Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain assessment, Rheumatoid arthritis
Clinical narrative: Flare/hands, wrists and elbows were painful; This is a solicited report from a non-Pfizer sponsored program from a contactable consumer, based on information received by Pfizer, license party for etanercept (ENBREL).   This serious solicited report was reported to Amgen on 19Apr2021 by a consumer from a commercial program  and involves a 73 year old female patient who had a flare/hands, wrists and elbows were painful [PT: rheumatoid arthritis] while receiving Enbrel, Single Dose Prefilled Syringe. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. The patient's concomitant medications included covid-19 vaccine. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Syringe on an unknown date (for over 10 years ago prior to this report). On 03Feb2021 and 24Feb2021, the patient stated that she received the Pfizer COVID vaccines and in both instances approximately 36 hours after the vaccine she experienced a flare. She stated that her hands, wrists and elbows were painful with a scale of five out of 10. The patient stated that the flares were resolved approximately six days later. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as recovered/resolved. The event rheumatoid arthritis was resolved on unknown date in Mar2021. Action taken with Enbrel and Single Dose Prefilled Syringe was reported as unknown for the event rheumatoid arthritis. The causal relationship between the event rheumatoid arthritis, Enbrel and Single Dose Prefilled Syringe was not provided by the consumer. The reporter declined to provide lot number. The reporter declined consent for follow up. Causality Assessment (etanercept):  Rheumatoid arthritis flare up, Per Company (Amgen) = No.   Amgen comment: This individual report does not change the safety profile of the product.   No follow-up attempts are possible. No further information is expected.   Follow-up (19Apr2021): This is a follow-up solicited report from a non-Pfizer sponsored program , based on information received by Pfizer from Amgen, license party for etanercept (ENBREL).   Correction Dated 19Apr2021: Version created to update covid-19 vaccine from concomitant medication to co-suspect medication as it was more likely associated with reported event rheumatoid arthritis.  The reporter's assessment of the causal relationship of the events with the suspect product etanercept 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Event a flare/She stated that her hands, wrists and elbows were painful with a scale of five out of 10 is likely due to underlying condition and unrelated to etanercept. Based on chronological connection to the vaccine the event rheumatoid arthritis flare was possibly related to BNT162B2 vaccine. 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.