Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colitis, Delirium, Loss of personal independence in daily activities
Clinical narrative: felt delirious; could barely do anything; colitis flare up; 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): 22K-163-4256297-00 (Agency).  A 40 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Nov2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single, intramuscular, administration date 15Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 25Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1155267) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DELIRIUM (medically significant) with onset Feb2021, outcome "recovered" (2021), described as "felt delirious"; COLITIS (non-serious) with onset 2021, outcome "recovering", described as "colitis flare up"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "could barely do anything". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of colitis flare up, felt delirious onset in Feb2021, felt delirious onset in Nov2021, could barely do anything onset in Nov2021 and could barely do anything onset in Feb2021 was not provided.  The reporter's assessment of the causal relationship of the events colitis flare up and felt delirious, could barely do anything with the suspect product BNT162B2 was not reported and possible at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  Clinical course: Solicited report from the by a consumer of a 40 year old female with events of non-serious colitis flare up, felt delirious and could barely do anything with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced colitis flare up. In Feb2021, the patient experienced felt delirious and could barely do anything. In Nov2021, the patient experienced felt delirious and could barely do anything. In 2021, the felt delirious and could barely do anything resolved. On unknown dates, felt delirious and could barely do anything resolved. pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of delirium, colitis flare up,loss of personal independence in daily activities. 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