Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Magnetic resonance imaging, Pain in extremity, Rotator cuff syndrome
Clinical narrative: torn rotator cuff right shoulder; arm soreness; This is a non-interventional study, solicited report based on the information received by Pfizer.   This is a solicited report from by a contactable consumer (patient) of a 65-year-old female with events of torn rotator cuff right shoulder and non-serious arm soreness with adalimumab (HUMIRA, 40 Mg/0.4ml). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on Feb2021 at the age of 65 years (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen, 40mg/0.4ml), via subcutaneous from an unspecified date and ongoing, at 40 mg,1 in 2 wk for moderate to severe rheumatoid arthritis.  Medical history included alcohol use stopped in 2006, tobacco use stopped in 2006, penicillin allergy manifested by tongue swelling, hives and itching. The patient's concomitant medications were not reported.  The patient's past medications included cortisone for unknown indication and penicillin for unknown indication. In Feb2021, the patient experienced torn rotator cuff right shoulder and arm soreness. In Fe2021, the arm soreness resolved. COVID-19 Vaccine was also considered suspect. On 03Mar2021, the patient had a right shoulder rotator cuff surgery and was sent home the same day. She had Cortisone shots and therapy before she had the magnetic resonance imaging and surgery. The causality of surgery was no reasonable possibility with adalimumab. She agreed to have physician contacted. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Jan2021, patient received first dose COVID-19 Vaccine (bnt162b2) at the age of 65 years for covid-19 immunization manufactured by Pfizer. In Feb2021, patient received second dose COVID-19 Vaccine manufactured by Pfizer. Primary reporter did not have the lot number information, because the packaging was discarded. In Feb2021, magnetic resonance imaging: showed torn rotator cuff right shoulder. The action taken in response to the events for bnt162b2 was not applicable, for adalimumab was unknown. Outcome of torn rotator cuff right shoulder was not recovered, of arm soreness was recovered in Feb2021.  ~ Causality for adalimumab: The reporter's causality for the events of torn rotator cuff right shoulder and arm soreness with adalimumab was no reasonable possibility.  Causality for BNT162B2: The reporter's causality for the event of torn rotator cuff right shoulder with BNT162B2 was not reported. The reporter's causality for arm soreness with BNT162B2 was reasonable possibility.  The reporter's assessment of the causal relationship of the torn rotator cuff right shoulder with the 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.  Follow-up (03May2021): This follow-up is being submitted to notify that the batch and lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2 ,a temporal association between the event rotator cuff syndrome and administration of BNT162B2 cannot be excluded. Due to limited information, a  complete medical assessment cannot be made. 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.