Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Foot deformity, Pyrexia, Sinus disorder
Clinical narrative: Won't feel good; Her toes on the right foot started to curl in; Runs a little fever; Enbrel bothers her sinuses; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASP2021057835), license party for etanercept (ENBREL).  This serious spontaneous report (USASP2021057835) was reported to Amgen on 14/APR/2021 by a consumer and involves a 86 year old female patient who runs a little fever [PT: pyrexia], Enbrel bothers her sinuses [PT: sinus disorder], won't feel good [PT: feeling abnormal], open heart surgery [PT: cardiac operation], her toes on the right foot started to curl in [PT: foot deformity] while receiving Enbrel with Multiple Dose Vial Kit For Reconstitution. Prior to starting Enbrel, the patient started losing her joints and said her physician nearly killed her with all of the medications including prednisone used to treat her rheumatoid arthritis. Nothing worked and she couldn't even brush her teeth because of decreased mobility in her hands and she also used a wheelchair and walker to help her get around. On an unknown date the patient switched from prednisone to Enbrel. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medications included Covid-19 vaccine. The patient began Enbrel with Multiple Dose Vial Kit For Reconstitution on an unknown date approximately 15 years ago. On an unknown date 13 years ago, the patient had open heart surgery and subsequently the Enbrel was temporarily withheld during her surgery, and during that time her toes on the right foot started to curl in and because of this, she was back in the hospital to get the pain down before she was able to restart Enbrel. On an unknown date, the patient also reported that Enbrel bothers her sinuses and sometimes she won't feel good the day after administering her Enbrel injections, but then it goes right away. The patient has been told by her doctor to skip a dose or two of Enbrel if she has a bad sinus infection. On an unknown date, when the patient received her first COVID-19 vaccine, she delayed her Enbrel injection from Saturday to Tuesday due to fear of an interaction. On 16/APR/2021, the patient was scheduled to receive her second COVID-19 vaccine and wanted to know if the vaccine would interfere with her Enbrel. The patient reported that sometimes she runs a little fever after giving her Enbrel injections but then the fever goes away. The patient was worried that if she had a fever after getting the COVID-19 vaccine, she wouldn't know if the fever was caused by the vaccine or her Enbrel. It was reported that after starting Enbrel the patient hasn't lost any more joints. The patient lived a happy life, and quality of life and has greatly improved since initiation of Enbrel. The patient said it was a wonderful drug for her but knew it had a lot of side effects. The patient also reported that her hands are almost normal now and was able to carry on a normal life, and also reported that without Enbrel she would probably be bed-ridden. The patient said that the multiple-dose-vial was hard to use because she could hardly use her hands due to the rheumatoid arthritis. The patient further explained the multiple-dose-vial was hard to use because she had to try to mix it and get it all together before injecting, which was hard for her due to decreased mobility in the hands and now the patient was using Enbrel with single-dose vial. No treatment information was received. The outcome of the events pyrexia, sinus disorder, feeling abnormal, cardiac operation, and foot deformity was reported as unknown. Action taken with Enbrel with Multiple Dose Vial Kit For Reconstitution was continued for the events pyrexia, sinus disorder and feeling abnormal. Action taken with Enbrel with Multiple Dose Vial Kit For Reconstitution was temporarily withheld for the event cardiac operation. The consumer reported event sinus disorder possibly related to Enbrel. The causal relationship between the events pyrexia, sinus disorder, feeling abnormal, cardiac operation, foot deformity and Enbrel with Multiple Dose Vial Kit For Reconstitution was not provided by the consumer. The causal relationship between the event sinus disorder and Multiple Dose Vial Kit For Reconstitution was not provided by the consumer. Follow up has been requested for the lot number only.   Amgen Comment: This safety report does not necessarily reflect a conclusion by Amgen that etanercept and device, caused or contributed to the adverse event(s) 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.