Delayed Fatal Pulmonary Hemorrhage Following COVID-19 Vaccination: Case Report, Batch Analysis, And Proposed Autopsy Checklist

Published: Feb. 20, 2024

We present a case of 47-year-old male who died unexpectedly from acute pulmonary hemorrhage 555 days after completing the BNT162b2 (Pfizer) COVID-19 vaccination primary series. Before death, he exhibited symptoms mild respiratory infection. Despite healthy medical history and no medication use, patient’s condition rapidly deteriorated experienced severe distress, followed by cardiopulmonary arrest with evidence profuse bleeding. Autopsy findings revealed massive lung congestion without embolism, normal heart size, moderate coronary atherosclerosis myocardial infarction, other hemorrhagic events. The patient tested negative for pathogens at autopsy. these findings, examiner determined cause death was attributed to atherosclerotic hypertensive cardiovascular disease, considering recent unremarkable history. Investigation into vaccine batch indicated higher-than-average number serious adverse events, including fatalities. patient's among top 2.8% reported deaths. Moreover, autopsy failed investigate potential contributions vaccine, such as presence Spike protein or related antibodies. suggests that hemorrhage, exacerbated viral infection, immediate potentially playing role in development pathology hemorrhage. propose protocols recipients better vaccine-related pathologies those one more prior injections.

Language: Английский

---

Response to: Van Wyk et al. letter to the editor regarding ‘Autopsy findings in cases of fatal COVID‐19 vaccine‐induced myocarditis’

ESC Heart Failure, Journal Year: 2024, Volume and Issue: 11(4), P. 2476 - 2478

Published: May 21, 2024

We thank Van Wyk et al. for their concerns about fatal COVID-19 vaccine induced myocarditis.1 agree with that papers such as ours should have 'major implications the public's health and perception of vaccination.' emphasized importance covariate information. Because each included case presented a dataset, covariates to degree they were disclosed considered in adjudication process. present all available information Table 1, including any co-morbities studies presented. Adjudicators reviewed vignettes described original reports. found none comorbidities proximate cause death. In cases, autopsy findings revealed myocarditis was primary Myocarditis has been linked vaccination years by Centers Disease Control Prevention (CDC).2 When performing autopsies, possible aetiologies are investigated, final death is assigned based upon clinical judgement examiner(s). mentioned temporality poorly established five cases died within 2 days after vaccination, however, this timeframe consistent production Spike protein, cardiac inflammation, resultant lethal arrhythmias. Patone an increased risk 28-day window vaccination.3 often results sudden before other symptoms appear.4 Since time writing our publication, more evidence published supporting biological mechanisms myocarditis. Isolated vaccine-induced protein causing cardiovascular inflammation myocarditis5, 6 may not be only mechanism(s) damage. Krauson mRNA, accompanied histologically confirmed myocardial injury, hearts individuals 30 vaccination.7 Schreckenberg inoculated adult rat cardiomyocytes mRNA-1273 (Moderna) BNT162b2 (Pfizer) resulted cellular dysfunctions seen cardiomyopathy.8 Along mRNA resulting adjuvants play role heart damage Kanuri Sirrkay.9 al.'s point World Health Organization (WHO) criteria considered. It WHO adverse event following immunization (AEFI) methodology10 emphasizes documents, complete medical history, results. For individual assessment, process met AEFI standards. raised issue on population level. important but beyond scope manuscript. The US Food Drug Administration Center Biologics Evaluation Research (CBER) designated follow-up period 5 15 novel genetic products, vaccines, observe effects might emerge exposed over time.11 2024, paper published, largest safety study date, conducted Global Vaccine Data Network (GVDN), published.12 multi-country study, which approximately 99 million vaccinated individuals, researchers observed notably higher than expected vaccinations. Specifically, dose two from vaccines 6.10 2.86 times baseline rates, respectively.12 Rose analysed Adverse Event Reporting System (VAERS) number reports 2021 223 average combined past years, concluding strongly associated serious signal myocarditis, hospitalization death.13 recognized transparency literature search paper, Figure 1 fully numbers screened, reviewed, included. we unaware missed during review period. Pantazatos14 Aarstad15 discussion, because preprints vital disseminating while undergo months long peer-review process.16 Skidmore17 retracted violation Committee Publication Ethics (COPE) guidelines18 republished at another journal.19 estimate 709 740 result derived applying underreporting factor VAERS data, indeed extrapolation requires careful interpretation support highlighted. well main limitation underreporting,20, 21 written official guide interpreting data.22 estimated fewer 1% events reported VAERS.19 While there no factor, it approximated fall range 20–40.13, 14, 23 Thus, Pantazatos al.14 20 utilized well-supported conservative estimate. Meissner 86% completed professionals or manufacturers.24 Healthcare submitting provide comprehensive vignettes, identity contact thoroughly documented under penalty law false reporting. can inferred reliable CDC verification. Overall, since new provided further population-level associations between myocarditis.12, 13 Additionally, now deleterious components protein,5, mRNA7, 8 adjuvants.9 coworkers state, 'we believe fails appropriately evaluate communicate impact mortality', implicate complication even larger public future published. these comments conclusions strong call continued vigilance research aimed mitigating outcome vaccination. RH WM longer Wellness Company. PM receives salary (modest) equity Company, had manuscript correspondence.

Language: Английский

---

COVID-19 Modified mRNA “Vaccines”: Lessons Learned from Clinical Trials, Mass Vaccination, and the Bio-Pharmaceutical Complex, Part 2

International Journal of Vaccine Theory Practice and Research, Journal Year: 2024, Volume and Issue: 3(2), P. 1275 - 1344

Published: Aug. 16, 2024

The COVID-19 modified mRNA (modmRNA) lipid nanoparticle-based “vaccines” are not classical antigen-based vaccines but instead prodrugs informed by gene therapy technology. Of considerable note, these products have been linked to atypical adverse and serious event profiles. As discussed in Part 1, health-related risks drawbacks were drastically misreported underreported the Pfizer Moderna trial evaluations of genetic products. Now 2, we examine main structural functional aspects injectables. modmRNA injectable introduce a unique set biological challenges human body with potential induce an extensive range adverse, crippling, life-threatening effects. Based on fact that there is no current method quantify host (cell-based) spike protein production vivo following injection prodrugs, standard “dose”. This part due differences output, which depends cell metabolism transfection efficiency. It therefore difficult predict profiles individual basis, considering millions adults across world reported severe events context products, valid concerns raised regarding infants younger age groups for whom poses only minimal risks. We address process-related impurities inherent mass posed contaminants. then categorize principal associated brief systems-based synopsis each six domains harms: (1) cardiovascular, (2) neurological, (3) hematologic; (4) immunological, (5) oncological, (6) reproductive. conclude discussion primary public health regulatory issues arising from this evidence-informed synthesis literature reiterate urgency imposing global moratorium modmRNA-LNP-based platform.

Language: Английский

---

Pharmaceutical product recall and educated hesitancy towards new drugs and novel vaccines

International Journal of Risk & Safety in Medicine, Journal Year: 2024, Volume and Issue: 35(4), P. 317 - 333

Published: Nov. 1, 2024

Background: Of many pharmaceutical products launched for the benefit of humanity, a significant number have had to be recalled from marketplace due adverse events. A systematic review found market recalls 462 between 1953 and 2013. In our current remarkable period medical history, excess mortality figures are high in countries. Yet these statistics receive limited attention, often ignored or dismissed by mainstream news outlets. This may include effects caused novel agents that use gene-code technology. Objective: To examine key product withdrawals derive lessons inform gene-based COVID-19 vaccines. Methods: Selective narrative historical comparative issues with recent Results: Parallels past drug vaccines distortion clinical trial data, critical event data absent high-impact journal publications. Delayed regulatory action on pharmacovigilance trigger withdrawal occurred Vioxx (rofecoxib) is apparent Conclusion: Public health requires access raw improved transparency corporations heightened, active worldwide.

Language: Английский

---

Comparative Risks Cardiovascular Adverse Events of COVID-19 and other Vaccines

The Gazette of Medical Sciences, Journal Year: 2024, Volume and Issue: 5(1), P. 50 - 60

Published: March 6, 2024

This population-based study reviewed rates of adverse events (AE’s) involving cardiac disease after COVID-19 vaccines. Data were from the US Centers for Disease Control and Prevention (CDC) Food Drug Administration (FDA) Vaccine Adverse Event Reporting System (VAERS) January 1, 1990 through May 5, 2023.

Language: Английский

---

Letter to the editor regarding ‘Autopsy findings in cases of fatal COVID‐19 vaccine‐induced myocarditis’

ESC Heart Failure, Journal Year: 2024, Volume and Issue: 11(4), P. 2467 - 2468

Published: April 25, 2024

Vaccination is a well-proven public health intervention. Since the latter half of 20th century, vaccination policies have been increasingly informed by peer-reviewed publications. Given this, Hulscher et al.1 may major implications on public's and perception COVID-19 vaccination. However, we believe conclusions drawn authors fail to match methodologies used. Therefore, caution should be exercised readers when drawing from study findings. The individual-level causal effects myocarditis deaths were poorly established in selected autopsy cases. First, information relevant covariates was limited. Covariates recorded Table 1 included sex, age, vaccine dose number, time between myocarditis, brand, notes.1 important variables that associated with death including non-cardiac comorbidities exposure other vaccinations or medications missing. In addition, demographic never discussed. Previous research shows risk only those younger than 40.2 Of 28 cases, 14 older 40 years age. These cases attributed vaccination, contrary prior evidence, require higher burden proof causality, which not provided authors. Furthermore, temporality association some Five occurred fewer 2 days after While before death, date initial signs symptoms reported. five where times so short, it biologically improbable onset due needed mount an immune response antigens result myocarditis. Finally, coincidental causes cannot ruled out given provided. Comorbidities contributing include genetically programmed disease, drug toxin over acceptable level, even non-measured infections present at immunization.3 al. failed address any potential comorbidities, instead used existence these as reason for '… establish[ing] all most likely causally linked independent review clinical presented each paper'.1 cited case reports, themselves stated inference made based their For example, commentary, Verma4 found fulminant report sample two individuals assessed PCR testing reported COVID-19. own discussion section, concluded no direct relationship could established. To further support hypothesis invoked Bradford Hill criteria. noted rather serving definitive checklist determine criteria are intended provide framework considerations constructing epidemiological assessments causality.5 this application, World Health Organization (WHO) establishing causality adverse event3 widely accepted. WHO consideration temporality, alternative explanations, association, biological plausibility, population-based conclude association. met, greatest missing component series autopsies. absence such would fall into either 'indeterminate' 'inconsistent association' categories. fact, conducted population-level assessment excess vaccinated groups.2 identified many inconsistencies misrepresented referenced papers various forms. opened Discussion section assertion findings link consistent available literature topic, referencing 994 retrieved PubMed through keyword search terms ('myocarditis' AND 'COVID-19 vaccination'). A alone sufficient articles agreement nor they investigated specific there several instances retracted peer-reviewed. one Skidmore3 marked editor's note regarding unsubstantiated claims 26 January 2023, resulting retraction 11 April approximately 9 months publication Lastly, estimate 709 740 people died countries using Vaccine Adverse Event Reporting System (VAERS). This estimation obtained multiplying 35 487 VAERS 16 June 2023 assumed underreporting factor 20, non source. small fraction total attributable vaccine, inconsistent claim specifically. text also fails acknowledge well-known limitations generate estimates, reports self-reported independently screened professionals. Consequently, use data make strong inappropriate. summary, vaccine-induced attempted extrapolate discussions population Research both pathophysiological evidence safety crucial. al.'s paper problematic key ways. justified. Second, lack baseline following infection precludes population. limitations, restrained appropriately reflect its design methods; interpretations Correspondingly, evaluate communicate impact mortality.

Language: Английский

---

Response to: Szuster‐Ciesielska, letter to the editor regarding ‘Autopsy findings in cases of fatal COVID‐19 vaccine‐induced myocarditis’

ESC Heart Failure, Journal Year: 2024, Volume and Issue: 11(4), P. 2479 - 2480

Published: May 22, 2024

We appreciate concerns expressed by Szuster-Ciesielska about COVID-19 vaccination playing a role in sudden unexplained deaths reported athletes after the institution of mandates Europe. Cadegiani has pointed out that setting vaccine induced myocarditis, surge catecholamines may play initiation lethal ventricular arrhythmias and cardiac arrest.1 In absence an autopsy death previously healthy player, antecedent subclinical myocarditis would be reasonable consideration given findings our paper,2 as inferred work Polykretis McCullough.3 Importantly, McCullough re-analysed data response to letter editor: 'We stratified age found 558 were ≤35 years 139 over 35 years. Such number documented events is likely largely underestimated, because difficulty gather from countries where script/alphabet not translatable. Notably, 38-years timespan (1966-2004), 1101 under died (~29/year) due various heart-related conditions, 50% whom had congenital anatomical heart disease cardiomyopathies 10% atherosclerotic with early onset. The finding 697 2021 forward [<24 months] concerning for secular change these suggest research registry unexpected arrest should initiated particular attention administration data'.3 other words, nearly 10-fold increase rollout was observed. report relied upon public blog athlete required multiple press releases confirmation occurred active player.4 At this time, there no scientific collates reports among vaccinated players, however, present paper suggests such important valuable field. conclusion, contributes knowledge understanding fatal vaccine-induced adhering rigorous standards while navigating challenges sourcing generalizable observations novel rapidly evolving thank their careful analysis share regarding sharp during period enforced European sports teams. RH WM are longer associated Wellness Company. PM receives salary support (modest) or equity Company, which original manuscript correspondence.

Language: Английский

---

Strategic Deactivation of mRNA COVID-19 Vaccines: New Applications for RIBOTACs and siRNA Therapy

Published: May 30, 2024

The rapid development and authorization of mRNA vaccines by Pfizer-BioNTech (BNT162b2) Moderna (mRNA-1273) in 2020 marked a significant milestone human product application, overcoming previous obstacles such as instability immunogenicity. This paper reviews the strategic modifications incorporated into these to enhance stability translation efficiency, inclusion nucleoside optimized design elements including 5’ cap poly(A) tail. We highlight emerging concerns regarding wide systemic biodistribution leading prolonged inflammatory responses other safety concerns. regulatory framework guiding studies is pivotal assessing profiles new formulations use today. vaccines, their pervasive distribution, longevity encapsulated along with unlimited production damaging potentially lethal Spike (S) protein call for strategies mitigate potential adverse effects. Here, we explore small interfering RNA (siRNA) ribonuclease targeting chimeras (RIBOTACs) promising solutions target, inactivate, degrade residual persistent vaccine mRNA, thereby preventing uncontrolled reducing toxicity. targeted nature siRNA RIBOTACs allows precise intervention, offering path prevent events mRNA-based therapies. review calls further research RIBOTAC applications antidotes detoxication products technology.

Language: Английский

---

COVID‐19 vaccine adverse events: Evaluating the pathophysiology with an emphasis on sulfur metabolism and endotheliopathy

European Journal of Clinical Investigation, Journal Year: 2024, Volume and Issue: 54(10)

Published: Aug. 8, 2024

Abstract In this narrative review, we assess the pathophysiology of severe adverse events that presented after vaccination with DNA and mRNA vaccines against COVID‐19. The focus is on perspective an undersulfated degraded glycocalyx, considering its impact immunomodulation, inflammatory responses, coagulation oxidative stress. paper explores various factors lead to glutathione inorganic sulfate depletion their subsequent effect glycocalyx sulfation other metabolites, including hormones. Components COVID‐19 vaccines, such as material, spike protein antigen lipid nanoparticles, are involved in possible cytotoxic effects. common thread connecting these endotheliopathy or degradation, caused by depleted levels, shear stress from circulating aggregation formation coronas; leading imbalanced immune responses chronic release pro‐inflammatory cytokines, ultimately resulting systemic response syndrome. By understanding underlying events, better treatment options can be explored.

Language: Английский

---

Risk Stratification for Future Cardiac Arrest after COVID-19 Vaccination

Published: Aug. 12, 2024

Unheralded cardiac arrest among previously healthy young people without antecedent illness, months or years after COVID-19 vaccination, highlights the urgent need for risk stratification. The most likely underlying pathophysiology is subclinical myopericarditis and reentrant ventricular tachycardia spontaneous fibrillation that commonly precipitated a surge in catecholamines during exercise waking hours of terminal sleep. Small patches inflammation and/or edema can be missed on imaging autopsy, heart appear grossly normal. This paper reviews evidence linking vaccines to where unfortunately majority victims have had no clinical evaluation. We propose comprehensive strategy evaluating cardiovascular post-vaccination, incorporating detailed patient history, antibody testing, diagnostics best attempt detect abnormalities before sudden death. approach aims identify individuals at higher events vaccination guide appropriate management. It prudent each primary care physician pre-established plan when addressing this issue their practice.

Language: Английский

---