Sex: F
Vaccine: COVID19
Symptoms: Gastroenteritis, Infection, Pancreatitis, Sepsis, Weight decreased
Clinical narrative: Hospitalization due to stomach issues/ took booster and got sick again with gastroenterocolitis, colitis, infection; Hospitalization due to stomach issues/ took booster and got sick again with gastroenterocolitis, colitis, infection; Hospitalization due to stomach issues/weight loss.; Hospitalization on 04/272021 pancreatitis and sepsis; Hospitalization on 04/272021 pancreatitis and sepsis/ second shot she got sepsis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) from License Party for a sponsored program. Other Case identifier(s): US-AMGEN INC-22-0012433-SR-01, US-AMGEN-USASL2022006996.  This serious solicited report (USASL2022006996) was reported to Agency on 12/JAN/2022 by a consumer from a commercial program and involves a 65 year old female patient who experienced hospitalization on 04/272021 pancreatitis and sepsis [PT: pancreatitis,PT: sepsis], hospitalization due to stomach issues/weight loss. [PT: gastric disorder,PT: weight decreased], while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. No current medical condition was reported. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On 27/APR/2021, the patient reported Hospitalization due to Pancreatitis and Sepsis. On 23/DEC/2021, the patient was again hospitalised due to stomach issues and weight loss. The outcome of the events pancreatitis, sepsis, gastric disorder, weight decreased was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events pancreatitis, sepsis, gastric disorder and weight decreased. The causal relationship between the events pancreatitis, sepsis, gastric disorder, weight decreased and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. No further information has been requested.  The reporter's assessment of the causal relationship of the event(s) 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.  Agency Comment: This safety report does not necessarily reflect a conclusion by Agency that etanercept, caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.  Agency Causality Assessment: Sepsis assessed as related while Pancreatitis, Gastric disorder, Weight loss assessed as unrelated to etanercept.  Follow-up (01Mar2022): This is a solicited follow-up report received from a contactable consumer from License Party for a non-Pfizer sponsored program (marketing program name not available). Other Case identifier(s): US-AMGEN INC-22-0012433-SR-01, US-AMGEN INC-22-0063302-SR-01, US-AMGEN-USASL2022006996.  ADDITIONAL INFORMATION RECEIVED ON 01/MAR/2022: In this follow u[p report previously reported event gastric disorder was deleted and subsumed with the events gastroenterocolitis. This follow up information was reported to Agency on by a consumer from a commercial program and involves a patient who had second shot she got sepsis [PT: sepsis], took booster and got sick again with gastroenterocolitis, colitis, infection and ended up in the hospital again [PT: gastroenteritis, and PT: infection] while receiving Enbrel, Single Dose Prefilled Autoinjector. The paitent's co-suspect medications included unspecified covid vaccine. The patient stated that she was fine with first covid vaccine. On an unknown date, the patient had second shot she got sepsis and was in the ICU (intensive care unit), autoimmune issues, took booster and got sick again with gastroenterocolitis, infection and ended up in the hospital again. The patient stated her healthcare team was concerned for second booster. Infections and hospitalizations were not related to Enbrel. The patient stated that her healthcare professional was trying to get her the medication evusheld and patient inquired if it was safe to take while being on Enbrel if she gets approved for it. The outcome of the events gastroenteritis, infection were reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events gastroenteritis, and infection. The consumer reported that the events sepsis, gastroenteritis, infection were not related to Enbrel. The causal relationship between the events gastroenteritis, infection and Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter did not and would never have access to lot number.The reporter declined consent for follow up. No further information has been requested.  Agency comment: This safety report does not necessarily reflect a conclusion by Agency that etanercept and device caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.   Enbrel is under agreement with Agency.  Agency Causality Assessment: Sepsis, Gastroenterocolitis, Infection assessed as related while Pancreatitis, Weight loss assessed as unrelated to etanercept.  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.; Reporter's Comments: ~~~; Sender's Comments: Based on the available information the event Sepsis is assessed as related to the suspect drug while Pancreatitis, Gastric disorder, Weight loss assessed as unrelated to etanercept.