Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Fatigue, Headache
Clinical narrative: Colitis ulcerative aggravated; Tiredness; Headache; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4419268-00 (AbbVie).  A 47-year-old female patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster) single (Batch/Lot number: unknown) at the age of 47 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1161756) at citrate free, subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 01, Intra-muscular, 1st Dose (1 in 1 once)), administration date: 02Feb2021, when the patient was 46-year-old, for COVID-19 immunization, reaction(s): "Covid-19"; BNT162b2 (Dose: 02, Intra-muscular, 2nd Dose (1 in 1 once)), administration date: 02Mar2021, when the patient was 46-year-old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021); FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Tiredness"; COLITIS ULCERATIVE (medically significant) with onset Jan2022, outcome "recovering", described as "Colitis ulcerative aggravated". The patient underwent the following laboratory tests and procedures: Colitis ulcerative: (Jan2022) Aggravated, notes: Colitis ulcerative aggravated. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of colitis ulcerative.  Clinical course: It was unknown if patient was enrolled in a Covid-19 vaccine trial. The patient was treated with Prednisone. Causality for Humira (Adalimumab): The reporter's causality for the events of COVID vaccine reactions included headaches and tiredness onset in 2021 and three ulcerative colitis flares was not provided. Causality for Humira: Causality as per reporter for Tiredness (Fatigue), headache (Drug/Vaccine): Not Related. Causality as per reporter for Colitis ulcerative aggravated (Drug/Vaccine): Not Reported. Causality for BNT162b2: Causality as per reporter (Drug/Vaccine): Possible. Causality as per reporter for colitis ulcerative aggravated (colitis ulcerative)(Drug/Vaccine): Not reported.  The reporter's assessment of the causal relationship of "colitis ulcerative aggravated", "tiredness" and "headache" with the suspect product(s) 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.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.