Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Crohn's disease, Hypophagia, Inappropriate schedule of product administration, Poor quality sleep
Clinical narrative: dose 1 on 17Mar2021 and dose 2 on 08May2021; Crohn's disease aggravated; Bowel incontinence; Oral intake reduced; Sleep unwell; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 08May2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for crohn's disease. Relevant medical history included: "Diarrhea" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Route of Admin: Intra-muscular, Therapy Dates/Duration: 17Mar2021), administration date: 17Mar2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: CROHN'S DISEASE (medically significant) with onset 2021, outcome "not recovered", described as "Crohn's disease aggravated"; ANAL INCONTINENCE (non-serious) with onset 2021, outcome "unknown", described as "Bowel incontinence"; HYPOPHAGIA (non-serious) with onset 2021, outcome "unknown", described as "Oral intake reduced"; POOR QUALITY SLEEP (non-serious) with onset 2021, outcome "unknown", described as "Sleep unwell"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08May2021, outcome "unknown", described as "dose 1 on 17Mar2021 and dose 2 on 08May2021". The patient underwent the following laboratory tests and procedures: weight decreased: (Dec2021) 15 lbs. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of crohn's disease, anal incontinence, hypophagia, poor quality sleep. Clinical course: The patient was treated with PREDNISONE. It was reported that, on an unknown date patient experienced Leakage In The Morning. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of Bowel Accident, Could Not Eat Much and Could Not Sleep Well was not provided. The reporter's causality for the event(s) of Crohn's Disease Flare Up and Leakage In The Morning with HUMIRA(ADALIMUMAB) was no reasonable possibility.  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 known safety profile and Limited information in the case report a possible causal relationship between the reported events crohn's disease, anal incontinence, hypophagia, poor quality sleep and 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