurological Disorders and Stroke (NINDS).
‘By September it was really quiet... then by December they cut us off’
Dressen says that by September, vaccine-injured people were emailing the NIH daily about their adverse reactions, “desperate for help.”
In one of the last emails Dressen received from Dr. Nath, dated September 16, 2021, he wrote:
Ordinarily when any drug is released it is the manufacturers responsibility to investigate and treat the side effects. Where are the vaccine manufacturers in all of this? Have you tried contacting them? It cannot be the government’s responsibility to pick up after them. They are a profit company and they should be the ones taking change (sic). Don’t you think?
Then, on December 15, Dr. Nath got in touch with Dressen again. He wrote:
I have received a few emails from other patients who have developed neurological complaints associated with the vaccines…It is best for such patients to receive care from their local physicians.5
It was the last time Dressen would hear from Dr. Nath. Her subsequent emails would be met with “radio silence.”
Despite this lack of follow up, the NIH study concluded that all the patients had fully recovered.
We had to precisely track what was happening in our bodies… so they knew that we were not 100% recovered. They knew people were struggling and they knew that we were not back to work. I know at least half of the participants in this study and none of them are better.
So why did the study claim that everyone was fully recovered, if it wasn’t true?
AstraZeneca’s COVID-19 vaccine adenovirus vector. Brianne Dressen was part of an AZ clinical trial when she received her vaccination.
Therapies used in the study worked temporarily, amounting to ‘academic fraud’
“This study is professional misconduct, academic fraud, and at best medical negligence,” says Dr. Syed. Willing to revise his view if new information emerges, for now, Dr. Syed says the delay in publication—initially planned for summer 2021—was because they didn’t want to draw attention to the “damage being caused by the COVID vaccines.”
Withholding the results exposed people to vaccine injury, allowed medical professionals to dismiss the symptoms of the vaccine injured and resulted in a lack of support for these patients, says Dr. Syed. The silence also kept insurance companies from having to pay for the medical care associated with the vaccine injuries, he says, with patients having to pay for treatments out of pocket.
Dr. Syed:
They only observed patients soon after the therapy. Of course, inflammation will go down after corticosteroids or IVIg administration and the patient will report improvement. However, the patient will become sick again as the root cause of the inflammation (dysregulated immune system) is not fixed. What they did is similar to giving a cancer patient, pain killers: When the patient says, ‘I feel better,’ the doctor declares that the cancer has been cured.
Treating the patients with these therapies can result in continued immune dysregulation causing tissue damage with potential long-term disabilities, says Dr. Syed. “Abandoning the study in September and not following-up with the patients, while still publishing the results is professional misconduct.”
Dressen says that while Dr. Nath privately acknowledged the need for early intervention, “it didn’t make it into the manuscript.”
Why were the study participants cut off without follow up appointments?
Why was there no recommendation included in the study about the need for early intervention?
Since her vaccine injury, Dressen co-founded the non-profit organization react19.org.
I reached out to Dr. Nath to find out why Dressen’s experience is not reflected in the patient outcomes. I have yet to receive a response.
Since Dressen’s interview with Dr. Syed, several more study participants have come forward saying they are still suffering despite the study claims. Stay tuned as we’ll continue to report on this story as it evolves.
Among the 23 patients evaluated, 92% were women, and ages ranged between 27 to 71 years (median 40 years). None had previous neurological illnesses and all developed neurological symptoms within 21 days of receiving their vaccination, with the median time being four days. The vaccines received included one manufactured by AstraZeneca (ChAdOx1 nCoV19), one by Janssen (JNJ-78436735), nine by Moderna (mRNA-1273) and 12 by Pfizer-BioNTech (BNT162b2).
Neuropathic symptoms included tachycardia (elevated heart rate), severe face and/or limb paresthesias (burning or prickling sensation), orthostasis (decrease in blood pressure after standing or sitting up), heat intolerance, palpitations, and positional orthostatic tachycardic syndrome (POTS).
AstraZeneca’s phase 3 “safety and efficacy” report for its COVID-19 vaccine was published in the New England Journal of Medicine (NEJM) on December 16, 2021. The report concluded: “AZD1222 was safe and efficacious in preventing symptomatic and severe COVID-19 across diverse populations that included older adults.” In fact, the trial found that the incidence of neurologic adverse events was similar in the vaccine group (0.5%) and the placebo group (0.4%). This was the same clinical trial that Dressen had enrolled in, though she suspects her adverse reaction was not included in the report. “The laundry list of my issues is not there,” she says. “In the clinical trial report, they claim to follow all serious adverse events for 730 days, but they followed me for about 60 days. It was obvious that something strange was happening with my data, just by the interaction with the clinic and marketing they were doing… which is why we initially reported to the NIH. They cut off access to the adverse reaction reporting app, so one day I just couldn’t access it anymore. They also say the participants chose to forego the second dose but in reality, they told me not to get the second dose.” (Personal communication with Brianne Dressen, May 24, 2022)
For each IVIg treatment, Dressen’s insurance covers $3,500 and she pays $1,100. With treatments scheduled twice a month, her monthly out of pocket expense is $2,200. Dressen says she is still waiting for AstraZeneca to step up. The pharmaceutical company is contractually obligated to pay for her medical expenses because she was enrolled in its clinical trial.
From email correspondence between Dr. Nath and Brianne and Brian Dressen (January 11, 2021 to January 14, 2022).
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