Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Therapeutic response shortened
Clinical narrative: ulcerative colitis symptoms; humira had lessened the stool frequency but that after a week or 1.5 weeks after humira injection symptoms came back and humira pen misfire with humira (adalimumab); FACILITATED COLLECT  This is a solicited report received from contactable reporter (Consumer or other non HCP)  for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4122310-00.  A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 11Apr2021 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single and intramuscular, administration date 21Mar2021 (Batch/Lot number: unknown) at age of 34 years old as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since May2021 (ongoing) (Batch/Lot number: unknown) at citrate free for colitis ulcerative. Relevant medical history included: "ulcerative pancolitis", start date: Apr2021 (unspecified if ongoing); "sulfa antibiotic allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset 2021, outcome "not recovered", described as "ulcerative colitis symptoms"; THERAPEUTIC RESPONSE SHORTENED (non-serious) with onset 2021, outcome "not recovered", described as "humira had lessened the stool frequency but that after a week or 1.5 weeks after humira injection symptoms came back and humira pen misfire with humira (adalimumab)". The action taken for adalimumab was dosage not changed. Clinical course: In 2021, the patient experienced ulcerative colitis symptoms/adalimumab (HUMIRA) had lessened the stool frequency but that after a week or 1.5 weeks after adalimumab (HUMIRA) injection symptoms came back and adalimumab (HUMIRA) pen misfire. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 21Mar2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 11Apr2021, she received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. Causality for humira (adalimumab): The reporter's causality for the event(s) of ulcerative colitis symptoms/adalimumab (HUMIRA) had lessened the stool frequency but that after a week or 1.5 weeks after adalimumab (HUMIRA) injection symptoms came back onset in 2021, ulcerative colitis symptoms/adalimumab (HUMIRA) had lessened the stool frequency but that after a week or 1.5 weeks after adalimumab (HUMIRA) injection symptoms came back onset in 2021 and HUMIRA PEN MISFIRE was not provided.  The reporter considered "ulcerative colitis symptoms" and "humira had lessened the stool frequency but that after a week or 1.5 weeks after humira injection symptoms came back and humira pen misfire with humira (adalimumab)" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible temporal relationship the causal role of the BNT162B2 Vaccination cannot be excluded for reported events. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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