Sex: M
Vaccine: COVID19
Symptoms: Physical examination, Polymerase chain reaction, Red blood cell sedimentation rate, Respiratory rate, SARS-CoV-2 antibody test
Clinical narrative: Acute Myocarditis Following COVID-19 Vaccination; This is a literature report.  A 25-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No alcohol and drug use" (unspecified if ongoing); "electronic tobacco products" (unspecified if ongoing), notes: for the past two months; "No alcohol and drug use" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE; HEPATITIS B VACCIN; TETANUS VACCINE; DIPHTHERIA VACCINE; PERTUSSIS VACCINE; HUMAN PAPILLOMA VACCINE. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Unknown Manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Single, Unknown Manufacturer), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "recovered", described as "Acute Myocarditis Following COVID-19 Vaccination". The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase MB (0-3.4): (03Jul2023) 5.5, notes: elevated; Blood pressure measurement: (2023) normal; Blood pressure measurement: (2023) 133/86 mmHg; Blood pressure systolic: (02Jul2023) normal; Blood pressure systolic: (02Jul2023) 25 mmHg; Body temperature: (2023) 98.7 Fahrenheit; Cardiovascular examination: (2023) revealed regular rate and rhythm with a normal S1, notes: and S2; Chest X-ray: (2023) was unremarkable; Coxsackie virus test: (2023) Negative; Drug screen: (2023) Negative, notes: for cocaine; (2023) Negative, notes: for THC; (2023) Negative, notes: for barbiturates; (2023) Negative, notes: for benzodiazepines; (2023) Negative, notes: for opiates; (2023) Negative, notes: for phencyclidine; Echocardiogram: (2023) showed evidence of race to mild pericardial, notes: effusion, mild tricuspid regurgitation, mild asymmetric mild left ventricular hypertrophy, and a left ventricular ejection fraction (LVEF) of 55%; (2023) Changes on the echocardiogram were not significant, notes: enough to use for the diagnosis of myocarditis solely; (2023) which showed trace pericardial effusion, mild, notes: tricuspid regurgitation, and mild asymmetric left ventricular hypertrophy but no wall motion abnormality was detected and LVEF was found to be normal; (2023) Septal wall view revealed mild asymmetric left, notes: ventricular hypertrophy; (2023) Lateral wall view revealed left ventricular, notes: filling pattern is normal for age, normal left ventricular systolic function, and normal LVEF of 55%; (2023) Diastolic view shows mitral valve and tricuspid, notes: valve are grossly normal in structure. Mild mitral regurgitation; (2023) Systolic view revealed mild tricuspid, notes: regurgitation with an RVSP of 25 mmHg and trace-to-mild pericardial effusion. The aortic root is normal in size; Ejection fraction: (2023) decreased; (2023) Normal; Ejection fraction: (02Jul2023) 55 %; Electrocardiogram: (2023) showed mild ST changes in leads V5-V6; Epstein-Barr virus test: (2023) Negative; Heart rate: (2023) 74, notes: Unit: per min; Hepatitis B virus test: (2023) Negative; Herpes simplex test: (2023) Negative; (2023) Negative; HIV test: (2023) Negative; Immunology test: (2023) Negative, notes: negative for COVID-19, hepatitis B, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), coxsackievirus, influenza virus as well as herpes simplex virus type 1 and 2; Influenza virus test: (2023) Negative; Oxygen saturation: (2023) 100 %; physical examination: (2023) the patient was well-developed for his age and a, notes: well-nourished man who was awake, alert, and oriented in time, place, and person; (2023) rest of the physical examination was unremarkable; Polymerase chain reaction: (2023) Negative, notes: negative for COVID-19, hepatitis B, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), coxsackievirus, influenza virus as well as herpes simplex virus type 1 and 2; Red blood cell sedimentation rate: (2023) Normal; Red blood cell sedimentation rate (0-15): (2023) 18, notes: Unit: mm/hr; Respiratory rate: (2023) 15; SARS-CoV-2 antibody test: (2023) Negative; Sinus rhythm: (2023) normal; Troponin: (04Jul2023) Non-reactive, notes: 3:04 pm; Troponin (0-0.03): (02Jul2023) 0.76 ng/ml, notes: 7:44 pm elevated; (03Jul2023) 1.60 ng/ml, notes: 12:30 am; (03Jul2023) 1.03 ng/ml, notes: 4:50 am; (03Jul2023) 0.37 ng/ml, notes: 1:50 pm; (04Jul2023) 1.46 ng/ml, notes: 4:22 am; (04Jul2023) 0.80 ng/ml, notes: 11:30 am; (05Jul2023) 0.66 ng/ml, notes: 4:10am. Therapeutic measures were taken as a result of myocarditis.  Clinical information: A 25-year-old male presented to the emergency department with a two-day history of palpitations and chest discomfort. He received multiple vaccines (final dose of COVID mRNA vaccine and single shots of live attenuated influenza vaccine (LAIV); HPV; hepatitis B; and tetanus, diphtheria, and pertussis (TDaP) during his immigration by the government agencies, three days prior to his symptoms. Following these vaccinations, he experienced abdominal discomfort, vomiting, palpitations, and burning chest pain as well as anxiety that he attributed to these symptoms. The patient completed his COVID-19 vaccine series and reported no symptoms or allergic reactions from the past COVID-19 vaccines. He denied any previous cardiac or other medical history. No alcohol or drug use was reported. The patient admits to using electronic tobacco products for the past two months. The patient has no known allergies. There is no pertinent family history of cardiac conditions. He had no recent hospitalizations. The review of symptoms was unremarkable except for palpitations and anxiety. On physical examination, the patient was well-developed for his age and a well-nourished man who was awake, alert, and oriented in time, place, and person. The patient was in no acute distress. Cardiovascular examination revealed regular rate and rhythm with a normal S1 and S2. There were no gallops, murmurs, or rubs; a normal point of maximal impulse palpated in the precordium to the left fifth intercostal space, halfinch medial to the left midclavicular line that was normal in character; and no jugular venous distention. The rest of the physical examination was unremarkable. The patient's blood pressure was 133/86 mmHg, pulse was 74/min, respiratory rate was 15, temperature was 98.7°F, and pulse oximetry was at 100 percent. Standard protocol for a patient presenting with chest pain in the inpatient setting includes serum biomarker analysis, cardiac electrical conduction analysis (electrocardiogram (ECG)), and structural evaluations of the heart (echocardiogram). Differentials for a patient presenting with palpitations or chest pain may include acute coronary syndrome, pericardial tamponade, myocarditis, pericarditis, stable/unstable angina, Prinzmetal angina, hypertrophic obstructive cardiomyopathy, congestive heart failure, aortic dissection, and pulmonary embolism. Non-cardiac differentials may include sickle cell crisis (acute chest syndrome), pleural effusion, pancreatitis, peptic ulcer disease, and gastroesophageal reflux disease. Investigations performed on this patient specific to his condition included serum troponin and creatine kinase-myocardial band (CK-MB) levels, ECG, echocardiogram, viral serology, and chest X-ray. Myocarditis was suspected based on the patient's clinical signs and symptoms in combination with acutely increased troponin levels during the episode of palpitations. On laboratory testing, results showed elevated troponin levels (0.76 ng/mL). Our medical team decided to admit the patient to the hospital. Over the course of a day, repeat troponin testing revealed an increase in level (1.60 ng/mL) (the normal range is between 0 and 0.04 ng/mL). Our cardiology service was then consulted. Further testing was ordered by the cardiology service, which included serial ECG, echocardiogram, serial troponin, erythrocyte sedimentation rate (ESR), c-reactive protein (CRP), drug screen, and lipid panel. Troponin levels fluctuated from July 2nd to July 5th, 2023 ranging between 0.76 and 0.66 (normal level: <0.03 ng/mL). The patient's CK-MB level was elevated at 5.5 ng/mL (normal level: 0.0-3.4 ng/mL), as well as the ESR at 18 mm/hr (normal level: 0-15 mm/hr). The echocardiogram showed evidence of race to mild pericardial effusion, mild tricuspid regurgitation, mild asymmetric mild left ventricular hypertrophy, and a left ventricular ejection fraction (LVEF) of 55%. Changes on the echocardiogram were not significant enough to use for the diagnosis of myocarditis solely. Decompensation of the heart after an acute episode of myocarditis may occur such as decreased ejection fraction and diffuse hypokinesis. As a result, a followup echocardiogram in a month was recommended to the patient in order to assess for these changes. Viral enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR) for COVID-19, hepatitis B, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), coxsackievirus, influenza virus as well as herpes simplex virus type 1 and 2 were all negative. ECG showed mild ST changes in leads V5-V6. Anterior-posterior X-ray of the chest was unremarkable. The drug screen was negative for cocaine, THC, barbiturates, benzodiazepines, opiates, and phencyclidine. Cardiac magnetic resonance imaging (MRI) is indicated but was not performed because of limited facility resources. While endomyocardial biopsy (EMB) is the gold standard for a myocarditis diagnosis, biopsy samples in otherwise healthy patients pose serious risks and complications. EMB would have been considered had the patient been in critical condition or hemodynamically unstable. A pathologic EMB with evidence of myocarditis would have shown inflammatory infiltrates of the myocardium with myocyte necrosis. Upon review of the results, the service decided to manage this patient as a case of myocarditis. In this case, the lack of a history of viral symptoms or positive viral serologies including ELISA or COVID-19 PCR test led us to assume that the vaccine, rather than an acute infection, was most likely to blame for the myocarditis. These immunization-associated myocarditis are most likely due to the hyperimmunity to vaccines. The cardiovascular service started the patient on losartan 25 mg tablet daily and metoprolol 25 mg tablet every 12 hours. On the fourth day of admission, the patient reported no chest pain, palpitations, and shortness of breath. He was medically stable and cleared for discharge. He was told to refrain from rigorous physical activity for three months and was discharged with beta-blockers (metoprolol 25 mg tablet every 12 hours) with angiotensin-converting enzyme (ACE) inhibitors (losartan 25 mg tablet daily) to help avoid cardiac remodeling. A follow-up visit in the next month is set up for the patient with the cardiologist.  No follow-up attempts are possible.; Sender's Comments: Based on the information provided in the narrative, a causal association between the event Myocarditis and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.