Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Cataract, Dry eye, Musculoskeletal disorder
Clinical narrative: hurted badly; dry eyes; stiffness in right arm; left ankle pain; In the morning the left eye was a little blurry; left and right eye cataract; could not lift arm; rotator cuff was out of place/worn out; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-3875318-00 (AbbVie).  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15May2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 15Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "she right eye cataract surgery and left eye cataract surgery", start date: 08Mar2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CATARACT (medically significant), outcome "recovered", described as "left and right eye cataract"; MUSCULOSKELETAL DISORDER (medically significant), outcome "unknown", described as "could not lift arm"; ROTATOR CUFF SYNDROME (medically significant) with onset 2021, outcome "not recovered", described as "rotator cuff was out of place/worn out"; PAIN (medically significant), outcome "recovered", described as "hurted badly"; DRY EYE (medically significant), outcome "not recovered", described as "dry eyes"; MUSCULOSKELETAL STIFFNESS (medically significant), outcome "unknown", described as "stiffness in right arm"; ARTHRALGIA (medically significant), outcome "not recovered", described as "left ankle pain"; VISION BLURRED (medically significant), outcome "recovered", described as "In the morning the left eye was a little blurry". The event "left and right eye cataract" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: unknown result. The action taken for upadacitinib was unknown. Therapeutic measures were taken as a result of cataract, dry eye.  Clinical information: Pfizer BioNTech covid-19 vaccine (tozinameran) was also considered suspect. The patient stated that her eyes were messed up so she went to the eye physician and she had cataract. On 08Mar2021, she right eye cataract surgery and left eye cataract surgery. Operation itself was nothing but before she had go to specialist, got drops to test and then had to went to the physician for blood test to saw if she could do anesthesia. After surgery she was advised, should not bend over after, did not strain if went to the bathroom. She put a cup over her eye at night until came back to physician. She puts three sets of drops in her eyes before she went back to the physician. Then dropped to two drops a day. In Apr2021, she was down to one drop per day. In the morning the left eye was a little blurry but it had only been a week. She had healed and was doing well. She had dry eyes so physician gave her over the counter eye drops. She was using reading glasses. She could not lift her arm. Her rotator cuff was out of place. So then the doctor sent her to another specialist. She said her Rotator Cuff was worn out. She had stiffness in right arm and pain in left ankle for a month. Rotator cuff issues at beginning of 2021 and pain was returning. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial . Causality for Rinvoq: The reporter's causality for the events of left and right eye cataract, could not lift arm and dry eyes with Rinvoq was no reasonable possibility. The reporter's causality for the event (s) of rotator cuff was out of place/worn out, stiffness in right arm and left ankle pain was not provided. The reporter's causality for the event (s) of hurted badly with rinvoq was a reasonable possibility,  opinion is that there is no reasonable possibility that the events of left and right eye cataract, could not lift rotator cuff was out of place/worn out, hurted badly, dry eyes, stiffness in right arm and left ankle pain are related to rinvoq. On 27May2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The event of "Dry Eyes" was added. The event of "Left Eye Cataract Surgery" was amended to "Left And Right Eye Cataract" The event of "Right Eye Cataract Surgery" was removed. On 22Nov2021, received updates to event information, reporter opinion of causality, company opinion of company alternative etiology, suspect drug information, concomitant drug information and narrative description. The events of "Stiffness in right arm" and "left ankle pain" were added.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the reported events and the suspect drug "BNT162B2" cannot be completely 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.