Sex: M
Vaccine: UNK
Symptoms: Condition aggravated, Crohn's disease, Drug interaction, Therapeutic product effect decreased
Clinical narrative: crohns was not bad at all but since the covid vaccination that had never been the same and patient was using the bathroom five or six times with humira; Humira not working, possible vaccination side effect/crohns was not bad at all but since the covid vaccination that had never been the same/patient was using the bathroom five/six times with humira; Humira not working, possible vaccination side effect/crohns was not bad at all but since the covid vaccination that had never been the same/patient was using the bathroom five/six times with humira; 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-163-4535553-00 (Agency).  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) at 40 mg weekly (40 mg, weekly (citrate free, 1 in 1 wk)) and second regimen (ongoing) (Batch/Lot number: unknown), all subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "not recovered", described as "crohns was not bad at all but since the covid vaccination that had never been the same and patient was using the bathroom five or six times with humira"; DRUG INTERACTION (medically significant), outcome "not recovered", described as "Humira not working, possible vaccination side effect/crohns was not bad at all but since the covid vaccination that had never been the same/patient was using the bathroom five/six times with humira"; THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious), outcome "unknown", described as "Humira not working, possible vaccination side effect/crohns was not bad at all but since the covid vaccination that had never been the same/patient was using the bathroom five/six times with humira ". The action taken for adalimumab was dosage not changed.  Clinical course: Solicited report from a consumer of an adult male with events of non-serious humira was not working/helping, possible vaccination side effect/crohns was not bad at all but since the covid vaccination that had never been the same and patient was using the bathroom five or six times with humira (adalimumab). There was no reported medical history. On unknown dates, the patient experienced humira was not working/helping, possible vaccination side effect/crohns was not bad at all but since the covid vaccination that had never been the same and patient was using the bathroom five or six times. pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter contact for lot number information was unsuccessful.   The reporter considered "crohns was not bad at all but since the covid vaccination that had never been the same and patient was using the bathroom five or six times with humira (adalimumab)." related to BNT162b2. The reporter's assessment of the causal relationship of "humira was not working/helping, possible vaccination side effect/crohns was not bad at all but since the covid vaccination that had never been the same and patient was using the bathroom five or six times with humira (adalimumab)" 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.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of humira was not working/helping with humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of possible vaccination side effect/crohns was not bad at all but since the covid vaccination that had never been the same with humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of patient was using the bathroom five or six times was not provided. Lack of drug effect with respect to Humira was considered as probable and crohns disease as not related.  Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran): The reporter's causality for the events Lack of drug effect was not reported, Crohns disease was possible.   No follow-up attempts are Needed: information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events CROHN'S DISEASE, DRUG INTERACTION and suspect drug cannot be excluded completely, the case will be reassessed once FU information received 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.