Sex: M
Vaccine: COVID19, UNK
Symptoms: Bronchitis, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Few bouts of bronchitis; COVID-19; COVID-19; 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, license party for etanercept (ENBREL).  This non-serious solicited report was reported to Amgen on 04Feb2021 by a consumer from a commercial program  and involves a 63 year old female patient who had COVID-19 [PT: covid-19] and few bouts of bronchitis [PT: bronchitis] 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. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient had a few bouts of bronchitis. Since then, the patient was diagnosed with COVID-19. No treatment information was received. The outcome of the events bronchitis and covid-19 was reported as unknown. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events bronchitis and covid-19. The causal relationship between the events bronchitis, covid-19 and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested for lot number.  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's Assessment: The events Covid-19, Bronchitis were assessed as non-serious and related to etanercept.  Follow-up (10May2021): 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).  ADDITIONAL INFORMATION RECEIVED ON 03/MAY/2021: In this follow-up, the patient's concomitant medications included COVID-19 vaccine. On an unknown date in JAN/2021 (previously reported as unknown), the patient stated he had COVID-19. On an unknown date in 2021, the patient received COVID-19 vaccine. 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.  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: COVID-19 and Bronchitis are related to etanercept.; Sender's Comments: A causal association between administration of etanercept and the onset of Covid-19, Bronchitis cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. The events Covid-19 and bronchitis are attributed to intercurrent medical conditions and assessed unrelated to BNT162B2 vaccine.