Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: PO2 decreased, Platelet count normal, Rales, Red blood cell sedimentation rate increased, Respiratory failure
Clinical narrative: Cardiogenic shock; Takotsubo Cardiomyopathy; This literature-non-study case was reported in a literature article and describes the occurrence of CARDIOGENIC SHOCK (Cardiogenic shock) and STRESS CARDIOMYOPATHY (Takotsubo Cardiomyopathy) in a 59-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.      The patient's past medical history included Ex-smoker (smoking history for five years, which she quit fifteen years ago.). Previously administered products included for COVID-19 prophylaxis: Covid-19 vaccine (first dose of COVID-19 vaccine and was asymptomatic after her subsequent doses). Past adverse reactions to the above products included Flu-like symptoms with Covid-19 vaccine. Concurrent medical conditions included Hypothyroidism, Hyperlipidemia and Celiac disease.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIOGENIC SHOCK (Cardiogenic shock) (seriousness criteria medically significant and life threatening) and STRESS CARDIOMYOPATHY (Takotsubo Cardiomyopathy) (seriousness criterion medically significant). At the time of the report, CARDIOGENIC SHOCK (Cardiogenic shock) and STRESS CARDIOMYOPATHY (Takotsubo Cardiomyopathy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase (8-57 international unit per litre): 49 international unit per litre. On an unknown date, Angiocardiogram: showing normal coronary arteries. On an unknown date, Angiogram: Diagnosis of TCM was supported by imaging findings and the absence of obstructive or thrombotic lesions.. On an unknown date, Blood alkaline phosphatase (36-95 mg/dl): 77 mg/dl. On an unknown date, Blood calcium (9.0-10 mg/dl): 9.9 mg/dl. On an unknown date, Blood creatine phosphokinase (42-152 international unit per litre): 198 international unit per litre. On an unknown date, Blood creatine phosphokinase MB (0-05 ng/dL): 19 ng/dL. On an unknown date, Blood creatinine (0.7-1.3 mg/dl): 1.1 mg/dl. On an unknown date, Blood lactate dehydrogenase (1240-222 international unit per litre): 499 international unit per litre. On an unknown date, Blood potassium (3.5-4.5 milliequivalent per litre): 3.7 milliequivalent per litre. On an unknown date, Blood pressure measurement: 150/90 mmHg. On an unknown date, Blood sodium (138-145 milliequivalent per litre): 138 milliequivalent per litre. On an unknown date, Blood urea (07-26 mg/dl): 19 mg/dl. On an unknown date, C-reactive protein (0.4-1.1 mg/dl): 3 mg/dl. On an unknown date, Cardiac ventriculogram: revealing apical ballooning ruling out  myocarditis. On an unknown date, Chest X-ray: showing prominent vascular marking suggestive  of acute pulmonary edema. On an unknown date, Echocardiogram: revealing apical ballooning of heart. On an unknown date, Electrocardiogram: revealing ST elevation in leads V2-V5. On an unknown date, Fibrin D dimer (0-1 microgram per millilitre): 5.8 microgram per millilitre. On an unknown date, Haemoglobin (13-15 g/dL): 11 g/dL. On an unknown date, Oxygen saturation: 89% on room air. On an unknown date, PCO2 (35-45 mmHg): 51 mmHg. On an unknown date, PO2 (75-100 mmHg): 69 mmHg. On an unknown date, Platelet count (150000-350000 microliter): 199000 microliter. On an unknown date, Red blood cell sedimentation rate: 31/hour (<21). On an unknown date, SARS-CoV-1 test: Negative. On an unknown date, Troponin I (0-14 ng/dL): 21 ng/dL. On an unknown date, White blood cell count (4000-11000 cubic millimetre): 8000 cubic millimetre. On an unknown date, pH body fluid (7.35-7.45): 7.8.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   She was commenced on intravenous norepinephrine and dobutamine due to cardiogenic shock.   She was brought to the emergency department with sudden onset dyspnea for the last six hours. She also complained of intermittent chest pain for the last two days. The pain was stabbing, progressive with each episode, non-radiating, and worse on exertion with no relieving factors. She received her booster dose of the Moderna COVID-19 vaccine three days ago. She was compliant with her medications. She had no history of alcohol or substance abuse. On chest auscultation, she had diffuse lung crepitations with normal heart sounds. Arterial blood gas analysis revealed type 1 respiratory failure,   Our patient presented with dyspnea and chest pain after COVID-19 vaccination and was diagnosed with TCM. She had no identifiable trigger for TCM, including stress, emotional and physical trauma. She had no identifiable risk factor for cardiovascular disease, normal creatine kinase level, and absence of obstructive or thrombotic lesion or coronary angiography in the presence of EKG, and echocardiography findings justify that ischemic heart disease was unlikely. Massive immune response after the COVID-19 vaccine may have contributed to the development of TCM.  She had persistent tachycardia and fluctuating blood pressure, and due to fluid overload, she became hemodynamically unstable leading to cardiac shock. Chest computed tomography (CT) was performed to rule out pulmonary embolism (PE), which was normal. She was brought to the cath lab urgently and underwent coronary angiography, which was unremarkable, demonstrating no thrombotic or obstructive lesion. Cardiac magnetic resonance imaging revealed apical ballooning of the heart excluding myocarditis. A provisional diagnosis of TCM with a TCM risk score of 61 was made, induced by the COVID-19 vaccine, as no other etiology was identified.  Company Comment: This is a literature-non-study case concerning a 59-year-old, female patient with a history of hypothyroidism, hyperlipidemia, and celiac disease and no risk factors for cardiovascular disease, no history of alcohol or substance abuse except for a smoking history, who experienced the unexpected serious (medically significant and life-threatening) AESI of Cardiogenic shock and unexpected serious (medically significant ) AESI of Stress cardiomyopathy. The events began one day after the administration of a booster dose with mRNA-1273 vaccine. The patient developed intermittent chest pain for two days when she had a sudden onset of dyspnea. She had an oxygen saturation of 89% on room air, blood pressure of 150/90 mmHg, and a respiratory rate of 24 breaths/minute and diffuse lung crepitations with normal heart sounds.  She had increase Troponin I of 21 ng/ml, Creatine phosphokinase 198 IU/L and Creatine kinase MB 19 ng/ml. An urgent electrocardiogram (EKG) revealed ST-segment elevation in leads V2-V5. Chest x-ray was significant for pulmonary edema and a transthoracic echocardiography showed diminished left ventricular systolic function with an estimated ejection fraction (EF) of 30% and moderate hypokinesia of the apex and anterolateral wall of the heart. She became hemodynamically unstable leading to cardiac shock. She required IV norepinephrine and dobutamine due to cardiogenic shock and underwent coronary angiography. Cardiac magnetic resonance imaging revealed apical ballooning of the heart excluding myocarditis. Several different diagnoses have been ruled out such as COVID-19, pulmonary embolism among others. Outcome is unknown. No further information was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Received and contains significant information which includes lab data, medial history, events and narrative updated.; Sender's Comments: This is a literature-non-study case concerning a 59-year-old, female patient with a history of hypothyroidism, hyperlipidemia, and celiac disease and no risk factors for cardiovascular disease, no history of alcohol or substance abuse except for a smoking history, who experienced the unexpected serious (medically significant and life-threatening) AESI of Cardiogenic shock and unexpected serious (medically significant ) AESI of Stress cardiomyopathy. The events began one day after the administration of a booster dose with mRNA-1273 vaccine. The patient developed intermittent chest pain for two days when she had a sudden onset of dyspnea. She had an oxygen saturation of 89% on room air, blood pressure of 150/90 mmHg, and a respiratory rate of 24 breaths/minute and diffuse lung crepitations with normal heart sounds.  She had increase Troponin I of 21 ng/ml, Creatine phosphokinase 198 IU/L and Creatine kinase MB 19 ng/ml. An urgent electrocardiogram (EKG) revealed ST-segment elevation in leads V2-V5. Chest x-ray was significant for pulmonary edema and a transthoracic echocardiography showed diminished left ventricular systolic function with an estimated ejection fraction (EF) of 30% and moderate hypokinesia of the apex and anterolateral wall of the heart. She became hemodynamically unstable leading to cardiac shock. She required IV norepinephrine and dobutamine due to cardiogenic shock and underwent coronary angiography. Cardiac magnetic resonance imaging revealed apical ballooning of the heart excluding myocarditis. Several different diagnoses have been ruled out such as COVID-19, pulmonary embolism among others. Outcome is unknown. No further information was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.