Received Apr 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | OT |
full blown RA; PROGRAM NAME NOT AVAILABLE This is a solicited report received from a Consumer or other non HCP from License Party. Other Case identifier(s): US-AMGEN-USCT2026130165. This serious solicited report USCT2026130165 was reported to regulatory authority on 26Mar2026 from Patient Support Program by a consumer or other non health professional and involves a female patient of unspecified age who experienced 'full blown ra' [PT: rheumatoid arthritis] while receiving Enbrel [etanercept], Single dose prefilled syringe. The patient's concurrent conditions included: rheumatoid arthritis. No past medical history was reported. No concomitant medications were reported. Co suspect drugs included: Covid-19 vaccine live for Drug use for unknown indication. The patient began Enbrel [etanercept], Single dose prefilled syringe on an date in 2001. The patient went into remission and was in remission for 11 years. The patient stated that she received the Covid vaccine and it "put her back into full blown Rheumatoid arthritis." The patient did mention that the autoinjector was "vicious" and was using the pre-filled syringe. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as unknown. Action taken with Enbrel was unknown for event Rheumatoid arthritis. The causal relationship between the event rheumatoid arthritis and Enbrel was not provided. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected. Causality assessment: For event causality assessment per reporter was not reported while causality per company was unrelated. The reporter's assessment of the causal relationship of "full blown ra" with the suspect product(s) BNT162b2 and 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. Batch/lot number is not provided, and it cannot be obtained. {LP} regulatory authority Comment: This individual case report does not change the safety profile of the product. ENBREL is under agreement with regulatory authority.; Sender's Comments: The event rheumatoid arthritis is assessed as unrelated to the suspect drug as attributed to the underlying condition
Rheumatoid arthritis
Enbrel