Preprint Review Version 1 Preserved in Portico This version is not peer-reviewed

Autopsy Proven Fatal COVID-19 Vaccine-Induced Myocarditis

Version 1 : Received: 17 July 2023 / Approved: 18 July 2023 / Online: 18 July 2023 (09:34:51 CEST)

How to cite: Hulscher, N.; Hodkinson, R.; Makis, W.; McCullough, P. Autopsy Proven Fatal COVID-19 Vaccine-Induced Myocarditis. Preprints 2023, 2023071198. https://doi.org/10.20944/preprints202307.1198.v1 Hulscher, N.; Hodkinson, R.; Makis, W.; McCullough, P. Autopsy Proven Fatal COVID-19 Vaccine-Induced Myocarditis. Preprints 2023, 2023071198. https://doi.org/10.20944/preprints202307.1198.v1

Abstract

Background: COVID-19 vaccines have been linked to myocarditis which in some circumstances can be fatal. This systematic review aims to investigate potential causal links between COVID-19 vaccines and death from myocarditis using post-mortem analysis. Methods: We performed a systematic review of all published autopsy reports involving COVID-19 vaccination-related myocarditis through July 3rd, 2023. All autopsy studies that include COVID-19 vaccine-induced myocarditis as a possible cause of death were included, without imposing any additional restrictions. Causality in each case was determined by three independent reviewers with cardiac pathology experience and expertise. Results: We initially identified 1,691 studies and, after screening for our inclusion criteria, included 14 papers that contained 28 autopsy cases. The cardiovascular system was the only organ system affected in 26 cases. In 2 cases, myocarditis was characterized as a consequence from multisystem inflammatory syndrome (MIS). The mean and median number of days from last COVID-19 vaccination until death was 6.2 and 3 days, respectively. Most of the deaths occurred within a week from the last injection. We established that all 28 deaths were causally linked to COVID-19 vaccination by independent adjudication. Conclusions: The temporal relationship, internal and external consistency seen among cases in this review with known COVID-19 vaccine-induced myocarditis, its pathobiological mechanisms and related excess death, complemented with autopsy confirmation, independent adjudication, and application of the Bradford Hill criteria to the overall epidemiology of vaccine myocarditis, suggests there is a high likelihood of a causal link between COVID-19 vaccines and death from suspected myocarditis in cases where sudden, unexpected death has occurred in a vaccinated person. Urgent investigation is required for the purpose of risk stratification and mitigation in order to reduce the population occurrence of fatal COVID-19 vaccine-induced myocarditis.

Keywords

myocarditis; sudden death; chest pain; autopsy; necropsy; COVID-19; COVID-19 vaccines; mRNA; SARS-CoV-2 vaccination; death; excess mortality; spike protein; organ system

Subject

Medicine and Pharmacology, Cardiac and Cardiovascular Systems

Comments (5)

Comment 1
Received: 24 July 2023
Commenter:
The commenter has declared there is no conflict of interests.
Comment: This manuscript does not prove the remarkable risk of mRNA vaccines: according to numbers given in this article, the risk of death from COVID-19 is 0.009% (6,948,764 : 767,726,861), whereas the risk of death from myocarditis after mRNA vaccine, documented here, is 3.647 x 10-8 (28 : 767,726,861), i.e., five orders of magnitude lower!

Crucial 6 references out of 39 references are non-peer-reviewed web site news.

I hope that the MDPI journal will not, after opinions of reliable reviewers, accept this manuscript for publication, especially since they had already had to withdraw a similar publication at least once [Retraction: Walach et al. The Safety of COVID-19 Vaccinations—We Should Rethink the Policy. Vaccines 2021, 9, 693, Vaccines Editorial Office, https://doi.org/10.3390/vaccines9070729].
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Comment 2
Received: 27 July 2023
Commenter:
The commenter has declared there is no conflict of interests.
Comment: Mr. Kusnierczyk, your arguments are not valid. A comparison between covid and vaccine deaths says nothing (!) about the risk factor after a vaccination. Its not the point of this study to argue for or against vaccinations. Your post shows that you just want the table empty of arguments against the vaccine.
There are not 39 references, there are 58. There is no reason why there only should be "peer-reviewd" references in a paper if theiy are for illustrational purposes. Finally: in a peer-review process its not about pass or deny. Its about making it better.
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Comment 3
Received: 19 August 2023
Commenter:
The commenter has declared there is no conflict of interests.
Comment: Mr. Kusnierczyk, when you calculate the risk of death from myocarditis after mRNA vaccine you write 28 : 767,726,861: now:

1) how can you state that *all* those deaths are *only* 28 and not more?

2) why do you relate those 28 deaths to the number of infected by SARS-CoV-2 around the world, i.e. 767,726,861? What does the former have to do with the latter?

Thank you
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Comment 4
Received: 30 August 2023
Commenter:
The commenter has declared there is no conflict of interests.
Comment: Unfortunately medicals have not a full knowledge about the Covid-19 mortality, as it is derived from official data based on irrational mechanical assumptions. In fact, if the pandemic was not announced the number of excess deaths would be only close to Zero, what can be directly proven/calculated:
https://zenodo.org/record/8264060 ...There is strong censorship concerning what medical journals let go (I could give examples even how many minutes it takes some of them remove an upload), so "peer-reviews" gives a strongly distorted view; besides presenting a work to such journals is no duty or will, the math proof can be verified by anybody, if it does not contain any data only in the authors' possesion.
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Comment 5
Received: 4 September 2023
Commenter:
The commenter has declared there is no conflict of interests.
Comment: The authors state in the introduction, "A PUBMED search performed at the time of writing for “myocarditis” and “COVID-19 vaccination” yielded 994 results, indicating a high prevalence of COVID-19 vaccine-related myocarditis in the peer-reviewed literature."
A high number of papers related to an adverse evict does not imply a high prevalence of the problem; rather, it implies a widespread interest in the problem, even if rare. Obviously, after the first reports, the risk of vaccine-induced myocarditis in young people raised a bear interest in the topic, yielding many studies. But what did these studies find?
Salah HM, Mehta JL. COVID-19 Vaccine and Myocarditis. Am J Cardiol. 2021 Oct 15;157:146-148 (15 cases). conclusions are: "This analysis shows that myocarditis related to COVID-19 vaccine has an overall fast recovery with no short-term complications."
Montgomery J, et al. Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military. JAMA Cardiol. 2021 Oct 1;6(10):1202-1206. : "the military administered more than 2.8 million doses of mRNA COVID-19 vaccine in this period. The observed number of myocarditis cases was small (23 cases)"
Oster ME, et al. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. JAMA. 2022 Jan 25;327(4):331-340. : ".Among 192 405 448 persons receiving a total of 354 100 845 mRNA-based COVID-19 vaccines during the study period, there were 1991 reports of myocarditis to VAERS and 1626 of these reports met the case definition of myocarditis. " This is NOT a high prevalence!
Patone M, et al. Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection. Nat Med. 2022 Feb;28(2):410-422. : "We estimated an extra two, one and six myocarditis events per 1 million people vaccinated with ChAdOx1, BNT162b2 and mRNA-1273, respectively, in the 28 days following a first dose and an extra ten myocarditis events per 1 million vaccinated in the 28 days after a second dose of mRNA-1273. This compares with an extra 40 myocarditis events per 1 million patients in the 28 days following a SARS-CoV-2 positive test."
And so on. Myocarditis has a LOW prevalence after vaccination.
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