Sex: F
Vaccine: COVID19, UNK
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Drug ineffective
Clinical narrative: Tested for covid-19 on 26/APR/2021 and came back positive today; Tested for covid-19 on 26/APR/2021 and came back positive today; Lost taste and smell; Lost taste and smell; Lot of coughing; Fatigue; Fever; 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-USASL2021066736), license party for etanercept (ENBREL).  This non-serious solicited report was reported to Amgen on 29/APR/2021 by a consumer from a commercial program and involves a 56 year old female patient who was tested for covid-19 on 26/APR/2021 and came back positive today [PT: sars-cov-2 test positive], lost taste and smell [PT: ageusia and PT: anosmia], lot of coughing [PT: cough], fatigue [PT: fatigue], and fever [PT: pyrexia] while receiving Enbrel with 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 unspecified Sunday, the patient took a dose of Enbrel and was able to complete the injection but after finishing it started flashing a cartridge light and chiming at her. On an unknown date in APR/2021, a week prior this report, the patient received her second COVID vaccination. On 22/APR/2021, Thursday, the patient developed fever, which was lasted for two to three days. On 26/APR/2021, Monday, the patient lost taste and smell and she had a lot of coughing and a lot of fatigue. The patient went to the physician and they teste her. On 29/APR/2021, on the day of this report, the patient came back positive.No treatment information was received. The outcome of the event pyrexia was reported as recovered/resolved. The outcome of the events sars-cov-2 test positive, ageusia, anosmia, cough, fatigue was reported as unknown. The event pyrexia was resolved on an unknown date in APR/2021. Action taken with Enbrel with Reusable Autoinjector was reported as unknown for the events pyrexia, ageusia, anosmia, cough, fatigue and sars-cov-2 test positive.The causal relationship between the events pyrexia, ageusia, anosmia, cough, fatigue, sars-cov-2 test positive and Enbrel with Reusable Autoinjector was not provided by the consumer.Follow up is not required.  The reporter's assessment of the causal relationship of the events with the suspect product 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 Causality Assessment: Fever, taste loss, smell loss, coughing, fatigue and COVID-19 virus test positive are unrelated to etanercept.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug BNT162B2 in the reported events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The events are considered  unrelated to the suspect drug Enbrel .               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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.