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Examples of products suspected to be associated with such cases are: drugs (phenothiazines, tricyclic antidepressants, lithium); vaccines (SARS-CoV-2 mRNA preparations, conjugate meningococcal C, hepatitis B, tetanus toxoid); and biologics (several monoclonal antibody agents). Signs and symptoms of myocarditis include: nonspecific signs and symptoms including chest pain, palpitations, dyspnea on exertion, diaphoresis, or sudden death; abnormal histopathologic examination of myocardial tissue; abnormalities on cardiac MRI, echocardiogram and/or EKG (including PR segment depression, ST segment elevation, conduction block, paroxysmal and sustained tachyarrhythmias); and abnormal laboratory parameters including elevated myocardial biomarkers. Signs and symptoms of pericarditis include: nonspecific signs and symptoms similar to those of myocarditis; abnormal physical examination findings including pericardial friction, pericardial rub, or pulsus paradoxus; abnormal histopathologic examination of pericardial tissue; and abnormalities of cardiac MRI, echocardiography, EKG (including PR segment depression, ST segment elevation, T wave inversion, low voltage tracings), nuclear medicine imaging, and/or heart silhouette enlargement on chest radiograph."],"label":[],"synonym":[],"obsolete":false,"prefixIRI":null,"subClassOf":[],"xref":null,"inScheme":[],"created":null,"modified":null,"memberOf":[],"altLabelXl":[],"hiddenLabelXl":[],"parents":[],"prefLabelXl":[],"isInActiveScheme":[null],"isInActiveCollection":[],"properties":{"http://purl.bioontology.org/ontology/MEDDRA/SMQ_STATUS":["A"],"http://www.w3.org/1999/02/22-rdf-syntax-ns#type":["http://www.w3.org/2002/07/owl#Class"],"http://bioportal.bioontology.org/ontologies/umls/tui":["T185"],"http://www.w3.org/2004/02/skos/core#notation":["20000239"],"http://purl.bioontology.org/ontology/MEDDRA/SMQ_LEVEL":["1"],"http://bioportal.bioontology.org/ontologies/umls/hasSTY":["http://purl.bioontology.org/ontology/STY/T185"],"http://purl.bioontology.org/ontology/MEDDRA/SMQ_ALGO":["N"],"http://purl.bioontology.org/ontology/MEDDRA/SOS":["Noninfectious myocarditis/pericarditis (SMQ) has been developed by the MedDRA MSSO and an international group of regulatory and industry experts, based on medical judgment. 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Giant cell myocarditis as a manifestation of drug hypersensitivity. Cardiovascular Pathology 9 (2000) 287-291. Imazio M and LeWinter M. Evaluation and treatment of pericarditis: a systematic review. JAMA 314 (2015) 1498-1506. Masek KP and Levis JT. ECG Diagnosis: Acute pericarditis. The Permanente Journal 17(4), (2013). Mevorach D, Anis E, Cedar N et al. Myocarditis after BNT161b2 mRNA Vaccine against Covid-19 in Israel. New England Journal of Medicine, October 6, 2021. Patone M, Mei XW, Handunnetthi L, Dixon S et al. Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection. Nature Medicine (2021) (accessed on 14 December 2021) https://www.nature.com/articles/s41591-021-01630-0. Taliercio CP, Olney BA and Lie JT. Myocarditis related to drug hypersensitivity. Mayo Clinic Proceedings 60 (1985) 463-468. Witberg G, Barda N, Hoss S et al. Myocarditis after Covid-19 Vaccination in a Large Health Care Organization. New England Journal of Medicine, October 6, 2021."],"http://www.w3.org/2004/02/skos/core#definition":["Myocarditis is defined as inflammation of the myocardium. Pericarditis is defined as inflammation of the pericardium. Myocarditis and pericarditis may be acute, subacute, or chronic. Both myocarditis and pericarditis can have various etiologies including infections, toxins, autoimmune disorders, and hypersensitivity reactions to drugs, biologics, and vaccines. The focus of this SMQ is to identify cases of noninfectious myocarditis and/or pericarditis possibly related to exposure to drugs, vaccines, and biologics. Examples of products suspected to be associated with such cases are: drugs (phenothiazines, tricyclic antidepressants, lithium); vaccines (SARS-CoV-2 mRNA preparations, conjugate meningococcal C, hepatitis B, tetanus toxoid); and biologics (several monoclonal antibody agents). Signs and symptoms of myocarditis include: nonspecific signs and symptoms including chest pain, palpitations, dyspnea on exertion, diaphoresis, or sudden death; abnormal histopathologic examination of myocardial tissue; abnormalities on cardiac MRI, echocardiogram and/or EKG (including PR segment depression, ST segment elevation, conduction block, paroxysmal and sustained tachyarrhythmias); and abnormal laboratory parameters including elevated myocardial biomarkers. 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