Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Vaccination complication
Clinical narrative: received a covid vaccine and was admitted to the hospital for 5 days due to complications; since she received the vaccine the patient has mental confusion; This is a solicited report received from a Consumer or other non HCP from License Party. Other Case identifier(s): US-AMGEN INC-24-0212922-SR-01 (AMGEN INC), US-AMGEN-USASL2024147532 (AMGEN).  This serious solicited report (USASL2024147532) was reported to Amgen on 24/JUL/2024 by a consumer from a commercial program and involves a 63 year old female patient who received a covid vaccine and was admitted to the hospital for five days due to complications [PT: ill-defined disorder ], since she received the vaccine the patient has mental confusion [PT: confusional state], had been without Enbrel for the last six months [PT: therapy interrupted] while receiving Enbrel. No historical medical condition was reported. No current medical condition was reported. No concomitant medications were provided. The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel on an unknown date. On an unknown date, the patient had received a covid (COVID-19 virus Disease) vaccine and was admitted to the hospital for five days due to complications. The reporter also reported that ever since the patient received the vaccine the patient had mental confusion. The reporter was unable to provide type of injection, dose/frequency, and diagnosis due to not having a complete prescription on file. On an unknown date in 2024, the patient had been without Enbrel for the last six months. No treatment information was received. The outcome of the events ill-defined disorder, confusional state, therapy interrupted were reported as unknown. Action taken with Enbrel was reported as unknown for the events ill-defined disorder and confusional state. The causal relationship between the events ill-defined disorder , therapy interrupted, confusional state and Enbrel was not provided by the consumer. Follow up has been requested.  Amgen Comment: This individual case report does not change the safety profile of the product.  Amgen Causality assessment: The events Mental confusion, Ill-defined disorder, Therapy interrupted are not related to Enbrel.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Enbrel is under agreement with LP Amgen.; Sender's Comments: Based on temporal association, the events vaccination complication and mental confusion are assessed as likely related to COVID-19 vaccine and are unrelated to Etanercept use. 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.