Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Gastric disorder, Knee arthroplasty, Post-acute COVID-19 syndrome
Clinical narrative: stomach problems; arthritis is getting bad since being off Enbrel; knee replacement; COVID in 2021 and got some long term side effects and cough from it; COVID in 2021 and got some long term side effects and cough from it; COVID in 2021 and got some long term side effects and cough from it/still has a cough sometimes from COVID; This is a report received from contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-AMGEN INC-23-0228739-SR-01, US-AMGEN-USASL2023148295.  This serious solicited report (USASL2023148295) was reported to Amgen on 21/AUG/2023 by a consumer from a commercial program (PSP00046b) and involves an approximately 63 year old female patient who experienced knee replacement [PT: knee arthroplasty], arthritis was getting bad since being off Enbrel [PT: rheumatoid arthritis], stomach problems [PT: gastric disorder], COVID in 2021 and got some long term side effects and cough from it/still had a cough sometimes from COVID [PT: post-acute COVID -19 syndrome], COVID in 2021 and got some long term side effects and cough from it [PT: COVID -19] while receiving Enbrel, Reusable Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medication included COVID-19 vaccine. The patient began Enbrel with Reusable Autoinjector on an unknown date in 2021. On an unknown date in 2021, the patient had COVID and got some long term side effects and cough from it. Patient reported that she stopped taking Enbrel while she had COVID and then restarted. Patient still had a cough sometimes from COVID . Patient stated that she got the first COVID vaccine and had a lot of health issues from it so she had to stop taking Enbrel again. Patient had knee replacement in June. Patient is getting ready to restart on Enbrel and states that if she has stomach problems from the medication again she may have to stop taking it again. Patient also reported that her arthritis was getting bad since being off Enbrel. No treatment information was received. The outcome of the event post-acute COVID -19 syndrome was reported as not recovered/not resolved. The outcome of the events knee arthroplasty, rheumatoid arthritis, COVID -19, gastric disorder was reported as unknown. Action taken with Enbrel with Reusable Autoinjector was temporarily withheld on an unknown date in 2021 for the events COVID -19, post-acute COVID -19 syndrome and gastric disorder. The consumer reported that the event gastric disorder was possibly related to Enbrel. The causal relationship between the events rheumatoid arthritis, COVID -19, knee arthroplasty, post-acute COVID -19 syndrome and Enbrel was not provided by the consumer. The causal relationship between the events rheumatoid arthritis, COVID -19, knee arthroplasty, post-acute COVID -19 syndrome, gastric disorder and Reusable Autoinjector was not provided by the consumer. Follow up has been requested. Amgen Causality Assessment: The event Gastric disorder is related, Rheumatoid arthritis aggravated, COVID-19, Knee replacement, Long COVID-19 is unrelated to etanercept. Amgen Comment: This individual case report does not change the safety profile of the product.  The reporter's assessment of the causal relationship of the events with the suspect products etanercept and COVID-19 Vaccine - Manufacturer Unknown 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. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "stomach problems" related to etanercept.  Enbrel is under agreement with Amgen.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective, COVID-19 and Post-acute COVID-19 syndrome cannot be ruled out. Other reported events of knee arthroplasty, Gastric disorder and rheumatoid arthritis were most likely intercurrent medical conditions and unrelated to BNT162B2 vaccine. Based on the available information a contributory role of the suspect product Enbrel to the reported gastric disorder cannot be excluded. It was reported that "she has stomach problems from the medication again she may have to stop taking it again". Other reported events were assessed as unrelated to Enbrel. Case will be reassessed upon receipt of additional information. 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.