Sex: M
Vaccine: COVID19
Symptoms: Coronary artery bypass, Device difficult to use
Clinical narrative: had a quadruple bypass; Unable to depress the pre filled syringe/ She said it will not go down to inject the medicine; The initial case was missing the following minimum criteria: adverse event. Upon follow-up information on 14Jun2021, this case now contains all required information to be considered valid.  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 Agency (manufacturer control number: US-AMGEN-USASL2020027635), license party for etanercept (ENBREL). This serious solicited report (USASL2020027635) was reported to Agency on 13/FEB/2020 by a consumer from a commercial program and involves an 87 years old male patient who had a quadruple bypass [PT: coronary artery bypass] while receiving Enbrel with Single Dose Prefilled Syringe. No historical medical condition was reported. No current medical condition was reported. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Syringe on an unknown date. On an unknown date, the patient had a quadruple bypass. Subsequently, the patient had to quit taking Enbrel therapy. The outcome of the event coronary artery bypass was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Syringe was withdrawn for the event coronary artery bypass. The causal relationship between the event coronary artery bypass and Enbrel and Single Dose Prefilled Syringe 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.  Agency Causality Assessment: event quadruple vessel bypass graft assessed as unrelated to etanercept.  Agency Comment: This individual case report does not change the safety profile of the product.  Follow-up (19Feb2020): 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 Agency (manufacturer control number US-AMGEN-USASL2020027635), license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 19/Feb/2020: It was reported that, the patient was taken off of medication by cardiologist due to quadruple heart bypass surgery. The patient was cleared to go back on medication by cardiologist. It was unknown that the patient resumed the therapy. Action taken with Enbrel with Single Dose Prefilled Syringe was temporarily withheld for the event coronary artery bypass. 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.   Agency comment: This individual case report does not change the safety profile of the product.  Agency Causality Assessment: Quadruple vessel bypass graft is unrelated to etanercept.  Follow-up (14Jun2021): 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 Agency (manufacturer control number US-AMGEN-USASL2020027635), license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 14/JUN/2021: In this follow-up, the patient's current medical condition included rheumatoid arthritis without rheumatoid factor, multiple sites. The patient's co-suspect medication included COVID-19 vaccine. On an unknown date, the patient stopped taking Enbrel with Single Dose Prefilled Syringe. On an unknown date, the patient switched to Enbrel with Single Dose Prefilled Autoinjector. On an unknown date, the patient stated that his COVID-19 (Coronavirus disease of 2019) vaccine had been destroyed in his blood and he has no antibodies to COVID-19. Subsequently, the patient discontinued Enbrel therapy. No treatment information was received. Action taken with Enbrel with Single Dose Prefilled Syringe was temporarily withheld for the event coronary artery bypass. The causal relationship between the event coronary artery bypass and Enbrel Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested.   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.   Agency comment: This individual case report does not change the safety profile of the product.  Agency Causality Assessment: Quadruple vessel bypass graft is unrelated to etanercept.  Follow-up (14Jun2021): This is a solicited follow-up report received from contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-AMGEN INC-20-0044736-SR-01, US-AMGEN-USASL2020027635.  ADDITIONAL INFORMATION RECEIVED ON 14/JUN/2021: In this follow up, patient was unable to depress the pre filled syringe/ She said it will not go down to inject the medicine [PT:device difficult to use] while receiving Enbrel with Single Dose Prefilled Syringe and Single Dose Prefilled Autoinjector. On an unknown date, the patient's wife was unable to depress the pre filled syringe. She said it would not go down to inject the medicine. The outcome of the event, device difficult to use was reported as unknown. The causal relationship between the event device difficult to use and Enbrel, Single Dose Prefilled Syringe, Single Dose Prefilled Autoinjector 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 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.   Agency comment: This individual case report does not change the safety profile of the product.  Agency Causality Assessment: Quadruple vessel bypass graft, Device difficult to use are unrelated to etanercept.  ENBREL is under agreement with Agency.; Sender's Comments: Based on the current available information, the reported event coronary artery bypass is more likely to be associated to underlying medical condition or inter-current condition and unlikely to be related to the suspect products BNT162B2 and Enbrel. The case will be reassessed once new information is available.