Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Scar, Vasculitis
Clinical narrative: blockage; scar tissue; Rheumatoid arthritis flare ups; fluid buildup in hands and neck; vasculitis on fingernail beds; stiffness in hands and neck; pain; joint pain; decreased appetite; limited mobility after receiving covid vaccine; high sugar level after receiving covid vaccine; 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): 22K-163-4277228-00.  A 77 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Dec2021 (Batch/Lot number: unknown) at the age of 77 years as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1150525) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OBSTRUCTION (hospitalization), outcome "recovering", described as "blockage"; SCAR (hospitalization), outcome "recovering", described as "scar tissue"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare ups"; FLUID RETENTION (non-serious), outcome "not recovered", described as "fluid buildup in hands and neck"; VASCULITIS (non-serious), outcome "recovered", described as "vasculitis on fingernail beds"; BLOOD GLUCOSE INCREASED (non-serious) with onset 05Dec2021, outcome "not recovered", described as "high sugar level after receiving covid vaccine"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiffness in hands and neck"; MOBILITY DECREASED (non-serious) with onset 05Dec2021, outcome "not recovered", described as "limited mobility after receiving covid vaccine"; PAIN (non-serious), outcome "not recovered", described as "pain"; ARTHRALGIA (non-serious) with onset 05Dec2021, outcome "unknown", described as "joint pain"; DECREASED APPETITE (non-serious) with onset 05Dec2021, outcome "unknown", described as "decreased appetite". The patient was hospitalized for obstruction, scar (start date: 10Jan2022, discharge date: Jan2022, hospitalization duration: 7 day(s)). The patient underwent the following laboratory tests and procedures: blood glucose: high. The action taken for upadacitinib was unknown.  The reporter considered "blockage", "scar tissue", "rheumatoid arthritis flare ups", "fluid buildup in hands and neck", "vasculitis on fingernail beds", "high sugar level after receiving covid vaccine", "stiffness in hands and neck", "limited mobility after receiving covid vaccine", "pain", "joint pain" and "decreased appetite" related to bnt162b2.  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 current available limited information in the case provided, the causal association between the events Obstruction, Scar, Rheumatoid arthritis, Fluid retention, Vasculitis, Blood glucose increased, Musculoskeletal stiffness, Mobility decreased, Pain, Arthralgia, Decreased appetite and the use of suspect product BNT162B2 cannot be fully 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 RAs, Ethics Committees, and Investigators, as appropriate.