Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood iron, Blood iron decreased, Condition aggravated, Thrombosis
Clinical narrative: now was dealing with low iron count and getting infusions.; now was dealing with low iron count and getting infusions.; superficial blood clot to left lower leg found last week at dr office/blood clots pt no longer having issues with clots; 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.  This serious solicited report was reported to Amgen on 26/FEB/2021 by a consumer from a commercial program and involves a 72 year old female patient who had superficial blood clot to left lower leg [PT: thrombosis] while receiving Enbrel, 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, Single Dose Prefilled Autoinjector on an unknown date. Last week on an unknown date in FEB/2021, the patient noticed a superficial blood clot to left lower leg at physician's office. The patient was treated with unspecified medications. The outcome of the event thrombosis was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the event thrombosis. The causal relationship between the event thrombosis and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer.The reporter declined to provide the lot number. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected  Amgen comment: This individual case report does not change the safety profile of the product.  Amgen Causality Assessment:  The event thrombosis leg  was assessed as related to etanercept by Amgen.  The reporter's assessment of thrombosis leg 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 (06May2021): This is a follow-up solicited report from a non-Pfizer sponsored program from a contactable consumer, based on information received by Pfizer from Amgen, license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 06/MAY/2021: In this follow up, it was reported that the patient experienced blood clots pt no longer having issues with clots [PT: thrombosis] while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient's current medical condition included low iron. The patient's concomitant medications included covid-19 (corona virus disease -2019) vaccine. On an unknown date, the patient received covid-19 (corona virus disease -2019) vaccine. On an unknown date in FEB/2021, the patient had blood clot (previously reported). Then on an unknown date in 2021, the patient stated that she had no longer having issues with clots. The patient stated that they thought it might be related to covid or covid vaccine. The patient stated that she now was dealing with low iron count and getting infusions. The patient stated she had low iron as a kid. The outcome of the event thrombosis was reported as recovered/resolved. The event thrombosis was resolved on an unknown date in 2021. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected.  Amgen comment:This individual case report does not change the safety profile of the product.     Amgen Causality Assessment Thrombosis leg is serious and related to etanercept.   The reporter's assessment of thrombosis leg 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.; Sender's Comments: Based on the information currently available and the safety profile of the drug there is a reasonable possibility that suspect product etanercept contributed to the occurrence of the event, thrombosis leg. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.