Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Nasopharyngitis, Rheumatoid arthritis
Clinical narrative: having a flare up; feeling "weak" after her last Enbrel/having a stressful week and feeling completely drained; also recently a " bad cold; 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-USASL2021087467), license party for etanercept (ENBREL).   This serious solicited report (USASL2021087467) was reported to Amgen on 04/JUN/2021 by a consumer from a commercial program and involves a 66 year old female patient who experienced having a "flare up [PT: rheumatoid arthritis], feeling "weak" after her last enbrel [PT: asthenia], also recently a bad cold [PT: nasopharyngitis] 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 were provided. The patient's co-suspect medication included covid-19 vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. The patient stated that she was weaning herself off of her Enbrel injections due to her inability to pay for them.Since on an unknown date in 2021, the patient was having a flare up after receiving her second covid-19 vaccine injection. The patient state that she was feeling weak after her last Enbrel injection prior to this report. Also, on an unknown date in 2021, the patient recently had a bad cold. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as not recovered/not resolved. The outcome of the events asthenia, nasopharyngitis were reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events asthenia, nasopharyngitis and rheumatoid arthritis. The causal relationship between the events asthenia, nasopharyngitis, rheumatoid arthritis and Enbrel with Single Dose Prefilled 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 report does not change the safety profile of the product.  Company (Amgen)'s causality assessment of event 'rheumatoid arthritis flare up and cold' was not related; of event 'weakness' was related.  The reporter's assessment of the causal relationship of event 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.  Follow-up (24Jun2021): 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-USASL2021087467), license party for etanercept (ENBREL).  Additional information received on 24/JUN/2021: It was reported that the patient was having a stressful week and feeling completely drained [PT: asthenia] while receiving Enbrel, Single Dose Prefilled Autoinjector. On an unknown date, the patient was having a stressful week and feeling completely drained. No treatment information was received. The reporter did not and would never have access to lot number. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: COVID-19 VACCINE was re-coded as Pfizer product.; Sender's Comments: Reported event RA flare and bad colds are assessed as intercurrent medical conditions and are not related to Enbrel. Asthenia is considered related to Enbrel based on temporal association. Events RA, asthenia, and nasopharyngitis are considered intercurrent conditions and unrelated to suspect BNT162B2.