Myocarditis and pericarditis: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data
Myocarditis and/or pericarditis (also known as myopericarditis) are inflammatory diseases involving the myocardium (with non-ischemic myocyte necrosis) and/or the pericardial sac. Myocarditis/pericarditis (MPC) may present with variable clinical signs, symptoms, etiologies and outcomes, including ac...
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Published in | Vaccine Vol. 40; no. 10; pp. 1499 - 1511 |
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Main Authors | , , , , , , , |
Format | Journal Article |
Language | English |
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01.03.2022
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Abstract | Myocarditis and/or pericarditis (also known as myopericarditis) are inflammatory diseases involving the myocardium (with non-ischemic myocyte necrosis) and/or the pericardial sac. Myocarditis/pericarditis (MPC) may present with variable clinical signs, symptoms, etiologies and outcomes, including acute heart failure, sudden death, and chronic dilated cardiomyopathy. Possible undiagnosed and/or subclinical acute myocarditis, with undefined potential for delayed manifestations, presents further challenges for diagnosing an acute disease and may go undetected in the setting of infection as well as adverse drug/vaccine reactions.
The most common causes of MPC are viral, with non-infectious, drug/vaccine associated hypersensitivity and/or autoimmune causes being less well defined and with potentially different inflammatory mechanisms and treatment responses. Potential cardiac adverse events following immunization (AEFIs) encompass a larger scope of diagnoses such as triggering or exacerbating ischemic cardiac events, cardiomyopathy with potential heart failure, arrhythmias and sudden death. The current published experience does not support a potential causal association with vaccines based on epidemiologic evidence of relative risk increases compared with background unvaccinated incidence. The only evidence supporting a possible causal association of MPC with a vaccine comes from case reports.
Hypersensitivity MPC as a drug/vaccine induced cardiac adverse event has long been a concern for post-licensure safety surveillance, as well as safety data submission for licensure. Other cardiac adverse events, such as dilated cardiomyopathy, were also defined in the CDC definitions for adverse events after smallpox vaccination in 2006. In addition, several groups have attempted to develop and improve the definition and adjudication of post-vaccination cardiovascular events. We developed the current case definitions for myocarditis and pericarditis as an AEFI building on experience and lessons learnt, as well as a comprehensive literature review. Considerations of other etiologies and causal relationships are outside the scope of this document. |
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AbstractList | Myocarditis and/or pericarditis (also known as myopericarditis) are inflammatory diseases involving the myocardium (with non-ischemic myocyte necrosis) and/or the pericardial sac. Myocarditis/pericarditis (MPC) may present with variable clinical signs, symptoms, etiologies and outcomes, including acute heart failure, sudden death, and chronic dilated cardiomyopathy. Possible undiagnosed and/or subclinical acute myocarditis, with undefined potential for delayed manifestations, presents further challenges for diagnosing an acute disease and may go undetected in the setting of infection as well as adverse drug/vaccine reactions.
The most common causes of MPC are viral, with non-infectious, drug/vaccine associated hypersensitivity and/or autoimmune causes being less well defined and with potentially different inflammatory mechanisms and treatment responses. Potential cardiac adverse events following immunization (AEFIs) encompass a larger scope of diagnoses such as triggering or exacerbating ischemic cardiac events, cardiomyopathy with potential heart failure, arrhythmias and sudden death. The current published experience does not support a potential causal association with vaccines based on epidemiologic evidence of relative risk increases compared with background unvaccinated incidence. The only evidence supporting a possible causal association of MPC with a vaccine comes from case reports.
Hypersensitivity MPC as a drug/vaccine induced cardiac adverse event has long been a concern for post-licensure safety surveillance, as well as safety data submission for licensure. Other cardiac adverse events, such as dilated cardiomyopathy, were also defined in the CDC definitions for adverse events after smallpox vaccination in 2006. In addition, several groups have attempted to develop and improve the definition and adjudication of post-vaccination cardiovascular events. We developed the current case definitions for myocarditis and pericarditis as an AEFI building on experience and lessons learnt, as well as a comprehensive literature review. Considerations of other etiologies and causal relationships are outside the scope of this document. Myocarditis and/or pericarditis (also known as myopericarditis) are inflammatory diseases involving the myocardium (with non-ischemic myocyte necrosis) and/or the pericardial sac. Myocarditis/pericarditis (MPC) may present with variable clinical signs, symptoms, etiologies and outcomes, including acute heart failure, sudden death, and chronic dilated cardiomyopathy. Possible undiagnosed and/or subclinical acute myocarditis, with undefined potential for delayed manifestations, presents further challenges for diagnosing an acute disease and may go undetected in the setting of infection as well as adverse drug/vaccine reactions.The most common causes of MPC are viral, with non-infectious, drug/vaccine associated hypersensitivity and/or autoimmune causes being less well defined and with potentially different inflammatory mechanisms and treatment responses. Potential cardiac adverse events following immunization (AEFIs) encompass a larger scope of diagnoses such as triggering or exacerbating ischemic cardiac events, cardiomyopathy with potential heart failure, arrhythmias and sudden death. The current published experience does not support a potential causal association with vaccines based on epidemiologic evidence of relative risk increases compared with background unvaccinated incidence. The only evidence supporting a possible causal association of MPC with a vaccine comes from case reports.Hypersensitivity MPC as a drug/vaccine induced cardiac adverse event has long been a concern for post-licensure safety surveillance, as well as safety data submission for licensure. Other cardiac adverse events, such as dilated cardiomyopathy, were also defined in the CDC definitions for adverse events after smallpox vaccination in 2006. In addition, several groups have attempted to develop and improve the definition and adjudication of post-vaccination cardiovascular events. We developed the current case definitions for myocarditis and pericarditis as an AEFI building on experience and lessons learnt, as well as a comprehensive literature review. Considerations of other etiologies and causal relationships are outside the scope of this document. |
Author | Savorgnan, Fabio Guggilla, Rama K. Sexson Tejtel, S. Kristen Khuri-Bulos, Najwa Munoz, Flor M. Engler, Renata J.M. Al-Ammouri, Iyad Phillips, Lee |
Author_xml | – sequence: 1 givenname: S. Kristen surname: Sexson Tejtel fullname: Sexson Tejtel, S. Kristen email: sxsexson@texaschildrens.org, bc-coordinator@taskforce.org organization: Department of Pediatrics, Cardiology Section, Baylor College of Medicine, Houston, TX, USA – sequence: 2 givenname: Flor M. surname: Munoz fullname: Munoz, Flor M. organization: Departments of Pediatrics, Section of Infectious Diseases, and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA – sequence: 3 givenname: Iyad surname: Al-Ammouri fullname: Al-Ammouri, Iyad organization: Pediatric Cardiology, The University of Jordan. Amman, Jordan – sequence: 4 givenname: Fabio surname: Savorgnan fullname: Savorgnan, Fabio organization: Department of Pediatrics, Section of Pediatric Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA – sequence: 5 givenname: Rama K. surname: Guggilla fullname: Guggilla, Rama K. organization: Department of Population Medicine and Lifestyle Diseases Prevention, Faculty of Medicine with the Division of Dentistry and Division of Medical Education in English, Medical University of Bialystok, Poland – sequence: 6 givenname: Najwa surname: Khuri-Bulos fullname: Khuri-Bulos, Najwa organization: Pediatric Infectious Diseases, Vaccines, The University of Jordan, Amman, Jordan – sequence: 7 givenname: Lee surname: Phillips fullname: Phillips, Lee organization: Pharmaco-epidemiology, Cardiovascular Drug Safety, USA – sequence: 8 givenname: Renata J.M. surname: Engler fullname: Engler, Renata J.M. organization: Allergy-Immunology-Immunizations, Department of Medicine, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, and Immunization Healthcare Division, Defense Health Agency, Bethesda, MD, USA |
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Keywords | Myocarditis Pericarditis Immunization Myopericarditis Adverse events Case definition Brighton Collaboration Guidelines |
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