Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19 pneumonia, Drug ineffective, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: COVID-19/low grade temperature/productive cough/pneumonia in both lungs; COVID-19/low grade temperature/productive cough/pneumonia in both lungs; 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-USASL2021132911), license party for etanercept (ENBREL).  This serious solicited report (USASL2021132911) was reported to Amgen on 24/AUG/2021 by a consumer from a commercial program (PSP00180, PSP00046b) and involves a 76 years old male patient who was diagnosed with COVID-19/ had low grade temperature/productive cough/pneumonia in both lungs [PT:COVID-19 pneumonia] while receiving Enbrel. No historical medical condition was reported. The patient's current medical condition included ankylosing spondylitis. The patient's concomitant medications included Dupixent (dupilumab). No co-suspect medications were reported. The patient began Enbrel on an unknown date. The reporter stated the patient received two doses of COVID vaccine. The patient was diagnosed with COVID-19 on 15/AUG/2021. The patient had a low grade temperature of 100 to100.8 (unit not provided) and productive cough. The cough worsened when he was first diagnosed. The patient was seen in the emergency department and was found to have pneumonia in both lungs and given antibiotics and sent home. The patient's oxygen levels were at 95. The patient was infused with monoclonal antibodies but was unable to find out when. The physician and patient held Enbrel and Dupixent (dupilumab). This morning on 24/AUG/2021, the oxygen levels were 88 and now up to 92. No treatment information was received. The outcome of the event COVID-19 pneumonia was reported as unknown. Action taken with Enbrel was temporarily withheld for the event COVID-19 pneumonia. The causal relationship between the event COVID-19 pneumonia and Enbrel was not provided by the consumer. 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 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.  Amgen's comment: This safety report does not necessarily reflect a conclusion by Amgen that etanercept, caused or contributed to the adverse event reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.  Amgen assessed the event COVID-19 pneumonia as serious and related to etanercept.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Reported event drug ineffective was assessed as related to BNT162B based on temporal association and drug safety profile however it is not related to the co-suspect drug etanercept. Event pneumonia is assessed as related to both suspect drugs based on drug safety profile. Case to be-assessed upon receipt of new information.