Age: 98.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Condition aggravated, Death, Dyspnoea, Fall
Clinical narrative: Pancreatitis; Hip fracture and operative fixation for hip fracture; Increased white count; Short of breath; Myocardial infarction; Pulmonary embolism; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 98 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Nov2021 11:45 (Batch/Lot number: unknown) at the age of 98 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "dementia" (unspecified if ongoing); "severe aortic stenosis" (unspecified if ongoing); "atrial fibrilation" (unspecified if ongoing); "recent pancreatitis" (unspecified if ongoing); "recent hip fracture and surgery" (unspecified if ongoing); "recent hip fracture and surgery" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant) with onset 27Nov2021 23:00, outcome "fatal", described as "Myocardial infarction"; PULMONARY EMBOLISM (death, medically significant) with onset 27Nov2021 23:00, outcome "fatal", described as "Pulmonary embolism"; PANCREATITIS (hospitalization, medically significant) with onset 27Nov2021 23:00, outcome "unknown", described as "Pancreatitis"; HIP FRACTURE (hospitalization, medically significant) with onset 27Nov2021 23:00, outcome "unknown", described as "Hip fracture and operative fixation for hip fracture"; WHITE BLOOD CELL COUNT INCREASED (hospitalization) with onset 27Nov2021 23:00, outcome "unknown", described as "Increased white count"; DYSPNOEA (hospitalization) with onset 27Nov2021 23:00, outcome "unknown", described as "Short of breath". The patient was hospitalized for pancreatitis, hip fracture, white blood cell count increased, dyspnoea (start date: 27Nov2021). The patient underwent the following laboratory tests and procedures: white blood cell count: (27Nov2021) increased. Therapeutic measures were not taken as a result of myocardial infarction, pulmonary embolism, pancreatitis, white blood cell count increased, dyspnoea. Therapeutic measures were taken as a result of hip fracture. The patient date of death was 28Nov2021. The reported cause of death was myocardial infarction, pulmonary embolism. No autopsy was performed. Clinical course: There were other medications the patient received within 2 weeks of vaccination. Patient received the vaccination 10 days (as reported) into a hospitalization for pancreatitis, hip fracture and operative fixation for hip fracture. She developed increased white count after immunization and 12 hours later was noted to be short of breath. 18 hours after vaccination she coded and expired in the hospital. No hospitalization prolonged. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of myocardial infarction, pulmonary embolism, pancreatitis, white blood cell count increased, dyspnoea, hip fracture but also consider patient's medical history of severe aortic stenosis, atrial fibrillation, recent pancreatitis, recent hip fracture and surgery and patient advanced age (98) as confounding factor. 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: likely pulmonary embolism or myocardial infarction; likely pulmonary embolism or myocardial infarction