Sex: F
Vaccine: COVID19
Symptoms: Hypervolaemia, Left ventricular dysfunction, Myocardial calcification, Oedema peripheral, Pleural effusion
Clinical narrative: She was admitted for heart failure exacerbation; Stress Induced Cardiomyopathy After the Covid-19 Vaccine; apical akinesis; coronary calcification; bilateral pleural effusions/worsening shortness of breath; peripheral edema/lower extremity edema; fluid-overloaded; left ventricular dysfunction; ejection fraction of 40-45%.; This is a literature report for the following literature source(s):  A 93-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "nonsmoker" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "alcohol or drug use" (unspecified if ongoing), notes: denied. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: CARDIAC FAILURE (hospitalization, medically significant, life threatening), outcome "recovering", described as "She was admitted for heart failure exacerbation"; STRESS CARDIOMYOPATHY (hospitalization), outcome "unknown", described as "Stress Induced Cardiomyopathy After the Covid-19 Vaccine"; VENTRICULAR HYPOKINESIA (hospitalization, medically significant), outcome "unknown", described as "apical akinesis"; MYOCARDIAL CALCIFICATION (hospitalization), outcome "unknown", described as "coronary calcification"; PLEURAL EFFUSION (hospitalization), outcome "unknown", described as "bilateral pleural effusions/worsening shortness of breath"; OEDEMA PERIPHERAL (hospitalization), outcome "recovered", described as "peripheral edema/lower extremity edema"; HYPERVOLAEMIA (hospitalization), outcome "unknown", described as "fluid-overloaded"; LEFT VENTRICULAR DYSFUNCTION (hospitalization), outcome "unknown"; EJECTION FRACTION DECREASED (hospitalization), outcome "recovered", described as "ejection fraction of 40-45%.". The patient underwent the following laboratory tests and procedures: Computerised tomogram: minimal coronary calcification and bilateral, notes: pleural effusions; Echocardiogram: ejection fraction of 40-45%; recovery of left ventricular ejection, notes: fraction to 61% by Simpsons biplane technique with no regional wall motion abnormalities; Ejection fraction: 40-45 %; 61 %, notes: Repeat echocardiogram. Therapeutic measures were taken as a result of cardiac failure.  Clinical course: The patient received her second dose of the Covid-19 mRNA vaccine five days prior to presentation. She had no history of heart disease, was a nonsmoker, and denied alcohol or drug use. In the ED she was noted to be fluid-overloaded, and her CT chest showed minimal coronary calcification and bilateral pleural effusions. She was admitted for heart failure exacerbation and started on IV furosemide. Her transthoracic echocardiogram showed an ejection fraction of 40-45%. The pattern of left ventricular dysfunction was consistent with stress induced cardiomyopathy with apical akinesis and basal sparing of the left ventricular wall segments. Cardiology was consulted and recommended management with diuretics and beta blocker. She had a diuresis of 5 liters during her hospitalization. At clinic follow-up, dyspnea had improved, and her peripheral edema had resolved. Repeat echocardiogram showed recovery of left ventricular ejection fraction to 61% by Simpsons biplane technique with no regional wall motion abnormalities. Further cardiac assessment to evaluate for obstructive coronary artery disease and myocarditis was discussed and offered to the patient but was declined due to her positive response to conservative management.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported Events Heart failure, Stress cardiomyopathy, Apical ventricular hypokinesia, Myocardial calcification, Bilateral pleural effusion, Peripheral edema, Fluid overload, Left ventricular dysfunction, Ejection fraction decreased and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.