Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Fall, Head injury, Nausea
Clinical narrative: dizzy; nauseous; patient fell; hit her head on the marble flooring; 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 Manufacturer (manufacturer control number US-AMGEN-USASL2021098747), license party for etanercept (ENBREL).  This serious solicited report (USASL2021098747) was reported to Manufacturer on 24/JUN/2021 by a consumer from a commercial program (PSP00017) and involves a 73 year old female patient who fell [PT: fall], hit her head on the marble flooring [PT: head injury], and had physical problems ever since [PT: ill-defined disorder] while receiving Enbrel with Multiple Dose Vial Kit For Reconstitution. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis unspecified. No concomitant medications were provided. The patient's co-suspect medication included covid-19 vaccine. The patient began Enbrel, Multiple Dose Vial Kit For Reconstitution on an unknown date. On 24/APR/2021, the patient had a fall (because the COVID vaccine which made her made her sick (dizzy & nauseous), hit her head on the marble flooring. She had physical problems ever since. She was in and out of the hospital since an unknown date in 2021. Patient missed dose while she was in the hospital. She stated she would prefer to not be contacted because the fall had nothing to do with the Enbrel. No treatment information was received. The outcome of the events fall, head injury, ill-defined disorder were reported as unknown. Action taken with Enbrel with Multiple Dose Vial Kit For Reconstitution was temporarily withheld for the events fall, head injury and ill-defined disorder. The consumer reported that the event fall was not related to Enbrel. The causal relationship between the events head injury, ill-defined disorder and Enbrel was not provided by the consumer. The causal relationship between the events fall, head injury, ill-defined disorder and Multiple Dose Vial Kit For Reconstitution was not provided by the consumer. The reporter declined consent for follow up. No follow up attempts were possible. No further information was expected.  The reporter's assessment of the causal relationship of the events (except event fall) 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.   Manufacturer Causality Assessment: The events fall, head injury, ill-defined disorder were assessed as unrelated to etanercept.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dizziness and nausea cannot be excluded, while the events fall and resulting head injury are considered to have resulted from other events and not the suspect drug, hence considered unrelated. The events are considered unrelated to etanercept. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.