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Administered by: Senior Living Purchased by: ?
Life Threatening? No
Write-up: pulmonary edema; Low heart rate; chest pain; This is a spontaneous report from a contactable pharmacist. An 80-years-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 28Jan2021 at single dose for COVID-19 Immunisation. Medical history included dementia, high blood pressure, COVID prior vaccination. He had no known allergies. Concomitant medication included diltiazem hydrochloride (CARDIZEM), anastrozole (ARIMIDEX), simvastatin and lorazepam. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 (at the age of 80-years-old) at single dose for COVID-19 Immunization. There was no other vaccine received in four weeks. The patient experienced pulmonary edema, low heart rate and chest pain on 26Feb2021. The events resulted in hospitalization and patient died. The patient was hospitalized from 26Feb2021 for 1 day. Treatment received for the events included Epinephrine, morphine, nitroglycerine. The patient underwent lab tests and procedures which included Covid test Nasal Swab post vaccination on 26Feb2021 indicated Negative. The patient died on 26Feb2021. An autopsy was not performed. information on the lot/batch number has been requested.; Sender''s Comments: Pulmonary edema, low heart rate, and chest pain, all reported as fatal, are deemed unrelated to BNT162B2 vaccine, being rather accidental occurrences, likely favored by the patient''s age and by the mentioned high blood pressure, known risk factor for cardiovascular diseases. The impact of this report on the benefit/risk profile of the Pfizer product 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.; Reported Cause(s) of Death: Low heart rate; pulmonary edema; chest pain
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