A narrative review of vaccine pharmacovigilance during mass vaccination campaigns: Focus on myocarditis and pericarditis after COVID-19 mRNA vaccination.

Vaccines have had a tremendous impact on reducing the burden of infectious diseases; however, they have the potential to cause adverse events following immunization (AEFIs). Prelicensure clinical trials are limited in their ability to detect rare AEFIs that may occur in less than one per thousand individuals. While postmarketing surveillance systems have shown COVID-19 mRNA vaccines to be safe, they led to the identification of rare cases of myocarditis and pericarditis after COVID-19 vaccination that were not initially detected in clinical trials. In this narrative review, we highlight concepts of vaccine pharmacovigilance during mass vaccination campaigns and compare the approaches used in the context of myocarditis and pericarditis following COVID-19 vaccination to historical examples. We describe mechanisms of passive and active surveillance, their strengths and limitations, and how they interacted to identify and characterize the safety signal of myocarditis and pericarditis after COVID-19 mRNA vaccination. Articles were synthesized from a PubMed search using relevant keywords for articles published on vaccine surveillance systems and myocarditis and pericarditis after COVID-19 vaccination, as well as the authors' collections of relevant publications and grey literature reports. The global experience around the identification and monitoring of myocarditis and pericarditis after COVID-19 mRNA vaccination has provided important lessons for vaccine safety surveillance and highlighted its importance in maintaining public trust in mass vaccination programmes in a pandemic context.

Ventricular Arrhythmia and COVID-19 Vaccine-associated Myocarditis.

17-year-old male presented with COVID-19 vaccine-associated myocarditis. Six months later, due to chest discomfort with exercise, the patient underwent an exercise stress test that revealed a 3-beat run of nonsustained ventricular tachycardia at 230 bpm at peak exercise. The long-term outcomes of COVID-19 vaccine-associated myocarditis are unclear. This patient had nonsustained ventricular tachycardia over 6 months after diagnosis.

Ventricular Arrhythmia and COVID-19 Vaccine-associated Myocarditis.

17-year-old male presented with COVID-19 vaccine-associated myocarditis. Six months later, due to chest discomfort with exercise, the patient underwent an exercise stress test that revealed a 3-beat run of nonsustained ventricular tachycardia at 230 bpm at peak exercise. The long-term outcomes of COVID-19 vaccine-associated myocarditis are unclear. This patient had nonsustained ventricular tachycardia over 6 months after diagnosis.

The Incidence of Myocarditis Following an Influenza Vaccination: A Population-Based Observational Study.

BACKGROUND AND OBJECTIVE: Recently, studies have pointed to a link between coronavirus disease 2019 vaccinations and myocarditis. Myocarditis following an influenza vaccine has been sporadically reported. However, it is not known whether this adverse event occurs among elderly individuals who have received influenza vaccines. We used a population-based database and a self-controlled case-series design to estimate the incidence of myocarditis following an influenza vaccination. METHODS: Data were extracted from Taiwan's National Health Insurance Research Database. The study population consisted of elderly people aged ≥ 65 years who had de novo myocarditis, which required hospitalization, within 6 months after receiving an influenza vaccination between 2003 and 2017. The first 1-7, 1-14, and 1-42 days after vaccination were defined as risk intervals, and the other periods were defined as control intervals. Poisson regression was used to calculate the incidence rate ratio for myocarditis between the risk and control periods. RESULTS: Within 180 days following a vaccination, 191 people were hospitalized for myocarditis among 19,678,904 people. In comparison with control intervals, the incidence rate ratios of an admission for myocarditis for days 1-7, 1-14, and 1-42 were 0.80 (95% confidence interval 0.36-1.81), 0.72 (95% confidence interval 0.39-1.32), and 0.73 (95% confidence interval 0.50-1.05), respectively. Subgroup analyses by sex, age, Charlson Comorbidity Index scores, and comorbidities did not yield significant differences in the incidence rate ratio. CONCLUSIONS: Regardless of the post-vaccination time and underlying baseline characteristics, the incidence risk of myocarditis is not significantly increased in the elderly following an influenza vaccination.

A narrative review of vaccine pharmacovigilance during mass vaccination campaigns: Focus on myocarditis and pericarditis after COVID-19 mRNA vaccination.

Vaccines have had a tremendous impact on reducing the burden of infectious diseases; however, they have the potential to cause adverse events following immunization (AEFIs). Prelicensure clinical trials are limited in their ability to detect rare AEFIs that may occur in less than one per thousand individuals. While postmarketing surveillance systems have shown COVID-19 mRNA vaccines to be safe, they led to the identification of rare cases of myocarditis and pericarditis after COVID-19 vaccination that were not initially detected in clinical trials. In this narrative review, we highlight concepts of vaccine pharmacovigilance during mass vaccination campaigns and compare the approaches used in the context of myocarditis and pericarditis following COVID-19 vaccination to historical examples. We describe mechanisms of passive and active surveillance, their strengths and limitations, and how they interacted to identify and characterize the safety signal of myocarditis and pericarditis after COVID-19 mRNA vaccination. Articles were synthesized from a PubMed search using relevant keywords for articles published on vaccine surveillance systems and myocarditis and pericarditis after COVID-19 vaccination, as well as the authors' collections of relevant publications and grey literature reports. The global experience around the identification and monitoring of myocarditis and pericarditis after COVID-19 mRNA vaccination has provided important lessons for vaccine safety surveillance and highlighted its importance in maintaining public trust in mass vaccination programmes in a pandemic context.

Post-COVID mRNA vaccine myocarditis in children: report of two cases.

The SARS-COV-2 pandemic led to the development of several vaccinations to contain the disease. The Pfizer-BioNTech COVID-19 (BNT162b2) vaccine was recommended on May 2021 for use in children above 12 years and older. The vaccine is safe, well tolerated and highly effective. Initial reports showed no serious adverse events; however, cases of myocarditis in young healthy male adolescents have been reported. We report two cases of myocarditis/perimyocarditis who presented with short history of chest pain following administration of the second dose of the MRN COVID-19 vaccine.

Case Report of COVID-19 mRNA Vaccine-Associated Myocarditis.

INTRODUCTION: We present a case report highlighting a single patient out of 3 who developed myocarditis within days after receiving Pfizer and Moderna COVID-19 mRNA vaccines. CASE PRESENTATION: A 19-year-old male was admitted to our hospitalist service with substernal chest pain that was sharp, constant, and varied with position. He had received his second dose of the Pfizer-BioNTech COVID-19 vaccine (Pfizer vaccine) 2 days prior. Electrocardiogram was consistent with pericarditis. He had persistently elevated troponins and globally reduced systolic function by echocardiogram, which was consistent with myocarditis. He received colchicine, ibuprofen, and proton pump inhibitors with a resolution of symptoms. After 32 days, follow-up echocardiogram had returned to normal, and his symptoms had resolved completely. DISCUSSION: Given the onset of symptoms after the second dose of vaccine and our review of similar cases in the literature, it seems likely the patient's myopericarditis was caused by the vaccine. Rare complications of new vaccines given to millions of people are rapidly identified by the Vaccine Adverse Event Reporting System. CONCLUSIONS: The identification of myopericarditis as a complication of mRNA vaccines will need further study to understand the pathophysiology, incidence, and prevalence in specific age groups and biological sexes.

Case Report of COVID-19 mRNA Vaccine-Associated Myocarditis.

INTRODUCTION: We present a case report highlighting a single patient out of 3 who developed myocarditis within days after receiving Pfizer and Moderna COVID-19 mRNA vaccines. CASE PRESENTATION: A 19-year-old male was admitted to our hospitalist service with substernal chest pain that was sharp, constant, and varied with position. He had received his second dose of the Pfizer-BioNTech COVID-19 vaccine (Pfizer vaccine) 2 days prior. Electrocardiogram was consistent with pericarditis. He had persistently elevated troponins and globally reduced systolic function by echocardiogram, which was consistent with myocarditis. He received colchicine, ibuprofen, and proton pump inhibitors with a resolution of symptoms. After 32 days, follow-up echocardiogram had returned to normal, and his symptoms had resolved completely. DISCUSSION: Given the onset of symptoms after the second dose of vaccine and our review of similar cases in the literature, it seems likely the patient's myopericarditis was caused by the vaccine. Rare complications of new vaccines given to millions of people are rapidly identified by the Vaccine Adverse Event Reporting System. CONCLUSIONS: The identification of myopericarditis as a complication of mRNA vaccines will need further study to understand the pathophysiology, incidence, and prevalence in specific age groups and biological sexes.

Two Cases of Acute Myocarditis in Young Male Adults After mRNA Vaccines Against COVID-19: Similarities and Differences.

Background: The advent of the new coronavirus SARS-CoV-2 has created unprecedented situations, both in terms of health and socio-economic level, worldwide. The emergence of vaccines against this highly contagious virus has raised hopes for its effective inhibition. The efficacy of vaccines, in more than a year of their application in clinical practice, is indisputable, both in terms of reducing serious hospitalizations and deaths, especially in high-risk populations. As with any new medication, the quest and investigation for side effects are reasonable. Myocarditis is one of the extremely rare side effects reported in mRNA vaccines, especially in young males. Case presentation: We present two cases of myocarditis that occurred in our hospital in a short time between them and compare them point by point to identify similarities and differences in order to draw conclusions about the severity of this side effect and its outcome. Conclusion: The benefits of vaccination against Covid-19 outweigh possible untoward effects and especially myocarditis. Health workers must close monitor the vaccinated patients for possible future cardiovascular complications.

Autopsy Histopathologic Cardiac Findings in 2 Adolescents Following the Second COVID-19 Vaccine Dose.

CONTEXT.­: Myocarditis in adolescents has been diagnosed clinically following the administration of the second dose of an mRNA vaccine for coronavirus disease 2019 (COVID-19). OBJECTIVE.­: To examine the autopsy microscopic cardiac findings in adolescent deaths that occurred shortly following administration of the second Pfizer-BioNTech COVID-19 dose to determine if the myocarditis described in these instances has the typical histopathology of myocarditis. DESIGN.­: Clinical and autopsy investigation of 2 teenage boys who died shortly following administration of the second Pfizer-BioNTech COVID-19 dose. RESULTS.­: The microscopic examination revealed features resembling a catecholamine-induced injury, not typical myocarditis pathology. CONCLUSIONS.­: The myocardial injury seen in these postvaccine hearts is different from typical myocarditis and has an appearance most closely resembling a catecholamine-mediated stress (toxic) cardiomyopathy. Understanding that these instances are different from typical myocarditis and that cytokine storm has a known feedback loop with catecholamines may help guide screening and therapy.