Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Peripheral swelling, Swelling, Vaccination site pain
Clinical narrative: 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-163-4284990-00. A 55-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for Covid-19 immunisation; upadacitinib (RINVOQ), first regimen from Sep2021 (Lot number: 1150528) to 14Feb2022 at 15 mg 1x/day, second regimen from 12Mar2022 (Lot number: 1155129) to 2022 at 15 mg 1x/day and third regimen since 2022 (ongoing) (Lot number: 1159963) at 15 mg 1x/day, all oral for rheumatoid arthritis. The patient's relevant medical history included: "Ulnar drift" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LIMB OPERATION (medically significant) with onset 22Feb2022, outcome "recovering", described as "right hand surgery"; SWELLING (medically significant), outcome "unknown"; JOINT INJURY (medically significant), outcome "unknown", described as "joint damage"; MUSCULOSKELETAL DISORDER (medically significant), outcome "unknown", described as "Some abilities were affected by limitations with right hand"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (medically significant), outcome "unknown", described as "some abilities were affected by titrations with right hand, unable to tie shoelaces/was having husband reach for things and drive, unable to open new milk cartons"; GRIP STRENGTH DECREASED (medically significant), outcome "unknown", described as "unable to tie shoelaces"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "sore arm"; PERIPHERAL SWELLING (medically significant), outcome "unknown", described as "swelling in left hand"; MIGRAINE (medically significant), outcome "unknown", described as "Migraine headache". The event "right hand surgery" required physician office visit. The action taken for upadacitinib was dosage not changed. The reporter's assessment of the causal relationship of "right hand surgery", "swelling", "joint damage", "some abilities were affected by limitations with right hand", "some abilities were affected by titrations with right hand, unable to tie shoelaces/was having husband reach for things and drive, unable to open new milk cartons", "unable to tie shoelaces", "sore arm", "swelling in left hand" and "migraine headache" 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Clinical Course: The patient reported that her Rinvoq was on hold from 14Feb2022 to 11Mar2022, as per physician instruction for hand surgery for ulnar drift and silicone joint replacement in four knuckles done on 22Feb2022. Ulnar drift started prior to Rinvoq, but surgery was not planned until after starting Rinvoq. Unknown if joint damage was present prior to Rinvoq when he went into surgery, the joint replacement had been discussed as a possibility but was not the planned surgery. Unknown if hospitalized with surgery. Physician wanted to see how the Rinvoq would help with the ulnar drift and swelling. Denied worsening symptoms while not taking Rinvoq. Denied all signs or symptoms of infection. She had been undergoing physical therapy and all surgical wounds were healing without complications. She referred back to physician. She was recovering from hand surgery took place on 22Feb2022. She had some abilities were affected by limitations with right hand during rehabilitation. She was unable to tie shoelaces, open new milk cartons, was having husband reach for things and drive. Referred back to physician. She was preparing for a colonoscopy on 04May2022 and the headache was due to not eating. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Rinvoq (UPADACITINIB), the reporter's causality for the event (s) of right hand surgery, swelling, joint damage, some abilities were affected by limitations with right hand, unable to tie shoelaces/was having husband reach for things and drive, unable to open new milk cartons, COVID vaccine issue, sore arm, swelling in left hand and migraine headache was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of right hand surgery, swelling, joint damage, some abilities were affected by limitations with right hand, unable to tie shoelaces/was having husband reach for things and drive, unable to open new milk cartons, COVID vaccine issue, sore arm, swelling in left hand and migraine headache are related to Rinvoq (Upadacitinib).Change History on 01Apr2022, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of "joint damage" was added. The event of "ulnar drift is now considered serious. On 25Apr2022, received updates to study information, patient demographics, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "hand surgery", "some abilities were affected by limitations with right hand", "unable to tie shoelaces/was having husband reach for things and drive" and "unable to open new milk cartons" were added. the event of "ulnar drift" was removed. On 03May2022, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of COVID vaccine issue, sore arm", "swelling in left hand" and "migraine headache" were added. the event of "hand surgery" was amended to "right hand surgery". Seq. No.: 1 Drug: RINVOQ Causality: Action(s) taken with drug: Dose Not Changed Causality as per Mfg. (Drug/Vaccine): No reasonable possibility Dechallenge: N/A Seq. No: 2 Drug: Pfizer BioNTech COVID-19 Vaccine (Tozinameran) (Tozinameran), Unknown, Unknown Causality: Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A. 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 available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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.