Received May 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | OT |
she had a stroke / hard for her to write now; This is a solicited report received from a Consumer or other non HCP from License Party. Other Case identifier(s): US-AMGEN INC-25-0118644-SR-01 (AMGEN INC), US-AMGEN-USASL2025083176 (AMGEN). This serious solicited report (USASL2025083176) was reported to Amgen on 24/APR/2025 by a consumer from a commercial program and involves a 74-year-old (Elderly) female patient who had a stroke / hard for her to write now [PT: cerebrovascular accident] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement. No concomitant medications were provided. The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, around three years ago, the patient had a stroke after taking a Covid vaccine injection. It was hard for her to write now due to stroke. No treatment information was received. The outcome of the events cerebrovascular accident was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the event cerebrovascular accident. The causal relationship between the event cerebrovascular accident and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested. This individual case report does not change the safety profile of the product. The reporter's assessment of the causal relationship of "she had a stroke / hard for her to write now" with the suspect product(s) COVID-19 Vaccine - Manufacturer Unknown 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. Amgen's Causality Assessment: The event Stroke was considered as unrelated to etanercept. Enbrel is under agreement with Amgen.; Sender's Comments: There is not a reasonable possibility that the event stroke was related to the suspect drugs considering the products safety profile and pharmacokinetic characteristics. The event could most likely be due to patient underlying contributory factors. Detailed clinical course and complete medical history with any other concomitant medication would aid in comprehensive medical assessment. This case will be reassessed upon receipt of additional information.
Rheumatoid arthritis
Enbrel