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Life Threatening? No
Write-up: deteriorated; shortness of breath; Bronchopneumonia; acute pulmonary oedema; low blood pressure; increased heart rate; pitting peripheral oedema; low oxygen saturations; This is a spontaneous report from a contactable other HCP received from the Administration (Regulatory authority number AU-TGA-0000522108). A 92-year-old male patient received BNT162b2 (COMIRNATY), via Intramuscular route, on 02Mar2021 09:50 (at the age of 92-years-old) for COVID-19 immunization, at an aged care facility. Medical History included Osteo Arthritis, Bowel cancer (1980 diagnosis), Hypertension, diverticulitis disease, dementia, Alzheimer, Chronic Cardiac failure (CCF). On 02Mar2021 the patient experienced general physical health deterioration, shortness of breath, bronchopneumonia, acute pulmonary oedema, low blood pressure, increased heart rate, pitting peripheral oedema, low oxygen saturations. The patient died 03Mar2021. The events were reported with fatal outcome. The clinical course was reported as follows, the man deteriorated that afternoon and overnight and ambulance service was called taken to hospital Emergency Department on 03Mar2021 at 09:15 with shortness of breath. Acute conditions: bronchopneumonia and acute pulmonary oedema on top of other chronic medical conditions upon presentation to hospital ED. The man had advanced directives in place which resulted in a conservative management plan and he died at hospital ED on 03Mar2021. Symptoms of low blood pressure, increased heart rate and pitting peripheral oedema and low oxygen saturations in line with heart failure on arrival to the hospital ED. Treatment Received: Trial of non-invasive ventilation, IV antibiotics and steroids did not improve clinical outcome. The patient was hospitalized for the events. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information provided, this elderly patient with a medical history relevant for Osteo Arthritis, Bowel cancer , Hypertension, diverticulitis disease, dementia, Alzheimer, Chronic Cardiac failure (CCF), experienced general physical health deterioration, shortness of breath, bronchopneumonia, acute pulmonary oedema, low blood pressure, increased heart rate, pitting peripheral oedema, low oxygen saturations with fatal outcome. The reported events and fatal outcome is most likely related to underlying disease conditions and not related to suspect product. 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: General physical health deterioration; Shortness of breath; Low blood pressure; Heart rate increased; Peripheral oedema; Oxygen saturation low; Bronchopneumonia; acute pulmonary oedema
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