Sex: F
Vaccine: COVID19, UNK
Symptoms: Pneumonia, Rheumatoid arthritis
Clinical narrative: Pain in fingers/flare ups with her Rheumatoid Arthritis; pneumonia; 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, license party for etanercept (ENBREL).   This serious solicited report was reported to Amgen on 29/JUN/2021 by a consumer from a commercial program and involves a 50 year old female patient who experienced pneumonia [PT: pneumonia], pain in fingers/flare ups with her rheumatoid arthritis [PT: rheumatoid arthritis] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications was reported. The patient's co-suspect medications included Covid-19 Vaccine (covid-19 vaccine). The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient reported that she had to stop taking Enbrel for a while due to the Covid-19 vaccine and got pneumonia after the second vaccine dose. On an unknown date, the patient also reported pain in her fingers and flare ups with her rheumatoid arthritis due to not being able to take the Enbrel. No treatment information was received. The outcome of the events pneumonia, rheumatoid arthritis were reported as unknown. The causal relationship between the events pneumonia, rheumatoid arthritis and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. No further information has been requested.  Amgen comments: This safety report does not necessarily reflect a conclusion by Amgen that etanercept, caused or contributed to the adverse events 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.  The reporter's assessment of the causal relationship of the events with the Covid-19 Vaccine 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's assessment: the event, Pneumonia, was assessed as related to etanercept. The event Rheumatoid arthritis flare up was assessed as unrelated to etanercept.  No follow-up attempts are possible; information about batch number cannot be obtained.  Follow-up (29Jun2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen, license party for etanercept (ENBREL).  CORRECTION DATED 29/JUN/2021: Version created to confirm that the patient's co-suspect medications included Covid-19 Vaccine (covid-19 vaccine).  Amgen Comments: This safety report does not necessarily reflect a conclusion by Amgen that etanercept, caused or contributed to the adverse events 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.  The reporter's assessment of the causal relationship of the events with the Covid-19 Vaccine 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's assessment: the event, Pneumonia, was assessed as related to etanercept. The event Rheumatoid arthritis flare up was assessed as unrelated to etanercept.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: Event pain in fingers/flare ups with her rheumatoid arthritis is likely due to underlying condition and unrelated to etanercept and BNT162B2. A contributory role of etanercept and BNT162B2 to event pneumonia cannot be excluded based on temporal association and available information. 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.