Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rotator cuff syndrome, Seasonal allergy, Throat irritation
Clinical narrative: Pain in arm; Fatigue; Rheumatoid arthritis flare up; Rotator cuff tear; Frozen shoulder exacerbated; Bone spur; Torn muscle; Mobility decreased; Itchy throat; Cough; Seasonal allergy; Postoperative complication; This is a solicited report received from a contactable Physician via a Pfizer marketing program (marketing program name not available). A 56-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8734), via intramuscular on 02Apr2021 as dose 1, single for COVID-19 immunization; adalimumab (HUMIRA; Solution for injection in pre-filled syringe; Batch/Lot number was not reported), subcutaneous from 2020 to an unspecified date in Feb2021 at 40 mg, unknown frequency; then subcutaneous from 28Mar2021 and ongoing at 40 mg, unknown frequency for moderate to severe rheumatoid arthritis. Medical history included right upper arm bone spurs from 2017, right frozen shoulder from 2017, right shoulder torn rotator cuff from 2017, no tobacco user, abstain from alcohol, sulfa drugs and penicillin allergy manifested by hives, cephalosporins allergy manifested by anaphylaxis. Concomitant medications included polycarbophil calcium (FIBERCON) as laxative, paracetamol (TYLENOL) for post-surgery pain, metformin for diabetes; multivitamins [Vitamins NOS] as supplement, naproxen taken for post-surgery pain; Insulin spart (NOVOLOG) for diabetes; Saxagliptin hydrochloride (ONGLYZA) for diabetes; Hydroxychloroquine phosphate (PLAQUENIL) taken for Rheumatoid arthritis and Sjogren's syndrome; Pravastatin taken for high cholesterol; Eletriptan hydrobromide (RELPAX) taken for Migraine; Dulaglutide (TRULICITY) for diabetes and Insulin degludec (TRESIBA) taken for diabetes. The patient previously took Penicillin NOS. The patient underwent lab tests and procedures which included Shoulder Magnetic Resonance Imaging on 19Jan2021 with results of Right shoulder torn rotator cuff, right frozen shoulder exacerbated and right upper arm bone spurs. It was reported that, on 30Mar2021, the patient had rheumatoid arthritis flare up. On an unspecified date in 2021, the patient experienced torn muscle, cough, mobility decreased, itchy throat, seasonal allergy and postoperative complication. On 02Apr2021, the patient experienced pain in arm and fatigue. The events Seasonal allergy and Postoperative complication was assessed as non-serious, whereas rest of the events were assessed as serious (medically significant). The action taken in response to the events with Humira was dose not changed. The outcome of the event rheumatoid arthritis flare-up, mobility decreased, Itchy throat, Cough, Pain in arm was not recovered, outcome of the events Rotator cuff tear, Frozen shoulder exacerbated, Bone spur was recovering, outcome of the event Fatigue was recovered on unspecified date in Apr2021, whereas outcome was unknown for the events torn muscle, seasonal allergy and postoperative complication.  Information about exp date has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event pain in arm, fatigue and the suspect drug BNT162B2. Also, there is limited information in the case provided, the causal association between the event Rheumatoid arthritis flare up, Rotator cuff tear, Frozen shoulder exacerbated, Bone spur, Torn muscle, Mobility decreased, Itchy throat, cough, Postoperative complication, Seasonal allergy and the suspect drug BNT162B2 cannot be 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.