Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Periarthritis, Post procedural complication, Post procedural swelling, Rheumatoid arthritis
Clinical narrative: Rotator cuff tear; Frozen shoulder exacerbated; Bone spur; Torn muscle; Post procedural swelling; Pain in arm; Fatigue; Rheumatoid arthritis flare up; Itchy throat; Seasonal allergy; Postoperative complication; Mobility decreased; Cough; This is a solicited report received from a contactable consumer reporting for herself and based on the information received by Pfizer.  Solicited report from a 57-year-old female consumer with events of worsening of right shoulder torn rotator cuff, worsening of right frozen shoulder, worsening of right upper arm bone spurs and right arm bicep muscle were torn and non-serious rheumatoid arthritis flare up, limited mobility was on a sling due to shoulder surgery, itchy throat due to seasonal allergy, cough, sore arms and fatigue with HUMIRA (adalimumab). The patient had a relevant medical history of right frozen shoulder, right shoulder torn rotator cuff and right upper arm bone spurs. On unknown dates, the patient experienced worsening of right shoulder torn rotator cuff, worsening of right frozen shoulder, worsening of right upper arm bone spurs and right arm bicep muscle were torn. In 2021, the patient experienced limited mobility was on a sling due to shoulder surgery, itchy throat due to seasonal allergy and cough. On 30Mar2021, the patient experienced rheumatoid arthritis flareup. On 02Apr2021 the patient experienced sore arms and fatigue. In Apr2021, the sore arms and fatigue resolved. COVID-19 vaccine was also considered suspect. The patient stated that she probably had the right shoulder torn rotator cuff, right frozen shoulder and right upper arm bone spurs a couple of years before starting on HUMIRA and it got worsen after starting on HUMIRA. She had the shoulder surgery done on 24Feb2021 to repair the torn rotator cuff and the frozen shoulder. During the surgery, it was found that her right arm bicep was torn and was also repaired. Bone spurs was being shaved off. She was taken off HUMIRA for a total of five weeks. She experienced rheumatoid arthritis flare up as manifested by joint pain and swelling of her right hand's two finger and knuckles. She stated that it started after she had her physical therapy. She was on a sling to immobilize the operated side. The alternative etiology of right shoulder torn rotator cuff was reported as work or activity related and age-related wear and tear. The alternative etiology of rheumatoid arthritis flares up was reported as due to being taken off HUMIRA for a total of five weeks and alternative etiology of limited mobility was reported as she was on a sling due to shoulder surgery. The alternative etiology of itchy throat was reported as seasonal allergy. The alternative etiology of sore arms was reported as relate to COVID-19 vaccine. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On 02Apr2021, patient received 1st dose COVID-19 vaccine manufactured by Pfizer BioNTech, lot number ER8734. Primary reporter did not have the lot number information, because the packaging was discarded (as reported). The patient was treated with prednisone. The patient's past medications include: penicillin for unknown indication.    Causality for HUMIRA (adalimumab) The reporter's causality for the events of worsening of right shoulder torn rotator cuff, worsening of right frozen shoulder, worsening of right upper arm bone spurs, right arm bicep muscle was torn, rheumatoid arthritis flares up, limited mobility was on a sling due to shoulder surgery onset in 2021, itchy throat due to seasonal allergy onset in 2021, cough, sore arms, andfatigue with HUMIRA (adalimumab) was no reasonable possibility. The reporter's causality for the events of itchy throat due to seasonal allergy onset in 2021 and limited mobility/was on a sling due to shoulder surgery onset in 2021 and Post procedural swelling was not provided. Company opinion is that there is no reasonable possibility that the events of worsening of right shoulder torn rotator cuff, worsening of right frozen shoulder, worsening of right upper arm bone spurs, right arm bicep muscle were torn, rheumatoid arthritis flare up, limited mobility was on a sling due to shoulder surgery onset in 2021, itchy throat due to seasonal allergy onset in 2021, cough, sore arms, fatigue, limited mobility/was on a sling due to shoulder surgery onset in 2021 and Post procedural swelling are related to HUMIRA (adalimumab).  Relevant laboratory and other diagnostic tests: 19Jan2021 shoulder magnetic resonance imaging: right shoulder torn rotator cuff, right frozen shoulder and right upper arm bone spurs.  Change history: On 05Apr2021, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, treatment drug information, past drug information, laboratory and diagnostic procedures and narrative description. The events of 'worsening of right frozen shoulder', 'worsening of right upper arm bone spurs', 'right arm bicep muscle were torn', 'rheumatoid arthritis flare up', 'limited mobility was on a sling due to shoulder surgery', 'itchy throat due to seasonal allergy', 'cough', 'sore arms' and 'fatigue' were added. The event of 'surgery' was amended to 'worsening of right shoulder torn rotator cuff'. The event of 'swelling in right finger' was removed.  The reporter considered that there was a reasonable possibility that the reported events Pain in arm and Fatigue were related to BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine. The reporter's assessment of the causal relationship of the other reported events with BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine 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.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that events Pain in arm and Fatigue were related to suspect drug.  The other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug.  The case will be reassessed if additional information becomes available.