IM doc pt 36
Apr. 25th, 2022 11:25 am![[personal profile]](https://www.dreamwidth.org/img/silk/identity/user.png){kind=small}
temporaryrealityNaked Capitalism ran this post on March 3rd. Here, IM Doc is quoted and he comments in the section below.: https://www.nakedcapitalism.com/2022/03/pfizer-february-2021-post-marketing-vaccine-side-effects-tally-raises-alarms.html. Although it's long, I'm just going to copy the whole thing here.
The topic is the Pfizer document with the extremely long list of adverse events they were prompted to look for during the course of the study. There seemed to be a fair amount of debate on the ecosophia site over whether this list was actual adverse events or a list of things frequently associated with vaccines in general that should be monitored in this case.
IM Doc seems to feel that this is not just a generic list but actually a list of reactions and results that for some reason were on the radar for this particular Pfizer cocktail.
I thought it was useful to include the entirety of the comments section to get a sense of the conversation.
Pfizer February 2021 “Post Marketing” Vaccine Side Effects Tally Raises Alarms
We are late to turn to a critical document obtained by FOIA by the Public Health and Medical Professionals for Transparency Documents. Called 5.3.6 Cumulative analysis of post-authorization adverse event reports of pf-07302048 (bnt162b2) received through 28-feb-2021. The publication of what ought to be regarded as an explosive revelation of the range and frequency of its Covid vaccine side effects has gotten barely any notice, even on Twitter. We’ve posted the document in full at the end of this post for your inspection.
Unfortunately, it’s impossible to reach any definitive conclusions about this information because it isn’t a Phase IV clinical trial, where participants trials are tracked to capture any adverse effects that occur over an intermediate period of time. Instead, this report is based on a hodge-podge of voluntary reports into various systems across 63 countries, with the overwhelming majority coming from the US and UK, from December 1, 2020 through February 28, 2021. I find putting the start as of December 1 misleading, since the first shots in the US were administered starting December 14, 2020. So you wouldn’t even start to see what happens after a full two-shot regime until end of December, which means this is effectively two, not three, months of data
Aside from side effect information not being gathered systematically and to a consistent standard, an even bigger problem is the lack of data about the denominator, the number and mix of vaccinated subjects. The lack of information about the underlying population means it’s impossible to determine the rate of these side effects. Recall that the initial rollout gave priority to the elderly, to at risk groups, and to medical workers. One of the things you’ll notice right away is that the side effects are far more common among women:
The fact that the reports don’t even capture the gender of 7% of the respondents tells you how casual and haphazard an exercise this was. Even so, at least 71% of the total is female. Is this because the underlying population was heavily female due to overrepresenting the aged (women live longer than men) and medical workers (nursing and housekeeping staff are typically women and outnumber doctors, who skew male)? Or because one of the common side effects is the triggering or intensification of autoimmune diseases, and women are more prone to them? Or both?
However, some who took an early look at the document discredited themselves by not bothering to understand its huge limits, and naively or disingenuously making claims about supposedly horribly high levels of bad outcomes among pregnant women, when there was no information whatsoever about how many pregnant women were vaccinated. Without that number, you can’t determine if those results were any worse than for a control of unvaccinated pregnant women.
Due to this document being released pursuant to the Emergency Use Authorization, as opposed to a typical drug approval process, I’m not sure what if any standards governed its production. Readers who know the ins and outs of FDA regulations are very much encouraged to pipe up. The commentary from Reuters at the end of January wasn’t terribly enlightening:
The document was submitted by Pfizer-BioNTech as part of its Biological License Application (BLA) to the U.S. Federal Drug Administration (FDA), Alison Hunt, an FDA Press Officer told Reuters via email.
The BLA is a request for permission to introduce or distribute a new biologic product across states ( here ). The FDA reviews the information in the BLA “to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.” ( here )
This large number of reports comes despite the fact that, as Pfizer blandly warns using boilerplate language, the number of side effects is almost certainly understated:
Reports are submitted voluntarily, and the magnitude of underreporting is unknown…
Among adverse event reports received into the Pfizer safety database during the cumulative period, only those having a complete workflow cycle in the safety database (meaning they progressed to Distribution or Closed workflow status) are included in the monthly SMSR. This approach prevents the inclusion of cases that are not fully processed hence not accurately reflecting final information. Due to the large numbers of spontaneous adverse event reports received for the product, the MAH has prioritised the processing of serious cases, in order to meet expedited regulatory reporting timelines and ensure these reports are available for signal detection and evaluation activity. The increased volume of reports has not impacted case processing for serious reports, and compliance metrics continue to be monitored weekly with prompt action taken as needed to maintain compliance with expedited reporting obligations.
Pfizer also points out that the reporting of an adverse event does not establish causality, as in that the jab was necessarily responsible.
Nevertheless, as IM Doc said:
This is a post marketing document.
in normal times, this would be in the Phase IV period. I have no idea how this is done for an EUA.
These are apparently side effects reported after the vaccines were rolled out.
No wonder they wanted to bury this.
OMG even my cynical self is whomperjawed. I have quite frankly never seen anything like this in all my years of IRB [Institutional Review Board] work. This is absolutely unprecedented.
Please look at starting at page 30. The list is overwhelming. Something about this tells me someone should be going to jail.
It is vindication for all the months I have been questioning my sanity. Having these happening to patients all the while the media and colleagues screaming about 100% safety. This is not the vindication I wanted though. This is just plain sad.
To provide further evidence that the adverse events are undercounted, menstrual period irregularities and post menopausal bleeding are not listed. The only female reproductive plumbing issue listed is “premature menopause”. Doctors tend to downplay menstrual cycle issues, since they can be affected by stress, weight loss, and intense exercise. But a subset of women is hyper regular and changes tell them something is amiss. Other I know first or second hand report extreme change, such as going from four to five days of flow to only one and remaining there.
Even though female non-fertility is treated less seriously that female fertility, period/bleeding among menopausal women is particularly troubling, since it can be a sign of cancer. I’ve had that side effect, three times, along with PMS bloating worse than I ever had in my youth. My sonogram at the top lists the bleeding as triggered by the vaccine, which means is it considered uncontroversial in NYC to link the vaccines to the resumption of periods. My doctor was sufficiently alarmed that she wanted me scraped out pronto. So I am having to have a medical procedure due to having gotten a jab. Yet if I understand Pfizer’s categorization correctly, they would deem a case like mine to be “non-serious”.
It’s bad enough to see a significant category of side effects omitted. But on top of that, no one is tracking whether cases Covid-vaccine-induced post-menopausal bleeding have a higher incidence of cancer than typical instances of post-menopausal bleeding bleeding.
More from IM Doc:
I want to explain the “appendix 1” starting on page 30.
There is always an “appendix 1” in these reports.
It is a comprehensive list of the ASE (Adverse side effects) that are especially attuned in the study. In general, it is a list of all the things that came up in the animal studies and the Phase 1-3 trials in humans. It is an index of the things that they were to keep a close eye on.
In general, this list in most documents like this I have ever seen is 2-3 maybe 4 pages long – NOT 10.
That is what so bowled me over this AM.
I can think of 2 possible things going on here –
1) The list of ASE from the previous phases of research really are this overwhelming.
2) Pfizer knew they had lots of side effects and just wanted “to put it all out there” in an attempt to cover their ass. They may have done this because of the warp speed emergency manner in which this was done – ie – we have not had time to fully assess risk – therefore we are going to just be a sponge and take in everything.
There may be other reasons I have not thought of. Whatever the case – I have never seen anything like this in my life.
But the really damning parts are these tables – where very elevated numbers of patients are having these problems.
I have seen any number of CHEMOTHERAPY agents with less problems than this in my life.
And we have to weigh risk and benefits even in these trials. If for example a novel CHEMO agent was saving 30% but killing 5% – it would likely be approved with LARGE BLACK BOX WARNINGS.
This agent – however – is not chemotherapy. It is a vaccine to be given out to everyone. It has been screamed from the rooftops for the people to hear that it was 100% safe. Any and all discussion in the media and social media of any problems has been squelched and those stating these things called quacks. It had a benefit of an absolute risk reduction of infection of 0.2%. And here we are with all these side effects. In huge numbers. Even more concerning – is two-six months of benefit worth all of these risks? I think not.
My question would be – when did the FDA and CDC and CEOs and media people know this information? How can anyone at FDA or the White House think it was a good idea for nationwide mandates – with this kind of problem?
This is very very troubling Someone must be held to account.
But Pfizer remains a big winner. The Biden administration is determined to move on from Covid, as if Covid doesn’t have a say. And Ukraine is a huge aid in diverting attention from the ongoing pandemic.
NC quotes IM Doc on the same topic a day or two later:
And we are only going from bad to worse, with the downtrade to Brown’s Dr. Ashish K. Jha no doubt reflecting the official Administration posture that Covid is over. As IM Doc said by e-mail:
We have now replaced a lying corrupt Bond villain with a moronic cipher.
I cannot remember a single thing this man has been correct about.
And I will always remember the glee with which he pounced on the unvaxxed.
This is really bad news.
“Biden’s Supreme Court nominee Ketanji Brown Jackson refuses to define the word ‘woman’ because she’s ‘not a biologist’ as she is grilled on day two of her confirmation hearing” [Daily Mail]. “Quoting late Supreme Court judge Ruth Bader Ginsburg, Blackburn said: ‘Physical differences between men and women are enduring. The two sexes are not fungible. A community made up exclusively of one sex is different from a community composed of both.’ ‘Do you agree with Justice Ginsburg that there are physical differences between men and women that are enduring?’ the senator asked. When Jackson claimed she had never heard the quote, Blackburn asked directly: ‘Can you define the word ‘woman’?’ ‘Can I provide a definition?’ Jackson responded. ‘No, I can’t,’ she declared, before adding: ‘I’m not a biologist’.
to which IM Doc replied:
Related to this:
“Harvesting the Blood of America’s Poor: The Latest Stage of Capitalism” [Mint Press]. “Teenager blood is in high demand in, of all places, Silicon Valley, where anti-aging technologies are the latest trend. One company, Ambrosia, charges $8,000 per treatment to aging tech executives, infusing them with the blood of the young, turning these individuals into bloodsuckers in more ways than one. Despite the fact that there is no clinical evidence that the practice has any beneficial effects, business is booming. One committed customer is PayPal co-founder turned Trump surrogate Peter Thiel, who is reportedly spending vast sums of money on funding anti-aging startups. Thiel claims that we have been conned by “the ideology of the inevitability of the death of every individual” and believes that his own immortality may be just around the corner, a notion that has deeply concerned academics and commentators alike.” • From 2019, still germane.
IM Doc replied
My, my, my, how Yves's tone has changed since the early days:
This post is probably worth reading, though I won't post it here because IM Doc isn't particularly present (a comment follows the link, though):
https://www.nakedcapitalism.com/2022/03/the-covid-data-is-making-me-queasy-and-cdc-changes-and-reform-proposals-arent-helping-me-any.html
The first I saw of this was a number of ‘debunking’ threads from the usual suspects on Twitter, which seemed suspiciously pre-prepared.
The information is far too haphazard for a definitive take – which may well be deliberate. But it certainly backs up the many anecdotes I’m sure plenty of us have heard. I have one friend who fell quite ill when she got the second Pfizer shot back in August and is still not fully recovered (she tested negative for Covid). There might of course be many other explanations for her ill health, but the incuriosity of the medical establishment is very telling.
intellectual curiosity is perhaps the opposite of hubris
I suspect many in the medical establishment are victims of their training which seems to promote rote-learning, hubris, and an adherence to hierarchical strictures while discouraging independent thinking from first principles (perhaps an unfortunate consequence of increasing specialisation?).
To offer a personal concrete example: my partner chose to get vaccinated and then boosted. While disagreeing with the latter (our low risk vs. the data long trending in the wrong direction) I pleaded that she should at the very least insist that the syringe be aspirated to reduce unnecessarily added risk.
The doctor effectively refused to respect her patient’s wishes citing institutional protocol, dismissing aspiration as outdated, and even cIaiming it could damage the mRNA vaccine in the syringe. I was furious with the outcome arguing aspirating clearly cannot harm the patient or vaccine but quite obviously help reduce (the very small) risk of unintended intravenous delivery.
About 10 weeks later the German vaccine authorities issued new guidelines revoking their standard recommendation for administering vaccines and now explicitly recommend aspiration for all SARS-CoV-2 vaccines. The aforementioned doctor will of course now dutifully aspirate everytime.
To my mind, such a doctor is not a practitioner of medicine and healing but simply a box-ticking, faithful servant of the medical establishment.
“To my mind, such a doctor is not a practitioner of medicine and healing but simply a box-ticking, faithful servant of the medical establishment.”
Some of us are trying to reverse this very real trend, but swimming upstream is exhausting.
Hallo KLG, no offence intended, more exasperation. Very trying times for me witnessing all the groupthink and scapegoating in German society at the moment.
I wish you strength in your struggles.
I had to make a bit of a (very polite) song and dance to get my syringe aspirated for my 2nd AZ shot. nurses were unable/unwilling so they had to get a doc to do it. He was happy to but slightly condescending re: my request. I mentioned the recently released (at the time) paper hypothesising that AZ thrombocytopenia may have been caused by vaccine binding with a protein in the blood (iirc) he said he and his colleagues had seen it but weren’t inclined to aspirate because “it wasn’t part of the protocol”
This was presumably part of the same constellation of protocols that insisted I take my FFP2 respirator off and replace it with a surgical mask upon entry to the vax clinic.
A Canadian doctor friend was a bit mystified that aspiration should be controversial because she’d just been taught that’s how you inject.
The publication of what ought to be regarded as an explosive revelation of the range and frequency of its Covid vaccine side effects has gotten barely any notice, even on Twitter.
Perhaps twitter purged all the accounts that critiqued the Pfizer vaccine after this report?
And can we expect more purged accounts with their “experimental Birdwatch program, which seeks to enlist Twitter’s users to flag and debunk misinformation on the social platform”?
https://www.msn.com/en-us/news/technology/to-fight-misinformation-twitter-expands-project-to-let-users-fact-check-each-other-s-tweets/ar-AAUyF83
In March of 2021 I went into the ER two weeks after my second shot of Pfizer. I had extreme dizziness and some pain in the middle of my chest, like a bubble or pressure in the esophagus. These symptoms were far outside my normal ongoing health concerns (which are fairly minimal for my age) and have not repeated since that time. They could find nothing at the ER and released me after a couple of hours when I felt better. I am 90% certain it was the vaccine. I will not take another MNRA vax from here on out.
Oh no, 7k people got a fever and 10k reporting here got a headache and the next largest side effect group is muscle aches. Gosh, I do seem to remember all of these being publicized and expected possible side effects. 20% of the self reported side effects are a headache, how terrifying. And continuing down reading the actual document instead of this fear-mongering bit, 1927 of these reports are Covid-19, which somehow, I don’t think is an actual side-effect of the vaccine. Off-label use is a ‘side effect’ reported here too. That gets you a lot of the way to N=42k, I gotta say.
I think the call out for changes to menstrual cycles is valid, and I’ve seen a lot of requests (speaking as someone with a menstrual cycle) to report those effects. For the actually concerning immune disorders, half the reported ones here are filed under ‘Hypersensitivity’ which seems to be a VERY general term and about the same number are ‘Resolved/Resolving’. But I don’t see anything here incredibly irresponsible. So many of these things are also side-effects of the virus itself, and speaking as someone who was in NYC when cases started going up, who got sick without being able to get a test and who remembers how accurate the antibody tests weren’t… Good luck clearing up that data, that’s all I have to say.
I suggest your read Appendix 1. Paints a very different picture. Try reading out all those possible side effects on a TV commercial.
It is not clear what that list represents. Are these all actually reported events from vaccinations? From the statement it appears to be a broader list of potential events, many of which are associated with COVID-19 (so might not be associated with vaccine):
“The AESI terms are incorporated into a TME list and include events of interest due to their
association with severe COVID-19 and events of interest for vaccines in general.”
Looks to me like CYA to say they looked for any possible adverse event.
No, per IM Doc, who was on the board of an IRB for about a decade and a half and its chair for a few years, Appendix 1 is a standard section. These are reported events.
With all due respect for IM Doc, his expertise, IRB experience, and wisdom this document was submitted to the FDA not an IRB. Whether IRB’s and the FDA have different criteria for reporting I do not know.
I can only speculate, based on the language referring to the appendix, that Pfizer included potential adverse conditions that may not have been caused by the vaccine. But rather included conditions associated with severe SARS-CoV-2 infections as well as those caused by other vaccines.
At least one scientist disagrees with such a reading 4:01
“This is not a list of adverse events that have occurred after covid vaccination, it is a list of adverse events of special interest. What that means is that they are events that are particularly important to track or monitor and the list is actually drawn up before the start of clinical trials, so they reflect what could potentially happen, not what has actually happened”
Good articulation of the type of resistance that will continue to be the boilerplate response rolled out each time any criticism is leveled at vaccines. “See, there’s no smoking gun.”.
Not sure you have ever sat on an IRB.
Before COVID, this would have never flown.
And I am glad you are so assured of the benign nature of the side effects of this vaccine. I would love for you to talk to a few dozen of my patients or their families. That is just it, though. Our entire media, officials, and official medicine have decided they are not real. Just imagine how these people feel. I do not have to imagine. I know.
Instead of dealing with this forthrightly, our officials have decided to conceal. And part of the consequences of that is the vaccination program for COVID is now moribund. The reputation of public health and medicine is on the lowest ebb I have ever seen. We may have permanently damaged our entire vaccine program for everything else. I typically give out 800 or so flu shots. This year was 62. And for the first time in my life, I am having threats of physical violence expressed to me by patients against health officials and authorities. Both of which came from family members of those suffering from the completely “ benign” side effects. I have been able to talk them down. But what happens if the pcp is someone telling them it is all in their head and the side effects are non-existent. What if their PCP is one who completely blows off this kind of document?
Give this whole process another several months. We are all going to find out what is real.
The people who are experiencing some of these effects are reporting in here http://www.realnotrare.org. I have been talking to my congressperson about it.
sorry, it is http://www.realnotrare.com
“20% of the self reported side effects are a headache, how terrifying.”
My sister-in-law, who almost never has headaches, got one the night of her second shot that lasted almost two months. Yes, some people find the prospect of never-ending pain to be terrifying. Please, learn how to empathize.
As for C-19 being a side effect, IM Doc noted on this blog back in February of last year:
“I have frankly been stunned by the number of people who become COVID positive with symptoms within a day or two of the first dose. Many HCW and fully 25-30% of the nursing home patients. I do not believe this is related to behavior because these are mostly a captive audience still following protocols in the NH, HCW who are still under directives for PPE, and the 75 and up crowd I know are still taking things very seriously. This was such an issue that they tested all our shot-givers and all were negative.
In other words, we are not vaccinating thirtysomethings who then go out to party. Nor are the shot-giving personnel seem to be infected and giving it to the patients.
Again, this is a very clear pattern. Vaccine is given and within 2 days they are coughing or fevering and are COVID positive.”
I’ve since seen this phenomenon confirmed elsewhere.
Please note that these post-shot cases are always counted as unvaccinated, thus increasing the supposed efficacy of the shots. Without this statistical sleight of hand, it’s likely the 50% efficacy required for FDA approval would never have been reached.
The illuminati already planned for this scenario back in 2017, did a rehearsal document Johns Hopkins Univ. – SPARS pandemic exercise.
It was covered in chapter 17 – Vaccine injury – in their SPARS pandemic exercise handbook. I guess they just look in the book for how to respond.
Its funny, it does feel like so much of it was premeditated. Like it was all script, with so many plot holes mind you, it was easy to see where they were trying to take us. Covid never scared me, but peoples reaction to it sure as heck did.
https://www.centerforhealthsecurity.org/our-work/Center-projects/completed-projects/spars-pandemic-scenario.html
I would submit they knew this before they rolled it out. I work for a very large Healthcare/insurance company. They had a townhall in Febuary of 2021 about the jabs. They were stating then, in Febuary of 2021 that you would likely need boosters, maybe up to three times a year. They didn’t state this to the public, i wonder why? But they knew. If you want to destroy our for profit corrupt medical system and replace it with something more humane, now is the time.
“But Pfizer remains a big winner. The Biden administration is determined to move on from Covid, as if Covid doesn’t have a say. And Ukraine is a huge aid in diverting attention from the ongoing pandemic.”
Many of us have resolved that this can not be swept under the rug like 2008. I myself think much of what happened in 2020 was connected to 2008. If you let this get swept under the rug, something even worse will happen again in the not to near future. Nobody got punished for 2008 and how well did that work out for us? This was even worse in my opinion then 08, do not let it fade away because it be even worse next time.
Also… what to make of this Swedish study?
Intracellular Reverse Transcription of Pfizer BioNTech COVID-19 mRNA Vaccine BNT162b2 In Vitro in Human Liver Cell Line
https://www.mdpi.com/1467-3045/44/3/73/htm
Not what the vax alarmists would have you believe.
First, the transcription was, as the headline clearly says in vitro.
Second, was done in a cancer cell line, as in not normal cells
Third and most important, the section transcribed was “junk” DNA, as in genetic code that normally does not do anything.
I think does not normally do anything is an overstatement of the inactivity of Junk DNA. That is what people said 20 years ago. Less so now. Line 1 elements (the ‘junk’ in question) are biologically active, and a part of multiple disease etiologies. Some examples:
https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC7426637/
https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC4124830/
https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC7426637/
The in vitro transcription is merely evidence that this needs to be looked into in vivo, which did not happen as a part of the vax safety testing and should have.
Biomedical prof KLG and scientist GM do not agree. First, from scientist GM via e-mail.
And KLG:
Yves has this about right. There is NO indication that biologically active DNA is transcribed in these cells, and yes the fact that Huh7 is a cancer line (something like HeLa) makes the headline results nearly meaningless.
What does matter is that LINE-1 is increased. LINE-1 is part of the regulatory network and is increased in several specific cancers. (colorectal being #1) But again, these are cancer cells; they clearly do respond to the mRNA with increased LINE-1, but how abnormal are they in this regard? I am pretty sure that we are seeing vax-associated increased cancers due to suppression of p53 which is a ubiquitous reguatory protein. I have not seen anything on LINE-1. So don’t worry about this, at least not yet. The greater threat based on current knowledge, is probably sub-clinical myocarditis.
It appears that everyone doesn’t with the CDC regarding DNA safety. See: https://americasfrontlinedoctors.org/news/post/how-worried-should-the-vaccinated-be-new-study-shows-vaccine-converts-to-dna/
This is a secondary reference. Peter McCullough, MD, whom I greatly respect, was very worked up when this issue broadly came out months ago. (I’m not gonna search for the paper. ) He and MIT prof Stephanie Seneff wrote about this earlier. Seneff is also worth our attention (glyphosate expert) I’m not saying it is not possible; just saying they don’t have evidence and their bias is to get worked up over this. Also, general note: AFLD does good work but they are not good with statistics. (Bayesian analysis eludes them.)
Question is, is this a sign that the vaccine has an extreme outlier number of side effects (rates aside) for a vaccine? Or is this a sign that the study did a sloppy job of controlling for variables and existent conditions? The list is big, but it also seems bizarre in the variety; like, even if you were designing a drug to create side effects it’d be impressive to get a list this long.
This wasn’t a study. It was a compilation of voluntary reports from all over the globe. I never reported my side effect, even though I regard it as pretty bad, and I suspect quite a few others didn’t either.
We didn’t report my two daughters’ menstrual issues post vaccine either. My poor younger daughter had just started her cycle 6 months prior and thought she knew what would happen. Post vax she had extreme bleeding – as in times when no amount of pads could help her. My oldest had the opposite. Almost complete cessation. Both were scared. Gynecologist told us they’re OK but they definitely experienced the kind of side effects that the media has decided cannot happen.
I think they list a huge number of possibilities along with real concerns. You will be worn out before you get to Guillame-Barre Syndrome. I believe that this is deliberate obfuscation.
Many of us knew in advance that a multiplicity of effects were possible (and I’m an amateur). James Lyons-Weiler in particular warned of many immunogenic epitopes on the spike protein. Some of this appears to be the result of an attempt to design a Live Attenuated Vaccine, so an accidnetal leak of Tony Fauci’s hubris is a leading hypothesis.
Beginning in November, following first our annual flu vaccines and then Covid Boosters… in my husband the side effect looked like a sudden attack of some systemic arthritis. All of his joints hurt; he was diagnosed with “frozen shoulder” and treated first by his doctor and then a PT. He lost the strength in his hands he’s just now recovering. He’s 63.
For me (64) it was cellulitis (Nov 3) that the combination of Keflex and Bactrim didn’t slow down in the least. It was only defeated by three days of prednisone. A month later (Dec 8) I woke up in the the night to a dull pain in my lower right abdomen. I tried to address it through the night but in the morning gave up and walked into the emergency room (which was btw completely empty at 6 a.m.). Diagnosis: appendicitis. And a fewer hours later I was wheeled in for an appendectomy. No further episodes for either of us; the recovery has been slow though. It took us a few months to look at what had happened to both us and the timing. Who got their shots when and what happened next.
If these unfortunate incidents had occurred to just one or the other, we would have passed it off as a run of bad luck but it was just too coincidental. I think the virus (even when delivered in minute amounts via syringe) exploits the holes in our individual immune systems. The list of side effects (cut and pasted in) acknowledges the sheer breadth of those immunological weaknesses across humanity.
We’ve been shoring up our immune systems ever since.
Last year I developed a frozen shoulder (aka adhesive capsulitis), subsequent to the 2nd jab of the shingles vaccine. It took ~8 months to resolve with aggressive PT–though it was too painful to do much PT in the first couple of months.
Relating my symptoms to two of my friends, I heard of two more cases of frozen shoulder after the Pfizer vaccine.
Turns out frozen shoulder has been reported after pneumococcal and influenza vaccines. It’s been blamed on the administration of the vaccine, but I know that wasn’t the case for me.
In a case report of bilateral adhesive capsulitis after the influenza vaccines, the authors postulated that cytokines may be involved in the pathogenesis and it is most likely that a systemic immune response.
https://onlinelibrary.wiley.com/doi/full/10.1002/ccr3.3072
Although I had shoulder pain and range of motion problems prior to the Pfizer vaccine, that pain was slightly worse after the shot. Is it a coincidence that pain in my right shoulder exacerbated several days after the first jab, which was administered in my right deltoid, whose responsibility is raising my arm? It is certainly conceivable that a shot in the deltoid caused local inflammation, which then incapacitates the muscle. I should note that I tend to sleep on my right side. The good news is my shoulder is pain free now.
The length of the adverse events on page 30 of the linked document was laughably long. I thought about “Alphabet Aerobics”, the alphabetical rap song by Blackalicious.
Yves states in the post that adverse events are undercounted. Here is my additional anecdotal side effect. I also had a flare up of eczema on my back one week after the first jab. I have had eccema before but never on my back.
My own bete noire is adverse event reporting in the US. Sometimes the forest is missed for all the trees.
Adverse event reporting post marketing is voluntary
Although FDA valiantly (/sarc) tries to justify volunteer adverse event reporting, it simply is absurd.
https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers#:~:text=FDA%20receives%20voluntary%20reports%20directly,report%20to%20the%20products'%20manufacturers.
Healthcare professionals, consumers, and manufacturers submit reports to FAERS. FDA receives voluntary reports directly from healthcare professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Healthcare professionals and consumers may also report to the products’ manufacturers
The closest image I have heard for the situation around this is ‘it’s like one of those [alien/zombie] movies, where they have infiltrated the population, the protagonists run to the authorities to warn, just to discover their eyelids are blinking vertically’.
I follow closely what are moderation-passing sources here on NC & will abide by local customs – if Malone/Kirsch et.al. are to screechy/ “over their skis”, then please have a peruse of Jessica Rose’s (was in links for ivm study a few days back) or Igor Chudov’s substacks.
German health insurer exec getting fired over reporting considerably higher adverse event numbers in his 11million insurees (over 10% of the German population = decent sample size one would think) than the public Paul Ehrlich Institut (PEI) numbers is like a brazen Orwell memory hole operation in plain sight. He gets fired within days. At the Bundespresskonferenz, the government spokesperson makes clear he is fully aware of the open letter (from BKK exec to the PEI, had been in Welt newspaper, not biggest, but major paper), but (one must assume deliberately) says the absolute numbers are “mostly people feeling a bit off and being written off sick for a few days”, while the letter is explicit in that it counts explicitly only vax adverse side effect diagnosis codes (in German health system all diagnoses have an alpha-numerical code & there are explicit vax side effect codes), not being written off sick (that is clearly not a diagnosis). Then a few days of Ukraine media distraction and then today the hit-piece on tagesschau.de that the exec is an anti-vax looney (Querdenker), nothing to see here. Never met the guy or seen an interview, but an insurance exec from one of Germany’s biggest health insurerers (prime PMC) speaking out, knowing that this is a likely career-ending move. I don’t know, working hypothesis is alien-movie * 1984. The gods help us.
I have 3 people in my immediate circle (all vaccinated and 2 boosted) who have significantly worsening health issues or new potentially serious health problems. My sister has a long standing auto immune disease that has flared significantly in the last 6 months. She developed a new problem with chronic anemia and is having to get iron infusions. This might be related to the vaccines or not. My best friend started having nosebleeds a week after her booster. After a month of this, she had blood tests done and her white blood cell counts are elevated. She beat leukemia 25 years ago with a bone marrow transplant and now we are worried that it has come back. More tests are coming. My father is having issues swallowing and had tests scheduled to image a mass or obstruction near his trachea/esophogas. I fear issue with his lymphatic system. Maybe cancer. He is 80 but was in excellent health. Both my best friend and my father had covid at some point as well as the vaccines so that muddies the water.
I’m frightened and sad. I anticipate spending a lot more time in the future helping those close to me deal with their health problems.
Similar stories in my circle of friends. Fit people, walkers, gardeners, but older, so one could say its only coincidence’. Problems began within a month of taking the second dose. Their docs are adamant it isn’t vox related. At this point I ask myself how their docs can be sure it isn’t related?
They can’t and neither can you, but all the lying and non-thinking with bonus massive corruption makes it very hard to believe that the vaccines and/or Covid are not responsible. Individually, it easily could be something else, but…. It is stuff like this that makes the antivaxxers believable, and next time when there is an effective vaccine for another lethal disease, could anyone be blamed for not taking it? That will get people killed. The stupidity, greed, and near-sightedness is just awesome to see.
Thanks Yves for sticking to the knitting. If these vaccines have been harming people, I have not participated in the experiment, then the cat is well and truly out of the bag. This links with the Edward Dowd’s revelations of fraud by the vaccine companies and much higher all cause deaths than they had been anticipating. There is no way the insurance companies are going to cop bigger than expected pay-outs if the deaths are linked to these vaccines.
Cannot be covered up. U
I’m a clinician with about 5 years on the research review committee of large health system, did a small bit of research during medical school, based in part upon research-tech training in immunohistochemistry and such – not average for an MD to start as I come from a science family. So I was early to the lab-leak hypothesis (99% proven now; you can ignore the NYT please) and early to analysis of the mRNA transfections as potentially very harmful. I am not surprised by any of this though the 3% mortality figure still seems high to me versus clinical observation and chatting with hospitalists and nurses (nurses often better observers and more ethical than docs). I did psychiatric consults to an ICU before losing my job as the hospital went to a vaccine mandate. (I’m a past reader of Naked Cap, MMT-informed, but too preoccupied teachng myself virology-immunology to keep up the past two years. I feel remiss in not contributing here in more ways than one.)
A few comments and references:
The lack of information about the underlying population –
we do know that the test population was enriched for healthier people. It is low in subjects with diabetes, HTN and obesity. We also know that people who had adverse events after the first jab were osmetimes dropped from the study, and that serious events were sometimes mislabeled.
IM Doc: “in normal times, this would be in the Phase IV period. I have no idea how this is done for an EUA.”
The control group was destroyed by the Pharma Cos., by vaccinating them. All we have left is the unvaccinated population. WE are probably in better general health to start with, so there is that limitation to what will be seen in the next few years, but we will begin to stand out for lower mortality, cancer and cardiovascular deaths and lower autoimmune diseases. This is already being seen in insurance data and reports are suppressed. Some of the intermediate term “vaccine” effects are buried within the massive increase of deaths in working age Americans. All the Sudden Adult Death Syndrome, footballer deaths and student athlete deaths that get reported (locally; suppressed nationally) are just the visible tip.
On insurance data, see: https://roundingtheearth.substack.com/p/vaccine-induced-mortality-part-9?utm_source=substack&utm_campaign=post_embed&utm_medium=email&s=r
I have not read it myself but I am familiar with the data and it is an excellent blog.
We are also seeing that effects of immune compromise (certainly Original Antigenic Sin and probably some percentage of Antibody Dependent Enhancement, probably some immune suppression-CD8 cells especially – due to toxicity of the spike protein) are resulting in NEGATIVE efficacy in Scotland and Israel, where they did keep better statistics. Both countries are now obscuring the figures.
We have thus far not seen the progression to severe disease as happened in Marek’s Disease. I think we got lucky with Omicron, but that is a complicated story. The vax-transfections have clearly pushed evolution of variants and almost certainly have prolonged the pandemic – another long discussion.
One check on VAERS under-reporting is the leaked CMS data reported by Attorney Thomas Renn. Deaths are probably 2.5 – 3 x the events reported through VAERS, which is deliberately designed as a bottleneck. (“Anybody can report” – No! it takes months for even something as obvious as Guillame-Barre Syndrome to make it through the gauntlet of reviewers.) Renn is also working with DOD figures that credibly show 10x the baseline rate of neurological events. I say credible as a 24 year-member of the Am. NeuroPsychiatric Assoc, and direct clinical experience of how neurologists under-report. Because MDs are afraid to “increase vaccine hesitancy” they do not report – sometimes for reasons as case histories can be complicated – so we do not know the variance from baseline for something like Bell’s Palsy. Doctor Porn like “MedPage Today” works hard at “debunking” suggestions that events are causally connected (spare me the “Correlation does not equal …” crap!)
A lot of doctors have been pretty nearly brainwashed and at this point their awakening from this nightmare may have less to do the size of Med School loans and mortgages than the impossible guilt over having been duped into harming patients (Meanwhile Janice Woodcock of the FDA opiate mafia has been made 2nd in command of the whole agency. You will find more truth in season 4 of Goliath than in all the NYT reporting of the last 2 years).
I cannot begin to tell you all the cheap-tricks-dumbed-down-immunology sold by Anthony Fauci over the last 30+ years. Doctors believe that crapification, and it has been pushed on the public by nearly all media.
IM Doc: “In general, this list in most documents like this I have ever seen is 2-3 maybe 4 pages long – NOT 10.”
I suspect that the list includes low probability events and possibilities in part as obfuscation.
These mRNA products should not be called vaccines. The 20+ year old term for this procedure is transfection.
Start saying it:
“mRNA transfection procedure” or “Vax-transfection”
Stop using the changed definition from the propaganda arms of the Big Pharm Octopus.
Finally, we have all been woefully miseducated. The twitter link here leads to a broadly and deeply educated neurobiologist who is self-educated in immunology and able to represent and critique the views of top world viro-immunologists like Wolfgang Wodard, and Geert Vanden Bossche, DNA/RNA experts and manufacturing process knowledgeable. He has been broadly correct from the beginning, unlike all the compromised “experts”, some of whom some of you follow. You can easily find links to Gigahom Biology on Twitch TV and to his own website.
SAR-CoV2 is not the last “leak” from a lab; Gates and Fauci have virtually promised us that. Better to get educated now: https://twitter.com/jjcouey/status/1499376101403111427
Thank you for your perspective, Doc, and thanks for helping to legitimize my very first “alternative” source on the topic of COVID, Jonathan Couey, aka J.C. on a Bike (on Youtube). During the early months of the pandemic, I had a number of posts linking to him removed, on various sites, because he dared to challenge the mainstream Zoonotic origin narrative.
Seeing your comment alone makes the effort worthwhile. When I read “Proximal Origins” by that group of virology-liars (since self-debunked along with Fauci thanks to FOIA’d emails) I had read the Ralph Baric Menachery-Zengli Li Shi 2015 paper https://pubmed.ncbi.nlm.nih.gov/26552008/ about 5 times. (Describes their creation of a chimeric CoV).
“Proximal Origins” was so immediately obviously bad science, so clearly a cover-up, that I felt a bit crazy. Cover-up? But yeah, NIH and NIAID intellectual property is behind all this; how exactly we cannot know. The structure of the spike protein, the RaTG13 oddities … so I felt relieved when J.C. took apart the paper. Chris Martenson saw almost exactly the same thing at the same time.
I have also fought for HCQ and against Remdesivir in my own hospital, where maybe half the staff is followers, but most docs looked at me like I have two heads. My previous supervisees (MDs) think of me as “retired” OK!
Healthier for me to be out of the corporate environment. In my own place soon, I’ll be able to host video conference seminars with “JC on a bike”. Tonight, he teaches network neurobiology – almost heaven for me!
Contrary to the safety norms we were used to, commercial press had a single and impossible to overcome “true” on the safety of a new vaccine never proved before.
We have seen this before. And it is repeating again in Ukraine.
I never reported my effects. There was/is not a service/platform to do that. I consulted two doctors and they aggressively dismissed any relation with the vaccine.
Maybe it’s just me, but between the opioid epidemic with the pill mills, to this, I don’t think big pharma gives one good $hit if they maim and kill people as long as they make money. Neither do the politicians nor the BS artists of the media.
And we still have people who think the jabs are perfectly safe, should be mandatory, and if you get the shots you will be safe from getting the virus.
Orwell would be proud.
Sotto voce: Screwball, I agree with you.
And this NC post is yet another reason why I have chosen to remain in the control group. I don’t think that these jabs are safe or effective.
We are in the same group Arizona Slim. I do all I can with what I have. I did read the other day (somewhere, maybe on Twitter) that someone who buys the drug that cannot be named ordered some more (I need to do the same) and it was held up in customs. That could be a problem.
I have also read the post office was refusing to deliver if they knew what it was. I know my mailman pretty well so I point blank asked him. He said he was not aware of any order to not deliver. That is good news.
I have to wonder as well, how long ago would this news we are reading about here be front and center to the public? From my perspective, any and all “non-good” news about the vaccines hasn’t been covered, or you had to really look hard to find it.
That just isn’t right. We have a right to know. Even if it’s people who won’t believe it anyway (and I think there are such people).
The most telling perspective RE: Table-7 (Pfizer footer pages 15-25) :: “Conclusion: This cumulative case review does not raise any new safety issues.”
Yves mentioned, Reuters commentary not particularly helpful. “Reuters Chairman Is Pfizer Investor and Board Member”. I’m sure nothing to see here.
https://www.pfizer.com/people/leadership/board-of-directors/james_smith
Thanks for this post.
Readers may be interested in this Twitter thread.
Thank you.
A few months ago I checked out VAERS. It is not too hard to navigate and I found that there were 8490 deaths reported for 2021 associated with the COVID vaccines and only 1880 deaths reported for all other vaccines from 1990 through 2018 combined. A dismissive doctor on a radio show who did not allow followup questions claimed 25% of Covid VAERS reports came from outside of the USA as if 6350-odd deaths vs 1880 is that much less alarming.
That the anomalous signal can be so strong yet the system rolls blindly along with the bulk of the population seemingly A-OK with things as they are speaks volumes to our apathy regarding our war mongering and our (unrecognizable to Adam Smith) form of “Free Market Capitalism”.
Dr. Fauci’s first approach was to abort the three-year clinical trials at six months and then vaccinate the controls —a preemption that would prevent detection of long-term injuries, including pathogenic priming. Regulators initially intended the Pfizer vaccine trial to continue for three full years, until May 2, 2023. (14)
Because the FDA allowed Pfizer to unblind and terminate its study after six months—and to offer the vaccine to individuals in the placebo group—we will never know whether vaccinated individuals in the trial suffered long- term injuries, including pathogenic priming, that cancelled out short-term benefits. Science and experience tell us that many vaccines can cause injuries like cancers, autoimmune diseases, allergies, fertility problems, and neurological illnesses with long-term diagnostic horizons or long incubation periods. A six- month study will hide these harms.
14 ClinicalTrials.gov, “Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-
19 in Healthy Individuals,” (April 30, 2020), https://clinicaltrials.gov/ct2/sho w/NCT04368728?term=NCT04368728&draw=2&rank=1
I suffered a serious systemic allergic reaction to Moderna and my spouse has suffered just about every vascular “side effect” that exists from this “vaccine,” all of which have been documented by specialists as vaccine injuries. A year later the medical bills caused by the vaccine continue to accumulate.
Although our lot number has been linked with a very high adverse events rate, I suspect the reason we had such severe reactions was also compounded by our early exposure to the virus.
I am absolutely convinced that every exposure to the spike protein increases likelihood of these severe reactions. Individual vulnerabilities are varied as are reactions, complicating population level analysis but the empirical evidence is growing to support this hypothesis. Yet, I see that Biden proposes to purchase 3 additional “vaccines” per US citizen (as reported in WSJ).
As a social theorists of liberalism, I was and remain shocked by citizens’ willingness to give up their bodies to a pharmaceutical-biotech complex that does not have a history of transparency and has had severe and recent proven ethical lapses.
But then again, how many of us voluntarily received the vaccine that was made mandatory for our employment?
As a student and teacher of crisis communications, I would regard pandemic crisis communications as ethically impaired and anti-democratic as censorship and stigmatization of dissent were deployed in the vastest, most well-orchestrated display of propaganda humanity has ever witnessed.
The country is divided so to avert civil war another spectacle will be devised to keep the emotional economies charged but fractured.
However, I believe we aren’t done with the spike protein and that we also aren’t done with the techno-fascism elements seeking to exploit it.
The challenge is preserving happiness, democracy, and human rights – especially rights over one’s own body and its mobilities – in an increasingly inhospitable and walled-world.
Although our lot number has been linked with a very high adverse events rate:
Are you in the NorthEast? higher spike fidelity in manfacturing in that area; “broken bioweapon is safer” per one Pfizer insider, Sasha Latypova.
I suspect the reason we had such severe reactions was also compounded by our early exposure to the virus.
Absolutely! 2-4 times higher rate of signif adverse events if vax tops off natural immunity.
The cumulative effects show up as reduced immune response to the N protein of CoV2 after third jab per UK NHS data.
Inflammatory effects are likely to be cumulative – but most of us think you can clear spike over time
We are in the southwest. Here is our Moderna Lot # Lot 030B21A
The question of the duration of these mutagenic spike proteins is indeed very salient.
I wonder if the reason there are more women reporting (apart from the sex-specific reproductive issues) is that women in general may be more sensitive and in touch with their bodies than men. It could be likely that men try to “power through” their symptoms and not report them unless they become very serious.
So Pfizer released more documents
The document discussed here is the post marketing experience
Lots of documents
https://www.icandecide.org/pfizer/
After my second dose of Pfizer, within 10 days I developed enthesitis in my knee (patellar tendon). Went from being a very good runner and triathlete, to not being able to run at all. It doesn’t heal, and flares up with even moderate exercise. I was suspicious that it was a vaccine injury, perhaps related to psoriatic arthritis, then subsequently saw a study about enthesitis as a Covid side-effect. So pretty sure they are related.
After my booster I also got tachycardia, and had elevated d-dimer and had to see a cardiologist.
None of this is documented. And I know several other people with significant unreported side effects.
Criminal fraud. I want to see some folks in jail. But I’m not holding my breath. (And yes I was very aware during the financial crisis and it’s aftermath.)
People are played russian roulettes with their bodies and health. Pulling the trigger with each injection of the booster they allow into their body.
Father of a friend died about a month ago. Fully vaccinated I believe (the whole family) a few months after this he has a mild stroke. Daughter drives him to the hospital where has seizures and a heart attack during a four hour wait before they move him to the IC and he’s put in a coma for the next 50 days. Wakes up with a lot of damage … A few days later his daughter gets the call that he died. Cause: herpes infection in the brain. I just knew that vaccination had something to do with it. Sure enough quite a lot of case reports post vaccination. This was weeks ago. Yesterday I saw these pages. My eye caught a few dozen mentions of herpes … encephelatis …. anyway. He was a kind man. They lost him and they don’t have any clue as to why. I have quite a few of those anecdotes. Look up theysayitsrare on instagram.
You are ignoring that IM Doc has seen precisely this sort of report from 15 years of being on the board of an IRB, which oversees drug trials. He’s never seen anything like this.