Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cataract, Vaccination site pain, Wrist surgery
Clinical narrative: Right cataract; Wrist surgery; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (Right cataract) and WRIST SURGERY (Wrist surgery) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Cataract operation (Left cataract surgery) in 2018.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 21-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRIST SURGERY (Wrist surgery) (seriousness criterion medically significant). On an unknown date, the patient experienced CATARACT (Right cataract) (seriousness criterion medically significant). The patient was treated with Surgery for Cataract. At the time of the report, CATARACT (Right cataract), WRIST SURGERY (Wrist surgery) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  In 2021, the patient experienced sore arm after covid-19 vaccination.   On 19 Oct 2021, the patient had right cataract surgery.  It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality for the event(s) of right wrist surgery, sore arm after covid-19 vaccination and right cataract was not provided.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.  Company comment.  This spontaneous case concerns a 76  year  old, female patient, with current condition of Rheumatoid arthritis in treatment with Upadacitinib, and cataract operation (left) three years before vaccination, who experienced the serious (medically significant) unexpected events of wrist surgery (right wrist) and cataract (right eye). The event wrist surgery occurred approximately six months after the second dose of mRNA  1273 vaccine. Onset date of cataract was not reported; hence latency and temporal association cannot be properly assessed. The patient had a surgery for the right cataract approximately 8 months after vaccination. No further clinical information was available for medical reviewing. Co  suspect product Upadacitinib remains as confounder. Patient´s age and previous cataract remains as confounder for cataract. Patient´s mentioned medical history could be confounder for wrist surgery. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 76  year  old, female patient, with current condition of Rheumatoid arthritis in treatment with Upadacitinib, and cataract operation (left) three years before vaccination, who experienced the serious (medically significant) unexpected events of wrist surgery (right wrist) and cataract (right eye). The event wrist surgery occurred approximately six months after the second dose of mRNA  1273 vaccine. Onset date of cataract was not reported; hence latency and temporal association cannot be properly assessed. The patient had a surgery for the right cataract approximately 8 months after vaccination. No further clinical information was available for medical reviewing. Co  suspect product Upadacitinib remains as confounder. Patient´s age and previous cataract remains as confounder for cataract. Patient´s mentioned medical history could be confounder for wrist surgery. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.