Severe acute myositis and myocarditis upon initiation of six-weekly Pembrolizumab post-COVID-19 mRNA vaccination
Robert A. Watson,
Weiyu Ye,
Chelsea A. Taylor
et al.
Abstract:We describe three cases of critical acute myositis with myocarditis occurring within 22 days of each other at a single institution, all within one month of receiving the initial cycle of the anti-PD-1 drug Pembrolizumab. Analysis of T cell receptor repertoires from peripheral blood and tissues revealed a high degree of clonal expansion and public clones between cases, with several T cell clones expanded within the skeletal muscle putatively recognising viral epitopes. All patients had recently received a COVID… Show more
“…My retrospective examination of BP records over the vaccination period, 11 together with the reports noted above, 9,10,12 indicate that, like the early-onset version, 5 cryptic lateonset post-vaccination myocarditis may be more frequent than is generally recognized. 7 Among the many millions on the planet taking antihypertensive medication, it is highly likely that some possess similar data that might be tapped as part of a "crowd-source" study.…”
Section: Crowd Source Study?mentioning
confidence: 97%
“…Meanwhile, aside from independent case studies, [9][10][11] Nakahara et al 12 were using noninvasive fluorodeoxyglucose-based PET/CT scans that sensitively detect inflammatory myocarditis. They studied 303 unvaccinated and 700 vaccinated subjects.…”
As we enter a new era of mRNA‐based therapeutics, evidence on genetic or environmental factors that might predispose to unknown off‐target side effects, gains in importance. Among these factors, exercise appears likely to have influenced otherwise cryptic cases of early‐onset postvaccination myocarditis. And the existence of a distinct late‐onset myocarditis is now being recognized. Here, three case‐history reports suggest crypticity (the author's own case), unless provoked by a preexisting cardiac morbidity (one case), or by immune checkpoint blockade to enhance anticancer autoimmunity (several cases). These reports are supported by noninvasive fluorodeoxyglucose‐based cardiac scan comparisons of multiple vaccinated and unvaccinated subjects. In pre‐pandemic decades, applications for funds by the leading innovator in mRNA‐based therapeutics seldom gained peer‐review approval. Thus, at the start of the pandemic, the meager data on such side effects could justify only emergency approval. We must do better.
“…My retrospective examination of BP records over the vaccination period, 11 together with the reports noted above, 9,10,12 indicate that, like the early-onset version, 5 cryptic lateonset post-vaccination myocarditis may be more frequent than is generally recognized. 7 Among the many millions on the planet taking antihypertensive medication, it is highly likely that some possess similar data that might be tapped as part of a "crowd-source" study.…”
Section: Crowd Source Study?mentioning
confidence: 97%
“…Meanwhile, aside from independent case studies, [9][10][11] Nakahara et al 12 were using noninvasive fluorodeoxyglucose-based PET/CT scans that sensitively detect inflammatory myocarditis. They studied 303 unvaccinated and 700 vaccinated subjects.…”
As we enter a new era of mRNA‐based therapeutics, evidence on genetic or environmental factors that might predispose to unknown off‐target side effects, gains in importance. Among these factors, exercise appears likely to have influenced otherwise cryptic cases of early‐onset postvaccination myocarditis. And the existence of a distinct late‐onset myocarditis is now being recognized. Here, three case‐history reports suggest crypticity (the author's own case), unless provoked by a preexisting cardiac morbidity (one case), or by immune checkpoint blockade to enhance anticancer autoimmunity (several cases). These reports are supported by noninvasive fluorodeoxyglucose‐based cardiac scan comparisons of multiple vaccinated and unvaccinated subjects. In pre‐pandemic decades, applications for funds by the leading innovator in mRNA‐based therapeutics seldom gained peer‐review approval. Thus, at the start of the pandemic, the meager data on such side effects could justify only emergency approval. We must do better.
BACKGROUND: Myocarditis has been considered a rare complication of COVID-19 vaccination that primarily affects young people. However, recent studies indicate under-reporting of cases in the elderly. Furthermore, post-mortem studies of five cases (median age 58) that died suddenly within 7 days of vaccination, indicate an autoimmune element. Albeit an individual case history, the author’s unexpected personal evidence supports the latter studies.
METHODS: Readings of blood pressure (BP) and pulse were taken twice daily.
RESULTS: Seven days after the fifth of a series of anti-COVID-19 vaccinations, a “stress test” (15 min jog) in an elderly subject exposed a cardiac problem – arrhythmia and a rapid fall of BP with slow recovery. The timing suggested myocarditis as a post-vaccination _early_ side-effect that usually targets those more likely to exercise (i.e., the young). Thus, it is usually cryptic in the elderly. In addition, retrospective studies of his own BP readings during the vaccination period (2021-2023) revealed the sudden emergence of transient, but prolonged, falls of BP _several weeks_ after each of his last four vaccinations. These hypotensive episodes were cryptic (asymptomatic) and likely not detected in shorter post-vaccination analyses.
CONCLUSIONS: Short-term post-vaccination side effects are distinct from those occurring after some weeks. The first category includes systemic or localized inflammatory responses that, in the case of the heart, might either trigger arrythmia and acute functional impairment, or remain cryptic. Localized responses could initiate tissue damage, culminating weeks later in the second category – asymptomatic but measurable functional impairment. Continuing regular dosages of antihypertensive medication during this period would likely intensify the hypotension. That this did not occur in the author’s case is attributed to his two-decade-long practice of modulating dosage daily, based on BP readings. Failure to follow this protocol might explain some sudden home deaths. A parallel is drawn with his previous study that showed the need to modify antihypertensive therapy in response to external temperature changes.
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