This post has Cases 4, Nina, and Case 5 BB. It links to a Brain Fog post on RxISK.
Nina was referred by her doctor for review of vaccine related problems. He had previously referred her for a possible myocarditis. The reference came with her medical history, prior treatments and some of the letters from other consults.
When she made contact, her email address included 007, hence the image above of the new 007.
She has a past history of struggling with Lyme disease for a decade, which she knows some doctors will view with skepticism. But this had been resolved five years previously. She was concussed two years prior to the vaccine and gave a good account of the after-effects of this, like swearing more than usual, and brain fog. These problems had all cleared up pre-vaccine.
She takes Synthroid and bupropion but no other prescription medicines. In her 60s, she is slim and has been very fit, walking her dogs daily, biking, hiking, cross country skiing and otherwise keeping active – but is less fit post vaccination.
She was not a vaccination enthusiast and had planned to see how others found it first. But she ended up having the Pfizer vaccine in April 2021 before others she knew and without being aware of anyone who had reported significant harms.
She had an immediate reaction and was one of those detained at the centre before being let go home. There was a dramatic increase in heart rate, from her mid-60s normal, to over 100 beats per minute. Her blood pressure also rose from its normal 115/75 to 140/90, where it has hovered ever since.
A month afterwards, she was referred for a review of possible myocarditis post-vaccine. By this time, whatever specifically inflammatory cardiac effects she originally had were likely to have settled down. There was no evidence for myocarditis but there was some pericardial effusion present.
She had a longstanding sensorineural hearing loss prior to the vaccination, mainly affecting her right ear and relatively mild. It causes her little impairment, and she hadn’t felt the need for a hearing aid.
After the vaccine, she developed a severe headache and tinnitus and hearing problems in her left ear. Her left ear now gives her more bother than her right ear.
Her headache was present for months but has now become a sense of head pressure rather than headache. The sense of pressure seems to be linked to the stereophonic tinnitus she has and her left ear hearing problems.
Nina’s tachycardia and blood pressure issues appear relatively consistent. This is inconsistent with a Postural Orthostatic Tachycardia Syndrome (POTS). But she also has temperature dysregulation and an internal tremor possibly consistent with POTS.
Nina’s main complaint is brain fog. Things were fine pre-vaccine but now she loses focus easily and cannot engage with things she cherishes like painting. After a lifelong career as an artists, she has lost her ‘feel’ for painting even down to losing her feel for mixing paints.
She loses words and her place in conversations. This is apparently noticeable to people who have known her over time. It was not the way things were before the vaccine.
She reports other problems from hair loss to temperature dysregulation. Her hair loss is more likely to be linked to physical stress rather than directly to any auto-immune issues. Her temperature dysregulation may be linked to her prior thyroid problems although she now prefers the cold, whereas previously she was keen on a temperate climate
She has an internal tremor, which has been worse than it is now. It is especially obvious when she is fatigued. This is commonly reported by the vaccine injured.
Fatigue is a major problem. She simply does not have the energy to get going in the way she once had. Her dogs help but walking is more like hard work now than it was, and when she is fatigued, she fears she may pass out. There is a degree of muscle weakness and wasting, which may be the cause of or a consequence of her fatigue.
Finally, she developed a relatively short-lived arthritic problem that affected almost all her joints and led to a referral and a diagnosis of fibromyalgia. This sounds more like a reactive arthritis than fibromyalgia.
Additional symptoms include vertigo, dizziness, sensitivity to lights and certain sounds.
There is a good case for saying Nina has a vaccination induced set of problems. Tachycardia and hypertension are common effects of these vaccines and in the absence of any history of the problems she has now it is difficult to explain them any other way.
Tinnitus, headache and head pressure are regular features of post vaccine reactions as are temporary arthritic problems, and sensitivity to light and sound, as well as fatigue.
She gives eloquent descriptions of brain fog. This is a real condition but likely arises from problems in her body rather than in her brain. She is cognitively intact and a very engaging person. Losing her way in conversations likely stems from unusual bodily signals to her brain rather than any early dementia or related problem. See What is Brain Fog?
Nina’s condition is likely to have an auto-immune component, but standard auto-immune tests come back as normal. This spike protein, however, targets ACE-2 receptors and tests for auto-antibodies to this receptor and G-coupled proteins are more likely to be positive. There are a number of facilities that offer this test – one is Cell Trend in Germany. Another is Washington University’s small fibre neuropathy antibody panel, especially for sensory neuropathy and including TS-HDS antibodies.
At the moment though nothing is sufficiently established to warrant the large amount of money tests would cost. Bri Dressen and react19.org are working on this.
At present there is no known treatment for Nina’s problems. A positive result on some of these tests might help steer treatment toward IVIg or a monoclonal antibody or at least it might stop us giving her inappropriate treatment.
She has a strong case for a medical exemption from further vaccination for Covid.
Few people in her shoes would willingly take a further dose. Many are forced to. For some the results are not good.
Case 5 is anonymous because she works in healthcare. Her story can be told through her blood tests, which she downloaded and sent. There is no need to interview her to be able to give a view as to what is likely going on.
B works in healthcare, is in her middle years and is in good health. She takes bisoprolol for minimal BP rise and Crestor for minimal cholesterol issues.
On April 10, she developed joint and muscle pain in her hands.
On April 12, she had a negative Covid test
On April 13, convinced she had Covid, she went to the Emergency Room (ER) short of breath, with a fever (104F, 40C), and raised white cells (16+). A second Covid test was negative. She was send home on prednisone 50mg and doxycycline.
On April 27, her fever was continuing. Her C-Reactive Protein (CRP) 136 normal range 0-4. This is a marker for inflammation and is very high.
On April 30, she had a repeat negative Covid Test
In May, she had negative Chest, Abdomen & Pelvis X Rays, Abdominal Ultrasound and Gastroscopy
On June 17, her prednisone was lowered to 15 mg and she had tingling, and numbness in toes.
On June 24, she stopped Prednisone
On June 25, she had a fever.
On June 29, her CRP was 260.
On July 8, she restarted Prednisone.
On July 12, her CRP was 3
On July 22, she had burning bright red feet, but they were cool to touch.
On July 30, she was wobbly on her feet (ataxia). A brain scan was negative.
On Aug 2, she had vomiting, diarrhea, fever. She restarted Prednisone
On Aug 6, she had burning of hands and feet with difficulty in bending her toes.
On Aug 12, she increased prednisone and the burning and pain in her hands and feet improved.
On Aug 24, she started Actonel to cover the effect of steroids on bone.
On Sept 15, it was suggested she wean prednisone from 15 mg to 12.5 mg
On Sept 18, the fever and joint pain returned and she increased prednisone to 15 mg
On Sept 19, the fever was gone and the pain easing.
On Sept 20, she increased prednisone to 20 mg
On Sept 23, her CRP was 53.
On Oct 9, she had joint pain, redness in hands and feet, and her arms, shoulders and elbows were weak and sore to touch. She was shaky, short of breath, and had difficulty going upstairs.
On Oct 16, she reduced prednisone to 18 mg
On Oct 18, she was feeling better but had muscle contractures
On Oct 20, her CRP was 3.
On Oct 21, she was diagnosed with seronegative Rheumatoid Arthritis
On Oct 26, she reduced prednisone to 16 mg
On Oct 28, she had sore hands and feet, fever, and night sweats
On Oct 29, she increased prednisone to 17 mg
On Oct 30, her pain subsided
In Nov, she reduced Prednisone 0.5 mg every 3 days
On Dec 5, she was on Prednisone 10 mg
From Dec 6-12, she had fever, shortness of breath, chest pain, vomiting, and diarrhea
On Dec 12, she increased prednisone to 10.5 mg
On Dec 13, the fever was gone, and her pain and shortness of breath easing
On Dec 15, her CRP was 75
From Dec 15-28, she had continuing shortness of breath and pain on deep inspiration
On Dec 28, she started Zithromax.
In Jan, she was reducing prednisone 0.5 mg every 3 days.
B’s Covid infection was mild. As with so many others, she was told she would have had a much more difficult time if she had not been vaccinated.
During this period B was seen by 3 internists and rheumatologists as well as family doctors. Her rheumatologist said her joint problems pointed to a seronegative rheumatoid arthritis. Peripheral neuritis might be a better option – there was no joint swelling.
When things began, B had a delayed onset of clinical symptoms from the point of vaccination. This initially deterred her from making a link to the vaccine, but she agrees the features of her case are difficult to explain other than in terms of a vaccine reaction.
None of her doctors appear to have made a link to the vaccine. She brought them articles on Multi-system Inflammatory Syndrome, which seemed to her to map onto the clinical picture but this was when MIS was linked to Covid and not the vaccine.
In mild form, MIS features map directly onto what is often termed vaccine reactogenicity. This is sometimes passed off as a ‘good sign’ – you are generating a response. These same features however are present in Multisystem inflammatory syndrome (MIS) in children (MIS-C) and adults (MIS-A), which are febrile syndromes with elevated inflammatory markers that usually manifest 2–6 weeks after a severe acute respiratory syndrome (SARS-CoV-2) infection. MIS kills.
These same problems have now been described as being triggered by the vaccine. B’s picture is like Karunya‘s from last week but fortunately for B hers are milder. B’s response to steroids suggests these might have helped Karunya if given earlier.
One of the surprising things is how willing some of us are to get further doses of the vaccine even when confident the vaccine is causing problems. Another is how slow our medical colleagues are to caution even one of their own to think twice about going ahead.
B is now taking bisphosphonates (Actonel), steroids and may start methotrexate in lieu of steroids, none of which are harmless. Things may look like they are now in control but while she stays on these treatments she risks further injury and has increased her medication burden by 100%.
If you look at what is reported about the BioNTech vaccine from the clinical trial, the vaccine seems to have minimal effects on CRP:
B’s case is clearly wildly beyond these levels.
Pfizer and BioNTech apparently had two candidate vaccines to choose from – b1 and b2 – beyond the last minute. Choosing between these two led to the only delay in the development of the vaccine.
There was lots of data on b1 and very little on b2. In terms of controlling what they were about to do, b1 seemed to make more sense – it would generate antibodies to the receptor blocking domain – the ACE-2 receptor.
B2 would generate antibodies to the whole Spike protein – offering a broader immune response (possibly).
Pfizer opted for b2. This feels from this distance like the kind of decision Lilly and other SSRI companies made in opting for Prozac 20 mg, which was an excessively high dose – adding more Prozac in doesn’t inhibit reuptake any more. So why do it. Well Lilly and all SSRI companies were scared their drug wouldn’t work in depression trials – it didn’t really work for depression. Not any better than 5 mg.
The company story was they wanted a convenient once size fits all dose but this is not the whole truth and nothing but the truth. The b1-b2 week long crisis in Pfizer looks like they were scared that b1, a cleaner candidate, might not work.
If b1 had been chosen, there might also have been more questions about whether it was a drug rather than a vaccine.
If b1 had been chosen, B’s CRP might have been more in line with the figures Pfizer reported to FDA.
Of course, as will be reported next week, who knows what the figures from this trial really look like.
Copyright © Data Based Medicine Americas Ltd.
because any hint or appearance of secrecy will be toxic here.
Pfizer and BioNTech Pick a Vaccine Candidate
In a bit of a surprise move, Pfizer and their partner BioNTech announced yesterday that they were moving their BNT162b2 mRNA vaccine candidate forward into Phase II/III trials. The surprise was because all the publications from this effort so far had been on another one of their four candidates, BNT162b1.
Fans keeping score at home will know that there were originally four candidates: two with modified RNA bases, one with extra uridines, and one self-amplifying RNA. From that press release linked above, it appears that the latter two fell behind during the preclinical and early clinical studies – we haven’t seen that data, but apparently BNT162b1 and BNT162b2 have been the front-runners for some time as far as the two companies were concerned. (In retrospect, maybe it’s a good thing that I never got around to doing a detailed post on the self-amplifying RNA mechanism! Update: OK, with the Imperial College vaccine doing human trials, I’ll go ahead and do that post anyway. . .) So what’s the difference between the two remaining ones?
It comes down to the antigen(s) being coded for. The b1 candidate, the one we’ve been hearing about, codes for the coronavirus Spike protein’s receptor-binding domain (RBD), and this was constructed as a trimer, three RBDs attached to a “foldon” protein core.
Meanwhile, the b2 candidate codes for what they say is an “optimized full-length Spike” protein instead, not just the receptor-binding domain. Pfizer’s press release says that both the b1 and b2 candidates “induced favorable viral antigen specific CD4+ and CD8+T cell responses, high levels of neutralizing antibody in various animal species, and beneficial protective effects in a primate SARS-CoV-2 challenge model”. But they made the choice for the b2 variety partly because it seemed to be better tolerated on injection, and also because it led to a wider variety of T-cell responses. These include both CD4+ and CD8+ T-cells, and these were raised not only to recognize the RBD region, but also other regions of the Spike protein that weren’t contained at all in the b1 candidate. And they’re quite right – that could well be beneficial, and the better tolerability is a bonus.
The release says that the neutralizing antibody response was similar between the two candidates.
I look forward to seeing the numbers on that – in fact, I look forward to seeing the numbers on everything. That’s going to be really important as we move forward, because any hint or appearance of secrecy will be toxic here. We already have enough people who are (1) suspicious of vaccines, (2) suspicious of what various authorities say about coronavirus treatments, and (3) suspicious of the motives of the pharmaceutical industry.
I might add a fourth group, who are suspicious of the motives of the Trump administration, particular as regards getting a vaccine announcement out in a timely manner before the November election. It’s a mess, an awful mess, and we do not need to make it any worse by giving one or more of these groups more ammunition.
The only solution (as far as I can see) is full disclosure. Let’s have all the clinical data for every candidate and have the decision-making process be as open as it can be. We have a lot of decisions to make (it’s going to take a whole other post to get into that), and it’s going to be way too easy to screw that process up and make things worse than they are already. That actually seems to have been the hot happenin’ trend here in the US for 2020; I’d be very happy if we could manage not to do it for the vaccine selection and rollout. . .
Witty’s phrase “all the data” sounds straightforward, but the company’s 11 October response to Jureidini implied that “all the data” would not include case report forms from study 329—or, it would seem, any other study. Nor, it seems, is GSK going to “publish” any of the deidentified patient level data on its new website, if “publish” means to make something public and freely accessible.
Two Peas in a Pod,,,
Talking to people about vaccines, it seems that most of them believe the fact checkers and simply won’t bother to look at data themselves. It will take a powerful emotional argument to move them to consider alternatives.
Most people will simply be unaware of the news media scandal about the Hunter Biden laptop. Even if they hear about it, there will be zero impact.
Otoh, if the New York Times hypothetically reports that Pfizer has to pay a ten billion dollar fine for covid vaccine damage, then people will notice.