A recently published peer-reviewed scientific paper just caught my attention. It is entitled “Improved diagnosis of COVID-19 vaccine-associated myocarditis with cardiac scarring identified by cardiac magnetic resonance imaging“, and was published in the respected journal Open Heart, which is a daughter journal to BMJ.
Here is the full citation…
Warren J, Cheng D, Crawford N, Jones B, Ng RL, Alafaci A, Stub D, Lew P, Taylor AJ. Improved diagnosis of COVID-19 vaccine-associated myocarditis with cardiac scarring identified by cardiac magnetic resonance imaging. Open Heart. 2025 Jul 18;12(2):e003333. doi: 10.1136/openhrt-2025-003333. PMID: 40681307; PMCID: PMC12278148.
…and a link to the paper is here.
What was done?
A passive ‘adverse events following immunization’ database was mined for reported cases of people that had received a diagnosis of “definite” or “probable” myocarditis following receipt of COVID-19 shots. Sixty-seven identified patients were then followed up by testing the health of their hearts via “cardiac magnetic resonance imaging”.
Adverse events are side-effects following a medical intervention. The type of database that was used to identify patients for this study is what is called a ‘passive’ monitoring system, as opposed to the type of ‘active’ monitoring occurs during clinical trials. Passive monitoring systems rely on medical information being voluntarily submitted to a database. Active monitoring systems bring people to researchers that actively search for evidence of harm.
A misleading statement made by the authors
In their ‘methods’ section, the authors stated, “All adverse vaccine-related events in Victoria, Australia, are reported to Surveillance of Adverse Events Following Vaccination In the Community, the state-wide vaccine safety service“ (bolding added). This is misleading because only known events can be reported and even disclosed medical events only become known if a report is actually submitted. This also infers that reports are only filed if causality has been attributed to receipt of the vaccine. This wording helps highlight fundamental flaws with relying on passive monitoring systems to identify potential harms of vaccines.
Passive monitoring systems substantially underestimate the number of clinical issues that occur following a medical intervention. In contrast, active monitoring involves setting appointments with study subjects to run batteries of tests to look for any potential evidence of harm.
An active monitoring system has the potential to identify harms that a person may not even be aware of. This would be the case for sub-clinical problems that fail to present with any clinically relevant signs or symptoms. Safety monitoring can be enhanced through the use of more extensive arrays of tests, as well as through the incorporation of tests that are more sensitive (i.e., they have a better chance of identifying a problem if the problem exists). Active monitoring was dramatically compromised for COVID-19 shots due to the massively abbreviated timeline in which they were developed. The amount of active monitoring that would occur for vaccines undergoing clinical trials over a typical span of ten to fifteen years would be substantially greater.
The problems inherent to passive monitoring systems may have become amplified throughout the declared COVID-19 pandemic because the field of vaccinology found itself operating in a highly politicized environment in which free speech by qualified experts was censored and livelihoods of anyone raising evidence-based concerns that contradicted the narrative were put at risk. Many people were never informed that they were supposed to report any medical event following the shots, without making any attempt to ascertain whether it was or was not related to the shots. This is because new interventions can cause new problems and the average person is not qualified to assess potential biological mechanisms of harm. Among those who tried to get their attending health care professional to submit a report on their behalf, many have stated that the health care provider refused to do so. Research to quantify this problem would be helpful and would aid in combating vaccine hesitancy.
Further, many physicians did not report medical issues despite being informed by their patients following receipt of a shot for a variety of reasons. These included being too busy (understaffed) to deal with what were sometimes time-consuming and non-intuitive processes and/or being too scared to deal with the potential consequences of submitting a report that could be viewed as a blemishing on what was being publicly purported to be a near-perfect medical intervention. Research to quantify this problem would be helpful and would aid in combating vaccine hesitancy.
Many physicians have also stated getting into trouble for trying to submit reports on behalf of their patients or having them rejected by local medical officers of health for questionable reasons. For some adverse event reporting systems, physicians (often local medical officers of health) were assigned the responsibility of making their own determinations of whether they thought a medical incident was related to the shot and to reject it from submission to the database if they deemed it irrelevant. This represents a major flaw in many passive monitoring systems for at least a couple of reasons:
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It relies on the expertise that a physician has within the field of vaccinology, which is a sub-discipline of immunology. And no offence intended, but many physicians lack sufficient expertise in this complex science to make such a unilateral decision unless they have undergone specialized education in the field.
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Some physicians view rare local medical occurrences as ‘outliers’ and on that basis may erroneously conclude that are not likely associated with a medical intervention. So, many rare local medical events likely didn’t get reported. The problem is this… Let’s say each medical officer of health across a country obtains rare reports of a medical event that they write-off as being an outlier because they do not see a clear pattern of association within their region. This robs a passive monitoring system of the ability to identify what may potentially be a genuine side-effect that is consequential when added up across an entire country’s population. If every medical officer of health reported this apparently ‘rare event’, it would become apparent that it is more common and it is possible that an association could be made at the whole-population level. A side-effect may not be an ‘outlier’ if it is occurring in every jurisdiction.
…research to quantify these problem would be helpful and would aid in combating vaccine hesitancy.
It is important to note that many medical incidents reported in both active and passive monitoring systems may not be caused by the medical procedure; they may be incidental and may have occurred anyways. But the risk of missing true side-effects is why all medical incidents should be reported.
The purpose of these monitoring systems is to provide data that can potentially identify disconcerting patterns that warrant further investigation. The better the quality of the data, the more accurate the identification of side-effects. Poor quality of data has been a chronic issue.
On the basis of these facts, the statement made by the authors should be qualified to acknowledge…
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Fewer than “all” adverse events are reported to monitoring systems. Research should be conducted to obtain an accurate estimate of the under-reporting factor for databases like the ‘Surveillance of Adverse Events Following Vaccination In the Community’ system in Australia. This would support public trust in vaccines.
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Asking physicians to submit “vaccine-related” reports places the onus on a vast number of individuals, many of which will be under-qualified, to make determinations of whether a medical event may or may not be associated with a new vaccine technology for which underlying biological mechanisms are still being explored. For example, it would be obvious to report swelling at the injection site when the basic medical textbooks state that vaccines stay at the injection site. It is not intuitive that swelling at a remote location might be associated with a ‘vaccine’ when said ‘vaccine’ has been publicly declared to stay at the injection site, but it actually gets distributed far and wide throughout the body via the circulatory system. This is an inherent flaw that ensures there will be an underestimation factor, especially for side-effects that are anything but very common.
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The part of the statement that says “adverse… events… are reported” actually means ‘are supposed to be reported’. Research should be done to ascertain what percentage of reports that should have been submitted were actually submitted. This is related to the suggestion in #1 above, because it is one contributor to an under-reporting factor.
The importance of understanding nuances of reporting of adverse events
Why is it so important to understand how potential side-effects are reported? Because it allows one to understand how these flawed databases have been used by some to publicize underestimates of potential harms of the COVID-19 shots.
The authors of the paper stated in the abstract that “Myocarditis is a rare but potentially serious complication of COVID-19 vaccination“ (bolding added). There is often an attempt to emphasize the rarity of the problem when reporting negative issues about COVID-19 shots, and it may even be necessary for some papers that highlight any concerns to get published in the current world of politicized science. But, it is nonetheless objectively wrong to firmly draw such a conclusion. It is based on the fact that relatively few of these cases are found in the vaccine adverse event monitoring systems, yet, as you have now seen with your own eyes, rather than acknowledging that there is an undefined but substantial under-reporting factor, it is assumed that the numbers in these databases represent, in the words of the authors, “All adverse vaccine-related events”.
Compounding this is the fact that too many physicians and scientists only read the abstracts of papers, and only a few more will read the introductions and/or conclusions that also include these kinds of statements that are irrelevant to the data being presented in the paper. Very few delve into the materials and methods section, then critically assess the raw data, and then formulate their own unbiased expert opinions.
The proper way to read a paper in an unbiased fashion is to start with the materials and methods to assess the validity and limitations of the data set, then the raw data and results, and then make an independent assessment. Only then should the rest of the paper (introduction, discussion, conclusions) be read to see if the authors agreed or disagreed with you, then adjust your thinking only if the authors provided sufficient rationale to do so. Remember, authors of a paper do not hold a monopoly on the ability to interpret their data. Sadly, exceptionally few people do this, even among subject matter experts. This is one area where subjectivity gets introduced into science. A harmful consequence is the regurgitation of these superficial statements in places like courts that then use these to over-rule proper critical assessments of the objective core data sets.
The paper works hard to fit into the narrative…
In an effort to try to further emphasize the rarity of myocarditis caused by the COVID-19 shots, the authors highlighted the massive number of doses administered. Again, this is a fatally flawed strategy, known as confounding, that gets people to look at the low number of cases of myocarditis reported in the paper in the context of the absolutely massive number of doses, which makes the problem seem incredibly minor. But, again, this fails to account for the undefined and substantial under-reporting of medical issues following administration of the doses, in addition to many other issues. So, the authors are using an apples to oranges-type of comparison as a way to cater to the narrative in a way that is misleading.
The authors of the paper also include the requisite statements of how fast the vaccine development had to be and cite over-inflated government-derived numbers of lives saved. These latter numbers are inaccurate for a plethora of reasons, including the mis-assignment of “COVID-19” in a substantial but undefined number of cases. COVID-19 is a disease, which means there must be manifestation of signs and or symptoms (i.e., a person must be sick). It is not a label to be applied in response to a positive result from a PCR test that is supposed to be limited to use as an aid to diagnosis. The data regarding cases of COVID-19 are so badly confounded that we will likely never know how much lower the case counts should actually be, but it would be worth conducting research with full access to all government-held data to get an estimate. Such a transparent analysis would help combat vaccine hesitancy.
But the core findings of the paper are narrative-busting…
The aforementioned facts were discussed because they showcase just how disconcerting the actual core findings of the paper are. Do you remember how the narrative shifted from ‘shot-induced myocarditis is misinformation’ to ‘yes, the shots cause myocarditis but it is rarer than myocarditis caused by natural infection, and it is generally mild and resolves quickly?
The only information that matters in any scientific paper is what is directly supported by the data that are presented therein and the logical conclusions that they lead to. In this case, the authors found that damage to the heart following receipt of COVID-19 shots was long-lasting. Specifically, in the patients that they assessed, damage to the heart was detected well beyond one year and up to almost two years following receipt of the shots. In the words of the authors, “In conclusion, long-term myocardial fibrosis is a common finding in patients with C-VAM [COVID-19 vaccine-associated myocarditis]“. This contributes to a growing data set that breaks the part of the narrative that says ‘the shot-induced heart damage is transient’.
The authors also found that the method they used to assess damage to the heart unveiled the troubling fact that one-third of the people originally assigned the label of “probable” myocarditis were mis-classified and should have been listed in the adverse event database as “definite” cases of myocarditis. Many people who have been arguing for the ‘rarity’ of shot-induced myocarditis de-emphasize or outright ignore anything but definitive diagnoses. This further breaks the narrative of shot-induced damage to the heart being rare.
Something that the authors failed to discuss, but that represents a logical conclusion is this: Their testing method was more sensitive in terms of identifying damage to the heart than what has typically been used to date. Indeed the authors argue that this more sensitive method should be incorporated into testing to capture the substantial number of definitive cases of myocarditis that are currently being missed in the system. But they are only insinuating that this be applied to people presenting with potential clinical cases of myocarditis. More importantly, I would argue that this more sensitive test should be incorporated into a battery of tests applied in the context of a research study enrolling those who received the shots but did not experience signs or symptoms of heart damage thereafter; and compare these to people that did not receive the shots. The question to be addresses would be, ‘do the shots cause sub-clinical damage to the heart that is not being captured in the passive adverse event monitoring systems?’. Again, this would be a great way to stem the growth of vaccine hesitancy. Why is such a study important? Because subclinical damage to largely non-renewable tissues in the body shortens lifespans.
Final thought
I laughed when I saw that the authors felt compelled to state in their discussion that “The overwhelmingly positive impact of the widespread global vaccination policy against COVID-19 must be acknowledged“. Again, this has become an all-too-common bookend in these otherwise narrative-busting papers. I don’t know whether the authors did this because they still wholeheartedly believe the fatally flawed narrative but wanted to build their resumes with data that otherwise hurt their world view, or if they said it to get through a potentially politicized review or editorial process. Either way, it is now a form of ‘noise’ that has become too common in scientific publications and it detracts from the objective, relevant truths of these papers.
This is why I remain devoted to educating people about how to sift fact from fiction in the complex world of biology, including when it is intermingled within the context of a single scientific paper. Knowing how to properly read and interpret a scientific publication is important for those who want to develop and/or retain critical thinking skills.
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Author: Dr. Byram W. Bridle
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