Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: N-terminal prohormone brain natriuretic peptide, Physical examination, Platelet count, Renal function test, Troponin
Clinical narrative: new-onset nonischemic cardiomyopathy and HF was doxorubicin cardiotoxicity as a delayed presentation; the patient was treated for new onset of HF (heart failure); This literature-non-study case was reported in a literature article and describes the occurrence of CARDIOMYOPATHY (new-onset nonischemic cardiomyopathy and HF was doxorubicin cardiotoxicity as a delayed presentation) and CARDIAC FAILURE (the patient was treated for new onset of HF (heart failure)) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis, FLUOROURACIL SODIUM (5-FLUOROURACIL [FLUOROURACIL SODIUM]) for Breast cancer female and DOXORUBICIN for Breast cancer female.    The patient's past medical history included Thyroidectomy, Mastectomy in 2005, Chemotherapy (adjuvant) in 2005 and Radiation therapy in 2005. Concurrent medical conditions included Breast cancer female, Thyroid cancer (s/p resection) and Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.   In 2005, the patient started FLUOROURACIL SODIUM (5-FLUOROURACIL [FLUOROURACIL SODIUM]) (unknown route) at an unspecified dose and DOXORUBICIN (unknown route) UNK, 20 years prior. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIOMYOPATHY (new-onset nonischemic cardiomyopathy and HF was doxorubicin cardiotoxicity as a delayed presentation) (seriousness criteria hospitalization and medically significant) and CARDIAC FAILURE (the patient was treated for new onset of HF (heart failure)) (seriousness criteria hospitalization and medically significant). The patient was treated with FUROSEMIDE (intravenous) for Heart failure, at a dose of 40 milligram twice a day; METOPROLOL SUCCINATE at an unspecified dose and frequency; SACUBITRIL;VALSARTAN at an unspecified dose and frequency and EMPAGLIFLOZIN at an unspecified dose and frequency. At the time of the report, CARDIOMYOPATHY (new-onset nonischemic cardiomyopathy and HF was doxorubicin cardiotoxicity as a delayed presentation) and CARDIAC FAILURE (the patient was treated for new onset of HF (heart failure)) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood electrolytes: normal. On an unknown date, Blood pressure measurement: 161/98 mmHg. On an unknown date, Catheterisation cardiac: revealed non-obstructive CAD.. On an unknown date, Chest X-ray: showed pulmonary vascular congestion and enlarged cardiac silhouette.. On an unknown date, Echocardiogram: revealed diffuse left ventricular hypokinesis, left ventricular ejection fraction (LVEF) of 10%, reduced right ven- tricular contractility, moderately dilated left atrium, 2 + mitral regurgitation, 2 + aortic regurgitation, and 2 + pulmonic regurgitation. and after 2 weeks showed an improved LVEF of 25%.. On an unknown date, Electrocardiogram: showed T-wave in- versions in leads V4-V6, left ventricular hypertrophy and J- point elevation in lead V3.. On an unknown date, Haemoglobin: normal. On an unknown date, Heart rate: 122 heart beats per minute. On an unknown date, N-terminal prohormone brain natriuretic peptide: 8400 pg/ml elevated. On an unknown date, Physical examination: skin was warm and lungs were remarkable for mild, faint bilateral crackles with jugular venous distention and lower extremity edema.. On an unknown date, Platelet count: normal. On an unknown date, Renal function test: normal. On an unknown date, Troponin: Negative, Negative and Negative. On an unknown date, White blood cell count: normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient presented with progressively worsening shortness of breath and worsened exercise tolerance for the past 1 month. In the past few days, patient had also experienced intermittent wheezing without any chest pain, cough, orthopnea, paroxysmal nocturnal dyspnea, edema, changes in diets, travel, or sick contacts.  The last dose of doxorubicin was 20 years prior to presentation. Total dose of doxorubicin administered was unknown. The patient had no prior or current history of smoking, alcohol, caffeine or illicit drug use, and her cardiac family history was noncontributory.  In the absence of traditional risk factors and her diagnostic findings, the most likely etiology of her new-onset non ischemic cardiomyopathy and HF (heart failure) was doxorubicin cardiotoxicity as a delayed presentation. She was subsequently started on guideline directed management therapy (GDMT). The patient discharged with outpatient cardiology follow up.   During follow-up, the patient reported good compliance with her medication and improvement in her symptoms where she has returned to her baseline exercise tolerance. The patient remained clinically stable without acute decompensation of her heart failure during the months following discharge.   It was found that anthracycline induced cardiotoxicity appears to be a multifactorial process with different mechanisms that induce cardiomyocyte injury and death. The slow process of injury would have rendered our patient increasingly susceptible to progressive dysfunction related to aging and other disease processes that culminated in the development of symptomatic HF.  The author concluded that Doxorubicin induced cardiomyopathy typically presents early, but delayed onset is also possible. The patient had a lack of cardiovascular risk factors, non- obstructive CAD, and a history of chemotherapy for breast cancer makes delayed onset doxorubicin induced cardiomyopathy the most likely diagnosis  Company Comment: This is a literature non-study case concerning a 60-year-old female patient with reported medical history of left sided breast cancer, thyroid cancer, hypothyroidism, thyroidectomy, mastectomy (2005) and chemotherapy (2005) and radiation therapy (2005) who experienced the serious (due to medically significant and hospitalization) unexpected, events of Cardiomyopathy reported as new-onset nonischemic cardiomyopathy and HF (heart failure) was doxorubicin cardiotoxicity as a delayed presentation. The patient presented with progressively worsening shortness of breath and worsened exercise tolerance for the past 1 month. In the past few days, patient had also experienced intermittent wheezing without any chest pain, cough, orthopnea, paroxysmal nocturnal dyspnea, edema, changes in diets, travel, or sick contacts. The patient had no prior or current history of smoking, alcohol, caffeine or il-licit drug use, and her cardiac family history was noncontributory. Vital signs were significant for sinus tachycardia of 122 bpm, blood pressure of 161/98 mmHg and physical examination showed warm skin and lungs were remarkable for mild, faint bilateral crackles with jugular venous distention and lower extremity edema. Diagnostic tests performed included: Blood electrolytes with normal results, cardiac catheterization which revealed non-obstructive CAD, chest X-ray which showed pulmonary vascular congestion and enlarged cardiac silhouette, initial echocardiogram which revealed diffuse left ventricular hypokinesis, left ventricular ejection fraction (LVEF) of 10%, reduced right ventricular contractility, moderately dilated left atrium, 2 + mitral regurgitation, 2 + aortic regurgitation, and 2 + pulmonic regurgitation, electrocardiogram which showed T-wave inversions in leads V4-V6, left ventricular hypertrophy and J- point elevation in lead V3, other lab tests included included haemoglobin within normal results, platelet count within normal results, renal function test resulted normal, White blood cell count resulted normal, initial and 2 follow up troponin levels were reported as negative and elevated N-terminal prohormone brain natriuretic peptide resulted in 8400 pg/ml (reference ranges not provided). Treatment for the event included furosemide for heart failure at a dose of 40 milligram twice a day, metoprolol succinate (indication and dose not reported), sacubitril/valsartan (indication and dose not reported). Other concomitant medication included empagliflozin (indication and dose not reported) and levothyroxine 25 mcg daily for hypothyroidism). After 2 weeks of treatment, follow up echocardiogram showed an improved LVEF of 25%. The event occurred after the booster dose of mRNA-1273 vaccine; dose number not provided. Co-suspect products included non-company product DOXORUBICIN 20 years before presentation of current diagnosis, 5-FLUOROURACIL for Breast cancer female and Pfizer- BioNTech COVID-19 vaccine (Tozinameran) for COVID-19 prophylaxis. The outcome of the events Cardiomyopathy and heart failure was reported as resolving.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2023: Live significant to follow-up received on 01-Feb-2023 contains mail and FTA included patient history, laboratory details, product and citation details were added.; Sender's Comments: Company Comment: This is a literature non-study case concerning a 60-year-old female patient with reported medical history of left sided breast cancer, thyroid cancer, hypothyroidism, thyroidectomy, mastectomy (2005) and chemotherapy (2005) and radiation therapy (2005) who experienced the serious (due to medically significant and hospitalization) unexpected, events of Cardiomyopathy reported as new-onset nonischemic cardiomyopathy and HF (heart failure) was doxorubicin cardiotoxicity as a delayed presentation. The patient presented with progressively worsening shortness of breath and worsened exercise tolerance for the past 1 month. In the past few days, patient had also experienced intermittent wheezing without any chest pain, cough, orthopnea, paroxysmal nocturnal dyspnea, edema, changes in diets, travel, or sick contacts. The patient had no prior or current history of smoking, alcohol, caffeine or il-licit drug use, and her cardiac family history was noncontributory. Vital signs were significant for sinus tachycardia of 122 bpm, blood pressure of 161/98 mmHg and physical examination showed warm skin and lungs were remarkable for mild, faint bilateral crackles with jugular venous distention and lower extremity edema. Diagnostic tests performed included: Blood electrolytes with normal results, cardiac catheterization which revealed non-obstructive CAD, chest X-ray which showed pulmonary vascular congestion and enlarged cardiac silhouette, initial echocardiogram which revealed diffuse left ventricular hypokinesis, left ventricular ejection fraction (LVEF) of 10%, reduced right ventricular contractility, moderately dilated left atrium, 2 + mitral regurgitation, 2 + aortic regurgitation, and 2 + pulmonic regurgitation, electrocardiogram which showed T-wave inversions in leads V4-V6, left ventricular hypertrophy and J- point elevation in lead V3, other lab tests included included haemoglobin within normal results, platelet count within normal results, renal function test resulted normal, White blood cell count resulted normal, initial and 2 follow up troponin levels were reported as negative and elevated N-terminal prohormone brain natriuretic peptide resulted in 8400 pg/ml (reference ranges not provided). Treatment for the event included furosemide for heart failure at a dose of 40 milligram twice a day, metoprolol succinate (indication and dose not reported), sacubitril/valsartan (indication and dose not reported). Other concomitant medication included empagliflozin (indication and dose not reported) and levothyroxine 25 mcg daily for hypothyroidism). After 2 weeks of treatment, follow up echocardiogram showed an improved LVEF of 25%. The event occurred after the booster dose of mRNA-1273 vaccine; dose number not provided. Co-suspect products included non-company product DOXORUBICIN 20 years before presentation of current diagnosis, 5-FLUOROURACIL for Breast cancer female and Pfizer- BioNTech COVID-19 vaccine (Tozinameran) for COVID-19 prophylaxis. The outcome of the events Cardiomyopathy and heart failure was reported as resolving.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.