Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Rheumatoid arthritis
Clinical narrative: flair of arthritis/can't use right hand due to it being swollen/upper neck and arm are in pain/can't get out of bed; she is very ill/ going through some trying difficult times; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) by a contactable consumer from a commercial program (PSP00017) based on information received by Pfizer, manufacturer control number US-AMGEN-USASL2021081990, license party for etanercept (ENBREL).  A 65-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on 22Feb2021 as dose number unknown, single for covid-19 immunisation. Patient received co-suspect etanercept (ENBREL), unknown on an unspecified date (Batch/Lot Number: 1117707; Expiration Date: 28Feb2023) as 50 milligrams, weekly for rheumatoid arthritis. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. The patient began Enbrel, Single Dose Prefilled Syringe on an unknown date. The patient received the Coronavirus disease (COVID-19) vaccine on 22Feb2021. On an unknown date in 2021, the patient was very ill and going through some trying difficult times. The patient also was swollen from the vaccine. The physician was aware. It was unclear if patient was taking Enbrel during this time. No treatment information was received. The patient had flair of arthritis/can't use right hand due to it being swollen/upper neck and arm in pain/can't get out of bed (PT: rheumatoid arthritis) while being off Enbrel. The patient was out of Enbrel and was experiencing pain since an unknown date in 2021. The patient had COVID shot and had a flare of arthritis. She could not use her right hand due to it being swollen. Her upper neck and arm were in pain. The patient could not get out of bed. No treatment information was received. The outcome of the events was unknown. Action taken with Enbrel and Single Dose Prefilled Syringe was reported as unknown for the event illness. The causal relationship between the event illness and Enbrel with Single Dose Prefilled Syringe was not provided by the consumer. The patient reported that it was not related to Enbrel but the vaccine. The consumer reported that the event rheumatoid arthritis was not related to Enbrel. The causal relationship between the event rheumatoid arthritis 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.  Amgen's comment: This individual case report does not change the safety profile of the product.   Causality Assessment: Enbrel Illness, Rheumatoid arthritis flare up Per Amgen = No  The reporter's assessment of the causal relationship of the event illness with the suspect product etanercept and COVID-19 vaccine 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: Pfizer comment: The events rheumatoid arthritis flare up and illness are assessed as unrelated to suspect drug etanercept or COVID-19 vaccine, as the events may be attributed to the natural pathology of underlying disease.