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Life Threatening? No
Write-up: DEATH; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB manufacturer report number NO-NOMAADVRE-FHI-2021-U4ezd, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014215. A 92-years-old female patient received the first dose of bnt162b2 (COMIRNATY; Lot #EJ6796 ) vaccine , via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunisation . Medical history included asthenia (Classified as level 8 on clinical frailty score) , living in residential institution The patient''s concomitant medications were not reported. The patient died from an unknown cause on 16Jan2021. The patient underwent lab tests and procedures which included investigation: score 8 on CLINICAL FRAILTY SCALE. It was not reported if an autopsy was performed. Sender Comment: Background: A woman in her 90s Clinical Frailty score of 8 received her first dose of the covid-19 vaccine Comirnaty. According to the doctor at the nursing home, she allegedly had no clear side effects, but died 10 days after vaccination. The doctor does not have access to more information about the patient with regard to any previous illnesses or drug use. Comment: The message does not contain sufficient information to be able to assess a possible causal link with the vaccination. We ask for more information to be able to assess the incident. If more information is not available, we would like advice from notifiers on who we can contact to obtain this information. On a general basis, we have the following comment: Normally between 300 and 400 people die per week in nursing homes and similar institutions. In a study of patients on long-term stays, a high degree of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. International, retrospective studies have similar findings and find, among other things, that the risk of death is increased in the first four months after hospitalization, and that patients who have recently been admitted to hospital have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. In general, the cause of death in nursing home patients is often multifactorial and difficult to establish with certainty. The cause of death is usually considered to be a chronic, underlying disease, which ultimately leads to a sequence of fatal complications. In a recently published cohort study that analyzed the causes of death in nursing home patients on long-term stays, cardio and cerebrovascular disease accounted for 1 in 4 registered deaths. Other common causes of death in the population were neurodegenerative disease (including dementia) (20%), respiratory and infectious diseases (including pneumonia and sepsis) (15%), and cancer (10%). When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. Since the patient''s death, the message is classified as serious, even though no causal link between the vaccine and the death has been established. Relatedness of drug to reaction/event Source of assessment Not assessable Reporter''s comment: Regulatory Authority have requested more information, but the reporting doctor at the nursing home does not have more information about the patient regarding the current course of events, any previous illnesses or whether she used any other drugs. No follow-up attempts possible. No further information expected; Reporter''s Comments: Regulatory Authority have requested more information, but the reporting doctor at the nursing home does not have more information about the patient regarding the current course of events, any previous illnesses or whether she used any other drugs.; Reported Cause(s) of Death: Death unknown cause
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