Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, C-reactive protein increased, Chest X-ray, Ejection fraction, Electrocardiogram
Clinical narrative: myocardial injury/acute myocarditis-like illness; This is a literature spontaneous report from a publication. This author reported similar events for 5 patients. This is the 1st of 5 reports.   Myopericarditis has been reported as a rare vaccination complication. There presented a case series of 7 patients hospitalized for acute myocarditis-like illness following COVID-19 vaccination. Six patients received mRNA (Moderna or Pfizer/BioNTech) and 1 received the adenovirus (Johnson & Johnson) vaccine. All patients presented 3-7 days post vaccination with acute onset chest pain and biochemical evidence of myocardial injury, by cardiac troponin I (Address withheld) (mean peak = 15.77ng/mL, median peak = 12.01ng/mL), or elevated high sensitivity troponin I (Address withheld) (peak=7000ng/L). All were hemodynamically stable and none had a pericardial friction rub or rash. Electrocardiogram (ECG) patterns varied from normal to ST segment elevation. Three patients underwent invasive coronary angiography and none had evidence of obstructive coronary artery disease. Echocardiograms showed left ventricular ejection fraction (LVEF) ranging from 35% to 62% with 5/7 having some degree of hypokinesis. Patients underwent cardiac magnetic resonance (CMR) between 3 and 37 days after vaccination, including multiplanar SSFP sequences, short axis T1 and T2 stacks, T1 mapping when available and multiplanar myocardial late gadolinium enhancement (LGE). Multi-focal subepicardial LGE was present in 7/7 patients and additional mid-myocardial LGE was demonstrated in 4/7 patients. There was corresponding myocardial edema in 3/7 patients. Two patients who underwent CMR> 7 days from presentation had no edema, with an additional patient's T2 images limited by artifact. One patient underwent endomyocardial biopsy without pathological evidence of myocarditis. None reported palpitations and there was no evidence of sustained arrhythmias. None had evidence of an active viral illness or autoimmune disease and 6/7 had PCR testing for acute COVID-19 infection during hospitalization, which was negative. Assessment of COVID-19 serology was obtained for 6/7 patients, with 4/6 showing presence of spike protein IgG antibodies.  Treatment varied and included beta-blocker and anti-inflammatory medication. Hospital length of stay was 3 plus or minus 1 days and all patients' symptoms resolved by hospital discharge. All cases were re-ported to the vaccine adverse event reporting system (VAERS) and the CDC.  A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Pfizer-BioNTech COVID-19 (BNT162b2) vaccine), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Denied history of prior COVID-19 infection, Negative PCR. The patient's concomitant medications were not reported. The patient presented symptoms as Sudden onset 7/10 chest pain 2days after vaccine, associated with shortness of breath, Worse when lying flat and with inspiration. Days from administration to presentation is 3 days. Vital Signs at Presentation: Temperature (C): 36.6; Heart Rate (bpm): 93; Blood Pressure (mmHg): 116/76; Respirations (per min): 18; CXR (cardiac magnetic resonance) findings: No acute Process. EKG findings: ST changes: PR depression in II , AVF , V4-V6 T wave inversion V1 ; Rhythm: normal sinus rhythm (NSR). Echocardiogram: 3 days post vaccine: LVEF (left ventricular ejection fraction): 35-40%; LVIDd (left ventricular end-diastolic internal dimension): 4.9 cm; IVS: 1.1 cm; RWMA (regional wall motion abnormalities): Mild, Global LV HKN Mildly decreased RV Function; Diastolic function: Normal. Cardiac MRI (magnetic resonance imaging): 11 days post vaccine: LVEF: 56% (no regional wall motion abnormalities); LGE (late gadolinium enhancement): Subepicardial  LGE Along the anterior and lateral walls. No pericardial thickening or effusion; T1 mapping (Native T1 values obtained by the Modified Look-Locker Inversion recovery (MOLLI) pulse sequence): 1000ms; T2 (Images acquired by T2 mapping or SA T2FS sequences): No Definitive edema. WBC (white blood cell count): 9.01; cTnI, ng/mL (< 0.04 ng/ml); Presentation: 4.24, Peak: 11.01, Post Discharge: <0.01; BNP, pg/Ml: 22; ESR, peak, mm/hr: 8; CRP, peak, mg/dL: 5.1; ANA, screen: negative; SARS-CoV-2 Ab: Spike IgG: Positive, Nucleocapsid IgG: Negative; Respiratory viral panel: ND; Coronary angiography findings: No Evidence of coronary artery disease (CAD). Clinical Course: The patient hospitalized for 4 days and received treatment as beta-blocker (BB), angiotensin receptor blocker (ARB), Statin. The outcome of event was unknown.  Our series of 7 male COVID-19 vaccination recipients who presented with myocarditis-like illness supports a potential causal association with vaccination given the temporal relationship, clinical presentation and CMR findings. The clinical course of vaccine-associated myocarditis-like illness appears favorable, with resolution of symptoms in all patients. Given the potential morbidity of COVID-19 infection even in younger adults, the risk-benefit decision for vaccination remains highly favorable. Vaccine adverse event reporting remains of high importance and further studies are needed to elucidate the pathophysiological mechanism to potentially identify or prevent future occurrences.  No follow-up attempts are needed. No further information is expected; Information about batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Heart injury cannot be 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.,Linked Report(s) : US-PFIZER INC-2021768175 same product/event/, different patient;US-PFIZER INC-2021768174 same product/event/, different patient;US-PFIZER INC-2021768172 same product/event/, different patient;US-PFIZER INC-2021768173 same product/event/, different patient