Sex: F
Vaccine: COVID19, UNK
Symptoms: Musculoskeletal discomfort, Pain assessment, Pain in extremity, Peripheral swelling
Clinical narrative: Collagenous Colitis; Pain in right index finger/ disfigurement and swelling; Colitis/inflammation of colon; Pain in right index finger/disfigurement and swelling; Index finger had discomfort with humira (adalimumab).; Bouts of diarrhea; Pain in right index finger/ disfigurement and swelling;  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): 21K-163-4096320-00.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS MICROSCOPIC (medically significant), outcome "recovered" (2021), described as "Collagenous Colitis"; FINGER DEFORMITY (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "Pain in right index finger/ disfigurement and swelling"; COLITIS (non-serious), outcome "recovered" (2021), described as "Colitis/inflammation of colon"; PAIN IN EXTREMITY (non-serious), outcome "recovered" (2021), described as "Pain in right index finger/disfigurement and swelling"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "not recovered", described as "Index finger had discomfort with humira (adalimumab)."; DIARRHOEA (non-serious), outcome "unknown", described as "Bouts of diarrhea". The patient underwent the following laboratory tests and procedures: colonoscopy: unknown; pain assessment: unknown. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of colitis microscopic, colitis, pain in extremity, musculoskeletal discomfort, diarrhoea, peripheral swelling and included treatment with prednisone.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of colitis/inflammation of colon, pain in right index finger/disfigurement and swelling and bouts of diarrhea was not provided. The reporter's causality for the event(s) of collagenous colitis and Index finger had discomfort with humira (adalimumab) was no reasonable possibility with both Pfizer suspect BNT162B2 and HUMIRA (ADALIMUMAB).  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 plausible temporal relation, the association between the events of colitis microscopic, finger deformity, colitis, pain in fingers, musculoskeletal discomfort, diarrhoea and peripheral swelling and the suspect product of BNT162B2 cannot be completely ruled out. 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.