Age: 15.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Cyst, Depressed mood, Dizziness, Fear
Clinical narrative: oral intake reduced; bloody stool; difficulty sleeping; fear; activities of daily living impaired; feeling sad; wound secretion; Cyst; Crohn's; dizziness; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a non-contactable consumer (the patient) based on the information received by Pfizer from AbbVie Inc. (MFR Control No.21K-163-3943648-00). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in 2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from 26May2021 (Batch/Lot number was not reported) to 26May2021, at 80 mg (day 1, loading dose), subcutaneous from 09Jun2021 (Batch/Lot number was not reported) to 09Jun2021, at 80 mg (day 1, loading dose), subcutaneous from 23Jun2021 (Batch/Lot number was not reported) and ongoing, at 40 mg (40 mg,1 in 14 D) for Crohn's disease. Medical history included eczema. The patient's concomitant medications were not reported. In May2021, the patient experienced Crohn's and dizziness. In Jun2021, the patient experienced difficulty sleeping, fear, activities of daily living impaired, feeling sad, wound secretion, and cyst. In Jul2021, the patient experienced bloody stool, dizziness, and oral intake reduced. The clinical course was reported as follows: In May2021, the patient experienced dizziness and no change in Crohn's symptoms after start of HUMIRA. In Jun2021, the patient experienced trouble sleeping, feeling afraid/scared, not able to do things other children could do, feeling sad/blue, and cyst inside butt and it was leaking. In Jul2021, the patient experienced dizziness, did not want to eat, and 1 to 2 formed stools a day without bleeding. The action taken in response to the events for BNT162B2 was not applicable, for adalimumab was dose not changed. The outcome of Crohn's was not recovered. The outcome of dizziness, wound secretion, cyst, was recovered in 2021. The outcome of other events was recovering.  The reporter's assessment of the causal relationship of the events with the suspect vaccine, 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 needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the  limited available information, the causal relationship between BNT162B2 and the events Haematochezia, Crohn's disease, Dizziness , Hypophagia, Insomnia , Fear, Loss of personal independence in daily activities, Depressed mood, Wound secretion and Cyst are considered related.   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.