Cardiac Manifestations of MCAS, with an Emphasis on POTS/Dysautonomia, Long COVID, and COVID Vaccine Injury

Cardiac Manifestations of MCAS with Dr. Andrew Maxwell
(interviewed by Tanya Dempsey, transcript here.  Dr. Maxwell is a board-certified pediatric cardiologist and pediatrician. He received his medical degree from Johns Hopkins Medical School and a residency in pediatrics at the University of California at San Francisco, followed by clinical and research fellowships in pediatric cardiology at Lucille Salter Packard in Stanford Hospitals and Children's Hospital of Philadelphia)

"Dr. Maxwell walks us through his thinking and how MCAS is linked to POTS and Long COVID. This episode is a must-listen for patients and practitioners alike."  He says this connection is more important than ever because " in the age of COVID where we're seeing more POTS, Kounis syndrome, myocarditis and even inappropriate sinus tachycardia, which I see a lot of, which is probably a localized version of myocarditis."

Mast cells can cause dysautonomia and POTS, and this is often connected with Ehlers-Danlos Syndrome (EDS).  He says the major issue underlying MCAS is an environmental exposure which can be a pathogen (like a virus) or a toxic substance.  In the case of Long COVID and COVID vaccine injury, he says it's probably the spike protein that is the toxic element activating mast cells because that's what the virus and the vaccine have in common.  He says that "mast cells are doing a lot of the things that we are seeing in these patients causing post COVID long haul syndrome leading to POTS with or without the post COVID long haul. I mean, it could be very specifically POTS, it could be very specifically Kounis syndrome. It could be very specifically myocarditis, could be very specifically inappropriate sinus tachycardia. But I believe mast cells are very frequently the underlying mediator of that inflammation. Now, it could be where it’s partly a mediator and something more direct or some other thing as being a mediator as well. But I see time and time again a pretty good response to full mast cell suppression. So that, that again informs us that very commonly it’s mast cells doing the mediation."

"Kounis syndrome is basically an allergic spasm of the coronary arteries. And so when you have a spasm of the coronary arteries, you have essentially all the signs and symptoms of the angina that might lead one to believe they’re having problems with coronary perfusion. And you are. But it is reversible with, with mast cell medications."  He says he doesn't think his colleagues are making the connection that this chest pain is related to mast cell activation and therefore can be treated with mast cell meds effectively.  He also believes that Kounis Syndrome is much more common than previously thought, so it's important to get the word out and inform more doctors about it.

He says he identifies MCAS patients by taking a close look at their clinical picture, really looking at their symptoms across body systems, and taking a thorough medical history.  This shows if a viral infection seems to have been the trigger.  He points out that some patients have never had a positive test for COVID but were known to have been exposed and developed "long haul" symptoms following the exposure at the right time, so they were just asymptomatic.  "What I kind of look, try to look for is the food sensitivities, the GI distresses that are a little bit different with mast cell activation. And then the one particular feature, what I call rushes of flushes, which is sure there’s tachycardia and palpitations, burst of racing heart palpitations, but you can find that in both the straightforward dysautonomia and mast cell activation. So how do you tell the difference between the two? You get the flushing and the rashiness with rushes of flushes. And that’s kind of how I say, okay, this is definitely a mast cell phenomenon going on."

In diagnosing and treating mast cell disease, he doesn't rely much on lab testing.  He feels it doesn't add much to his understanding of the patient or how he will treat them, which is driven by their symptom presentation "we might start with that type of therapy including fludrocortisone, midodrine, corlanor, beta blockers, pyridostigmine, that type of medication directed toward dysautonomia slash POTS."  After that, he will employ what he calls his "bicycle tire management strategy" which means:

"What I mean by the bicycle tire management strategy is you gotta consider mast cell activation like a bicycle tire with about seven holes in it. And those holes are you know, excessive histamine consumption in the diet. The GI tract as being a source of additional mast cell activation, so having the GI tract in order, and then mast cell action itself, both systemically and within the GI tract. And then those particular receptors of histamine, H1 and H2. So therapy would be an H1 blocker, an H2 blocker, mast cell suppression systemically with usually a lukast. Zafirlukast is what I prefer. I usually avoid montelukast and with a cromolyn substance in the gut. So Gastrocrom here in the US. Finally, quercetin is a natural version of the systemic mast cell stabilizer. So I usually have patients on quercetin. I consider it kind of a freebie that not really being exposed to a med is very safe, so why not? And then making sure the GI motility is working well, making sure that there’s no evidence of what we call SIBO, small intestinal bacterial overgrowth, doesn’t necessarily mean I work them up for that in any way. I just mean I put ’em on probiotics. Make sure if they have any evidence of slow GI motility, put ’em on a burra, gass or ginger root extract (not sure what "burra" or "gass" refer to). Rarely have to go something more extensive medication-wise with that. And then of course, put them on a low histamine diet, make sure they’re not adding histamine to their system. That’s usually the, the, in my view, patching all seven holes of that bicycle tire. And when you have all seven holes patched, You can expect a change."

When asked why he prefers Zafirlukast over Monteleukast, he says it is primarily because he sees Monteleukast cause a lot of depression in his patients.  He attributes this to mast cells releasing elastases, that breakdown the blood-brain-barrier (and also the gut barrier and the endothelial layer in capillaries) by breaking down small proteins called cadherins that hold these things together, making them "leaky".  He says he sees similar results with a lot of the dopamine agonist antagonists like Reglan.  He speculates that this scenario may be more common in children.  Dr Dempsey points out that she sees better responses to Monteleukast (and other meds) when they are compounded, so the excipients used in the standard formulations may be the problem.  

(This is his complete quote from above, included because it may be of particular interest to some readers "Mast cells not only secrete histamine, but they secrete elastases and elastases breakdown the little proteins that hold things together, what are called cadherins and maybe other proteins too. But I really focus on the cadherins. Cadherins hold together, the GI epithelium, that’s the E-cadherin. So that’s where your leaky gut comes from and it holds together what are called VE-cadherins hold together, the capillaries, the endothelium within capillaries. And so if they break down, you get increased leaky capillary in general, but blood-brain barrier. And we see that with not only montelukast, we see it with a lot of the dopamine agonist antagonists like Reglan where patients will much more commonly have extra pyraminal effects being put on Reglan and other types of dopamine modifying agents.")

They go on to discuss the idea of grouping together conditions like MCAS, POTS, and other commonly comorbid conditions because it's clear that these conditions frequently occur together.  At first, doctors referred to "the triad" which included MCAS, EDS, and dysautonomia.  It then expanded to "the pentad" when GI dysmotility (GI involvement in general) and autoimmunity were added.  The direction of causality is unclear- which condition came first?  Did the leaky gut become an "auto-antibody generator over time"?  Did the autoimmunity start this whole progression?  The idea of identifying the 5 main pieces is that a patient would then need to set up a team of 5 doctors to manage these conditions, although in reality that is often not possible to do.  Then the next two conditions were added, bringing it to "the septad"- many patients had underlying infections, such as Lyme Disease, and they also had what is often called "ME/CFS" which is now generally recognized to be mitochondrial dysfunction.  Dr Dempsey than added 3 more things to bring it up to a "decad" including small fiber neuropathy, cervical instability and tethered cord, and autoimmune encephalopathy (such as PANDAS/PANS).  This last component acknowledges the brain fog and cognitive issues, the neuropsychiatric issues, and endocrine issues especially thyroid, adrenal, and sex hormone issues.  Dr Maxwell adds that he sees many of these additional pathologies that are being added to the list as sub-forms of things already on the list, so it may not make much difference how much you expand the list or keep it short in terms of making sure that you recognize and treat the patient's whole picture.  

It's worth noting that in the above discussion, Dr Maxwell puts forth the idea that there can be localized expressions of some of these conditions that may not meet full criteria, that were caused by a localized environmental exposure.  For example, a person who was exposed to "something that’s aerosolized and breathed in, and what happens is you have a localized nasal pharyngeal mast cell activation that then causes havoc in the nasal pharyngeal region, specifically CCI, TMJ issues, and then loss of airway. So the airway becomes floppy for different reasons. And so you see these particular patients and they’re kind of a setup for this phenomenon I see and call "spiky leaky syndrome." (CCI is cranial cervical instability, meaning the vertebrae in the neck are unstable).

Dr Maxwell is then asked if how he sees the patient picture changes how he treats the mast cells and he says generally, no, that he pretty much starts everyone on his usual mast cell protocol.  If a patient seems to need more than that, he says "another strategy I have are IV infusions of mast cell meds... getting saline along with Benadryl, Toradol, Ativan, and famotidine and IV form, and oftentimes on ondansetron as well. And so that often works much more effectively than the oral forms."  He may also increase the dose of LDN (Low Dose Naltrexone).  He also adds that if a patient is really "POTSie" and has "angina type symptoms and you’re thinking the mast cell meds aren’t gonna work fast enough for that, you might try some antianginal type strategy, something like a nitric oxide releaser to open up their coronaries as quick as possible."  

They then go on to discuss how mast cells are related to and can cause Dysautonomia and POTS, and specifically how the COVID virus and the COVID vaccines have both been shown in research to contribute to the onset of both Dysautonomia and POTS specifically.  This discussion begins at [00:26:26] in the interview- if this is very interesting to you, I suggest going to the interview and reading the entire very long quote.  This is my summary of what Dr Maxwell is saying:

POTS is basically what happens when the person's venous system becomes "saggy" and "stretchy" rather than as rigid as it needs to be to appropriately control blood flow throughout the body as the body moves around and changes position.  When the person stands up, the venous system is too "saggy" to bring the full amount of blood up to the heart to fill it when ti pumps so it pumps partially empty, resulting in low cardiac output.  This causes the heart to beat faster, as tachycardia, in an attempt to increase cardiac output.  One of the reasons that MCAS more broadly and COVID or COVID vaccine injury more specifically can cause this situation is that the spike protein activates mast cells, which then release mediators that break down the connective tissue of the venous system itself, causing it to become too "saggy" to function properly. 

He says there are also several ways that mast cell activity can affect the functioning of the autonomic nervous system directly, which is the branch of the nervous system that regulates things like circulation, heart rate, and blood pressure.  "(M)ast cells activated in the gut can then cause inflammation of the sensory portion of the Vagus nerve. It’s the information heading back to the brain. And so if it’s irritating and inflaming the sensory portion of the Vagus nerve, it’s as I consider it like almost like a CPU u you know, computer system with information going into the CPU, if it’s garbage in, it’s gonna be garbage back out. And so, it affects how the motor portion of the Vagus nerve works. And so you have a dysautonomia of the motor portion of the Vagus nerve that results from a inflammation of the sensory portion of the Vagus."

He outlines another way that mast cell activation can lead directly to dysfunction of the Vagus nerve as well as several other cranial nerves, which could also be leading to POTS and Dysautonomia in patients following a COVID infection or vaccine injury.  Mast cells in the neck becoming activated could be releasing the mediators mentioned above that can "tenderize" connective tissues, in this case ligaments in the neck that hold the cervical vertebrae in place.  This could in theory result in a situation very similar to what is called CCI (Cranial Cervical Instability) and is often seen in EDS patients (Ehlers-Danlos Syndrome, which is often comorbid with MCAS). He sees this as essentially "carpal tunnel syndrome" of the neck but says that because it acquired by mast cell activation, it is more of a clinical diagnosis and may not show up on the radiology and other types of testing used to identify CCI in EDS patients, that is more structural.  In this scenario, the C1 vertebra (aka the atlas) becomes loose and unstable, and gets pushed forward, which compresses the cranial nerves 9, 10 (the Vagus nerve), and 11 that are exiting the spine at that spot.  Those nerves are then compressed against the jugular vein, which is then compressed against the stylo hyoid ligament.  If this situation becomes chronic, these nerves can become damaged, which can then lead to dysfunction of the parasympathetic nervous system by way of a little bit of CCI.  

More evidence that this happening is that you’re also seeing cranial nerve 9 and cranial nerve 11 dysfunction, which can present as tinnitus, phonophobia (sensitivity to and/or fear of certain sounds) and hyperacusis (an abnormally strong reaction to sound, occurring within the auditory pathways), vertigo, and what’s called globus feeling of a mass in the back of the throat.  Dr Maxwell says he also sometimes sees "what’s called eagle syndrome type symptoms with turning the head and having pain upon turning your head. From side to side, sharp stabbing pains in the neck or pain at the base of the tongue. Those are all glossopharyngeal nerve findings. And then the cranial nerve 11 is a motor nerve to the trapezius and it innervates the trapezius. So when it’s injured, oftentimes will cause a knottiness something beyond coat hanger pain in the trapezius, but rather a knottiness in the trapezius. So when you hear these patients complaining of all these symptoms, that it sounds almost crazy that they’re related. No, there’s one place in the body where these three nerves are together and they happen to run right in front of the lateral process of c1. So when that slips forward and chronically does so, I think it causes this, this list of symptoms together."

When Dr Maxwell is asked how he manages and treats this situation with the slipped C1 vertebra if he suspects it, he responds "I will get the physical therapist involved. And I’ll often assess their airway as well, because if they have that going on, they may have a floppy airway as well, and they may be losing it at night and showing what we call upper airway resistance syndrome, which is a subtle form of sleep apnea. So we oftentimes, I get sleep studies to look at that. Oftentimes I’ll get ENT and the oral airway doctors including oral surgeons involved to make sure that they’re not losing their airway, myofunctional therapists to help strengthen the musculature of the airway. And then there’s a class of physical therapists that are geared entirely toward CCI. So I will get them and get them involved. One of the things that I’ve found useful as a test of concept in these patients is what happens if they were to get some what’s called NUCCA therapy, NUCCA. And that’s a particular form of chiropractic therapy that focuses on the Atlas. And so these NUCCA chiropractors have been very, very helpful in putting C1 back in place. And these patients can respond right away to their POTS like symptoms. Their dysautonomia improves right away."  He says this is a test of concept because while the NUCCA therapy is very effective, the improvements don't last long. He discusses prolotherapy as an option and says that he encourages the therapist to inject platelet-rich plasma (from the patient in order to avoid MCAS being triggered by something foreign).  

He sees this therapy, like he does the POTS therapies, as "band-aid" therapies to help as the longer-term stabilization of the mast cells and treatment of any residual COVID is taking effect.  This may include the body clearing residual spike protein, treating a lingering COVID infection, or treating another infection that was latent and reactivated from the immune suppression of the COVID or vaccine (such as HHV6, EBV, or Lyme).  He says he will treat with anti-virals if "the PCRs are positive or if the IGMs for those viruses are positive".  

They discuss this paper Apparent risks of postural orthostatic tachycardia syndrome diagnoses after COVID-19 vaccination and SARS-Cov-2 Infection, which found a significantly higher risk of developing certain conditions associated with POTS after both COVID infection and COVID vaccines, including Dysautonomia, POTS, and MCAS, as well as some other conditions including UTIs, lower back pain, and symptoms like dizziness, fatigue, and anxiety.  They go on to talk about how complicated it is to weigh the costs and benefits of vaccination for the population of people who already have any of these conditions or who are at higher risk for developing them, especially given that the nature of COVID infection has changed. 

Dr Maxwell's last message for patients "for the patients seeking help, you know, find the right provider that works with you. Don’t let someone dismiss you. I hear again and again being told, you know, there’s no point in managing anything. You’re gonna get better with your long COVID. And you know, we’ve seen long COVID patients two years out who were just struggling, not everybody. And it’s great to see some patients getting better even on their own. But you never know who thoses are gonna be, and so you’re gonna want to try to modify what could be a very long road. And so you know, make sure you’re finding someone who’s addressing your issues that has a a pretty good handle on the underlying causes that can do it in a systematic way. And I think you’ll have some success."

Further information on the topics discussed in this interview:

Mast cells in the autonomic nervous system and potential role in disorders with dysautonomia and neuroinflammation
"Mast cells... having potential involvement in the pathophysiology of dysautonomias and neuroinflammatory disorders. MC are located perivascularly close to nerve endings and sites such as the carotid bodies, heart, hypothalamus, the pineal gland, and the adrenal gland that would allow them not only to regulate but also to be affected by the autonomic nervous system (ANS). MC are stimulated not only by allergens but also many other triggers including some from the ANS that can affect MC release of neurosensitizing, proinflammatory, and vasoactive mediators. Hence, MC may be able to regulate homeostatic functions that seem to be dysfunctional in many conditions, such as postural orthostatic tachycardia syndrome, autism spectrum disorder, myalgic encephalomyelitis/chronic fatigue syndrome, and Long-COVID syndrome."

Phonophobia and Hyperacusis: Practical Points from a Case Report

NUCCA

Prolotherapy

POTS association with COVID-19 vaccination and COVID-19 infection
"Although any comparison of post-exposure rates should be interpreted cautiously, given the baseline differences in POTS incidence in the two mutually exclusive populations, these results indicate that POTS might be occurring at a higher-than-expected frequency following COVID-19 vaccination, although at an overall rate lower than the frequency of POTS occurring following SARS-CoV-2 infection."

Apparent risks of postural orthostatic tachycardia syndrome diagnoses after COVID-19 vaccination and SARS-Cov-2 Infection
 "POTS-related diagnoses appear to be acquired with increased frequency after, compared to before, COVID-19 vaccination, particularly when compared to more commonly diagnosed conditions"

"For new diagnoses made after vaccination, we found that the five conditions with the highest post-vaccination odds of new diagnoses were myocarditis, dysautonomia, POTS, mast cell activation syndrome and urinary tract infection (UTI). Two POTS-associated conditions had lower odds, with fatigue demonstrating a moderate ratio and Ehlers–Danlos syndrome (EDS) having the second from the lowest ratio."

"There is biological plausibility for the association between POTS and COVID-19 vaccination in particular. Before the pandemic, mRNA vaccination had been administered in small trials predominantly involving cancer therapy, demonstrating rare off-target neurological effects such as Bell’s palsy, which has also been seen with COVID-19 vaccination^25,26. In SARS-CoV-2 infection, multiple reports of post-infection POTS invoke the possibility of an immune-mediated mechanism triggered by an antigenic component of the spike protein shared with vaccination^13,24,27. Given the broad expression of ACE2 preceptors, inflammasome activation by synthetic spike protein could result in multi-systemic effects, including neurocardiogenic targets and potential induction of variable types of autoimmunity^28,29,30. Additionally, the lipid nanoparticle coating in mRNA vaccine formulations is known to be highly inflammatory, although effects related to the lipid coating appear less likely contributors than spike-protein-mediated effects³¹. Further research is needed to clarify potential mechanisms related to either vaccine formulation or vaccine target."

Postural orthostatic tachycardia syndrome after COVID-19 vaccination
"Ten patients (3.9%) at a quaternary-care POTS clinic reported new or worse POTS symptoms after the mRNA COVID-19 vaccine. All patients had pre-existing comorbidities, suggesting a potential group of patients to monitor for post-vaccine POTS. Symptoms responded to guideline-directed POTS therapy."  (Pre-existing conditions included previous COVID-19 infection, Hypermobile EDS, MCAS, and auto-immune cardiac, neurological, and gastrointestinal symptoms)

The Global Impact of Pharmaceutical Profiteering and Corruption

The Meriam-Webster dictionary defines profiteering as "the act or activity of making an unreasonable profit on the sale of essential goods especially during times of emergency".  Profiteering by pharmaceutical companies has been an increasing problem worldwide for decades.  The fact that medical care is so often needed during times of crisis and emergency makes profiteering easy and commonplace.  This is also facilitated by changing power dynamics globally, providing more opportunities for pharmaceutical companies to exploit.    

Johnson and Johnson are trying to extend their patent for anti-tuberculosis medications that are needed to save millions of lives, but instead of letting the patent expire so that the drug can be made affordably enough to be available to the rest of the world, they are trying to falsely extend the patent to bolster their own profits.  Learn more about it here.

French company bungled clinical trial that led to a death and illness, report says "Why one man died and four others fell ill during a drug safety study in France last month is still very unclear. But a preliminary inspection report lashes out at Biotrial, the company that conducted the study, for how it responded after the first volunteer in the clinical trial was hospitalized. Three major errors by Biotrial put other volunteers at risk, says the report, published yesterday by France's General Inspectorate of Social Affairs (IGAS). Responding to the report, Touraine said that from now on any hospitalization during a clinical trial should be regarded as "new fact" that needs to be brought to the attention of health authorities immediately. Such events should "lead to an immediate suspension of the trial until the safety of volunteers is guaranteed," she said. "Volunteers must be clearly informed about the suspension of the study and its reasons."

Bill Gates Almost Single-Handedly Derailed the Plan That Could Have Led to a 'People's Vaccine'
"But the inspiring plan devised by the scientists—which promised to create a vaccine essentially belonging to the world's people, not to corporate shareholders—was crushed fairly decisively when Bill Gates ventured into the fray."

 "Among other things, the vaccine tragedy highlights the danger posed by the extreme concentration of wealth and power that Bill Gates represents. It turns out that his mega-philanthropy comes with a hitch: it enables Gates to develop extraordinary influence over crucial matters, such as whether or not the world's poor will have a chance to survive the pandemic."

 

How Bill Gates Impeded Global Access to Covid Vaccines: Through his hallowed foundation, the world’s de facto public health czar has been a stalwart defender of monopoly medicine.

Neuropathic Injuries From SARS CoV 2 Vaccination

First Ever NIH/NIND Study on Vaccine Caused Neurological Injuries (Preprint)

NIH/NIND Vaccine Injury Study Participant Interview (Dr. Danice Hertz)

Neuropathic symptoms with SARS-CoV-2 vaccination
"This observational study suggests that a variety of neuropathic symptoms may manifest after SARS-CoV-2 vaccinations and in some patients might be an immune-mediated process." 
'100% reported sensory symptoms comprising severe face and/or limb paresthesias, and 61% had orthostasis, heat intolerance and palpitations. Autonomic testing in 12 identified seven with reduced distal sweat production and six with positional orthostatic tachycardia syndrome. Among 16 with lower-leg skin biopsies, 31% had diagnostic/subthreshold epidermal neurite densities (≤5%), 13% were borderline (5.01-10%) and 19% showed abnormal axonal swelling. Biopsies from randomly selected five patients that were evaluated for immune complexes showed deposition of complement C4d in endothelial cells. Electrodiagnostic test results were normal in 94% (16/17). Together, 52% (12/23) of patients had objective evidence of small-fiber peripheral neuropathy."
In the study it is claimed that some of the patients received IVIG treatments and that all symptoms resolved with two weeks (with minor residual symptoms in one), which is know to be untrue for at least one participant, whose symptoms returned in full force when the IVIG wore off after about 3 weeks.  It is well known that IVIG only cleans out the circulating antibodies and antigens temporarily and that these often begin to return after about 3 weeks. 

Why Was Michelle Zimmerman Running Into The Walls?
Dr Mobeen inteerviews Michelle Zimmerman regarding her serious neuropathic consequences following COVID vaccination (she received a single shot of (Johnson and Johnson).  It's been well documented that she never had COVID.  Within 5 minutes of receiving her vaccine, her injection arm went completely numb.  Her wrist dropped and she was unable to move it, she had shooting pain that went up her arm into her ear, her tongue and throat became swollen, and that evening she became unresponsive with a fever of 104.8 and her heart rate became very high.  The medical advice was that she was tired and to let her sleep it off.  When she woke up in the hospital she was completely paralyzed, unable to even open her eyes.  In the time immediately after this she had extreme sensitivity to light and sound and felt intense pain in her abdomen and back.  She was too weak to stand on her own in the shower.  She makes the point that she got the vaccine to show her support of science, she assumed that there were ethical safeguards in place for safety, and was disturbed when she found out later how little was known and how much pressure there was to stay quiet about her injuries to keep from bringing any doubt onto the vaccine program.  She is an accomplished scientist herself and says "good science asks questions, they don't disregard questions.  They find answers to do things better next round. 

She did extensive research herself that she discusses here.  SPECT scans, which image the brain with the aid of a radioactive tracer, showed reduced functioning in several areas of her brain including the Prefrontal Cortex (responsible for working memory and focus) and the Temporal Lobes (speech and language).  MRIs failed to pick up on these injuries.  She presented with what she was told was a stroke-like episode, but not a stroke itself, in which she had left-sided weakness and was unable to respond or speak.  She had vestibular hypofunction.  For over a year she had been tipping to the right which is something the brain is doing to try to accommodate the altered input from one side.  This means that things weren't where she saw them to be so when she would reach, she would reach in the wrong direction. 

Her situation involves vision anomalies caused by some sort of concussive or traumatic brain injury.  In doing research in trying to get help she found that this is a known condition that has been studied in soldiers returning from abroad.  She has 20/20 vision, and there is nothing wrong with her eyeballs themselves, but there has been damage that affects the signal from her eyes into her brain.  One aspect of her condition is called a Visual Midline Shift.  Additional visual symptoms included shaking of her eyes, white lights breaking down into a rainbow as her eyes moved, and sometimes it appeared as though she was looking through a foggy window. 

Once she realized that her problems were visual she began to research them and found that people with Long COVID, post COVID vaccination injuries, people who had been in car crashes or had head injuries from sports, seemed to share similar symptoms.  Symptoms can be made worse by sitting in a moving car (car sickness), being on an escalator, or other types of movement.  Also trying to stand up straight.  A scopolamine patch made it worse, showing that this was not a neurotransmitter issue like it is in motion sickness.  These things brought on nausea, dizziness,   Areas of her visual field were sometimes blocked out with a blurry patch which is a symptom shared by some people with ocular migraines.  She could not be diagnosed with either TBI or concussion because both require that there had been impact to the head.  Her PCP told her that her MRI did look like a concussion patient, and was willing to diagnose "encephalopathy".

She worked with Dr Cap and Katie Chapman.  Dr Cap recognized what was happening.  Her diagnosis stated that she had "deficiencies of saccadic eye movement", that she had "significantly reduced visual skills required for efficient and effective reading and computer work", and that she was "presenting very similar to TBI patient.  Noticing difficulty with light sensitivity, tracking, visual motion hypersensitivity, memory, and fatigue."  She said that reading was very painful and it seemed that her eyes were bouncing around.  She had speech difficulties that her vestibular therapist described as like those that an older person or person with dementia has, as if her brain is trying to do too many taxing things at one time.  Her vestibular therapist is named Dr Sarah Maddingly.  The therapist figured out that her speech problems occurred because her visual processing problems were so taxing to her brain that they caused her brain to "drop" some other taxing abilities when it became too tired.

One therapeutic approach to treating this visual problem is called Binasal Occlusion, in which a pair of glasses frames (sometimes without lenses) has opaque pieces added on to block visual input from some directions.  The idea is that this helps to reset how her brain and eyes process information.  She has also had benefit from some medications, HBOT dives, methylated B vitamins had helped with headaches (but not standard B vitamins), she is taking fish oil because it is known to treat vascular damage and inflammation, and Astaxanthin because it is a powerful antioxidant. 

She has a lot of insights about the COVID vaccination problem and medical science, even just science in general.  One of these is the idea that when designing something, such as a response to a pandemic, it is important to think in terms of multiple iterations...of finding out what worked, what didn't work, and how to make changes to the next version rather than simply saying that the first attempt was perfect and needs no adjustment. 

Pfizer's Vaccine Data Integrity Failures and the FOIA Request

The Many Integrity Problems Regarding the Pfizer mRNA Vaccine
Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
"Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight."

 

All of the data and information that Pfizer collected during it's clinical trials phase, everything that it submitted to the FDA for it's EUA (Emergency Use Authorization), and all the data and information filed with the FDA for approval of the vaccine, has up until now been kept secret.  This is not the way this has been handled in the past and is not considered ethical by existing standards.  There is something called "medicine by PR" which means that sometimes doctors practice medicine based on PR releases rather than all of the actual data regarding a product or treatment.  This is not uncommon in situations where the medication or other product is needed immediately, but what usually happens is that the PR release contains a fair amount of information and the rest of the information is provided soon afterwards.  In this case not only was no additional information released, but the PR releases did not contain much info.  Doctors were asked to promote Pfizer's vaccine on faith and while many of them were uncomfortable about this, they did have enough faith in the health authorities and the concept of vaccination that they went along with it.  Over time there has been increasing frustration among many doctors and other health care professionals about the continued refusal to provide even the basic data, which is pretty much unprecedented, and a corresponding loss of faith in those medical authorities, to the point that there is a lot of anger at how the FDA and CDC have not only destroyed their own credibility but are actually destroying the credibility of medicine and science in general in the US.  This is already having a harmful effect on the credibility of climate science in particular.

A non-profit called Public Health and Medical Professionals for Transparency (PHMPT) submitted a FOIA request (FOIA stands for Freedom of Information Act).  On their website, they state that
"This non-profit, made up of public health professionals, scientists, and journalists exists solely to obtain and disseminate the data relied upon by the FDA to license COVID 19 vaccines.  The organization takes no position on the data other than that it should be made publicly available to allow independent experts to conduct their own review and analyses.  Any data received will be made public on this website." 

ALSO:

"Four days after the Pfizer vaccine was approved for ages 16+, we submitted a Freedom of Information Act Request to the FDA for all of the data within Pfizer’s COVID-19 vaccine biological product file. We have now sued the FDA for not releasing the data. Click below for court documents and for productions of Pfizer’s documents from the FDA."

This is website of Public Health and Medical Professionals for Transparency (PHMPT)

This is the FOIA request that was filed on their behalf

This is the lawsuit that they filed against the FDA to compel them to release the data
These are two documents linked to in the above filing:
FDA Approves First COVID-19 Vaccine
Covid-19 vaccines: In the rush for regulatory approval, do we need more data? (published in the BMJ)

Neil Oliver discusses Pfizer releasing initial trial data
A guest on the show, who is a diagnostic pathologist, discusses her thoughts on the first set of papers released from Pfizer.  She makes the point that one document, which lists harm and injuries reported to Pfizer, had already been released into the public domain.  She also points out that this is a list of diagnoses and side effects that was reported to the surveillance systems of individual countries, not directly to Pfizer, and that the information is not there to be able to measure these outcomes or to confirm that they were caused by the vaccine.  Additionally she notes that vaccine adverse events have a history of being highly under reported, for a number of reasons, some more than others.  Adverse events in older people are often written off as just aging, common health problems are more likely to be written off as coincidental, while certain other conditions are rare and more widely known to be related to vaccination.  

Another guest, Dr Anthony Hinton, suggests that their has already been a lot of data that is available, showing significant complications of vaccination, that the medical profession have been "burying their heads in the sand" about.  For example the UK health service estimated that the rate of myocarditis in children was around two per million whereas careful record keeping (prospectively) in Hong Kong found a rate of 425 cases per million (a rate 200 times higher when it was specifically looked for rather than not).  Both guests so far have floated the question of why Pfizer fought to keep this information hidden for up to 75 years, what were they trying to hide?  They also point out that the most alarming information will likely be released last so what we are seeing already is not the worst of it.  The original data from the original trial Pfizer only claimed a modest reduction in severe symptoms, they did not claim it would stop people from catching the disease or transmuting it to others, that claim came from somewhere else.  They also didn't claim that it would reduce deaths or hospitalizations because there weren't enough people in the trials to show that.  The trial participants were also healthy and in the age range of about 18 to 70 years old.  They didn't include elderly people or people with existing conditions that increased their risk.  So basically not the population that needed it.  There are also other situations in which more information will probably be released including a legal case brought by Brooke Jackson, who is a whistleblower who worked at one of the sites hired by Pfizer to do the trials. 

The Economics and Politics of COVID 19 Vaccines and Other Therapeutics

How Politics Corrupted Science: Dr. Vinay Prasad on COVID

For Fraction of Pentagon Budget, World Could Prevent 1.5 Million Covid Deaths

As World Confronts Omicron Variant, Top 8 Pfizer & Moderna Investors Make $10 Billion in a Week

How Bill Gates Impeded Global Access to Covid Vaccines

Bill Gates: The Billionaire Who Puts Vaccine Profiteering Above Human Life 

Bank Blocks Donations Supporting Cuban Effort to Vaccinate World

Researchers develop patent-free Covid vaccine for developing nations

WHO says: “Countries shouldn’t require proof of vaccination as international travel requirement”

“Pandemic, Inc.”: J. David McSwane on Chasing Capitalists & Thieves Who Got Rich While We Got Sick (interview with book author)
"In “Pandemic, Inc.: Chasing the Capitalists and Thieves Who Got Rich While We Got Sick,” ProPublica investigative reporter J. David McSwane tracks pandemic federal relief funds and finds many contracts to acquire critical supplies were wrapped up in unprecedented fraud schemes that left the U.S. government with subpar and unusable equipment. He says an array of contractors were “trying to take advantage of our national emergency,” and calls the book “a blueprint of what not to do” during the next pandemic."

The U.S. Billionaires Profiting the Most from the Pandemic
"(billionaires) in the United States have accumulated an additional $1.7 trillion of net worth since the start of the pandemic two years ago...  The net worth gain of every U.S. billionaire combined over the last two years could finance a majority of the ambitious plan (Build Back Better) without the profiteers becoming any poorer in the process. The immense wealth disparity is also evident when comparing the U.S.' 704 billionaires with the 65 million households making up the bottom half of U.S. society in terms of income. The latter's combined net worth clocks in at around $3.4 trillion, that of the billionaire class adds up to $4.6 trillion." 

Zero Covid And The POWER, INCENTIVES of the Chinese Regime | Breaking Points with Krystal and Saagar  
A discussion of whether capital or political power controls public policy in the US and China.
"On December 21st 2021, Delta Airlines CEO Ed Bastian asked the CDC to shorten the COVID isolation policy from 10 days to 5 days.  On December 7 the CDC updated and revised their isolation and quarantine guidelines from 10 to 5 days.  

Dr Fauci (speaking with CNN's Jim Acosta) "with the sheer number of cases we are having, and that we expect to continue with omicron, one of the things we want to be careful of is that we don't want to have so many people out.  I mean obviously if you have symptoms you should stay home, but if you're asymptomatic and you're infected...we want to get these people back to jobs, particularly those with essential jobs that keep our society running smoothly."

AFTER 2 YEARS OF COVID, U.S. BILLIONAIRES ARE $1.7 TRILLION, OR 57%, RICHER
"Two years into the biggest national health crisis in recent history, U.S. billionaires’ wealth continues to soar above the misery: as of March 10, their collective wealth has shot up by $1.7 trillion, or 57%, since the pandemic emergency was proclaimed in mid-March 2020. Their total wealth reached $4.6 trillion, up from $2.95 trillion on March 18, 2020, according to the latest report from Americans for Tax Fairness (ATF) based on Forbes data. The number of U.S. billionaires increased by 15%, from 614 to 704. Data can be found in the table below and here for all billionaires"

A Poor People’s Pandemic Report "Mapping the Intersections of Poverty, Race and COVID-19
April 2022"
"In the US, the pandemic was debilitating, resulting in an estimated 1.2 million increase of people living with disabilities, totaling one in four adults living with disabilities in the US. All faced inaccessible and inadequate healthcare resources during the pandemic, as well as higher rates of unemployment, and over-representation in low-wage positions (Roberts et al. 2022; CDC, 2020; Adler et al. 2021; Kinsella, 2022)."

"People over the age of 65 experienced the greatest loss of life, comprising 75% of COVID-19 deaths in the US - or -1 in 100 older Americans died, compared to 1 in 1,400 people under the age of 65 (Bosman et al. 2021). While the greatest number of deaths have been among non-Hispanic white people, the rates of COVID-19 cases, hospitalizations, and deaths have been higher among people of color: American Indian or Alaska Natives are 3.1 times more likely to be hospitalized, Black or African Americans are 2.5 times more likely to be hospitalized and 1.7 times more likely to die, and Hispanic or Latino persons are 1.5 times more likely to get COVID and 2.3 times more likely to be hospitalized (CDC, 2022)." 

'A Poor People's Pandemic': Poorest US Counties Suffered Twice the Covid Deaths of Richest
"A first-of-its-kind examination of the coronavirus pandemic's impact on low-income communities published Monday shows that Covid-19 has been twice as deadly in poor counties as in wealthy ones, a finding seen as a damning indictment of the U.S. government's pandemic response."

Excess mortality during the Coronavirus pandemic (COVID-19)

Calling Me a Hero Only Makes You Feel Better 

Wisconsin sees at least seven cases of COVID-19 as a result of in-person voting amid pandemic

After Two Years of Covid, Report Finds Pandemic Made Far Deadlier by 'Greed'
"While effective vaccines provide hope, their rollout has tipped, from a natural desire to protect citizens, into nationalism, greed, and self-interest," reads Oxfam's report, compiled on behalf of the People's Vaccine Alliance. "Large numbers of people in low-income countries face the virus unprotected and millions of people would still be alive today if they had had access to a vaccine. Big pharmaceutical corporations have been given free rein to prioritize profits ahead of vaccine equality."

"The richest 10 men doubled their fortunes during the pandemic and a new billionaire is being created every 26 hours," the report notes. "Of those new billionaires, 40 of them have made their billions profiting from vaccines, treatments, tests, and [personal protective equipment]."
Here is the OXFAM report
PANDEMIC OF GREED A wake-up call for vaccine equity at a grim milestone

“Davos Man”: How Billionaires Devour the World & Fuel Global Inequality, Prolonging the Pandemic

EU Chief Defends Vaccine Patents as 'Precious' as South Africa Demands Waiver
"We are talking about the lives of millions, hundreds of millions, of people rather than the profitability of the few companies," he continued. "It is not acceptable that Africa is consistently at the back of the queue in relation to access to medicines. While we appreciate the donations, they are never a sustainable way or mechanism to build resilience.  Help to empower us, let us tackle obstacles together." 

Documents Reveal Biden Admin Not Fighting for a Covid Vaccine Patent Waiver, Despite Public Statements

Daniel Barnett's guide to coronavirus vaccine passports - are they legal?

'A Game-Changer': Defying Big Pharma, WHO Expands Vaccine Tech Sharing
"This is a game-changer," Dearden said in a statement. "The pharmaceutical system is being remade from the ground up by lower- and middle-income countries. These countries have seen the damage that reliance on the profit-hungry big pharmaceutical corporations has done."

"While some countries have barely received any Covid-19 vaccines, rich nations are throwing millions of doses in the bin, and the three big corporations producing mRNA vaccines are raking in $1,000 a second in profit," he added. "It's time to end this obscenity."

Model-based estimates of deaths averted and cost per life saved by scaling-up mRNA COVID-19 vaccination in low and lower-middle income countries in the COVID-19 Omicron variant era
"Findings Global scale up of vaccination to provide two doses of mRNA vaccine to everyone in LIC/LMIC would cost $35.5 billion and avert 1.3 million deaths from COVID-19, at a cost of $26,900 per death averted. Scaling up vaccination to provide three doses of mRNA vaccine to everyone in LIC/LMIC would cost $61.2 billion and avert 1.5 million deaths from COVID-19 at a cost of $40,800 per death averted. Lower estimated infection fatality ratios, higher cost-per-dose, and lower vaccine effectiveness or uptake lead to higher cost-per-death averted estimates in the analysis."

FDA asks federal judge for 55 years to complete FOIA request for Pfizer vaccine information
"The Food and Drug Administration is asking a federal court to allow it to take nearly 55 years to release data on Pfizer's COVID-19 vaccine to the public. 

PHMPT also made a request for expedited processing of its FOIA submission, arguing there is a "compelling need" for the FDA to speedily release Pfizer vaccine data "because a lack of transparency erodes the confidence the medical and scientific community and the public have in the conclusions reached by the FDA."

"During a time when COVID-19 vaccine mandates are being implemented over the objection of those that have questions about the data and information supporting the safety and efficacy of the Pfizer Vaccine, and individuals with these questions are being expelled from employment, school, transportation, and the military, the public has an urgent and immediate need to have access to this data," PHMPT said in its FOIA request."

"It took the FDA precisely 108 days from when Pfizer started producing the records for licensure (on May 7, 2021) to when the FDA licensed the Pfizer vaccine (on August 23, 2021). Taking the FDA at its word, it conducted an intense, robust, thorough, and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure," he wrote."

Lessons We’ve Learned — Covid-19 and the Undocumented Latinx Community
"After years of anti-immigrant rhetoric and policy, the fear and mistrust in this community was understandable, painful, and palpable.

Speaking with patients, we learned that transmission was fueled by poverty and economic necessity. Patients were grateful that Maryland’s stay-at-home orders didn’t apply to their jobs in construction, landscaping, cleaning, and cooking. Ineligible for unemployment benefits and with barely any savings, undocumented immigrants couldn’t afford to stay home, even if their jobs entailed traveling in vans with sick people or working without masks in crowded settings. Many people working under informal arrangements and without government protections continued to work while sick, fearing being fired.

Housing instability was so prevalent that we began routinely asking people whether they lived in a basement.

Another patient, who was using a high-flow nasal cannula and was on the verge of requiring intubation, asked to leave so he could work and send money to his family in Guatemala.

essential workers need occupational protections, higher wages, and access to care. People who take risks to keep society functioning shouldn’t struggle to pay rent or medical bills when they get sick. State and local officials should work with employers and hold them accountable for protecting workers and providing adequate paid medical leave."

Adverse Events from COVID 19 Vaccination and Other Medical Interventions

Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults
"The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets."

"Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI -0.4 to 20.6 and -3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI -23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI -3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39)."

What Happens If You Have a Bad Reaction to the COVID Vaccine
In the US vaccine manufacturers are exempt from liability if someone is harmed by a vaccine they produce.  The US government established a program in the 1980s called the Vaccine Injury Compensation Program (VICP) that compensates some people who demonstrate that they (or their child) were injured or killed by a vaccine.  This program is funded by a tax paid by consumers as part of the cost of the vaccine.  In the case of vaccines for COVID 19 however, injured people are not allowed to file in the VICP and must file instead with the Countermeasures Injury Compensation Program (CICP).  It has been explained that this is because COVID 19 vaccines were developed to address a pandemic.  The CICP is a far less robust system- it gives you 1 year to file a claim compared to 3 years in the VICP, the CICP is not a legal system (the VICP is somewhat) so there is no right to counsel or appeal.  In the case of the H1N1 vaccine only 29 claims out of 499 that were filed were compensated.  A legal specialist from George Washington University who is involved in the VICP says that insisting that COVID 19 vaccines fall under the umbrella of the CICP rather than the VICP, as the Trump administration did, builds distrust with the public and fuels vaccine hesitancy because the CICP is such a weaker system and one that almost universally denies compensation for claims.

HRSA Countermeasures Injury Compensation Program (CICP) Data

The PREP Act and COVID-19: Limiting Liability for Medical Countermeasures
From the Congressional Research Service

The VAERS toll-free number is 1‐800‐822‐7967 or report online to
https://vaers.hhs.gov/reportevent.html 

In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985

The VAERS Vaccine Adverse Events Reporting System with the CDC

How to file a report of a vaccine injury

What to do when vaccines go wrong

Vaccine damage schemes in the US and UK reappraised: making them fit for purpose in the light of Covid-19
"A longstanding problem of governments has been the extent to which they should assume responsibility for the compensation of those injured by vaccines. This paper reappraises the vaccine damage schemes currently available in the US and UK in the light of the Covid-19 pandemic. It argues that any improvements to both US and UK schemes should be included in a revised national vaccine policy which takes into consideration their respective long-term national vaccine strategies to prepare for future pandemics."

“First Do No Harm”. No-Fault Compensation Program for COVID-19 Vaccines as Feasibility and Wisdom of a Policy Instrument to Mitigate Vaccine Hesitancy
"Vaccines are so far proven to be safe, although related adverse events cannot be excluded. The urgency for COVID-19 vaccines determined a dilution of the general expectations of safety and efficacy of vaccination (from safe and effective to safe and effective enough). In many countries, a no-fault program was established to compensate individuals who experienced serious vaccine-related injuries. The impressive number of administrations worldwide and the legal indemnity afforded to manufacturers of approved vaccines that cannot be pursued for compensation fed the debate about the availability of a compensation model for COVID-19 vaccine-related injuries. Several European countries have long introduced a system, Vaccine Injury Compensation Programs, to compensate people who suffer physical harm because of vaccination."

No-fault compensation schemes for COVID-19 medical products
^{"No-fault compensation schemes for severe adverse events can help build confidence in vaccine safety after marketing.  25 of the 194 WHO member states have implemented such no-fault vaccine injury compensation programmes.  Although the USA is covering COVID-19 vaccine-associated adverse events with the US Countermeasures Injury Compensation Program (CICP) for the duration of the public health emergency declaration, the country is having challenging issues as CICP does not have the ease of access to, and levels of compensation provided by the US National Vaccine Injury Compensation Program available at normal times, exacerbating long-standing inequities based on income, race, and ethnicity."}

Covid-19 Vaccine Injuries — Preventing Inequities in Compensation
"Vaccine-related adverse events would especially burden low-income people, who have limited financial resources to obtain medical care, weather any resulting job loss, and pursue compensation and who are disproportionately non-White."

"The United States has developed a robust system for vaccine-injury compensation to alleviate the burdens of adverse medical consequences of vaccines. But this system will be unavailable to people who receive Covid-19 vaccines during the declared public health emergency. All potential vaccine recipients, and especially people in high-risk communities, therefore face a dilemma: should they risk becoming infected or risk having a vaccine injury without sufficient access to compensation?"

"The declaration of a public health emergency by the Department of Health and Human Services in March 2020, however, resulted in exclusion of Covid-19 vaccine injuries from the VICP. This declaration triggered the Public Readiness and Emergency Preparedness (PREP) Act, a federal law that requires that all people injured by vaccines given as countermeasures during a declared emergency bring claims under only the Countermeasures Injury Compensation Program (CICP). The CICP is far less generous and less accessible than the VICP. It compensates people for only the most serious injuries, has a higher burden of proof than the VICP, has a 1-year statute of limitations after the date of vaccination, and limits awards for damages. For example, the CICP limits lost-income recovery to $50,000 for each year out of work and doesn’t include compensation for pain, suffering, or emotional distress."

"Congress could require that a 75-cent excise tax be applied to all vaccines for pandemic viruses in the United States — which is already done for childhood vaccines — to finance the Vaccine Injury Compensation Trust Fund. Allowing injured people, including members of vulnerable communities, to obtain compensation by means of the VICP will promote public health goals and enhanced equity while ensuring that anyone who has a vaccine-related injury receives adequate compensation."

Senator Johnson Expert Panel on COVID Vaccine Injuries and Federal Vaccine Mandates
"I suffered a life-altering reaction to my COVID vaccine on November 4, 2020, almost a year ago to the date. I suffered a cascade of neurological symptoms that persisted for months. And while my life has improved, I still feel I’m being electrocuted 24/7. For the first several months, I was totally alone. I kept my symptoms and my story completely to myself. I thought that this was an isolated incident. But in the spring, I started finding more and more like me, and before we knew it there were thousands of us. All of us unable to receive medical care, recognition… either from the drug companies, the CDC, the FDA. We all suffered the same constellation of symptoms, which is very strange… it’s a brand new disease, nobody knew anything about this."

Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials
"Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest, with an absolute risk increase of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95% CI -0.4 to 20.6 and -3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an absolute risk increase of serious adverse events of special interest of 12.5 per 10,000 (95% CI 2.1 to 22.9). The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials (2.3 and 6.4 per 10,000 participants, respectively)."

Latest risk figures from UK Health Security Agency (UKHSA) presentation to the Joint Committee on Vaccination and Immunisation (JCVI)  on October 25, 2022
This report breaks down the numbers into "number needed to treat", which means how many people need to get vaccinated to prevent a single hospitalization.  In this case they're talking about mRNA COVID 19 boosters in for autumn.  For people aged 16 to 19, 73,500 people need to be vaccinated to prevent ONE hospitalization, and 185,100 needed to prevent ONE serious hospitalization (meaning ICU admission or requiring oxygen supplementation).  A review of Pfizer's randomized controlled trial data showed a rate of serious adverse events of about 1 in 1,000 people vaccinated, which means that people in this age group are 73 times more likely to have a serious adverse event if they are boosted than to be hospitalized with COVID if they are not.  

For people aged 20 to 29, 169,200 people without any risk factors would need to receive the autumn booster to prevent ONE hospitalization, and 706,500 to avoid ONE serious hospitalization.  For those in this age group who do have risk factors the numbers drop such that 7,500 people need to be vaccinated to avoid ONE hospitalization and 59,500 from this group need to be vaccinated to avoid ONE serious hospitalization.  Again, compare those numbers to the rate of serious adverse events from the Pfizer mRNA vaccine of about 1 in 1,000 and the rate for the Moderna vaccine of about 1 in 650.  This makes the risk/benefit analysis very skewed. 

How many more adverse effects have been covered up during the trials? - Maddie de Garay's story

Large German health insurer says up to 3 million people potentially suffered Covid-19 vaccine side effects
"One of Germany’s largest health insurance companies, BKK, analyzed the records of 10.9 million insured individuals to determine the rate of Covid-19 vaccine complications and has found alarming data, according to a new report from one of Germany’s best-selling newspapers"

“If these figures are extrapolated to the year as a whole, 2.5 to 3 million people in Germany likely received medical treatment because of the side effects of vaccination after the Covid-19 vaccination. We see this as a significant alarm signal that must be taken into account when the vaccines are used further. In our opinion, the figures can be validated relatively simply and at short notice by asking the other types of insurance (AOKen, substitute health insurance companies, etc.) to evaluate the data available to them accordingly.”   The original German article in Die Welt is here.

Data, we want it all (regarding vaccine trials)
Dr Campbell talks about how 2 years into the pandemic, even with vaccine mandates, the actual clinical trial data is being withheld.  This goes against the basic premise of science and therefore is almost never seen.  The last time this happened was around 2009 in the case of the anti-influenza drug Tamiflu.  Academics who requested access to the clinical trial data to verify the results (standard practice in medicine) were denied.  Most of the clinical trials had been sponsored by the manufacturer and it turned out that they had actually been ghostwritten by the manufacturer, but this didn't come out until after governments had spent billions stockpiling it.  The drug has since fallen out of favor and seems not to be used much if at all (3 papers about this are listed at 4:13in the video).

As for the denial of access to the data from the clinical trials of the COVID 19 vaccines, the BMJ says "This is morally indefensible for all trials, but especially for those involving major public health interventions.”  Pfizer has announced it will not “entertain” requests for its clinical trial data for external review before 2025. Moderna *may* allow access to their clinical trial data with the publication of their final study results,  which is estimated to occur on October 27, 2022. AstraZeneca data was made available on December 31^st 2021, but it may take up to one year to fulfill a request. 

Clinical trial data is also being with held for some of the treatments for COVID 19 in addition to the vaccines.  Regeneron, makers of the monoclonal antibody therapy Regen-Cov, will not be making the participant-level data from its phase 3 trial available while the product is under Emergency Use Authorization.  Regeneron will consider sharing this data after (and if) the treatment is given full approval.  In the case of Remdesivir, which was funded by the NIH (National Institutes of Health, an American governmental agency), "the longitudinal data set only contains a small subset of the protocol and statistical analysis plan objectives" (???).  

We are left to wonder why access to all of this data is being restricted, when this is an extremely unusual thing to do.  Again, from the BMJ "In our view, there is no dilemma.  The anonymized individual participant data from clinical trials must be made available for independent scrutiny.  US Food and Drug Administration, freedom of information request to the agency for Pfizer's vaccine data.  The Medicines and Healthcare Products Regulatory Agency in the UK (their version of the FDA) is also not releasing clinical trial data.  This lack of transparency, which is something the BMJ calls essential, has devastating effects on public trust, something that is essential during a pandemic.  

Also from the BMJ "At least three of the many companies making COVID 19 vaccines have past criminal and civil settlements costing them billions of dollars."  The BMJ further states that they support vaccination policy based on sound evidence, they are very clearly "pro-vaccine" as a medical technology.  They say the same regarding COVID 19 treatments.  Also from the BMJ:

"Data must be available when trial data are announced, published, or used to justify regulatory decisions."  

"There is no place for wholesale exemptions from good practice during a pandemic"

"The public has paid for COVID 19 vaccines through vast public funding of research"

Self-Reported Real-World Safety and Reactogenicity of COVID-19 Vaccines: A Vaccine Recipient Survey
"An online survey was conducted to compare the safety, tolerability and reactogenicity of available COVID-19 vaccines in different recipient groups. This survey was launched in February 2021 and ran for 11 days. Recipients of a first COVID-19 vaccine dose ≥7 days prior to survey completion were eligible. The incidence and severity of vaccination side effects were assessed. The survey was completed by 2002 respondents of whom 26.6% had a prior COVID-19 infection. A prior COVID-19 infection was associated with an increased risk of any side effect (risk ratio 1.08, 95% confidence intervals (1.05-1.11)), fever (2.24 (1.86-2.70)), breathlessness (2.05 (1.28-3.29)), flu-like illness (1.78 (1.51-2.10)), fatigue (1.34 (1.20-1.49)) and local reactions (1.10 (1.06-1.15)). It was also associated with an increased risk of severe side effects leading to hospital care (1.56 (1.14-2.12)). While mRNA vaccines were associated with a higher incidence of any side effect (1.06 (1.01-1.11)) compared with viral vector-based vaccines, these were generally milder (p < 0.001), mostly local reactions. Importantly, mRNA vaccine recipients reported a considerably lower incidence of systemic reactions (RR < 0.6) including anaphylaxis, swelling, flu-like illness, breathlessness and fatigue and of side effects requiring hospital care (0.42 (0.31-0.58)). Our study confirms the findings of recent randomised controlled trials (RCTs) demonstrating that COVID-19 vaccines are generally safe with limited severe side effects. For the first time, our study links prior COVID-19 illness with an increased incidence of vaccination side effects and demonstrates that mRNA vaccines cause milder, less frequent systemic side effects but more local reactions."

Why People With PhD's Are More Hesitant To Take The Covid-19 Vaccine

Mistakes in Administration of COVID vaccines
Several Bay Area kids sick after receiving wrong dose of COVID vaccine
14 children were given the wrong dose of COVID vaccine at a pop-up clinic.  They received 20mcg instead of 10mcg.  Several children have been reported sick afterwards, including stomach pain and falling down.

100 Kids In Virginia Given Wrong Dose Of Covid Vaccine

Woman accidentally given Pfizer vaccine after receiving Moderna dose: daughter

In this video British doctor Dr Campbell explains clearly the proper method of injecting a vaccine.  Vaccines are designed to be injected into the muscle (usually the deltoid muscle in the upper arm) and NOT directly into the bloodstream, which would be intravenous or IV administration.  The contents of the vaccination would have significantly different interactions with a person's body and immune system if injected IV by accident.  Evidence suggests that injection into the bloodstream may be one of the factors leading to certain adverse events including Myocarditis and Pericarditis, Vaccine-Induced Thrombotic Thrombocytopenia, blood clotting leading to other complications, and some neurological complications.  This also raises the question of whether vaccination administered IV provides the same level of immune protection from the virus.

COVID-19 vaccine shoulder complication.
Sometimes the vaccine is accidentally injected into the bursa in the shoulder rather than into the deltoid muscle where it is intended to be given.  When this happens it can cause intense inflammation called bursitis which is very painful.

Compensation for Vaccine Injuries and Adverse Events
No-Fault Compensation for Vaccine Injury — The Other Side of Equitable Access to Covid-19 Vaccines
"For a vaccine that will most likely be distributed worldwide, there is an inevitable risk of serious adverse events, such as seizures and allergic reactions, even with a very safe product. Such events might not begin surfacing until a substantial number of people have been vaccinated....  (F)or most countries, offering pharmaceutical companies indemnity or complete immunity from lawsuits is constitutionally or financially impossible. Some governments will refuse to make such offers because of basic fairness principles: manufacturers should pay for the injuries their products cause...  Creating a comprehensive system for no-fault vaccine-injury compensation would be feasible and would promote justice...  We believe that the global community that promotes immunization as a collective interest, knowing that people will be injured, must share the burden of these injuries’ costs."

Japan’s SUPERB vaccine ethics…USA, Europe, Oz Governments: please TAKE NOTE
The government of Japan has approached COVID vaccination in a transparent way, acknowledging the unavoidable reality that there will be people harmed by vaccination and establishing a process to provide assistance when that happens.  They are also very clear that vaccination is only to be given with informed consent, that no one should be pressured or manipulated into being vaccinated.  Additionally they state that people who are not vaccinated must not be discriminated against.

In Australia, the government is creating a compensation program for people who are injured by a COVID 19 vaccination as part of negotiations to issue a vaccine mandate.  Originally people could file a claim if the medical expenses and/or lost wages exceeded $5,000, but this threshold has been lowered to losses of at least $1,000.

General and Multisystem Adverse Reactions
Delayed Large Local Reactions to mRNA Covid-19 Vaccines in Blacks, Indigenous Persons, and People of Color
"Delayed large local reactions may be less commonly recognized or reported in BIPOC vaccine recipients than in White recipients. Such reactions may result in vaccine hesitancy or incomplete vaccination; as such, proactive outreach is needed to increase education regarding these reactions across diverse communities. We hope that this letter encourages additional research and communication regarding cutaneous vaccine reactions, including delayed large local reactions, in BIPOC recipients."

Anti-idiotype Antibodies in SARS-CoV-2 Infection and Vaccination

Why did patients die in Norway after Pfizer vaccine administration?
Deaths occurred in nursing home patients, most of whom were on hospice care (shortened life expectancy). This doctor believes that the deaths were due to per-existing disease or his belief that the patients were so sick that they couldn't tolerate any side effects no matter how mild. 

Receipt of mRNA Covid-19 Vaccines and Risk of Spontaneous Abortion

Herpes infection possibly linked to COVID-19 vaccine | New York Post
Six patients in Israel developed Shingles infections after vaccination with the Pfizer vaccine.

Moderna COVID-19 vaccine causes painful side effects in patients who have facial fillers
In the Moderna trials, some participants who had had cosmetic facial filler had a painful reaction to the vaccine that involved pain and swelling at the site where the filler had been applied.  The participants recovered after treatment with steroids and anti-histamine medications.  Millions of Americans have cosmetic facial filler. 

Covid-Arm: Moderna Vaccine Complication Experience Firsthand
A doctor who teaches at a medical school (teaches dermatology) experienced a reaction to the Moderna vaccine that appeared 13 days after vaccination, at the vaccination site on his upper arm (typical delayed hypersensitivity reactions normally take up to 48 hours to happen).  A dermatologist at Stanford told him she'd seen this before and it was being called "COVID arm". His arm was itchy and had a red rash.  It is a type of allergy that almost never takes this long, and no one seems to understand why it did in this case.  It was completely gone in about 5 days. 

Boston Doctor Reports Serious Allergic Reaction After Getting Moderna’s Covid Vaccine

Myocarditis and Pericarditis

Cardiac Multiple Micro-Scars: An Autopsy Study
"Multiple micro-scars (MMS) found in the myocardium of 3 patients who died of unexplained cardiac arrest were presented at our clinicopathology conference. Upon review of the clinical record, patients with MMS before death had arrhythmia (ie, atrial fibrillation and nonsustained ventricular tachycardia, including new onset). Interestingly, MMS were found in the left ventricle, the junction of the pulmonary vein and left atrium, and the right ventricle and right atrium. All 3 patients had histories of COVID-19 booster vaccination, and 1 of the 3 patients had a history of COVID-19."

Myocarditis with COVID mRNA Vaccines - AHA Journals (Dr Mobeen lecture)

Dr Mark Gorelik, Pediatric Rheumatologist & Immunologist on Vaccine Induced Myocarditis

CDC confirms 226 cases of myocarditis after COVID-19 vaccination in people 30 and under

Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel
"The incidence of myocarditis, although low, increased after the receipt of the BNT162b2 vaccine, particularly after the second dose among young male recipients. The clinical presentation of myocarditis after vaccination was usually mild."

Myocarditis after Covid-19 Vaccination in a Large Health Care Organization
"Among patients in a large Israeli health care system who had received at least one dose of the BNT162b2 mRNA vaccine, the estimated incidence of myocarditis was 2.13 cases per 100,000 persons; the highest incidence was among male patients between the ages of 16 and 29 years. Most cases of myocarditis were mild or moderate in severity."

13 year old boy dies 3 days after COVID Vaccine | Post Vaccine Deaths
This video provides a lot of information about Myocarditis and Pericarditis following vaccination as well as infection with the SARS Cov2 virus.

Orange County health care worker dies after receiving 2nd dose of COVID vaccine
(had adverse event within hours of getting vaccine including difficulty breathing and stomach problems, died within days)

CA person dies hours after receiving COVID-19 vaccine
(The person in question had COVID 19 about a month before receiving the vaccine, began having symptoms within an hour, admitted to ICU for ventilator support, dies within 3 hours of vaccination)

Blood Clots
Clear link between AstraZeneca and rare blood clots | DW News
Germany halted use of AstraZeneca vaccine in people under the age of 60 due to the European Medicines Agency confirmed that there is a connection between this vaccine and blood clots.  Nine people have died due to rare blood clotting following this vaccine.  Young women seem to be at highest risk for this, which is opposite to the risk of clots from the disease itself, which is more likely to cause clotting in older men.  A virologist suggests that the clotting is the result of a hypersensitivity reaction to the vaccine.  In the U.K. the vaccine may be limited to be used only in people older than 30, and in Scandinavian countries and Canada the vaccine is being limited to use only in those over 55. 

New questions over safety of AstraZeneca vaccine for young adults raised by UK - BBC News
"Up to the end of March, there have been 79 cases of rare clots with low platelets following the first dose of the AstraZeneca vaccine.  19 people have died."  This adverse reaction seems to occur at a rate of 1 in 250,000 vaccinations.  Very few people under the age of 30 have died from COVID 19 which also effects the risk/benefit calculation. 

Oregon woman dies after receiving Johnson and Johnson vaccine
A 50 yo woman in Oregon died after developing a blood clot and very low levels of platelets after receiving the J and J vaccine.

Dekalb teacher hospitalized for blood clots after getting Johnson and Johnson vaccine
Woman hospitalized with multiple blood clots in her lungs following the Johnson and Johnson vaccine, requiring hospitalization.  The woman had developed a blood clot and had very low levels of platelets.  Her death was reported 2 days after the J and J vaccine was paused by the CDC. 

Vaccine-Induced Thrombocytopenia (VITT)
Clinical Features of Vaccine-Induced Immune Thrombocytopenia and Thrombosis
"Vaccine-induced immune thrombocytopenia and thrombosis (VITT) is a new syndrome associated with the ChAdOx1 nCoV-19 adenoviral vector vaccine against severe acute respiratory syndrome coronavirus 2. Data are lacking on the clinical features of and the prognostic criteria for this disorder."

Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination
"Vaccination with ChAdOx1 nCov-19 can result in the rare development of immune thrombotic thrombocytopenia mediated by platelet-activating antibodies against PF4, which clinically mimics autoimmune heparin-induced thrombocytopenia." (Funded by the German Research Foundation.)

Thrombocytopenia and splenic platelet directed immune responses after intravenous ChAdOx1 nCov-19 administration
Vaccines are intended to be injected into a muscle, usually the deltoid, (intramuscular injection) but are sometimes accidentally injected into a blood vessel (intravenous injection).  This pre-print (a research paper that has not yet been peer reviewed or published) demonstrates that in the rare event that the adenovirus vaccine (the Oxford DNA vaccine) is injected intravenously the virus particles trigger the platelets to form blood clots.  This can be avoided by simply pulling back on the syringe when administering the vaccine (aspirating).  If blood returns into the syringe than the syringe has accidentally hit a blood vessel and the injection should NOT be given until a new needle is properly inserted.  For a thorough explanation of how this works this video by Dr Campbell is very helpful.

Pathologic Antibodies to Platelet Factor 4 after ChAdOx1 nCoV-19 Vaccination
"vaccination against SARS-CoV-2 remains critical for control of the Covid-19 pandemic. A pathogenic PF4-dependent syndrome, unrelated to the use of heparin therapy, can occur after the administration of the ChAdOx1 nCoV-19 vaccine. Rapid identification of this rare syndrome is important because of the therapeutic implications."

Therapeutic Plasma Exchange in Vaccine-Induced Immune Thrombotic Thrombocytopenia
"VITT is a severe complication after ChAdOx1 nCoV-19 vaccination. Up-front treatment remains anticoagulation and IVIG. Although further validation is required, we suggest that therapeutic plasma exchange may be effective for the treatment of refractory VITT."

SARS-CoV-2 Vaccine–Induced Immune Thrombotic Thrombocytopenia
"The Journal has now highlighted three independent descriptions of 39 persons with a newly described syndrome characterized by thrombosis and thrombocytopenia that developed 5 to 24 days after initial vaccination with ChAdOx1 nCoV-19 (AstraZeneca), a recombinant chimpanzee adenoviral vector encoding the spike protein of SARS-CoV-2. These persons were healthy or in medically stable condition, and very few were known to have had previous thrombosis or a preexisting prothrombotic condition. Most of the patients included in these reports were women younger than 50 years of age, some of whom were receiving estrogen-replacement therapy or oral contraceptives. A remarkably high percentage of the patients had thromboses at unusual sites — specifically, cerebral venous sinus thrombosis or thrombosis in the portal, splanchnic, or hepatic veins. Other patients presented with deep venous thrombi, pulmonary emboli, or acute arterial thromboses. The median platelet counts at diagnosis were approximately 20,000 to 30,000 per cubic millimeter (range, approximately 10,000 to 110,000), but the rate of decline in platelet counts that preceded thrombosis is unknown. High levels of d-dimers and low levels of fibrinogen were common and suggest systemic activation of coagulation. Approximately 40% of the patients died, some from ischemic brain injury, superimposed hemorrhage, or both conditions, often after anticoagulation." 

"Additional cases have now been reported to the European Medicines Agency, including at least 169 possible cases of cerebral venous sinus thrombosis and 53 possible cases of splanchnic vein thrombosis among 34 million recipients of the ChAdOx1 nCoV-19 vaccine, 35 possible cases of central nervous system thrombosis among 54 million recipients of the Pfizer–BioNTech mRNA vaccine, and 5 possible (but unvetted) cases of cerebral venous sinus thrombosis among 4 million recipients of the Moderna mRNA vaccine. Six possible cases of cerebral venous sinus thrombosis (with or without splanchnic vein thrombosis) have been reported among the more than 7 million recipients of the Johnson & Johnson/Janssen Ad26.COV2.S adenoviral vector vaccine. It must be emphasized that not all of these case reports have been subject to rigorous central review, nor have results of tests for anti-PF4 antibodies been reported; however, these numbers may be underestimates, since reporting is voluntary. Nevertheless, they clearly indicate the need for maintaining a high level of concern when patients present with central nervous system or abdominal symptoms after receiving any SARS-CoV-2 vaccine."

Florida doctor's death after receiving COVID-19 vaccine sparks investigation
Dr Gregory Michael, a doctor in Florida, developed Immune Thrombocytopenia (a rare disorder that limits clotting ability).  He died of a hemorrhagic stroke caused by this rare autoimmune disease.  This disease cam be triggered by several different viral infections.

Neurological Adverse Events
First Ever NIH/NIND Study on Vaccine Caused Neurological Injuries (Preprint)

Patient Interview - Neurological Issues After Vaccination
This is an interview with a man who is a nurse practitioner and who has had serious neurological side effects from taking a 2-dose mRNA vaccine protocol.  He developed parasthesias on his right side, mostly his right arm, almost immediately after his first dose.  As the symptoms progressed he developed a very uncomfortable feeling in his right eye and his ear became red and inflamed for several days.  He received the second shot, and after that developed severe tinnitus, POTS with very pronounced tachycardia, and severe intractable insomnia.  He says basically his autonomic nervous system just didn't seem to work right.  He found that a low histamine diet helped as did a round of treatment with a steroid.  He later developed generalized neuropathies including stinging and burning sensations.  Testing of a skin biopsy showed signs of Small Fiber Neuropathy developing.  

The explanations that have been suggested include elevated cytokine levels (testing did show some for him), non-classical monocytes, C4D deposition at the blood barrier, MCAS (Mast Cell Activation Syndrome), glutamine storms,

A Chemist Describes His Wife's Major Adverse Reaction After Her COVID Vaccine | The Megyn Kelly Show
A previously healthy 39yo woman took part in a vaccine trial for AstraZeneca and experienced a number of significant adverse reactions including neuropathy, sensitivity to light and sound, "drop foot" which progressed to inability to walk, incontinence, sensory sensitivities worsened to the point that she needed to wear ear muffs and dark glasses when not in a quiet, dark room. She was seen at the "test clinic" (vaccine trials, like many drug trials, are carried out through testing sites hired for this purpose) but they offered no help.  Her adverse reaction was not included in the final results of the clinical trials.  She was eventually diagnosed at the NIH with a number of vaccine-induced injuries.  Because of her adverse neurological reactions to the first dose of the vaccine, the group running the trial recommended that she not receive the second dose.  As in trials for other COVID 19 vaccines, people enrolled in this study were given an app on their phone as the only way to report adverse events. This app included only a list of certain minor reactions such as pain at the injection site, fever, muscle aches and pains, and a few more as options.  There was no way for trial participants to report other adverse reactions.

Unheard Concerns: Thousands blame COVID-19 vaccine for hearing problems
There have been more than 10,000 reports of hearing problems, including tinnitus and hearing loss, following vaccination for COVID 19.  This is recognized as real by many in the mainstream.  The mechanism is not known.  Most affected people are getting better over time, sometimes very slowly.

Eric Clapton's "Disastrous" Vaccine Experience

Mississippi man partially paralyzed, unable to talk after J&J vaccine | New York Post Paralyzed after 2nd COVID shot
Following the second dose of Pfizer vaccine for a woman in Nashville with epilepsy and who had already recovered from a previous COVID 19 infection.

Woman paralyzed 12 hours after first dose of Pfizer vaccine, doctors search for answers

Doctors: nervous system played a part, after being left paralyzed after first dose of Pfizer vaccine
(Appears to be same woman as in above report.  Woman has no underlying medical conditions)

Woman's severe reaction to Pfizer COVID vaccine prompts investigation
Woman in Louisiana with no underlying medical conditions develops convulsions and seizure-like uncontrollable leg movements after receiving Pfizer vaccine.

Woman describes reaction to Johnson & Johnson vaccine 

Utah mom Kassidi Kurill dies four days after second dose of Moderna 

Three more people die after receiving AstraZeneca vaccine in S. Korea