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Life Threatening? No
Write-up: PNEUMONIA; BLOOD CLOTS; This spontaneous report received from a consumer concerned an 89 year old male. Initial information was received on 13-APR-2021 and processed with additional information received on 15-APR-2021. The patient''s height, and weight were not reported. The patient''s past medical history included congestive heart failure (ejection fraction 20%), large lower left groin hernia, atrial fibrillation, and dementia. No known drug allergies was reported. There was no history of blood clots. The patient received vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. Vaccination site was not reported. Batch number was not reported, will be requested. Concomitant medications included apixaban twice a day for atrial fibrillation. On 11-MAR-2021, the patient was taken to Emergency Room (ER) and diagnosed with pneumonia. Patient was awake over 48 hours ''felt due to dementia and illness''. On 14-MAR-2021, the patient was taken back to hospital and X-ray and CAT scan showed saddle pulmonary embolism. On 15-MAR-2021, the patient was discharged to a home with hospice. On 23-MAR-2021, the patient deceased. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, Hospitalization Caused / Prolonged).; Sender''s Comments: V0: An 89-year old man experienced fatal saddle pulmonary embolism 10 days after vaccine. Relevant medical history included congestive heart failure with ejection fraction 20%, atrial fibrillation (A Fib), and dementia. Relevant concomitant medication (others not reported) included Eliquis for A fib. The patient was diagnosed with pneumonia in the Emergency Department 7 days after vaccine, and 3 days later was brought back to the hospital and diagnosed with saddle pulmonary embolus. He was discharged home on hospice the next day and died 19 days after vaccine. There was no reported thrombocytopenia. The patient''s age, concurrent pneumonia, and complicated past medical history are confounders. There is insufficient information to make a meaningful medical assessment. Additional information has been requested, including attempts to contact the patient''s treating physicians.; Reported Cause(s) of Death: PNEUMONIA; BLOOD CLOTS
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