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A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products

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  • Independent Researcher

Abstract

Following the global rollout and administration of the Pfizer Inc./BioNTech BNT162b2 and Moderna mRNA-1273 vaccines on December 17, 2020, in the United States, and of the Janssen Ad26.COV2.S product on April 1st, 2021, in an unprecedented manner, hundreds of thousands of individuals have reported adverse events (AEs) using the Vaccine Adverse Events Reports System (VAERS). We used VAERS data to examine cardiac AEs, primarily myocarditis, reported following injection of the first or second dose of the COVID-19 injectable products. Myocarditis rates reported in VAERS were significantly higher in youths between the ages of 13 to 23 (p<0.0001) with ∼80% occurring in males. Within 8 weeks of the public offering of COVID-19 products to the 12-15-year-old age group, we found 19 times the expected number of myocarditis cases in the vaccination volunteers over background myocarditis rates for this age group. In addition, a 5-fold increase in myocarditis rate was observed subsequent to dose 2 as opposed to dose 1 in 15-year-old males. A total of 67% of all cases occurred with BNT162b2. Of the total myocarditis AE reports, 6 individuals died (1.1%) and of these, 2 were under 20 years of age - 1 was 13. These findings suggest a markedly higher risk for myocarditis subsequent to COVID-19 injectable product use than for other known vaccines, and this is well above known background rates for myocarditis. COVID-19 injectable products are novel and have a genetic, pathogenic mechanism of action causing uncontrolled expression of SARS-CoV-2 spike protein within human cells. When you combine this fact with the temporal relationship of AE occurrence and reporting, biological plausibility of cause and effect, and the fact that these data are internally and externally consistent with emerging sources of clinical data, it supports a conclusion that the COVID-19 biological products are deterministic for the myocarditis cases observed after injection.
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Journal Pre-proof
TEMPORARY REMOVAL: A Report on Myocarditis Adverse Events
in the U.S. Vaccine Adverse Events Reporting System (VAERS) in
Association with COVID-19 Injectable Biological Products
Jessica Rose PhD, MSc, BSc , Peter A. McCullough MD, MPH
PII: S0146-2806(21)00226-7
DOI: https://doi.org/10.1016/j.cpcardiol.2021.101011
Reference: YMCD 101011
To appear in: Current Problems in Cardiology
Please cite this article as: Jessica Rose PhD, MSc, BSc , Peter A. McCullough MD, MPH , TEMPO-
RARY REMOVAL: A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Re-
porting System (VAERS) in Association with COVID-19 Injectable Biological Products, Current Prob-
lems in Cardiology (2021), doi: https://doi.org/10.1016/j.cpcardiol.2021.101011
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TEMPORARY REMOVAL: A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse
Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products
Jessica Rose, PhD, MSc, BSc
*
jessicarose1974@protonmail.com and Peter A. McCullough, MD,
MPH
Institute of Pure and Applied Knowledge, Public Health Policy Initiative (PHPI)
Truth for Health Foundation, Tucson, AZ, USA
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*
Corresponding author.
... COVID-19 infection is a potential trigger of myocarditis, as it affects the vascular system, resulting in myocardial injury in 12-20% of hospitalized patients [92,93]. Since a variety of reports is linking the mRNA vaccines to myocarditis adverse events, several mechanisms have been proposed [94][95][96]. ...
... Naïve T cells can be primed by viral antigens or other proteins released by damaged cardiomyocytes, leading to inflammation [98]. Moreover, a past COVID-19 infection can predispose a higher incidence of myocarditis after vaccination, with previously primed T cells attacking both the vaccine's spike protein and the cardiac antigens [95,96]. Molecular mimicry between the spike protein and self antigens is another possible mechanism. ...
... Myocarditis is more frequently reported in young adults, as testosterone enhances Th1 responses and leads to inflammation, while • Overstimulation of T cells and macrophages [34,35] • Previous formation of antibodies against LNPs / PEG (IgM,IgG,IgE) [31,38] • Naked RNA [31,39] • Amino acid residues (437-508 sequence of the spike protein) [40] • Estrogen activates Th2 responses, while testosterone diminishes them [33,40] • Stress, drugs, genetic factors [31,35,40,[42][43][44] Ad26. CoV2 [97] • Past COVID 19 infection contribute to previous primed antigens [95,96] • Molecular mimicry [92,99] • Heart reactive autoantibodies and deregulation of cytokines [92,100] • RNA antigenic properties [101] • Sex hormone differences [92,102] • Vaccine components and manufacturing practice [103] Ad26. ...
Article
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COVID-19 is an infectious disease caused by a single-stranded RNA (ssRNA) virus, known as SARS-CoV-2. The disease, since its first outbreak in Wuhan, China, in December 2019, has led to a global pandemic. The pharmaceutical industry has developed several vaccines, of different vector technologies, against the virus. Of note, among these vaccines, seven have been fully approved by WHO. However, despite the benefits of COVID-19 vaccination, some rare adverse effects have been reported and have been associated with the use of the vaccines developed against SARS-CoV-2, especially those based on mRNA and non-replicating viral vector technology. Rare adverse events reported include allergic and anaphylactic reactions, thrombosis and thrombocytopenia, myocarditis, Bell’s palsy, transient myelitis, Guillen-Barre syndrome, recurrences of herpes-zoster, autoimmunity flares, epilepsy, and tachycardia. In this review, we discuss the potential molecular mechanisms leading to these rare adverse events of interest and we also attempt an association with the various vaccine components and platforms. A better understanding of the underlying mechanisms, according to which the vaccines cause side effects, in conjunction with the identification of the vaccine components and/or platforms that are responsible for these reactions, in terms of pharmacovigilance, could probably enable the improvement of future vaccines against COVID-19 and/or even other pathological conditions.
... Besides development, numerous vaccines have been settled and proposed for emergency use. Some of these vaccines are reported for unusual thrombosis, immune thrombocytopenia (ITP), vaccine-induced thrombocytopenia (VITT), intracranial hemorrhage, myocarditis and pericarditis issues Rose and McCullough, 2021). So, immunogenicity evaluation is an urgent need to understand the performance and type of immune response produced by COVID-19 vaccination, and to adapt better strategies in future. ...
... A high mortality, intracranial hemorrhage and 69% cases with myocarditis/pericarditis have been determined, suggesting that the latter case is recoverable within days to weeks . Another data from "Vaccine Adverse Events Reporting System-VAERS," concluded 19-fold higher vaccine-induced myocarditis-e.g., 80% male adolescents (12-15 years old) (Rose and McCullough, 2021). Till to date, thrombocytopenia/thrombosis or vaccine-induced thrombotic thrombocytopenia (VITT) with increased rate of myocarditis and death has been caused by more vaccines. ...
... Till to date, thrombocytopenia/thrombosis or vaccine-induced thrombotic thrombocytopenia (VITT) with increased rate of myocarditis and death has been caused by more vaccines. These incorporate-e.g., viral vector ChAdOx1-nCoV-19/AZD1222 (efficacy 70.4%), adenovirus-26/5 (rAd26/rAd5, 91.6% efficacy) and Janssen/Johnson & Johnson (Rose and McCullough, 2021;Pai et al., 2021;Schultz et al., 2021;Pottegård et al., 2021). Among ARs, the rate of VITT has was shown to be due to the activated platelets antibodies against platelet factor-4 (Smith et al., 2021). ...
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In this review, the disease and immunogenicity affected by COVID-19 vaccination at the metabolic level are described considering the use of nuclear magnetic resonance (NMR) spectroscopy for the analysis of different biological samples. Consistently, we explain how different biomarkers can be examined in the saliva, blood plasma/ serum, bronchoalveolar-lavage fluid (BALF), semen, feces, urine, cerebrospinal fluid (CSF) and breast milk. For example, the proposed approach for the given samples can allow one to detect molecular biomarkers that can be relevant to disease and/or vaccine interference in a system metabolome. The analysis of the given biomaterials by NMR often produces complex chemical data which can be elucidated by multivariate statistical tools, such as PCA and PLS-DA/OPLS-DA methods. Moreover, this approach may aid to improve strategies that can be helpful in disease control and treatment management in the future.
... Heart inflammation, such as endocarditis, myocarditis, and pericarditis, is the adverse reaction associated with mRNA vaccination reported in several countries during the COVID-19 vaccination development and after the onset of the vaccination campaign (1)(2)(3)(4)(5)(6). Overall, six cases of myocarditis after the BNT162b2 vaccination were reported by Abu Mouch and Roguin et al. (1), with five patients presenting myocarditis after the second and one after the first dose of the vaccine. ...
... Additional cases of myocarditis were also reported in individuals who received the Moderna mRNA COVID-19 vaccine (1). In adolescents and young adults, the reports of myocarditis and pericarditis were higher in frequency after the second dose than the first dose of one mRNA COVID-19 vaccine (Pfizer-BioNTech or Moderna) (1,4,6). ...
Article
Full-text available
A 23-year-old man started with chest pain 8 h after his first Pfizer-BioNTech COVID-19 vaccination. ECG evaluation showed sinus tachycardia with ST-segment elevation in D1, AVL, V5, and V6, the findings compatible with acute subepicardial myocardial damage. However, cardiac MRI documented myocardial fibrosis, with cardiac late enhancement non-ischemic pattern with diffuse edema. He had no other symptoms to suggest another etiology than the vaccination. The patient was hospitalized and received corticosteroid (prednisolone) daily. Then, 2 weeks after hospitalization, all laboratory parameters and ECG were normal and the patient was discharged from the hospital. The patient had a history of Wolf-Parkinson White that was corrected with ablation when he was 11 years old. This report calls attention to myocardial adverse reaction risk for mRNA COVID-19 vaccines for people with a previous cardiac disease history.
... She should be referred to the VAERS database (Rose & McCullough, 2021;Guetzkow, 2023) concerning the frequency of under-reported anaphylactic reactions and to research connecting such reactions to the COVID-19 concoctions (Cabanillas et al., 2021;Children's Health Defense, 2020;Shimabukuro et al., 2021;Smout, 2020;Sobczak & Pawliczak, 2022). "Allergic potential" can result in real anaphylaxis, real cases, which can end up as real dead cases. ...
Article
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While Professor A. Ulrich (2024) raised justifiable questions about the interpretation of microscopic images from incubated COVID-19 injectables from Pfizer and Moderna, her message treats the world-wide genetic modification experiment with COVID-19 injectables on humans — an experiment on us without our consent — as normal. I will not discuss the physico-chemistry of the 10 trillion lipid nanoparticles she claims are in every dose of the injectables. She acknowledges that “many of the lipid constituents . . . tend to induce inflammation” (p. 1244.3) but says they account for all the self-assembling structures documented in what she describes as the “reliable” and “fully consistent” findings (Ulrich, p. 1244.7) of Lee and Broudy (2024). Though I believe the self-assembling structures also merit in-depth study, the technology underlying them, must be contained in the concoctions injected into the arms of two-thirds of the world’s population without proper preclinical testing and without the informed consent required by the Nuremberg Code. My focus is on that violation of medical ethics turning humans into genetically modified organisms. Here I illustrate in her words that such a genetic experiment on humans is underway. Instead of refuting any of the evidence in Lee and Broudy (2024) —that whatever the injectables may actually contain they are harming the human population of the world — she actually admits in closing that those “risks will be exacerbated with the next generation of self-amplifying or self-replicating RNA vectors for vaccines” (1244.8).
... However, if preprint servers only accept papers that commend the public health agencies, they undermine the fundamental role of science for oversight and for the correction of https://doi.org/10.56098/fdrasy50 policy errors (Prasad, 2023;Rose & McCullough, 2021). They must, in the long run, also undermine public trust in the medical profession and the pharmaceutical industry in general. ...
Article
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Our understanding of COVID-19 synthetic, modified mRNA (modmRNA) products and their public health impact has evolved substantially since December 2020. Published reports from the original randomized placebo-controlled trials concluded that the modmRNA injections could greatly reduce COVID-19 symptoms. However, the premature termination of both trials obviated any reliable assessment of potential adverse events due to an insufficient timeframe for proper safety evaluation. Following authorization of the modmRNA products for global distribution, problems with the methods and execution of the trials have emerged. The usual safety testing protocols and toxicology requirements were bypassed. Many key trial findings were either misreported or omitted entirely from published trial reports. By implication, the secondary estimates of excess morbidity and mortality in both trials must be deemed underestimates. Rigorous re-analyses of trial data and post-marketing surveillance studies indicate a substantial degree of modmRNA-related harms than was initially reported. Confidential Pfizer documents had revealed 1.6 million adverse events by August 2022. A third were serious injuries to cardiovascular, neurological, thrombotic, immunological, and reproductive systems, along with an alarming increase in cancers. Moreover, well-designed studies have shown that repeated modmRNA injections cause immune dysfunction, thereby potentially contributing to heightened susceptibility to SARS-CoV-2 infections and increased risks of COVID-19. This paper also discusses the insidious influence of the Bio-Pharmaceutical Complex, a closely coordinated collaboration between public health organizations, pharmaceutical companies, and regulatory agencies. We recommend a global moratorium on the modmRNA products until proper safety and toxicological studies are conducted.
... In fact, many people advancing critical views towards lockdowns and mass vaccination experienced censorship, not only on social media, but from scientific journals themselves [86]. In one such episode, a manuscript for publication in the journal Current Problems in Cardiology by Jessica Rose, PhD, and Peter A. McCullough, MD, was withdrawn after publication without explanation [87]. Several examples exist of articles retracted for ostensibly political, as opposed to scientific, reasons [88,89]. ...
Article
Full-text available
The COVID crisis of the past three years has greatly impacted stakeholder relationships between scientists, health providers, policy makers, pharmaceutical industry employees, and the public. Lockdowns and restrictions of civil liberties strained an already fraught relationship between the public and policy makers, with scientists also seen as complicit in providing the justification for the abrogation of civil liberties. This was compounded by the suppression of open debate over contentious topics of public interest and a violation of core bioethical principles embodied in the Nuremberg Code. Overall, the policies chosen during the pandemic have had a corrosive impact on public trust, which is observable in surveys and consumer behaviour. While a loss of trust is difficult to remedy, the antidotes are accountability and transparency. This narrative review presents an overview of key issues that have motivated public distrust during the pandemic and ends with suggested remedies. Scientific norms and accountability must be restored in order to rebuild the vital relationship between scientists and the public they serve.
... Beginning with initial reports of myocarditis following mRNA vaccination [11], additional pharmacovigilance, health system surveillance, and case series studies have suggested an association between SARS-CoV-2 vaccination and development of both myocarditis and pericarditis [7,[12][13][14][15][16][17][18][19][20][21][22][23][24][25]. However, formal epidemiologic studies comparing observed and expected cases of myocarditis and other clinical outcomes like pericarditis, are sparse and inconsistent [26][27][28]. ...
Article
Full-text available
Introduction We aimed to assess harms (post-vaccine myocarditis and pericarditis) and benefits (preventing severe disease) of COVID-19 vaccination. Methods We conducted a population-based retrospective cohort study. Using the integrated platform of the vaccination campaign of Lombardy Region (Italy), after the exclusion of 24,188 individuals not beneficiaries of the Regional Health Service, 9,184,146 citizens candidates to vaccine at December 27, 2020 were followed until November 30, 2021 (the loss to follow-up rate was 0.5%). From the date of administration of each vaccine dose to day 28 post-administration, three periods that covered exposure to the first, second, and third dose were defined. The benefit–risk profile of vaccines was performed by comparing the number needed to harm (NNH) and number needed to treat (NNT) by sex, age, and vaccine type. Results Incidence rates of myocarditis were 9.9 and 5.2 per million person-months during the exposure and no-exposure periods, respectively, and the incidence rates of pericarditis were 19.5 and 15.9 per million person-months, respectively. The risk of myocarditis was highest following exposure to the second dose of the Moderna vaccine (adjusted HR: 5.5, 95% CI: 3.7 to 8.1). Exposure to the Moderna vaccine was also associated with an increased risk of pericarditis (adjusted HR 2.2, 1.5 to 3.1). NNT was higher than NNH (9471 vs. 7213) for 16 to 19-year-old men who received the Moderna vaccine, while all other sex, age, and vaccine subgroups had a favourable harm-benefit profile. Conclusions Men 16 to 19 years of age has the highest rates of myocarditis within a few days after receiving the Moderna vaccines. The balance between harms and benefits was almost always in favour of vaccination.
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Retracted COVID-19 articles have circulated widely on social media. Although retractions are intended to correct the scientific record, when trust in science is low, they may instead be interpreted as evidence of censorship or simply ignored. We performed a content analysis of tweets about the two most widely shared retracted COVID-19 articles, Mehra20 and Rose21, before and after their retractions. When Mehra20 was seen as a politicized attack on Donald Trump and hydroxychloroquine, its retraction was broadly shared as proof that the article had been published for political reasons. However, when Rose21 was seen as evidence of vaccine harm by vaccine opponents, its retraction was either ignored or else framed as a conspiracy to censor the truth. These results demonstrate how retractions can be selectively used by scientific counterpublics to reframe the regulation of science as evidence of its institutional corruption.
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Public trust in science was tested and relied on during the SARS-CoV-2 pandemic, which has shaped global events since the WHO declaration in March 11, 2020. Public trust has been impacted through the government recommendations and mandates informed by public health guidance, including non-pharmaceutical and pharmaceutical interventions. The free-flow of ideas and in-formation so essential to the functioning of science has faced unprecedented challenge from widespread censorship in both the media and in scientific journals. This has created a poisoned environment for the building of trust between science and society. Scientific norms and ac-countability must be restored in order to rebuild the vital relationship between scientists and the public they serve.
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Myocarditis is a common cardiovascular manifestation seen in patients diagnosed with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. However, because of the similarity of presentation with other cardiopulmonary pathologies, identification of coronavirus disease 2019 (COVID-19) related myocarditis can be challenging. Transthoracic echocardiography is a key component in initial diagnosis. COVID-19 related myocarditis is increasingly identified as an underlying problem in COVID-19 patients with low ejection fraction. Early recognition is critical with a low threshold for screening echocardiogram. Utilization of cardiac MRI (CMRI) can be helpful in recognition of early manifestations of COVID-19 myocarditis, with the added benefit of avoidance of invasive testing such as endomyocardial biopsy (EMB). Once diagnosis is established, disease-specific treatment can lead to rapid recovery of ventricular systolic function. We present a case series including two similar cases of COVID-19 myocarditis in which we utilized echocardiography as an early diagnostic tool and prompt treatment led to better prognosis.
Article
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The mRNA vaccines against COVID-19 infection have been effective in reducing the number of symptomatic cases worldwide. With widespread uptake, case series of vaccine-related myocarditis/pericarditis have been reported, particularly in adolescents and young adults. Men tend to be affected with greater frequency, and symptom onset is usually within 1 week after vaccination. Clinical course appears to be mild in most cases. On the basis of the available evidence, we highlight a clinical framework to guide providers on how to assess, investigate, diagnose, and report suspected and confirmed cases. In any patient with highly suggestive symptoms temporally related to COVID-19 mRNA vaccination, standardized workup includes serum troponin measurement and polymerase chain reaction testing for COVID-19 infection, routine additional lab work, and a 12-lead electrocardiogram. Echocardiography is recommended as the imaging modality of choice for patients with unexplained troponin elevation and/or pathologic electrocardiogram changes. Cardiovascular specialist consultation and hospitalization should be considered on the basis of the results of standard investigations. Treatment is largely supportive, and myocarditis/pericarditis that is diagnosed according to defined clinical criteria should be reported to public health authorities in every jurisdiction. Finally, we recommend COVID-19 vaccination in all individuals in accordance with the Health Canada and National Advisory Committee on Immunization guidelines. In patients with suspected myocarditis/pericarditis after the first dose of an mRNA vaccine, deferral of a second dose is recommended until additional reports become available.
Article
Full-text available
Importance The BNT162b2 (Pfizer-BioNTech) messenger RNA COVID-19 vaccine was authorized on May 10, 2021, for emergency use in children aged 12 years and older. Initial reports showed that the vaccine was well tolerated without serious adverse events; however, cases of myocarditis have been reported since approval. Objective To review results of comprehensive cardiac imaging in children with myocarditis after COVID-19 vaccine. Design, Setting, and Participants This study was a case series of children younger than 19 years hospitalized with myocarditis within 30 days of BNT162b2 messenger RNA COVID-19 vaccine. The setting was a single-center pediatric referral facility, and admissions occurred between May 1 and July 15, 2021. Main Outcomes and Measures All patients underwent cardiac evaluation including an electrocardiogram, echocardiogram, and cardiac magnetic resonance imaging. Results Fifteen patients (14 male patients [93%]; median age, 15 years [range, 12-18 years]) were hospitalized for management of myocarditis after receiving the BNT162b2 (Pfizer) vaccine. Symptoms started 1 to 6 days after receipt of the vaccine and included chest pain in 15 patients (100%), fever in 10 patients (67%), myalgia in 8 patients (53%), and headache in 6 patients (40%). Troponin levels were elevated in all patients at admission (median, 0.25 ng/mL [range, 0.08-3.15 ng/mL]) and peaked 0.1 to 2.3 days after admission. By echocardiographic examination, decreased left ventricular (LV) ejection fraction (EF) was present in 3 patients (20%), and abnormal global longitudinal or circumferential strain was present in 5 patients (33%). No patient had a pericardial effusion. Cardiac magnetic resonance imaging findings were consistent with myocarditis in 13 patients (87%) including late gadolinium enhancement in 12 patients (80%), regional hyperintensity on T2-weighted imaging in 2 patients (13%), elevated extracellular volume fraction in 3 patients (20%), and elevated LV global native T1 in 2 patients (20%). No patient required intensive care unit admission, and median hospital length of stay was 2 days (range 1-5). At follow-up 1 to 13 days after hospital discharge, 11 patients (73%) had resolution of symptoms. One patient (7%) had persistent borderline low LV systolic function on echocardiogram (EF 54%). Troponin levels remained mildly elevated in 3 patients (20%). One patient (7%) had nonsustained ventricular tachycardia on ambulatory monitor. Conclusions and Relevance In this small case series study, myocarditis was diagnosed in children after COVID-19 vaccination, most commonly in boys after the second dose. In this case series, in short-term follow-up, patients were mildly affected. The long-term risks associated with postvaccination myocarditis remain unknown. Larger studies with longer follow-up are needed to inform recommendations for COVID-19 vaccination in this population.
Article
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Two previously healthy males presented to the emergency symptoms with signs of pericarditis/myocarditis after being vaccinated with an mRNA vaccine for COVID‐19.
Article
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Abstract: This is a cross-sectional study of 29 published cases of acute myopericarditis following COVID-19 mRNA vaccination. The most common presentation was chest pain within 1–5 days after the second dose of mRNA COVID-19 vaccination. All patients had an elevated troponin. Cardiac magnetic resonance imaging revealed late gadolinium enhancement consistent with myocarditis in 69% of cases. All patients recovered clinically rapidly within 1–3 weeks. Most patients were treated with non-steroidal anti-inflammatory drugs for symptomatic relief, and 4 received intravenous immune globulin and corticosteroids. We speculate a possible causal relationship between vaccine administration and myocarditis. The data from our analysis confirms that all myocarditis and pericarditis cases are mild and resolve within a few days to few weeks. The bottom line is the risk of cardiac complications among children and adults due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection far exceeds the minimal and rare risks of vaccination-related transient myocardial or pericardial inflammation.
Preprint
Background There have been recent reports of myocarditis (including myocarditis, pericarditis or myopericarditis) as a side-effect of mRNA-based COVID-19 vaccines, particularly in young males. Less information is available regarding the risk of myocarditis from COVID-19 infection itself. Such data would be helpful in developing a complete risk-benefit analysis for this population. Methods A de-identified, limited data set was created from the TriNetX Research Network, aggregating electronic health records from 48 mostly large U.S. Healthcare Organizations (HCOs). Inclusion criteria were a first COVID-19 diagnosis during the April 1, 2020 - March 31, 2021 time period, with an outpatient visit 1 month to 2 years before, and another 6 months to 2 years before that. Analysis was stratified by sex and age (12-17, 12-15, 16-19). Patients were excluded for any prior cardiovascular condition. Primary outcome was an encounter diagnosis of myocarditis within 90 days following the index date. Rates of COVID-19 cases and myocarditis not identified in the system were estimated and the results adjusted accordingly. Wilson score intervals were used for 95% confidence intervals due to the very low probability outcome. Results For the 12-17-year-old male cohort, 6/6,846 (0.09%) patients developed myocarditis overall, with an adjusted rate per million of 876 cases (Wilson score interval 402 - 1,911). For the 12-15 and 16-19 male age groups, the adjusted rates per million were 601 (257 - 1,406) and 561 (240 - 1,313). For 12-17-year-old females, there were 3 (0.04%) cases of myocarditis of 7,361 patients. The adjusted rate was 213 (73 - 627) per million cases. For the 12-15- and 16-19-year-old female cohorts the adjusted rates per million cases were 235 (64 - 857) and 708 (359 - 1,397). The outcomes occurred either within 5 days (40.0%) or from 19-82 days (~60.0%). Conclusions Myocarditis (or pericarditis or myopericarditis) from primary COVID19 infection occurred at a rate as high as 450 per million in young males. Young males infected with the virus are up 6 times more likely to develop myocarditis as those who have received the vaccine.
Article
Myocarditis has been recognized as a rare complication of coronavirus 2019 (COVID-19) mRNA vaccinations, especially in young adult and adolescent males. According to the U.S. Centers for Disease Control (CDC), myocarditis/pericarditis rates are approximately 12.6 cases per million doses of second dose mRNA vaccine among 12-39-year-olds. In reported cases, patients with myocarditis invariably presented with chest pain, usually 2-3 days after a second dose of mRNA vaccination and had elevated cardiac troponin levels. ECG was abnormal with ST elevations in most, and cardiac MRI was suggestive of myocarditis in all tested patients. There was no evidence of acute COVID-19 or other viral infections. In one case, a cardiomyopathy gene panel was negative, but autoantibody levels against certain self-antigens and frequency of natural killer cells were increased. Although the mechanisms for development of myocarditis are not clear, molecular mimicry between the spike protein of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and self-antigens, trigger of preexisting dysregulated immune pathways in certain individuals, immune response to mRNA and activation of immunological pathways, and dysregulated cytokine expression have been proposed. The reasons for male predominance in myocarditis cases are unknown, but possible explanations relate to sex hormone differences in immune response and myocarditis, and also under-diagnosis of cardiac disease in women. Almost all patients had resolution of symptoms and signs, and improvement in diagnostic markers and imaging with or without treatment. Despite rare cases of myocarditis, the benefit-risk assessment for COVID-19 vaccination shows a favorable balance for all age and sex groups; therefore COVID-19 vaccination is recommended for everyone 12 years of age and older.
Article
Importance Vaccine-associated myocarditis is an unusual entity that has been described for the smallpox vaccine, but only anecdotal case reports have been described for other vaccines. Whether COVID-19 vaccination may be linked to the occurrence of myocarditis is unknown. Objective To describe a group of 7 patients with acute myocarditis over 3 months, 4 of whom had recent messenger RNA (mRNA) COVID-19 vaccination. Design, Setting, and Participants All patients referred for cardiovascular magnetic resonance imaging at Duke University Medical Center were asked to participate in a prospective outcomes registry. Two searches of the registry database were performed: first, to identify patients with acute myocarditis for the 3-month period between February 1 and April 30 for 2017 through 2021, and second, to identify all patients with possible vaccine-associated myocarditis for the past 20 years. Once patients with possible vaccine-associated myocarditis were identified, data available in the registry were supplemented by additional data collection from the electronic health record and a telephone interview. Exposures mRNA COVID-19 vaccine. Main Outcomes and Measures Occurrence of acute myocarditis by cardiovascular magnetic resonance imaging. Results In the 3-month period between February 1 and April 30, 2021, 7 patients with acute myocarditis were identified, of which 4 occurred within 5 days of COVID-19 vaccination. Three were younger male individuals (age, 23-36 years) and 1 was a 70-year-old female individual. All 4 had received the second dose of an mRNA vaccine (2 received mRNA-1273 [Moderna], and 2 received BNT162b2 [Pfizer]). All presented with severe chest pain, had biomarker evidence of myocardial injury, and were hospitalized. Coincident testing for COVID-19 and respiratory viruses provided no alternative explanation. Cardiac magnetic resonance imaging findings were typical for myocarditis, including regional dysfunction, late gadolinium enhancement, and elevated native T1 and T2. Conclusions and Relevance In this study, magnetic resonance imaging findings were found to be consistent with acute myocarditis in 7 patients; 4 of whom had preceding COVID-19 vaccination. Further investigation is needed to determine associations of COVID-19 vaccination and myocarditis.