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Keywords = COVID-19 related myocarditis

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10 pages, 708 KB  
Article
Cardiac MRI for COVID-19-Related Late Myocarditis: Functional Parameters and T1 and T2 Mapping
by Sena Ünal, Elif Peker, Sena Bozer Uludağ, Sezer Nil Yılmazer Zorlu, Ruhi Erdem Ergüden and Arda Ayhan Hekimoğlu
Diagnostics 2025, 15(19), 2441; https://doi.org/10.3390/diagnostics15192441 - 25 Sep 2025
Cited by 1 | Viewed by 1060
Abstract
Background/Objectives: Myocarditis is a recognized complication of COVID-19 infection, with potential long-term cardiac sequelae. While acute cardiac involvement has been frequently reported, late-stage myocardial effects remain less well characterized. Cardiac magnetic resonance (CMR) imaging, particularly T1 and T2 mapping, offers non-invasive tissue [...] Read more.
Background/Objectives: Myocarditis is a recognized complication of COVID-19 infection, with potential long-term cardiac sequelae. While acute cardiac involvement has been frequently reported, late-stage myocardial effects remain less well characterized. Cardiac magnetic resonance (CMR) imaging, particularly T1 and T2 mapping, offers non-invasive tissue characterization for myocardial inflammation and fibrosis. This study aimed to evaluate segmental myocardial tissue changes in patients with late-stage COVID-19–related myocarditis using CMR and compare findings with patients with non-COVID-19 myocarditis and healthy controls. Methods: This retrospective, single-center study included 25 patients with clinically suspected COVID-19 myocarditis who underwent CMR between 36 and 565 days post-infection. T1 and T2 mapping values and late gadolinium enhancement (LGE) patterns were assessed and compared with 14 non-COVID-19 myocarditis patients and 19 healthy controls. Subgroup analyses were performed according to vaccination status and left ventricular ejection fraction (LVEF). Results: Patients with reduced LVEF had significantly higher T1 and T2 values in several myocardial segments. Compared to controls, the COVID-19 myocarditis group showed significantly elevated T1 values in all segments except 2 and 3. No significant difference in T2 values was observed. LGE was present in 61% of COVID-19 myocarditis patients, predominantly with a subepicardial pattern. No significant differences were observed between vaccinated and unvaccinated patients. Conclusions: Late-stage COVID-19 myocarditis is associated with persistent segmental myocardial tissue abnormalities, particularly elevated T1 values and subepicardial LGE. Segmental CMR mapping may provide additional diagnostic value in identifying residual myocardial injury in patients with ongoing cardiac symptoms after COVID-19 infection. Full article
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16 pages, 395 KB  
Article
Serious Adverse Drug Reactions to COVID-19 Vaccines in the Pediatric Population: A Retrospective, Cross-Sectional Study Utilizing the Eudravigilance Database for the European Economic Area
by Grzegorz Nazar, Julia Olszlegier, Aleksandra Kamińska, Katarzyna Plata-Nazar and Wojciech Nazar
J. Clin. Med. 2025, 14(18), 6542; https://doi.org/10.3390/jcm14186542 - 17 Sep 2025
Viewed by 6487
Abstract
Background: During the global fight against the COVID-19 pandemic, vaccinations have been widely recognized as the most effective and generally safe method for preventing the spread of COVID-19. However, it has been reported that children may experience post-vaccination serious adverse drug reactions (SADRs). [...] Read more.
Background: During the global fight against the COVID-19 pandemic, vaccinations have been widely recognized as the most effective and generally safe method for preventing the spread of COVID-19. However, it has been reported that children may experience post-vaccination serious adverse drug reactions (SADRs). Thus, we aimed to analyze the risk of SADRs to COVID-19 vaccines in the pediatric population. Methods: In this retrospective, cross-sectional study, 5422 cases of SADRs (n = 5018 for Pfizer BioNTech, Comirnaty and n = 494 for Moderna, Spikevax) were analyzed after 37,344,343 doses of COVID-19 vaccines were administered. This study covered the European Economic Area. The analysis period for both vaccinations and SADRs spanned from 7 December 2020 to 5 October 2023. The analysis encompassed 207 types of SADRs grouped into 12 categories. All estimated real-world reporting rates were reported as normalized per million ADR reports and adjusted using real-world trial-based scaling (APMR). Results: The total estimated real-world reporting rates of SADRs were 5792 APMR for Comirnaty and 5671 for Spikevax. The most commonly reported clinical categories of suspected SADRs for both vaccines were neuropsychiatric, cardiovascular and gastroenterological disorders. The most often reported SADRs encompassed headaches, myocarditis, episodes of syncope, dizziness and dyspnea. Conclusions: According to the data from this study, several SADRs were reported in children following COVID-19 vaccination. The estimated real-world reporting rates of SADRs related to COVID-19 vaccines seem to be rare among children. Additionally, the data suggest that Comirnaty (Pfizer-BioNTech) may have a similar risk profile compared to Spikevax (Moderna). Full article
(This article belongs to the Special Issue Infectious Disease Epidemiology: Current Updates and Perspectives)
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13 pages, 2627 KB  
Article
Declining Myocarditis Mortality in the United States and the Impact of the COVID-19 Pandemic
by Ali Bin Abdul Jabbar, Daniyal Ali Khan, John Osborne, William Thomson, Ameya Chinawalkar, Mason Klisares, Kyle Gilkeson and Ahmed Aboeata
J. Clin. Med. 2025, 14(14), 5116; https://doi.org/10.3390/jcm14145116 - 18 Jul 2025
Viewed by 5133
Abstract
Background: Myocarditis is associated with increased mortality due to complications such as cardiogenic shock and arrhythmia. Trends of myocarditis-related mortality in the United States, along with demographic and regional disparities and changes during the COVID-19 pandemic, are unknown. Methods: We used the Centers [...] Read more.
Background: Myocarditis is associated with increased mortality due to complications such as cardiogenic shock and arrhythmia. Trends of myocarditis-related mortality in the United States, along with demographic and regional disparities and changes during the COVID-19 pandemic, are unknown. Methods: We used the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research (CDC WONDER) database to extract data for myocarditis deaths from 1999 to 2023. The Joinpoint Regression Program was used to analyze long-term trends in mortality, and R Studio (version 4.4.1) was used to calculate expected and excess mortality for 2020 to 2023. Results: There were 33,016 myocarditis-related deaths from 1999 to 2023. The age-adjusted mortality rate (AAMR) of myocarditis deaths decreased by 46.08% from 7.40 (95% CI: 7.04–7.76) in 1999 to 3.99 (95% CI: 3.74–4.23) in 2019, with an APC of −2.59 (95% CI: −2.97 to −2.24). From 2019 to 2021, the AAMR increased by 46.62% to 5.85 (95% CI: 5.56–6.14) by 2021 (2019–2021 APC 22.3%*), reversing the gains of the previous two decades. By 2023, the AAMR recovered to 4.33 (95% CI: 4.09 to 4.58), though mortality was still higher than expected from pre-pandemic trends. From 2020 to 2023, there were 40.12% more deaths than expected, with 54.94% higher mortality in 2021. Briefly, 70.33% of excess myocarditis-related deaths also had COVID-19, with a peak of 76.15% of excess myocarditis deaths in 2021 being reported as involving COVID-19 infection. Significant disparities in mortality trends persisted, with males, NH Black or African Americans, and the elderly having higher mortality rates. Conclusions: Myocarditis mortality decreased in the United States from 1999 to 2019 but significantly increased during the COVID-19 pandemic years 2020 and 2021. At the height of the pandemic, COVID-19 infection contributed to almost three-quarters of excess myocarditis mortality. Significant disparities in myocarditis mortality persisted from 1999 to 2023. Full article
(This article belongs to the Special Issue Clinical Trends in Cardiomyopathy)
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18 pages, 783 KB  
Review
COVID-19 and Myocarditis: Trends, Clinical Characteristics, and Future Directions
by Mohammad Abumayyaleh, Tobias Schupp, Michael Behnes, Ibrahim El-Battrawy, Nazha Hamdani and Ibrahim Akin
J. Clin. Med. 2025, 14(13), 4560; https://doi.org/10.3390/jcm14134560 - 27 Jun 2025
Cited by 1 | Viewed by 5093
Abstract
Summary: COVID-19, caused by SARS-CoV-2, has been associated with a range of cardiovascular complications, including myocarditis. This review aims to systematically present the clinical manifestations, underlying pathophysiological mechanisms, diagnostic approaches, and management strategies for both COVID-19-associated myocarditis and myocarditis related to SARS-CoV-2 vaccination. [...] Read more.
Summary: COVID-19, caused by SARS-CoV-2, has been associated with a range of cardiovascular complications, including myocarditis. This review aims to systematically present the clinical manifestations, underlying pathophysiological mechanisms, diagnostic approaches, and management strategies for both COVID-19-associated myocarditis and myocarditis related to SARS-CoV-2 vaccination. We conducted a literature search using the PubMed database, covering studies published up to early 2024. Search terms included combinations of “COVID-19”, “Coronavirus”, “SARS-CoV-2”, and/or “vaccination” with “cardiac injury”, “cardiac inflammation”, “myocarditis”. The reported prevalence of COVID-19-associated myocarditis varies between 2.3% and 5.0%, though myocardial injury is more frequently observed than confirmed myocarditis. Pathophysiological mechanisms include direct viral damage, immune-mediated injury, and molecular mimicry. Clinically, patients may present with chest pain, dyspnea, and fever. Diagnostic workup includes electrocardiography (ECG), troponin measurement, echocardiography, cardiac magnetic resonance imaging (cMRI), and in selected cases, endomyocardial biopsy (EMB). The management and disposition of COVID-19-associated myocarditis varies according to severity, especially to allow targeted treatment of complications. Glucocorticoids are a mainstay of treatment in severe cases. Myocarditis following SARS-CoV-2 vaccination is rare, more frequently reported in males under 30 years, and is generally associated with a favorable prognosis. Despite this, the benefits of vaccination continue to outweigh the risks. COVID-19 is associated with an increased risk of heart failure and other cardiovascular complications, underlining the importance of long-term follow-up and preventive strategies. Further research is needed to better understand the pathogenesis and optimal management of myocarditis in the context of COVID-19, with the goal of developing evidence-based therapeutic algorithms. Full article
(This article belongs to the Section Cardiology)
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16 pages, 2069 KB  
Review
Expanded Spectrum and Increased Incidence of Adverse Events Linked to COVID-19 Genetic Vaccines: New Concepts on Prophylactic Immuno-Gene Therapy, Iatrogenic Orphan Disease, and Platform-Inherent Challenges
by Janos Szebeni
Pharmaceutics 2025, 17(4), 450; https://doi.org/10.3390/pharmaceutics17040450 - 31 Mar 2025
Cited by 4 | Viewed by 37393 | Correction
Abstract
The mRNA- and DNA-based “genetic” COVID-19 vaccines can induce a broad range of adverse events (AEs), with statistics showing significant variation depending on the timing and data analysis methods used. Focusing only on lipid nanoparticle-enclosed mRNA (mRNA-LNP) vaccines, this review traces the evolution [...] Read more.
The mRNA- and DNA-based “genetic” COVID-19 vaccines can induce a broad range of adverse events (AEs), with statistics showing significant variation depending on the timing and data analysis methods used. Focusing only on lipid nanoparticle-enclosed mRNA (mRNA-LNP) vaccines, this review traces the evolution of statistical conclusions on the prevalence of AEs and incidents associated with these vaccines, from initial underestimation of atypical, severe toxicities to recent claims suggesting the possible contribution of COVID-19 vaccinations to the excess deaths observed in many countries over the past few years. Among hundreds of different AEs listed in Pfizer’s pharmacovigilance survey, the present analysis categorizes the main symptoms according to organ systems, with nearly all of them being affected. Using data from the US Vaccine Adverse Event Reporting System and a global vaccination dataset, a comparison of the prevalence and incidence rates of AEs induced by genetic versus flu vaccines revealed an average 26-fold increase in AEs with the use of genetic vaccines. The difference is especially pronounced in the case of severe ‘Brighton-listed’ AEs, which are also observed in COVID-19 and post-COVID conditions. Among these, the increases in incidence rates relative to flu vaccines, given as x-fold rises, were 1152x, 455x, 226x, 218x, 162x, 152x, and 131x for myocarditis, thrombosis, death, myocardial infarction, tachycardia, dyspnea, and hypertension, respectively. The review delineates the concept that genetic vaccines can be regarded as prophylactic immuno-gene therapies and that the observed chronic disabling AEs might be categorized as iatrogenic orphan diseases. It also examines the unique vaccine characteristics that could be causally related to abnormal immune responses which potentially lead to adverse events and complications. These new insights may contribute to improving the safety of this platform technology and assessing the risk/benefit balance of various products. Full article
(This article belongs to the Special Issue Trends in mRNA Vaccine Development and Applications)
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12 pages, 677 KB  
Review
COVID-19 and Myocarditis: Pathogenetic Mechanisms and Histological Features
by Cecilia Salzillo and Andrea Marzullo
Acta Microbiol. Hell. 2025, 70(1), 3; https://doi.org/10.3390/amh70010003 - 26 Jan 2025
Cited by 1 | Viewed by 5492
Abstract
The COVID-19 pandemic has highlighted several cardiovascular complications, including myocarditis, which can be a significant cause of sudden cardiac death in young people. SARS-CoV-2 infection can cause cardiac muscle inflammation through direct mechanisms, such as viral invasion of myocardial cells, and indirect mechanisms, [...] Read more.
The COVID-19 pandemic has highlighted several cardiovascular complications, including myocarditis, which can be a significant cause of sudden cardiac death in young people. SARS-CoV-2 infection can cause cardiac muscle inflammation through direct mechanisms, such as viral invasion of myocardial cells, and indirect mechanisms, such as the systemic inflammatory response. Myocarditis can lead to life-threatening electrical dysfunctions and arrhythmias. Although post-infection myocarditis is more common, rare cases of post-vaccination myocarditis have also been reported, especially with mRNA vaccines. However, these post-vaccination cases tend to be mild and self-limiting, with a good response to treatment. Despite the associated risks, the benefits of vaccination far outweigh the risks, significantly reducing the incidence and severity of COVID-19 infections and related heart complications. It is crucial to continue surveillance and research to better understand the association between COVID-19, myocarditis and sudden cardiac death in the young and improve prevention and intervention strategies. In this literature review, we analyzed the pathogenetic mechanisms and histological features of myocarditis associated with COVID-19 and its vaccination, and focused on the correlation with sudden cardiac death. Full article
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15 pages, 1311 KB  
Review
Myocarditis Associated with COVID-19 Vaccination
by Kamila Florek and Mateusz Sokolski
Vaccines 2024, 12(10), 1193; https://doi.org/10.3390/vaccines12101193 - 19 Oct 2024
Cited by 7 | Viewed by 18507
Abstract
Myocarditis after the COVID-19 vaccine is one of the important adverse events following immunization, observed mainly after mRNA-based vaccines. Importantly, post-vaccination myocarditis was less common than myocarditis after SARS-CoV-2 infection, as it was scored at 19.7 per 1,000,000 doses and 2.76 per 1000 [...] Read more.
Myocarditis after the COVID-19 vaccine is one of the important adverse events following immunization, observed mainly after mRNA-based vaccines. Importantly, post-vaccination myocarditis was less common than myocarditis after SARS-CoV-2 infection, as it was scored at 19.7 per 1,000,000 doses and 2.76 per 1000 infections. Predominantly, its course was benign and, compared with the myocarditis after COVID-19 infection, significantly fewer patients developed heart failure or died among patients with post-vaccination myocarditis. The group at highest risk of myocarditis related to COVID-19 vaccination were young males who received a second dose of an mRNA vaccine. It was observed that, among mRNA vaccines, specifically mRNA-1273 was associated with a higher risk of myocarditis. The mechanism underlying myocarditis after COVID-19 vaccination is still under investigation and certain processes are being considered. Currently, some follow-up assessments of patients who developed vaccine-induced myocarditis are available and suggest a favorable prognosis. The aim of this review is to discuss the most recent data on myocarditis after COVID-19 vaccination considering its epidemiology, clinical presentation, diagnosis, management, relative risk of myocarditis compared with SARS-CoV-2 infection, potential underlying mechanism, and follow-up data of patients who developed post-vaccination myocarditis. Full article
(This article belongs to the Special Issue Recent Discoveries and Developments in RNA and DNA Vaccines)
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9 pages, 3362 KB  
Brief Report
The Role of Cardiac Magnetic Resonance in mRNA COVID-19 Vaccine-Related Myopericarditis: An Evolutive Case Series
by Gisela Feltes, Violeta Sánchez Sánchez, Esther Pérez-David, José Luis Moreno-Hurtrez, Juan Delgado Jiménez and Iván J. Núñez-Gil
J. Cardiovasc. Dev. Dis. 2024, 11(9), 259; https://doi.org/10.3390/jcdd11090259 - 25 Aug 2024
Cited by 1 | Viewed by 1975
Abstract
Numerous cases of myocarditis related to mRNA vaccines for COVID-19 have recently been described, usually in young men. Long-term evolutive cardiac magnetic resonance imaging (CMR) data are lacking. We describe four consecutive cases of COVID-19 vaccine-induced myocarditis. The pathological findings of cardiac magnetic [...] Read more.
Numerous cases of myocarditis related to mRNA vaccines for COVID-19 have recently been described, usually in young men. Long-term evolutive cardiac magnetic resonance imaging (CMR) data are lacking. We describe four consecutive cases of COVID-19 vaccine-induced myocarditis. The pathological findings of cardiac magnetic resonance confirmed the diagnosis in the acute phase, showing edema, as well as pericardial enhancement, with light pericardial effusion and late gadolinium enhancement (LGE), predominantly in the inferolateral wall. These cases highlight the unique value of cardiac magnetic resonance in patients with suspected myocarditis induced by COVID-19 RNAm vaccines as a tool to confirm the diagnosis, avoiding other invasive techniques, as well as for the long-term follow-up of patients. Our iterative CMR imaging demonstrated frequent long-term LGE persistence. Full article
(This article belongs to the Special Issue Current Practice in Cardiac Imaging)
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9 pages, 6488 KB  
Case Report
A Single Nucleotide Variant in Ankyrin-2 Influencing Ventricular Tachycardia in COVID-19 Associated Myocarditis
by Erin Haase, Chandana Kulkarni, Peyton Moore, Akash Ramanathan and Mohanakrishnan Sathyamoorthy
Cardiogenetics 2024, 14(2), 84-92; https://doi.org/10.3390/cardiogenetics14020007 - 6 May 2024
Viewed by 2686
Abstract
Introduction: This paper explores the potential influence of a single nucleotide variant in the ANK-2 gene on COVID-19 myocarditis-related ventricular tachycardia. Case Description: A 53-year-old female with a history of Crohn’s disease and asthma developed COVID-19. Shortly after infection, she experienced [...] Read more.
Introduction: This paper explores the potential influence of a single nucleotide variant in the ANK-2 gene on COVID-19 myocarditis-related ventricular tachycardia. Case Description: A 53-year-old female with a history of Crohn’s disease and asthma developed COVID-19. Shortly after infection, she experienced symptoms of chest pressure, palpitations, and shortness of breath, leading to the eventual diagnosis of myocarditis complicated by recurrent ventricular tachycardia. Treatment with mechanistically driven anti-arrhythmic therapy and beta-blockers suppressed this highly symptomatic ventricular tachycardia. Genetic testing to further risk stratify and influence long term care identified a single nucleotide variant in the ANK-2 gene, which is known to be associated with arrhythmic risk. Discussion: This case study highlights the use of rationally selected anti-arrhythmic therapy, mexiletine, in the management of ventricular tachycardia associated with COVID-19 myocarditis and the presence of a single nucleotide variant in ANK-2, raising the possibility of its contribution to VT susceptibility and severity. Our patient demonstrated significant improvement with administered therapeutics, including the resolution of myocarditis and ventricular tachycardia. The normalization of the QT interval during the resolution phase further supports the potential influence of the genetic variant in ANK-2 on potassium channel activity. Full article
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14 pages, 3078 KB  
Review
An Update on Myocarditis in Forensic Pathology
by Jessica Falleti, Pasquale Orabona, Maurizio Municinò, Gianluca Castellaro, Giovanna Fusco and Gelsomina Mansueto
Diagnostics 2024, 14(7), 760; https://doi.org/10.3390/diagnostics14070760 - 3 Apr 2024
Cited by 7 | Viewed by 5249
Abstract
In forensic medicine, myocarditis is a complicated topic in the context of sudden death and medical malpractice. A good knowledge of the etiopathology, histopathology, and available literature are both indispensable and essential for the correct management and evaluation of the causal link. Some [...] Read more.
In forensic medicine, myocarditis is a complicated topic in the context of sudden death and medical malpractice. A good knowledge of the etiopathology, histopathology, and available literature are both indispensable and essential for the correct management and evaluation of the causal link. Some agents, which are rarely lethal for humans, are not necessarily related to death from myocarditis, even if an infection in other organs such as the gastrointestinal tract is documented. The diagnosis of the causes of death is often difficult and confusing. In some cases, the hypothetical diagnosis of myocarditis as the cause of death is formulated by deduction, causing error and misleading the correct temporal evaluation of pathological events. We reviewed the literature realizing that histomorphological data are scarce and often poorly documented. Only after COVID-19 have the histomorphological aspects of myocarditis been better documented. This is due to poor autopsy practice and poor accuracy in identifying the specific histotype of myocarditis with identification of the responsible agent. We believe that four points are essential for a better understanding and complete diagnosis of the disease: (1) clinical classification of myocarditis; (2) etiological classification of myocarditis; (3) pathophysiology of viral and bacterial infections with host response; and (4) histopathological diagnosis with precise identification of the histotype and pathogen. In the review we provide histological images from authoritative scientific references with the aim of providing useful information and food for thought to readers. Full article
(This article belongs to the Special Issue New Perspectives in Forensic Diagnosis)
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14 pages, 699 KB  
Review
Spontaneous Coronary Artery Dissection and COVID-19: A Review of the Literature
by Grigorios Tsigkas, Maria Bozika, Kassiani-Maria Nastouli, Anastasios Apostolos, Michaela Routoula, Athanasia-Maria Georga, Anastasia Latta, Angeliki Papageorgiou, Michail I. Papafaklis, Georgios Leventopoulos, Grigoris V. Karamasis and Periklis Davlouros
Life 2024, 14(3), 315; https://doi.org/10.3390/life14030315 - 28 Feb 2024
Viewed by 4000
Abstract
SARS-CoV-2 is responsible for the global coronavirus disease 2019 (COVID-19) pandemic. While the cardiovascular effects of COVID-19 have been thoroughly described, there are limited published studies in the literature establishing a connection between spontaneous coronary artery dissection (SCAD) and COVID-19. Cardiovascular manifestations include, [...] Read more.
SARS-CoV-2 is responsible for the global coronavirus disease 2019 (COVID-19) pandemic. While the cardiovascular effects of COVID-19 have been thoroughly described, there are limited published studies in the literature establishing a connection between spontaneous coronary artery dissection (SCAD) and COVID-19. Cardiovascular manifestations include, among others, myocarditis, acute myocardial infraction, and thrombosis. In general, SCAD is an uncommon and underdiagnosed cause of acute myocardial infarction (AMI), particularly in younger women and in patients with underlying fibromuscular dysplasia (FMD). Many patients with SCAD often report significant emotional stress, especially in relation with job loss, during the week preceding their cardiac event. Moreover, the COVID-19 pandemic has led to societal stress and increased unemployment, factors that have been associated with cardiovascular morbidity. SCAD emerges as a rare manifestation of coronary artery disease, which a few recent case reports link to COVID-19. The aim of this article is to summarize the relevant data on the pathophysiology of COVID-19 and SCAD along with a review of the reported cases on acute coronary syndrome (ACS) following SARS-CoV2 infection and, thus, to provide insights about the relationship between COVID-19 and SCAD. Full article
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10 pages, 1343 KB  
Case Report
Fatal Myocarditis following COVID-19 mRNA Immunization: A Case Report and Differential Diagnosis Review
by Pedro Manuel Barros de Sousa, Elon Almeida Silva, Marcos Adriano Garcia Campos, Joyce Santos Lages, Rita da Graça Carvalhal Frazão Corrêa and Gyl Eanes Barros Silva
Vaccines 2024, 12(2), 194; https://doi.org/10.3390/vaccines12020194 - 13 Feb 2024
Cited by 2 | Viewed by 36930
Abstract
Carditis in childhood is a rare disease with several etiologies. We report a case of infant death due to pericarditis and myocarditis after the mRNA vaccine against COVID-19 (COVIDmRNAV). A 7-year-old male child received the first dose of the COVIDmRNAV and presented with [...] Read more.
Carditis in childhood is a rare disease with several etiologies. We report a case of infant death due to pericarditis and myocarditis after the mRNA vaccine against COVID-19 (COVIDmRNAV). A 7-year-old male child received the first dose of the COVIDmRNAV and presented with monoarthritis and a fever non-responsive to oral antibiotics. The laboratory investigation showed signs of infection (leukocytosis, high levels of c-reactive protein). His condition rapidly deteriorated, and the patient died. The autopsy identified pericardial fibrin deposits, hemorrhagic areas in the myocardium, and normal valves. A diffuse intermyocardial inflammatory infiltrate composed of T CD8+ lymphocytes and histiocytes was identified. An antistreptolysin O (ASO) dosage showed high titers. The presence of arthritis, elevated ASO, and carditis fulfills the criteria for rheumatic fever. However, valve disease and Aschoff’s nodules, present in 90% of rheumatic carditis cases, were absent in this case. The temporal correlation with mRNA vaccination prompted its inclusion as one of the etiologies. In cases of myocardial damage related to COVID-19mRNAV, it appears to be related to the expression of exosomes and lipid nanoparticles, leading to a cytokine storm. The potential effects of the COVID-19mRNAV must be considered in the pathogenesis of this disease, whether as an etiology or a contributing factor to a previously initiated myocardial injury. Full article
(This article belongs to the Special Issue 2nd Edition: Safety and Autoimmune Response to SARS-CoV-2 Vaccination)
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9 pages, 397 KB  
Review
Pharmacovigilance in Brazil: The Government Monitoring of Adverse Events Reported from COVID-19 Vaccine—A Narrative Review
by Mariana Carvalho de Moraes, Ivone Duarte and Rui Nunes
Healthcare 2024, 12(3), 371; https://doi.org/10.3390/healthcare12030371 - 1 Feb 2024
Viewed by 3903
Abstract
Background: Is pharmacovigilance at a moment of prominence for science, and in relation to governments’ responsibilities towards their nations, as the new coronavirus pandemic has surprised everyone in a negative and lethal way? Objective: Evaluate pharmacovigilance as a resource for controlling and understanding [...] Read more.
Background: Is pharmacovigilance at a moment of prominence for science, and in relation to governments’ responsibilities towards their nations, as the new coronavirus pandemic has surprised everyone in a negative and lethal way? Objective: Evaluate pharmacovigilance as a resource for controlling and understanding adverse events caused by vaccines in use. Methods: This is a narrative review of the literature. Scientific articles available in databases, government bulletins and similar bodies were used. The search was carried out using the descriptors: “Pharmacovigilance AND COVID-19 in Brazil”, “Vaccine Development AND COVID-19”, “Vaccination Hesitancy AND COVID-19”, “Public Health Surveillance AND COVID-19”. The period from May 2021 to June 2022 was covered. Results: The occurrence of some adverse events was observed, including cases of allergy, myocarditis and rheumatoid arthritis. It is important to highlight that these adverse events were identified as rare, occurring in a small percentage of the vaccinated population. Despite these adverse events, the benefits of vaccines proved to be essential for controlling the pandemic. Conclusions: The information presented highlights the importance of pharmacovigilance to continuously monitor and evaluate the safety of vaccines, identifying any potential adverse events early. This balance between risk and benefit emphasizes the need for a careful and informed approach when making decisions about vaccination policies, prioritizing public health and population safety. Full article
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10 pages, 252 KB  
Article
Uneventful COVID-19 Infection and Vaccination in a Cohort of Patients with Prior Myocarditis
by Anna Baritussio, Andrea Silvio Giordani, Cristina Basso, Cristina Vicenzetto, Giulia Lorenzoni, Matteo Gasparin, Sabino Iliceto, Bruno Scarpa, Dario Gregori, Renzo Marcolongo and Alida Linda Patrizia Caforio
Vaccines 2023, 11(12), 1742; https://doi.org/10.3390/vaccines11121742 - 22 Nov 2023
Cited by 2 | Viewed by 1740
Abstract
Myocarditis has in rare cases been associated with COVID-19 infection and has emerged as a possible rare side effect of vaccination with anti-COVID-19 messenger RNA vaccines. However, little is known about possible COVID-19 infection- and/or vaccination-related myocarditis relapse in patients with previous clinically [...] Read more.
Myocarditis has in rare cases been associated with COVID-19 infection and has emerged as a possible rare side effect of vaccination with anti-COVID-19 messenger RNA vaccines. However, little is known about possible COVID-19 infection- and/or vaccination-related myocarditis relapse in patients with previous clinically suspected or biopsy-proven myocarditis. Myocarditis may relapse, particularly in females with immune-mediated/autoimmune features and a predisposing immunogenetic background. We aimed to assess the prevalence of myocarditis relapse during the COVID-19 outbreak and following COVID-19 vaccination in a cohort of patients with prior myocarditis. We included in the analysis myocarditis patients on active follow-up, for whom COVID-19 infection and vaccination statuses were known, and collected data on clinical, laboratory and echocardiographic findings, and myocarditis relapse. We enrolled 409 patients, of whom 114 (28%) reported COVID-19 infection and 347 (85%) completed the vaccination scheme. Only one patient, having COVID-19 infection before the vaccination campaign started, was admitted to hospital because of pneumonia; the remaining patients had an uneventful COVID-19 infection course, with only mild symptoms. No myocarditis relapse was recorded following COVID-19 infection or vaccination. Moreover, the frequency of new myocarditis cases following the COVID-19 outbreak was not different compared to the three-year period preceding the COVID-19 era. In conclusion, in our cohort of patients with prior myocarditis, both COVID-19 infection and vaccination were uneventful. Full article
(This article belongs to the Special Issue SARS-CoV-2 Infections; Treatment and Development of Vaccine)
22 pages, 430 KB  
Review
Clinical Syndromes Related to SARS-CoV-2 Infection and Vaccination in Pediatric Age: A Narrative Review
by Maria Vincenza Mastrolia, Camilla De Cillia, Michela Orlandi, Sarah Abu-Rumeileh, Ilaria Maccora, Valerio Maniscalco, Edoardo Marrani, Ilaria Pagnini and Gabriele Simonini
Medicina 2023, 59(11), 2027; https://doi.org/10.3390/medicina59112027 - 17 Nov 2023
Cited by 3 | Viewed by 3180
Abstract
This narrative review aims to report the main clinical manifestations, therapeutic strategies, outcomes, and complications of acute SARS-CoV-2 infection in childhood and to summarize the data relating the SARS-CoV-2 vaccination efficacy and safety in pediatric age. SARS-CoV-2 infection mostly occurs asymptomatically in the [...] Read more.
This narrative review aims to report the main clinical manifestations, therapeutic strategies, outcomes, and complications of acute SARS-CoV-2 infection in childhood and to summarize the data relating the SARS-CoV-2 vaccination efficacy and safety in pediatric age. SARS-CoV-2 infection mostly occurs asymptomatically in the pediatric population, while multisystem inflammatory syndrome in children (MIS-C) represents the most severe coronavirus disease 2019 (COVID-19)-related illness, a life-threatening event with a high morbidity rate. After the development of SARS-CoV-2 vaccines and their subsequent approval in children, the rate of infection as well as the number of its related complications have shown a drastic decrease. Fully vaccinated children are protected from the risk of developing a severe disease and a similar protective role has been observed in the reduction of complications, in particular MIS-C. However, long-lasting immunity has not been demonstrated, booster doses have been required, and reinfection has been observed. With regards to vaccine safety, adverse events were generally mild to moderate in all age groups: local adverse events were the most commonly reported. Nevertheless, a potential association between SARS-CoV-2 vaccine and the subsequent development of inflammatory manifestations has been suggested. Myocarditis has rarely been observed following vaccination; it appeared to be more frequent among adolescent males with a mild clinical course leading to a complete recovery. SARS-CoV-2 vaccine-related MIS-C cases have been described, although a univocal definition and an exact time interval with respect to vaccination has not been reported, thus not establishing a direct causal link. Current evidence about COVID-19 vaccination in children and adolescents suggest that benefits outweigh potential risks. Long-term data collection of the post-authorization safety surveillance programs will better define the real incidence of SARS-CoV-2 vaccine-related complications in the pediatric population. Full article
(This article belongs to the Section Pediatrics)
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