Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: minor flares/had a flare/my RA is very active/left hand looks as if someone put air in it/its just giant and swollen and I can''t move it and its painful; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-AMGEN-USASL2021186478), license party for etanercept (ENBREL).  This serious solicited report (USASL2021186478) was reported to Amgen on 21/NOV/2021 by a consumer from a commercial program (PSP00046b) and involves a 68 year old female patient who experienced minor flares/had a flare/my ra is very active/left hand looks as if someone put air in it/its just giant and swollen and I can't move it and its painful [PT: rheumatoid arthritis] while receiving Enbrel, Multiple Dose Vial Kit For Reconstitution. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. The patient's concomitant medications included Arava (leflunomide). No co-suspect medications were reported. The patient began Enbrel with Multiple Dose Vial Kit For Reconstitution on an unknown date in 2000. Also, the patient started Arava (leflunomide) on an unknown date in 2000. On an unknown date in 2010, the patient discontinued Enbrel therapy and Arava (leflunomide). On an unknown date, the patient went on a vegan diet and was in remission for 11 years. The patient only had couple of minor flares during those 11 years and only thing she took was ibuprofen only when she had a flare. On an unknown date in MAR/2021, the patient took the first COVID-19 (Coronavirus disease) vaccine which jacked up her immune system, so now she was protected from the covid. On an unknown date, the patient stated that the price she paid was that now her RA (rheumatoid arthritis) was very active and it had been since five days after her first covid vaccine. The patient stated that after the first one that she started having a lot of pain frequently. The patient stated that her left hand looks as if someone put air in it, you could not see the knuckles, it was just giant and swollen and she could not move it and it was painful and was feeling like she need to go back on her Enbrel because this had been persistent for the last six months since she got the covid shot. A month later on an unknown date in APR/2021, the patient stated that she had second covid vaccine. On an unknown date in NOV/2021 this month, the patient had a booster. The patient stated that her HCP (healthcare professional) was aware. The outcome of the event rheumatoid arthritis was reported as not recovered/not resolved. The causal relationship between the event rheumatoid arthritis and Enbrel, Multiple Dose Vial Kit For Reconstitution was not provided by the consumer. The reporter did not and would never have access to lot number. No further information has been requested.  The reporter's assessment of the causal relationship of the event 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.  Amgen comment: This individual case report does not change the safety profile of the product.  Causality Assessment: Rheumatoid arthritis flare up Per Company (Amgen) = No; Sender's Comments: The event rheumatoid arthritis flare up is considered more likely to be part of the natural clinical course of the underlying disease but unrelated to etanercept or BNT162B2.