Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Faeces soft, Haematochezia
Clinical narrative: Lack of drug effect; Soft stools; Blood in stool; 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-163-4517294-00.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160839) at unk (citrate free), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (non-serious) with onset 01Jul2022, outcome "not recovered", described as "Lack of drug effect"; HAEMATOCHEZIA (medically significant) with onset Jul2022, outcome "unknown", described as "Blood in stool"; FAECES SOFT (non-serious) with onset Jul2022, outcome "unknown", described as "Soft stools". The action taken for adalimumab was unknown.  Clinical course: Solicited Report from by a Consumer Of A 55 Year Old Male With Events Of Non-Serious Soft Mushy Stool With Blood And Humira Lack Of Effect With Humira (Adalimumab). There Was No Reported Medical History. In Jul2022, the Patient Experienced Soft Mushy Stool with Blood. On 01Jul2022, the patient experienced Humira Lack Of Effect. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) Was Also Considered Suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "blood in stool" and "soft stools" related to BNT162b2. The reporter's assessment of the causal relationship of "lack of drug effect" 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 Soft Mushy Stool With Blood Onset In Jul2022 And Soft Mushy Stool With Blood Onset In July 2022 Was Not Provided. The Reporter's Causality For The Event(S) Of Humira Lack Of Effect With Humira (Adalimumab) Was A Reasonable Possibility. The reporter's causality for the event(s) of Blood in stool (Hematochezia) and Soft stools (Faeces soft) with Humira (Solution for injection in pre-filled pen) (Adalimumab) was Not reported. The reporter's causality for the event(s) of Lack of drug effect (Drug ineffective) with Humira (Solution for injection in pre-filled pen) (Adalimumab)) was Probable.  The reporter's causality for the event(s) of Blood in stool (Hematochezia) and Soft stools (Faeces soft) with Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was Possible. The reporter's causality for the event(s) of Lack of drug effect (Drug ineffective) with Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was 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 the information provide and plausible temporal association, the causality between BNT162B2 and events(HAEMATOCHEZIA, FAECES SOFT ) cannot be completely excluded. 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.