Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Discomfort
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4409156-00. A 74-year-old female patient received BNT162b2 (BNT162B2), on 15Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 01Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 73 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) till 2022, subcutaneous for colitis ulcerative; prednisone (PREDNISONE), (ongoing) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant), outcome "unknown", described as "Ulcerative colitis symptoms returned"; DISCOMFORT (non-serious), outcome "unknown", described as "uncomfortable". The action taken for prednisone was unknown. The action taken for adalimumab was dosage permanently withdrawn in 2022. The reporter considered "ulcerative colitis symptoms returned" related to BNT162b2. The reporter's assessment of the causal relationship of "uncomfortable" 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. Additional information: Solicited report by a consumer of an elderly female with events of non-serious uncomfortable, ulcerative colitis symptoms returned and Humira did not work/Humira failed/Humira was waning with Humira (Adalimumab). There was no reported medical history and no Concomitant Drugs.  On unknown dates, the patient experienced uncomfortable, ulcerative colitis symptoms returned and Humira did not work/Humira failed/Humira was waning. Prednisone and Pfizer BioNTech COVID-19 vaccine (Tozinameran) were also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter declined to be contacted. Causality: Drugs: Humira: Discomfort, Ulcerative colitis relapse, Lack of drug effect, Action taken with drug is Drug discontinued and Causality as per reporter is Not reported. On 15 Aug 2022, received updates to event information, reporter opinion of causality, suspect drug information, and narrative description. The event of ulcerative colitis symptoms returned was added. The event of Humira did not work was amended to Humira did not work/Humira failed/Humira was waning. Drugs: Prednisone: Discomfort, Ulcerative colitis relapse, Lack of drug effect, Action taken with drug is unknown and Causality as per reporter is Not reported. Drug: Pfizer BioNTech COVID-19 Vaccine: Discomfort, Ulcerative colitis relapse, Lack of drug effect, Action taken with drug is unknown and Causality as per reporter is Not reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events colitis ulcerative and discomfort and BNT162B2. 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.