Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Diagnosed with COVID-19/Patient had COVID; three weeks after starting Enbrel, the patient was diagnosed with 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 Health Authority (manufacturer control number: US-AMGEN-USASL2021123396), license party for etanercept (ENBREL).  This solicited report (USASL2021123396) was reported to Health Authority on 09/AUG/2021 by a consumer from a commercial program (PSP00086) and involves a 53 year old male patient who was diagnosed with COVID-19 [PT: COVID-19] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. The patient's historical drugs included COVID-19 (Coronavirus disease 2019) vaccine. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date in 2021. On an unknown date in 2021, three weeks after starting Enbrel, the patient was diagnosed with COVID-19 (Coronavirus disease 2019) and was told to discontinue injections. The patient's last injection was on or around 6/21/21 but he could not remember the exact date. The patient did have one injection left from the shipment but he was not at home and did not have access to the lot number. No treatment information was received. The outcome of the event COVID-19 was reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was withdrawn on an unknown date in 2021 for the event COVID-19. The causal relationship between the event COVID-19 and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested for the lot number only.  The reporter's assessment of the causal relationship of the event with the suspect product etanercept was not provided at the time of this report. Since no determination has been received, the case was managed based on the company causality assessment.  Health Authority's Causality Assessment: The event "COVID-19" was considered as non-serious and related to etanercept.  Follow-up (16Aug2021):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 Health Authority (manufacturer control number: US-AMGEN-USASL2021123396), license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 16/AUG/2021:In this follow up report was reported by a consumer from a commercial program (PSP00180) and patient had COVID (Coronavirus disease of 2019) ([PT: COVID-19] while receiving Enbrel with Single Dose Prefilled Autoinjector. The patient had COVID (Coronavirus disease of 2019) while being on medication. The outcome of the event COVID-19 was reported as unknown. Action taken of Enbrel with Single Dose Prefilled Autoinjector was reported as continued for the event COVID-19. The causal relationship between the event COVID-19 and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Lot number updated. Follow-up attempts are completed. No further information is expected.  The reporter's assessment of the causal relationship of the event with the suspect product etanercept was not provided at the time of this report. Since no determination has been received, the case was managed based on the company causality assessment.  Health Authority's Causality Assessment: The event "COVID-19" was considered as non-serious and related to etanercept.  Amendment: This follow-up report is being submitted to amend previously reported information: Case considered serious with drug ineffective for added co-suspect BNT162B2. Initial report states: patient's historical drugs included COVID-19 (Coronavirus disease 2019) vaccine. three weeks after starting Enbrel, the patient was diagnosed with COVID-19.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of drug ineffective and COVID 19 cannot be excluded. Based on immunosuppressive property of the product, a possible contributory role of etanercept to the development of COVID 19 cannot be excluded. Drug ineffective is unrelated to etanercept.