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Life Threatening? No
Write-up: Death; A spontaneous report was received from a nurse concerning a 91-year-old, female patient who received Moderna''s COVID-19 Vaccine (mRNA-1273) and died two days later. The patient''s medical history included dementia. Concomitant medications reported included paracetamol. On 21 Jan 2021, approximately two days prior to her death, the patient received the first of two planned doses of mRNA-1273, intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient died. The nurse reporting the event stated that the patient''s death was considered as due to "natural causes" and that she was not aware of any new-onset symptoms of illness prior to the patient''s death. The patient was described as "fragile" and was under hospice care at the time of her death. An autopsy was not performed. Action taken with the drug in response to the event is not applicable. The patient died on 23 Jan 2021. The cause of death was natural cause of death related to dementia. Autopsy was not performed.; Reporter''s Comments: This case concerns a 91-years-old female patient, with medical history of dementia, who experienced a serious unexpected event of death. This event occurred 2 days after first dose of mRNA-1273, lot # unknown. At the time of death, the subject was very fragile and was in hospice care. Concomitant medication included Tylenol. Treatment details were not provided. The doctor considered that the death was due to natural causes. However, autopsy was not performed. Very limited information regarding this event has been provided at this time. Based on the limited information available, it is difficult to assess a cause and effect relationship. The benefit-risk relationship of Moderna''s COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Natural cause of death related to dementia
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