Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis, Visual impairment
Clinical narrative: Eye disorder; Sickness; Eye inflamed; Visual impairment; She was not able to drive and kids and husband helped her around the house.; Rheumatoid arthritis; Hair loss; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4376307-00 (Agency).  A 49-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Batch/Lot number: unknown), on 01Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 01Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), since Sep2021 (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious) with onset Apr2022, outcome "unknown", described as "Hair loss"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown"; EYE DISORDER (non-serious), outcome "unknown"; ILLNESS (non-serious), outcome "recovering", described as "Sickness"; EYE INFLAMMATION (non-serious), outcome "recovering", described as "Eye inflamed"; VISUAL IMPAIRMENT (non-serious), outcome "unknown"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "She was not able to drive and kids and husband helped her around the house.". The action taken for upadacitinib was unknown.  Clinical course: The report received from consumer of a 49-year-old female with events of non-serious hair loss, issues with eyes, sick, eyes inflamed and it was hard for patient to see and rheumatoid arthritis got bad with Rinvoq (Upadacitinib). There was no reported medical history. Concomitant drugs not reported. The patient had no relevant medical history and no known allergies. On unknown dates, the patient experienced issues with eyes, sick, eyes inflamed and it was hard for patient to see and rheumatoid arthritis got bad. In Apr2022, the patient experienced hair loss and lost about all of her hair in Apr2022. Physician told her that it was not a side effect of the Rinvoq. She also had issues with eyes and had seen a physician. No concomitant drugs taken. She stopped rinvoq while she was sick, because she did not know what made her sick. But she had started it back up in last couple of weeks. Her rheumatoid arthritis got bad and made her eyes inflamed and it was hard for her to see. She was not able to drive and kids and husband helped her around the house. It was unknown if patient was enrolled in a covid-19 vaccine trial. Product-Reaction level, Causality for for drug: Rinvoq (Upadacitinib) and event Hair loss (Alopecia), Eye disorder (Eye disorder), Sickness (Illness), Eye inflamed (Eye inflammation), Visual impairment (Visual impairment) and Rheumatoid arthritis (Rheumatoid arthritis) was action(s) taken with drug was unknown, causality as per reporter (Drug/Vaccine) was not reported and dechallenge was not applicable. Causality for vaccine and event Hair loss (Alopecia), Eye disorder (Eye disorder), Sickness (Illness), Eye inflamed (Eye inflammation), Visual impairment (Visual impairment) and Rheumatoid arthritis (Rheumatoid arthritis) was action(s) taken with drug was unknown, causality as per reporter (Drug/Vaccine) was possible and dechallenge was not applicable.  The reporter's assessment of the causal relationship of "rheumatoid arthritis", "hair loss", "eye disorder", "sickness", "eye inflamed", "visual impairment" and "she was not able to drive and kids and husband helped her around the house." with the suspect product(s) BNT162b2 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.  Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of hair loss, issues with eyes, sick, eyes inflamed and it was hard for patient to see unknown onset, eyes inflamed and it was hard for patient to see unknown onset and rheumatoid arthritis got bad was not provided.  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 information provided by the reporter, it appears unlikely that suspect drug contributed to the reported events .The reported events likely represent intercurrent medical conditions.