Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Weight
Clinical narrative: ST elevated myocardial infarction (STEMI); acute left lower extremity deep venous thrombosis; Symptomatic COVID-19 infection; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (ST elevated myocardial infarction (STEMI)), DEEP VEIN THROMBOSIS (acute left lower extremity deep venous thrombosis) and COVID-19 (Symptomatic COVID-19 infection) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.   LITERATURE REFERENCE:  Previously administered products included for COVID-19 prophylaxis: Moderna (Dose 1) and Moderna (Dose 2). Past adverse reactions to the above products included No adverse reaction with Moderna and Moderna. Concurrent medical conditions included Hypertension, Morbid obesity and Obstructive sleep apnea syndrome (continuous positive airway pressure (CPAP)).  On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE MYOCARDIAL INFARCTION (ST elevated myocardial infarction (STEMI)) (seriousness criteria hospitalization and medically significant), DEEP VEIN THROMBOSIS (acute left lower extremity deep venous thrombosis) (seriousness criteria hospitalization and medically significant) and COVID-19 (Symptomatic COVID-19 infection) (seriousness criterion hospitalization). The patient was treated with IBUPROFEN for Chest pain, at a dose of one tablet; ALTEPLASE (intracoronary) for Thrombolysis, at a dose of 4 milligram; EPTIFIBATIDE (intravenous) at a dose of drip for 18 hours; ASPIRIN [ACETYLSALICYLIC ACID] (oral) at a dose of 81 milligram once a day; TICAGRELOR (oral) at a dose of 90 milligram twice a day; HEPARIN at a dose of Heparin drip; WARFARIN at a dose of (for a goal international normalised ratio (INR) of 2-3) and CLOPIDOGREL at a dose of 75 milligram once a day. At the time of the report, ACUTE MYOCARDIAL INFARCTION (ST elevated myocardial infarction (STEMI)) was resolving and DEEP VEIN THROMBOSIS (acute left lower extremity deep venous thrombosis) and COVID-19 (Symptomatic COVID-19 infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiocardiogram: significant for 100% occlusion of the proximal right coronary artery (RCA) and thrombotic occlusion of the distal left anterior descending artery (LAD) and showed residual organized thrombus in the mid-distal RCA and right posterior left ventricular branch (RPLV), with flow further improving to TIMI-2 flow. Additional findings include minimal residual thrombus found in the distal LAD, with flow improved to TIMI-2 flow  (repeat right and left coronary angiogram was performed with right radial artery access). On an unknown date, Blood pressure measurement: 132/86 mmHg. On an unknown date, Body temperature: 36.4 degree Celsius. On an unknown date, C-reactive protein: greater than 18 mg/dl. On an unknown date, Echocardiogram: demonstrated moderately reduced left ventricular systolic function, an ejection fraction estimated at 30-35%, global hypokinesis with some regional wall motion abnormality suspected, the right ventricle was not well visualized, grossly normal in size with reduced systolic function, valve function not fully evaluated, a dilated ascending aorta, and an echogenic density seen in the posterior part of the pericardial sac, likely fat, but it was unable to rule out clot or effusion and Repeat transthoracic echo showed that the left ventricular systolic function was normal, the ejection fraction improved from prior levels of 30-35 percent to 60-65 percent, the right ventricular systolic function was normal, and no clot or effusion was noted.. On an unknown date, Electrocardiogram: revealed ST elevation in inferior leads II, III, and aVF suggestive of acute inferior infarct secondary to right coronary involvement and also demonstrated sinus tachycardia.. On an unknown date, Heart rate: 92 heart beats per minute. On an unknown date, Laboratory test: Demonstrated leukocytosis, thrombocytosis.. On an unknown date, Oxygen saturation: 97 % on a 2 L nasal cannula. On an unknown date, Physical examination: significant for morbid obesity and bilateral lower extremity edema, with the left lower extremity appearing more edematous than the right lower extremity.. On an unknown date, Respiratory rate: 25 breaths per minute. On an unknown date, SARS-CoV-2 test: Negative and Positive. On an unknown date, Serum ferritin: 585 ng/mL. On an unknown date, Transaminases: Elevated. On an unknown date, Troponin I (0-0.04 ng/mL): 44.3 ng/mL Elevated. On an unknown date, Ultrasound Doppler: Found no clot, six months after PCI.. On an unknown date, Ultrasound scan: showed an acute nonocclusive thrombus in the midsegment of the femoral vein to the popliteal vein and bilateral lower extremities revealed an acute left lower extremity deep venous thrombosis (DVT) extending from the mid-femoral to the popliteal vein. On an unknown date, Weight: 166 kg on admission.  For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient presented in acute distress with chest pain and shortness of breath. The symptoms started two days before admission. The chest pain was gradual in onset, intermittent, substernal in location, described as dull pressure in nature, radiated to the left arm, alleviated by lying down, and associated with mild shortness of breath. The chest pain was not resolved with Ibuprofen. Due to the persistence of chest pain, the patient was brought to the emergency department. COVID-19 was diagnosed 12 days prior to presentation.  The differential diagnosis of COVID-induced STEMI versus COVID/booster-associated STEMI was made on presentation.  The patient underwent percutaneous coronary intervention (PCI) with left heart catheterization and was noted to have severe thrombosis of the RCA and distal LAD. A twin pass catheter was passed across the proximal RCA lesion after multiple attempts to restore flow. This resulted in an improvement from thrombolysis in myocardial infarction (TIMI)-0 to marginal TIMI-1. Aspiration thrombectomy (AngioJet) was performed, and significant clot burden was maintained in the RCA and distal LAD despite interventions, with the PCI achieving slight success (TIMI-0 flow improving to TIMI-1 flow).  Intracoronary alteplase was not used in the LAD because, at that point in the procedure, the patient had exceeded radiological exposure of greater than 5 GY and was nearing the contrast limit of 290 ml. A transvenous pacemaker placed in the right lower extremity, which was removed next day and the patient was shifted to the cardiovascular intensive care unit.  Beta-blockers were initiated once the patient's heart rate was sustained. An acute left lower extremity deep venous thrombosis (DVT) extending from the mid-femoral to the popliteal vein was found After the PCI procedure. COVID was suspected to be the cause of the clot burden. An angiotensin-converting enzyme (ACE) inhibitor was added.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2023: Live Significant Follow up received by safety on 11-May-2023 has Email with full text article received and contains significant information: reporter details, literature citation details, relevant medical history, laboratory test, suspect product details, treatment medications, event details and an updated narrative. On 11-May-2023: Live follow up received by safety on 12-MAY-23 has email with updated IRD.  Company Comment: This is a literature non-study case concerning a 44 year-old, male patient with a history of hypertension, morbid obesity, obstructive sleep apnea on continuous positive airway pressure, who experienced the serious (due to medically significant-hospitalization) unexpected, AESI acute myocardial infarction and deep vein thrombosis (acute left lower extremity deep venous thrombosis) and the serious (hospitalization) unexpected event of COVID-19. The  events  occurred approximately 12 days after the third booster dose of mRNA-1273. 222 (Original/Omicron BA.4/5). The patient presented to ER in acute distress with chest pain and shortness of breath. Test performed showed: elevated troponin level of 44.3 ng/mL. Physical exam noted morbid obesity and bilateral lower extremity edema, with the left lower extremity appearing more edematous than the right one. The electrocardiogram revealed ST elevation in inferior leads II, III, and aVF. The Echo demonstrated moderately reduced left ventricular systolic function, an ejection fraction estimated at 30-35% and global hypokinesis. Coronary angiography was significant for 100% occlusion of the proximal RCA and thrombotic occlusion of LAD. The patient underwent percutaneous coronary intervention (PCI) with left heart catheterization and was noted to have severe thrombosis of the RCA and distal LAD. After the PCI procedure, the patient complained of left leg pain. An ultrasound of bilateral lower extremities revealed an acute left lower extremity deep venous thrombosis (DVT) extending from the mid-femoral to the popliteal vein. The outcome of the event acute myocardial infarction was reported as recovering and deep vein thrombosis was reported as recovered. The outcome of COVID-19 was reported as not provided. Obesity and COVID-19 could be confounders factors for these prothrombotic effects. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a literature non-study case concerning a 44 year-old, male patient with a history of hypertension, morbid obesity, obstructive sleep apnea on continuous positive airway pressure ,who experienced the serious (due to medically significant-hospitalization) unexpected, AESI acute myocardial infarction and deep vein thrombosis (acute left lower extremity deep venous thrombosis) and the serious (hospitalization) unexpected event of COVID-19. The  events occurred approximately 12 days after the third booster dose of mRNA-1273. 222 (Original/Omicron BA.4/5) The patient presented to ER in acute distress with chest pain and shortness of breath. Test performed showed: elevated troponin level of 44.3 ng/mL. Physical exam noted morbid obesity and bilateral lower extremity edema, with the left lower extremity appearing more edematous than the right one. The electrocardiogram revealed ST elevation in inferior leads II, III, and aVF. The Echo demonstrated moderately reduced left ventricular systolic function, an ejection fraction estimated at 30-35% and global hypokinesis. Coronary angiography was significant for 100% occlusion of the proximal RCA and thrombotic occlusion of LAD. The patient underwent percutaneous coronary intervention (PCI) with left heart catheterization and was noted to have severe thrombosis of the RCA and distal LAD. After the PCI procedure, the patient complained of left leg pain. An ultrasound of bilateral lower extremities revealed an acute left lower extremity deep venous thrombosis (DVT) extending from the mid-femoral to the popliteal vein. The outcome of the event acute myocardial infarction was reported as recovering and deep vein thrombosis was reported as recovered. The outcome of COVID-19 was reported as not provided. Obesity and COVID-19 could be confounders factors for these prothrombotic effects. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.