Age: 79.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Computerised tomogram liver, Rotator cuff syndrome, Stress fracture, X-ray limb
Clinical narrative: Stress fracture; Rotator cuff injury; This is a non-interventional study report from an unspecified marketing program received from a contactable consumer, information received by Pfizer.  A 79-years-old female patient received second dose of bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EN6205), intramuscular on 08Mar2021 as single dose, first dose received via intramuscular on 15Feb2021 (Batch/Lot Number: EL9269) as single dose for COVID-19 immunisation (Age at vaccination 79 years); upadacitinib (RINVOQ), oral from 13Dec2019 to Feb2021, at 15 mg,1x/day, oral from Mar2021 (Batch/Lot number was not reported) to Mar2021, at 15 mg, 1x/day, oral from 2021 (Batch/Lot number was not reported) to May2021, at 15 mg, 1x/day for rheumatoid arthritis. Medical history included alcohol use/wine, occasionally, tobacco user from 1961 to 1996 Pack Of Cigarettes a day /Tobacco Use/Tobacco Smoker From Age twenty to fifty five years, amount ten to twenty per day, hysterectomy from 1980 to 1980 , hysterectomy from 1994 to 1994, foot operation from 2021 to 2021, arthralgia, Long Standing left Shoulder pain as result of Rheumatoid arthritis , drug hypersensitivity. Codeine Allergy Manifested by Severe Nausea and Itching, drug hypersensitivity. Diladid Allergy Manifested by Severe Nausea and Itching, drug hypersensitivity Ceftin Allergy Manifested by Itching. Concomitant medication(s) included sofalcone (SCOWE) taken for thyroid disorder, sulfasalazine taken for arthritis; hydroxychloroquine phosphate (PLAQUENIL) taken for arthritis; prednisone taken for arthritis; methotrexate taken for arthritis; folic acid taken for arthritis; levothyroxine sodium (SYNTHROID) taken for thyroid disorder; nebivolol hydrochloride (BYSTOLIC) taken for thyroid disorder; amiodarone hydrochloride (AMIODAREX) taken for thyroid disorder. The patient experienced shoulder pain on 2020, reverse shoulder operation on 25Feb2021, cartilage damage on 08Feb2021, rotator cuff injury on 08Feb2021, unspecified disorder of joint of shoulder region on an unspecified date, arthritis on an unspecified date, stress fracture on May2021, pain on Apr2021, upper extremity dysfunction on 25Feb2021, arthralgia on Mar2021. The patient underwent lab tests and procedures which included computerised tomogram liver: Showed damaged cartilages and rotator cuff on the left shoulder on 08Feb2021 result , x-ray limb: May2021 Stress fracture of shoulder and the bone detaches to shoulder and on 08Feb2021, x-ray limb: result Showed damaged cartilages and rotator cuff on the left shoulder. The action taken in response to the event(s) for upadacitinib was unknown. The alternate etiology for the event stress fracture of shoulder was stress. The outcome for events Shoulder operation, Cartilage damage and Rotator cuff injury was Recovering/resolving, for Unspecified disorder of joint of shoulder region and Arthritis it was Unknown, Stress fracture recovered on an unspecified date in May2021, Pain recovered on an unspecified date in 2021, Shoulder pain outcome was Recovered on an unspecified date in Mar2021 and Upper extremity dysfunction and Arthralgia Not recovered/not resolved.  Causality for BNT162B2 for event Upper extremity dysfunction and Arthralgia it was Not Related for rest all event it was not reported.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information in the case, the events stress fracture,rotatory cuff syndrome are most likely related to an underlying condition of Rheumtoid arthritis which is not related to suspect product BNT162B2.The case will be reassessed if additional information becomes available.