Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Angiocardiogram, Blood pressure measurement, C-reactive protein, COVID-19 pneumonia, Computerised tomogram thorax
Clinical narrative: Takotsubo Cardiomyopathy; COVID-19 pneumonia; This literature-non-study case was reported in a literature article and describes the occurrence of STRESS CARDIOMYOPATHY (Takotsubo Cardiomyopathy) and COVID-19 PNEUMONIA (COVID-19 pneumonia) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     The patient's past medical history included Methicillin-resistant Staphylococcus aureus infection, Cerebellar infarction and Brain stem infarction. Concurrent medical conditions included Chronic obstructive pulmonary disease, Hypertension, Obesity and Hepatitis C.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced STRESS CARDIOMYOPATHY (Takotsubo Cardiomyopathy) (seriousness criteria hospitalization and medically significant) and COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization and medically significant). The patient was treated with DEXAMETHASONE at a dose of 10 milligram once a day and REMDESIVIR at an unspecified dose and frequency. At the time of the report, STRESS CARDIOMYOPATHY (Takotsubo Cardiomyopathy) and COVID-19 PNEUMONIA (COVID-19 pneumonia) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiocardiogram: found to have no significant coronary artery stenosis with good thrombolysis in myocardial infarction (TIMI) 3 flow and a left ventriculogram with apical ballooning and (Negative) negative coronary findings. On an unknown date, Blood pressure measurement: 127/73 mmHg and 147/75 mmHg (on hospital day two). On an unknown date, C-reactive protein: 91.4 milligram per litre. On an unknown date, Computerised tomogram thorax: Chest scan with contrast was negative for an acute pulmonary embolism but found bilateral interstitial opacities. On an unknown date, Culture: positive methicillin-resistant Staphylococcus aureus respiratory culture. On an unknown date, Echocardiogram: Showed ejection fraction 20-25%, normal left ventricular chamber size with basal wall hyperkinesis, and apical wall hypokinesis and at follow up showed return of normal cardiac function, ejection fraction of greater than 55%, and no regional wall abnormalities. On an unknown date, Electrocardiogram: showed 1-mm upsloping ST elevations in leads II, III, and avF on hospital day two. On an unknown date, Fibrin D dimer: 28.45 microgram per millilitre. On an unknown date, Heart rate: 127 beats/min and 127 beats/min on hospital day two. On an unknown date, Hepatitis C antibody: Hepatitis C antibody reactivity. On an unknown date, Inflammatory marker test: trended down. On an unknown date, Interleukin level: 54.9 pg/ml. On an unknown date, Oxygen saturation: 60 %  on room air and 92 % Improved on Bi-level positive airway pressure. On an unknown date, Physical examination: Irregular tachycardia and scattered rhonchi was observed and showed increasing respiratory effort, irregular tachycardia, no significant murmurs and warm extremities on hospital day two. On an unknown date, Respiratory rate: 33 breaths per minute. On an unknown date, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Troponin: highly sensitive troponin level of less than 60 ng/L on admission and highly sensitive troponin level of greater than 3000ng/L on hospital day two.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered STRESS CARDIOMYOPATHY (Takotsubo Cardiomyopathy) to be not related. No further causality assessment was provided for COVID-19 PNEUMONIA (COVID-19 pneumonia).    A fully vaccinated 67-year-old, female patient with multiple comorbidities, no concomitant medications reported, and a recent exposure to COVID-19 infected relative, presented with shortness of breath, fever, and fatigue for 10 days. While dyspneic, she received a 2nd dose of mRNA-1273 vaccine and was hospitalized 4 days later for respiratory failure and management of COVID-19 pneumonia. Exam showed irregular tachycardia, scattered rhonchi, BP of 127/73mmHg, HR of 127 bpm, and O2 saturation of 60 percent on room air that improved to 92 percent on BiPAP. Lab tests were Chest CT scan revealing negative pulmonary embolism but with bilateral interstitial opacities, troponin level of less than 60ng/L, and a positive PCR COVID-19 test. Dexamethasone for 10 days and remdesivir for 5 days were started. Tocilizumab was not started due multiple comorbidities.   On hospital day 2, Patient presented with chest pain, an increasing respiratory effort, irregular tachycardia with HR of 127 beats/min, no significant murmurs, warm extremities, and BP of 147/75 mmHg. COVID-19 pneumonia with Takotsubo cardiomyopathy was established. ST elevation in leads II, III, and aVF on ECG, elevated troponin, inflammatory markers (IL-6, CRP) as well as D-dimer levels were reported. No significant coronary artery stenosis with good TIMI 3 flow on cardiac angiogram and a transthoracic echocardiogram with contrast showed consistent findings with TCM. She was transferred to the ICU and underwent elective intubation. Tracheostomy and percutaneous gastrostomy tube placement for long term convalescence were also reportedly done.  On the 22nd day, patient's follow-up echocardiogram showed return to normal cardiac function. Her condition improved.  The 2-dose series of mRNA-1273 provided viral protection with more than 92 percent efficacy 14 days after dose 1 and 94 percent after dose 2, but severe COVID-19 could still occur. Per the authors, natural viral transmission led to TCM in the patient.  Company comment: This literature non-study case concerns a 67-year-old, female patient with a recent exposure to a COVID-19 infected relative, who experienced the unexpected, medically significant events of AESI Stress cardiomyopathy and COVID-19 pneumonia in association with a 2nd dose of mRNA-1273 vaccine that led to hospitalization. Events' onset dates and the date of vaccination were not reported. Relevant history included vaccination with a 1st dose of m RNA-1273 vaccine on an unknown date, chronic obstructive pulmonary disease, hypertension, obesity, Hepatitis C, positive methicillin-resistant Staphylococcus aureus infection, and a recent large area infarction of the left cerebellar and the left aspect of the brain stem. Patient presented with a 10 day-history of shortness of breath, fever, and fatigue. While dyspneic, she received a 2nd dose of mRNA-1273 vaccine. She was hospitalized 4 days later for respiratory failure and management of COVID-19. Medical examination revealed irregular tachycardia with heart rate of 127 beats/min, scattered rhonchi on auscultation with a respiratory rate of 33 breaths/min, blood pressure of 127/73 mmHg, and oxygen saturation of 60 percent on room air which improved to 92 percent on Bi-level Positive Airway Pressure. Diagnostics on admission included a computerized tomography chest scan with contrast that was negative for an acute pulmonary embolism but with bilateral interstitial opacities; high sensitivity troponin level of less than 60 ng/L; and a positive nasal swab polymerase chain reaction for COVID-19. Initial treatments were dexamethasone for 10 days and remdesivir for 5 days. Tocilizumab was not started due to hepatitis C antibody reactivity, positive methicillin-resistant Staphylococcus aureus respiratory culture, and recent cerebellar and brain stem infarction. On the 2nd hospital day, she presented with chest pain, an increasing respiratory effort, irregular tachycardia with a heart rate of 127 beats/min, no significant murmurs, warm extremities, and blood pressure of 147/75 mmHg. COVID-19 pneumonia with Takotsubo cardiomyopathy was established. Supporting diagnostics were 1 mm-upsloping ST elevations in leads II, III, and aVF on electrocardiogram, troponin level of greater than 3000 ng/L, interleukin-6 level of 54.9 pg/mL, D-dimer level of 28.45 mcg/mL, C-reactive protein level of 91.4 mg/L, cardiac angiography that showed no significant coronary artery stenosis with good thrombolysis in myocardial infarction (TIMI) 3 flow and a left ventriculogram with apical ballooning, and a transthoracic echocardiogram with contrast that showed ejection fraction 20-25%, normal left ventricular chamber size with basal wall hyperkinesis, and apical wall hypokinesis. Patient was transferred to the intensive care unit and was intubated electively to reduce viral transmission. No significant improvement and continued ventilator dependence were reported, which prompted tracheostomy and percutaneous gastrostomy tube placement for long term convalescence. On the 22nd hospital day, her condition improved as supported by a follow-up echocardiogram that showed return of normal left ventricular function, ejection fraction of greater than 55%, and no regional wall abnormalities. Inflammatory markers and oxygen demand decreased, and cardiac angiogram was negative for coronary findings. Stress and infection may induce myocardial injury through IL-6 activation. Per the authors, the timing and exposure with positive PCR in this case pointed to natural viral transmission that led to TCM. The authors noted of severe COVID-19 infection despite complete vaccination in the patient. Patient's multiple comorbidities remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed per medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2022: Live follow up received by safety on 30-Sep-2022 has Email and contains significant information: Reporter information, citation details, medical history, treatment, laboratory tests and event details was updated.; Sender's Comments: This literature non-study case concerns a 67-year-old, female patient with a recent exposure to a COVID-19 infected relative, who experienced the unexpected, medically significant events of AESI Stress cardiomyopathy and COVID-19 pneumonia in association with a 2nd dose of mRNA-1273 vaccine that led to hospitalization. Events' onset dates and the date of vaccination were not reported. Relevant history included vaccination with a 1st dose of m RNA-1273 vaccine on an unknown date, chronic obstructive pulmonary disease, hypertension, obesity, Hepatitis C, positive methicillin-resistant Staphylococcus aureus infection, and a recent large area infarction of the left cerebellar and the left aspect of the brain stem. Patient presented with a 10 day-history of shortness of breath, fever, and fatigue. While dyspneic, she received a 2nd dose of mRNA-1273 vaccine. She was hospitalized 4 days later for respiratory failure and management of COVID-19. Medical examination revealed irregular tachycardia with heart rate of 127 beats/min, scattered rhonchi on auscultation with a respiratory rate of 33 breaths/min, blood pressure of 127/73 mmHg, and oxygen saturation of 60 percent on room air which improved to 92 percent on Bi-level Positive Airway Pressure. Diagnostics on admission included a computerized tomography chest scan with contrast that was negative for an acute pulmonary embolism but with bilateral interstitial opacities; high sensitivity troponin level of less than 60 ng/L; and a positive nasal swab polymerase chain reaction for COVID-19. Initial treatments were dexamethasone for 10 days and remdesivir for 5 days. Tocilizumab was not started due to hepatitis C antibody reactivity, positive methicillin-resistant Staphylococcus aureus respiratory culture, and recent cerebellar and brain stem infarction. On the 2nd hospital day, she presented with chest pain, an increasing respiratory effort, irregular tachycardia with a heart rate of 127 beats/min, no significant murmurs, warm extremities, and blood pressure of 147/75 mmHg. COVID-19 pneumonia with Takotsubo cardiomyopathy was established. Supporting diagnostics were 1 mm-upsloping ST elevations in leads II, III, and aVF on electrocardiogram, troponin level of greater than 3000 ng/L, interleukin-6 level of 54.9 pg/mL, D-dimer level of 28.45 mcg/mL, C-reactive protein level of 91.4 mg/L, cardiac angiography that showed no significant coronary artery stenosis with good thrombolysis in myocardial infarction (TIMI) 3 flow and a left ventriculogram with apical ballooning, and a transthoracic echocardiogram with contrast that showed ejection fraction 20-25%, normal left ventricular chamber size with basal wall hyperkinesis, and apical wall hypokinesis. Patient was transferred to the intensive care unit and was intubated electively to reduce viral transmission. No significant improvement and continued ventilator dependence were reported, which prompted tracheostomy and percutaneous gastrostomy tube placement for long term convalescence. On the 22nd hospital day, her condition improved as supported by a follow-up echocardiogram that showed return of normal left ventricular function, ejection fraction of greater than 55%, and no regional wall abnormalities. Inflammatory markers and oxygen demand decreased, and cardiac angiogram was negative for coronary findings. Stress and infection may induce myocardial injury through IL-6 activation. Per the authors, the timing and exposure with positive PCR in this case pointed to natural viral transmission that led to TCM. The authors noted of severe COVID-19 infection despite complete vaccination in the patient. Patient's multiple comorbidities remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed per medical judgement.