Sex: F
Vaccine: COVID19, UNK
Symptoms: Angiogram, Balance disorder, Dizziness, Injection site pain, Investigation
Clinical narrative: She did get an infection in her leg and had to be hospitalized; She has developed psoriasis/ the lesions are on both of her lower legs; It hurt too much; she couldn't handle that; balance issue; She had constant feeling of lightheadedness/this lightheaded feeling changed to a "balance issue"/she is not steady, and gets dizzy easily; This is a 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 Amgen (manufacturer control number US-AMGEN-USASL2021116257), license party for etanercept (ENBREL).  This serious solicited report was reported to Amgen on 27/JUL/2021 by a consumer from a commercial program and involves an adult female patient who got an infection in her leg and had to be hospitalized [PT: localised infection], she has developed psoriasis/ the lesions are on both of her lower legs [PT: psoriasis], she had constant feeling of lightheadedness/this lightheaded feeling changed to a "balance issue"/she was not steady, and gets dizzy easily [PT: dizziness] and it hurt too much; she could not handle that [PT: injection site pain] while receiving Enbrel, Multiple Dose Vial Kit For Reconstitution. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. The patient's concomitant medications included lisinopril. The patient's co-suspect medication included ''Pfizer COVID-19 Vaccine''. The patient began Enbrel with Multiple Dose Vial Kit For Reconstitution on an unknown date, over 20 years ago. Patient stated that she has been on Enbrel for over 20 years, since Enbrel first came out, and used the Lyophilized MUV (multi use vial); 25 mg (milligram) two times per week. On an unknown date, shortly after starting Enbrel over 20 years ago, she did got an infection in her leg and had to be hospitalized. Subsequently, she did have to stop Enbrel during that time. Patient stated that, on an unknown date, she did tried 50 mg per week, but that it was too strong. On an unknown date, in the last eight to 10 years of being on Enbrel and patient had developed psoriasis. Patient stated that the lesions were on both of her lower legs. Patient reported that her HCP (health care professional) told her to get in the sun to help it. Patient stated that one time, on an unknown date, several years ago, her HCP had her try a different unspecified automatic injection of Enbrel. Patient stated that it hurt too much; she could not handle that. Patient was unsure if that formulation was the SureClick. Patient stated that she received the ''Pfizer COVID-19 Vaccine'', two doses back in FEB/2020 and MAR/2020 (as reported, pending clarification). The patient stated she has had problems ever since getting the first vaccine. On an unknown date in 2020, 10 days after the first vaccine, patient had constant feeling of lightheadedness. Then, patient went to several doctors, including and ENT (Ear Nose and Throat) specialist and her heart doctor; cardiologist did decrease her lisinopril dose from 10 mg/day to 05 mg/day. Patient stated this did not helped her. Then, about two weeks late, on an unknown date in 2020, this lightheaded feeling changed to a balance issue. Patient stated that she was not steady, and gets dizzy easily. Patient stated that the ENT tested for Vertigo and also sent her for an MRA (Magnetic resonance angiography). Patient stated that it was not vertigo, and her MRA was normal. Patient has also gone to a Balance specialist and was given exercises to do. Patient stated nothing has helped; and was convinced that the COVID-19 vaccine has caused all of this; she was fine and healthy before the vaccine. No treatment information was received. The outcome of the events localised infection, psoriasis, dizziness and injection site pain was reported as unknown. Action taken with Enbrel was temporarily withheld for the event localised infection. Action taken with Enbrel was reported as unknown for the events psoriasis, dizziness and injection site pain. Action taken with Multiple Dose Vial Kit For Reconstitution was temporarily withheld for the event localised infection. Action taken with Multiple Dose Vial Kit For Reconstitution was reported as unknown for the events psoriasis and dizziness. The causal relationship between the events localised infection, psoriasis, dizziness, injection site pain and Enbrel with Multiple Dose Vial Kit For Reconstitution was not provided by the consumer. No further information has been requested.  Amgen Comment: This safety report does not necessarily reflect a conclusion by Amgen that etanercept, and device 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.  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.  Amgen's Causality assessment: The events leg infection, psoriasis, and injection site pain were related to etanercept. The event lightheadedness was unrelated to etanercept.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the events lightheadedness and balance disorder with BNT162b2 can not be fully excluded. Based on the temporal relationship, the association between the event injection site pain, leg infection, and psoriasis with ENBREL use can not e fully excluded.  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.