Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site erythema, Injection site pruritus, Rheumatoid arthritis
Clinical narrative: having a flare up/fingers hurt like I broke them/inflammation with her finger; redness and itchiness at the injection site/ had increasing injection site reactions; redness and itchiness at the injection site/ had increasing injection site reactions; 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 from Amgen (manufacturer control number: US-AMGEN-USASL2021008630), license party for etanercept (ENBREL).   This serious solicited report (USASL2021008630) was reported to Amgen on 18/JAN/2021 by a consumer from a commercial program (PSP00086) and involves a 76 year old female patient who was having a flare up/ fingers hurt like she broke them [PT: rheumatoid arthritis] 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. No co-suspect medications were reported. The patient began Enbrel, Reusable Autoinjector on an unknown date. On an unknown date, the patient was having a flare up of her RA and that her fingers hurt like broke them. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as unknown. Action taken with Enbrel with Reusable Autoinjector was reported as unknown for the event rheumatoid arthritis. The causal relationship between the event rheumatoid arthritis and Enbrel with Reusable Autoinjector was not provided by the consumer. The reporter declined consent for follow up.   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 event 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 the company causality assessment.  Amgen's Causality Assessment: The event Rheumatoid arthritis flare up was serious and unrelated to etanercept.  Follow-up (12Mar2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021008630), license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 12/MAR/2021: The patient's date of birth was updated. The previously reported action taken with Enbrel and Reusable Autoinjector was updated from unknown to not applicable for the event rheumatoid arthritis. The previously reported outcome for the event rheumatoid arthritis was updated from not recovered/not resolved to unknown. In this follow up, it was reported that the patient had inflammation with her finger [PT: rheumatoid arthritis], redness and itchiness at the injection site [PT: injection site erythema, PT: injection site pruritus] while receiving Enbrel, Reusable Autoinjector. The patient's concomitant medications included covid-19 vaccine. On unknown date, the patient stated that she was off of Enbrel in order for her to take the covid-19 vaccine. Subsequently, she had inflammation on her finger that required an unspecified steroid injection. On unknown date, the patient restarted Enbrel therapy. The patient stated that she noted redness and itchiness at the injection site. Treatment for the event rheumatoid arthritis included unspecified steroid injection. The outcome of the events rheumatoid arthritis, injection site erythema, injection site pruritus was reported as unknown. Action taken with Enbrel with Reusable Autoinjector was reported as unknown for the events injection site erythema and injection site pruritus. The causal relationship between the events injection site erythema, injection site pruritus and Enbrel with Reusable Autoinjector was not provided by the consumer. The reporter declined to provide lot number. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected.  Amgen comment: This individual case report does not change the safety profile of the product.   Amgen Causality Assessment Rheumatoid arthritis flare up was serious and unrelated to etanercept.  Injection site redness, Injection site itching are non-serious and related to etanercept.   The reporter's assessment of the causal relationship of the events injection site erythema and injection site pruritus 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 the company causality assessment.  Follow-up (19May2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021008630), license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 19/MAY/2021: In this serious solicited follow up report the patient had increasing injection site reactions while receiving Enbrel with Reusable Autoinjector. The patient's co-suspect medication included COVID-19 Vaccine (Previously reported concomitant medication). On an unknown date, the patient had increasing injection site reactions after taking the COVID vaccine. Subsequently, the patient discontinued Enbrel therapy due to increasing injection site reactions. Action taken with Enbrel and Reusable Autoinjector was withdrawn for the events injection site erythema and injection site pruritus. The reporter declined consent for follow up.  Amgen Comment: This individual case report does not change the safety profile of the product.  Causality Assessments: Injection site itching, Injection site redness Per Company (Amgen) = Yes Rheumatoid arthritis flare up Per Company (Amgen) = No.  The reporter's assessment of the causal relationship of the events rheumatoid arthritis flare up, injection site erythema and injection site pruritus with the suspect products etanercept and BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.; Sender's Comments: Event flare up of her RA is likely due to underlying condition and unrelated to etanercept. Injection site redness, Injection site itching are related to etanercept based on temporal association and known drug safety profile.   Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be excluded. 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 RAs, Ethics Committees, and investigators, as appropriate.