Autopsy findings of post-COVID-19 vaccination deaths in Tokyo Metropolis, Japan, 2021

Suzuki, Hideto; Ro, Ayako; Takada, Aya; Saito, Kazuyuki; Hayashi, Kino

doi:10.1016/j.legalmed.2022.102134

Cited by 14 publications

(11 citation statements)

References 38 publications

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“…5 including myocarditis deaths, with the authors declaring that several of these deaths did 'show a causal relationship to vaccination'. 6 Kitano et al are omitting relevant data from their analysis, including data they do have access to. Furthermore, counting windows, concerning both cases and adverse effects, so affecting efficacy and safety estimates, are limited to 4-5 months after the last dose.…”

Section: Potentially Overstating Safety In Vaccine Observational Studiesmentioning

confidence: 99%

How the adverse effect counting window affected vaccine safety calculations in randomised trials of COVID‐19 vaccines

Lataster

2024

Evaluation Clinical Practice

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Several articles published recently in the Journal of Evaluation in ClinicalPractice raise important questions about how the efficacy and safety of COVID-19 vaccines have been and are being measured. First, Fung, Jones, and Doshi explained that statistical biases, particularly the case counting window bias, can greatly exaggerate the perceived effectiveness of COVID-19 vaccines in observational studies. 1 A follow-up article by myself explained that this effect may be understated, due to the often accompanied definitional bias, and also that these biases could likewise exaggerate the perceived safety of COVID-19 vaccines in observational studies. 2 Doshi and Fung then added further to the discussion by finding issues with case counting windows in COVID-19 vaccine clinical trials, relating to vaccine effectiveness. 3 In this final article, I shall provide an example justifying my prior concern about counting windows in observational studies concerning safety, and further explain that there are also concerns around adverse effect counting windows in COVID-19 vaccine clinical trials, which may have exaggerated claims about vaccine safety.

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Section: Potentially Overstating Safety In Vaccine Observational Studiesmentioning

confidence: 99%

How the adverse effect counting window affected vaccine safety calculations in randomised trials of COVID‐19 vaccines

Lataster

2024

Evaluation Clinical Practice

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“…2 The gold standard for the diagnosis of myocarditis is the histological examination of the myocardium, after endomyocardial biopsy or at autopsy. As of February 2023, the literature contained descriptions of only 14 cases of autopsy-proven myocarditis, [3][4][5][6][7][8][9][10] originating from Germany (7), Japan (3), United States (2), New Zealand (1), and China (1) (Table 1). mRNA vaccines had been administered in 13/14 cases.…”

mentioning

confidence: 99%

Fatal Myocarditis After COVID-19 Vaccination: Fourteen Autopsy-Confirmed Cases

Manu¹

2023

American Journal of Therapeutics

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“…The histological presentation of this case was similar to that of previous cases of vestibular schwannoma with intratumoral hemorrhage, showing pathologically foamy macrophages and surrounding necrotic tissue [ 6 , 7 ]. In addition, similar to myocarditis after vaccination, acute inflammation with predominantly lymphocytic infiltration was observed pathologically [ 8 , 9 ]. Kawashima et al have reported that microhemorrhage or thrombosis due to vascular endothelial damage is likely to cause intratumoral hemorrhage [ 4 ].…”

Section: Discussionmentioning

confidence: 99%

Two Cases of Rare Intratumoral Hemorrhage Following COVID-19 Vaccination

Sugasawa¹,

Kimura²,

Bae³

et al. 2022

Cureus

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The increase in the rate of mRNA vaccination against coronavirus disease 2019 (COVID-19) worldwide has been accompanied by reports of an increase in the side effects of the vaccine. In the field of neurosurgery, several cases of venous thrombosis have been reported as possible complications after COVID-19 vaccination. However, no such side effects have been reported in patients with brain tumors, and COVID-19 vaccination is considered safe for this patient population. In this report, we present the cases of two patients with brain tumors who experienced intratumoral hemorrhage as a possible side effect of the COVID-19 vaccine. In the first case, a 54-year-old man who had received CyberKnife treatment for a vestibular schwannoma eight years prior presented with tongue discomfort, right-side facial numbness, and dizziness since the day after his COVID-19 vaccination. MRI revealed intratumoral hemorrhage of the vestibular schwannoma. The second patient was a 60-year-old woman who presented with a sudden-onset headache and vomiting that had started three days after her COVID-19 vaccination. CT revealed a meningioma with intratumoral hemorrhage. Both patients had undergone surgery prior to this presentation, and their symptoms had improved. They had no risk factors for intratumoral hemorrhage, suggesting that it may be a side effect of the mRNA vaccine against COVID-19. Although the causal relationship is unclear, acute inflammation with predominantly lymphocytic infiltration and thrombogenicity after COVID-19 vaccination may damage the fragile microcirculation of the tumor.

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Autopsy findings of post-COVID-19 vaccination deaths in Tokyo Metropolis, Japan, 2021

Cited by 14 publications

References 38 publications

How the adverse effect counting window affected vaccine safety calculations in randomised trials of COVID‐19 vaccines

How the adverse effect counting window affected vaccine safety calculations in randomised trials of COVID‐19 vaccines

Fatal Myocarditis After COVID-19 Vaccination: Fourteen Autopsy-Confirmed Cases

Two Cases of Rare Intratumoral Hemorrhage Following COVID-19 Vaccination

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