Your Health. Your Family. Your Choice.
Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: Acute myocardial infarction; Cardiac failure acute; respiratory failure; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is v21105121. A 93-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: ET9096; Expiration Date: 31Jul2021), via an unspecified route of administration, on 22Apr2021 at 10:25 (at the age of 93-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and deep vein thrombosis (on oral treatment with anticoagulant agents). Concomitant medications included unspecified anticoagulant agents. The patient experienced acute myocardial infarction, cardiac failure acute, and respiratory failure on 23Apr2021 at 14:00, which required hospitalization on 23Apr2021 and were reported as fatal. The clinical course was reported as follows: On 22Apr2021 (the day of vaccination), the patient received the vaccination. On 23Apr2021 around 14:00 (1 day after the vaccination), the patient experienced vomiting and subsequently had blood pressure decreased and poor oxygenation (blood pressure (BP): 64/46 mmHg and oxygen saturation (SpO2): 88%). The patient visited the outpatient department of the reporting hospital and was admitted there for respiratory failure. On 24Apr2021, the patient received furosemide (MANUFACTURER UNKNOWN) 10 mg for low urine output; even after this, she did not pass urine. Electrocardiogram (ECG) recorded on admission revealed ST elevation in II, III, and aVF leads and T wave abnormalities in anterior wall leads on 23Apr2021. Later, the blood sample was positive to troponin T and creatine kinase-myocardial band (CK-MB) on 24Apr2021. The patient would receive inpatient unspecified treatment as much as possible for acute coronary syndrome. Continuous infusion of heparin (MANUFACTURER UNKNOWN) 8000 unit (U) and isosorbide dinitrate (NITOROL) was started. Because of no urination and low blood pressure, carperitide (genetical recombination) human atrial natriuretic peptide (HANP) 0.025 gamma was administered. On 26Apr2021, oxygen 15 liters (via reservoir mask) was administered, after which the SpO2 had fluctuated in 80-90%, and heart rate (HR) in 100-110 beats per minute (bpm). Dopamine (MANUFACTURER UNKNOWN) 3.0 mL/hour was administered, and the blood pressure was in 80-90 mmHg; respiratory distress was noted. On 26Apr2021 at 12:15, the patient was confirmed dead. Therapeutic measures were taken as a result of the events as aforementioned. The patient died on 26Apr2021 at 12:15. The causes of death were reported as acute myocardial infarction, cardiac failure acute, and respiratory failure. It was not reported if an autopsy was performed. The reporting physician assessed the causality between the events and BNT162B2 as unassessable. There was no other possible cause of the events such as any other diseases.; Reported Cause(s) of Death: Cardiac failure acute; Acute myocardial infarction; respiratory failure
Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166