Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site pain, Injection site rash, Ophthalmological examination, Rheumatoid arthritis, Vision blurred
Clinical narrative: Injections burn like crazy/ injection is extremely painful; Rash at the injection site; Experiencing flares; Blurry vision / blurriness; This is a solicited report received from a contactable consumer based on information received by Pfizer.  This solicited report (USASL2020210290) was reported to Amgen on 23/DEC/2020 by a consumer from a commercial program (PSP00086) and involves a 55 years old, female patient whose injections burn like crazy [PT: injection site pain] and blurry vision/blurriness [PT: vision blurred] while receiving Enbrel with 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 with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient's injections burn like crazy. For past three and a half to four weeks in Nov2020, the patient has had blurry vision. The patient saw an Ophthalmologist who stated everything looked fine with her eyes but blurriness persists. No treatment information was received. The outcome of the event vision blurred was reported as not recovered/not resolved. The outcome of the event injection site pain was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events injection site pain and vision blurred. The causal relationship between the events injection site pain, vision blurred and Enbrel with 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. ADDITIONAL INFORMATION RECIEVED ON 02Apr2021: This case is upgraded to serious. In this follow up, the patient was experiencing flares [PT: rheumatoid arthritis], injection is extremely painful [PT: injection site pain], rash at the injection site [PT: injection site rash] while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient's co-suspect medications included covid-19 vaccine. On an unknown date, the patient reported that each injection was extremely painful and she gets a rash at the injection site with almost every dose. On 09Mar2021, she has been experiencing flares since having a COVID vaccine on 09Mar2021. She was not home to provide lot. No treatment information was received. The outcome of the events injection site pain, injection site rash were reported as not recovered/not resolved. The outcome of the event rheumatoid arthritis was reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the events injection site rash and rheumatoid arthritis. The causal relationship between the events injection site rash, rheumatoid arthritis and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow up attempts were possible. No further information was expected.  Amgen's causality assessment: events injection site pain and injection site rash were related to etanercept, while events blurry vision and rheumatoid arthritis flare up were unrelated to etanercept.   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 Comment: This individual case report does not change the safety profile of the product.; Sender's Comments: Based on information provided, the time association and vaccine's safety profile, the possible contribution of suspect BNT162B2 to the events rheumatoid arthritis flare up ,injection site pain and injection site rash cannot be excluded. The event blurry vision occurred prior to the administration of vaccine BNT162B2, considered unrelated to vaccine injection. The causal relationship of the drug etanercept to the events injection site pain and injection site rash is possible given the implied time association, while the events blurry vision and rheumatoid arthritis flare up were assessed as unrelated to etanercept. The rheumatoid arthritis would involve in eye's disorder when the rheumatoid arthritis is in active status. The clinical course of rheumatoid arthritis would be helpful for further assessment. 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.