Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Injection site reaction, Rheumatoid arthritis, SARS-CoV-2 test
Clinical narrative: have so much pain and swelling and rheumatoid flare ups/more noticeable symptoms of her rheumatoid arthritis such as the pain and swelling; doesn''t like how Enbrel is making her feel lately/as of late, she is experiencing injection site reactions consistently with her Enbrel use; contracted COVID-19/ been battling complications and sequelae of the infection over the past year; 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-22-0061117-SR-01, US-AMGEN-USASL2022036336.  This serious solicited report (USASL2022036336) was reported to Agency  on 28/FEB/2022 by a consumer from a commercial program and involves a 62 years old female patient who had so much pain and swelling and rheumatoid flare ups/more noticeable symptoms of her rheumatoid arthritis such as the pain and swelling [PT: rheumatoid arthritis], contracted covid-19/ been battling complications and sequelae of the infection over the past year [PT: covid-19], doesn't like how Enbrel is making her feel lately/as of late, she is experiencing injection site reactions consistently with her Enbrel use [PT: injection site reaction] while receiving Enbrel. 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 (Corona Virus Disease 2019 Vaccine). The patient began Enbrel on an unknown date. On an unknown date in NOV/2020, the patient contracted COVID-19 (Corona Virus Disease 2019). On an unknown date, the patient stopped taking Enbrel. The reason why she stopped taking the medication was because she contracted COVID-19 in NOV/2020 and the patient had been battling complications and sequelae of the infection over the past year including more noticeable symptoms of her rheumatoid arthritis such as the pain and swelling, which she did not really have much of before. The patient did not like how Enbrel was making her feel lately. The patient even had anaphylaxis to the COVID (Corona Virus Disease 2019) vaccine. The patient also reported that as of late, she was experiencing injection site reactions consistently with her Enbrel use. The patient was not happy with Enbrel this time around. On an unknown date in 2022, the patient recently restarted Enbrel after being off the medication for over a year. The patient now had so much pain and swelling and rheumatoid flare ups. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as not recovered/not resolved. The outcome of the event covid-19 was reported as recovered/resolved with sequelae. The outcome of the event injection site reaction were reported as unknown. Action taken with Enbrel was temporarily withheld for the events covid-19 and rheumatoid arthritis. Action taken with Enbrel was reported as unknown for the event injection site reaction. The consumer reported that the event injection site reaction were possibly related to Enbrel. The causal relationship between the events covid-19, rheumatoid arthritis and Enbrel was not provided by the consumer. The reporter did not and would never have access to lot number. Follow up has been requested.  Agency comment: This individual case report does not change the safety profile of the product.  Etanercept (ENBREL) is under agreement with Agency.  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.  Agency's Causality Assessments: Events COVID-19, Injection site reaction were assessed to be related to etanercept.  Event Rheumatoid arthritis flare up were assessed to be unrelated to etanercept.; Sender's Comments: The event rheumatoid arthritis flare up is likely due to the natural course of the underlying condition of the patient and is not related to Etanercept or suspect vaccine. The event injection site reaction is likely related to Etanercept based on its known safety profile and not related to the suspect vaccine. While a causal association cannot be excluded for the event COVID-9 and suspect drugs.  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.