Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gallbladder disorder, Histamine abnormal, Histamine level, Malaise, Pyrexia
Clinical narrative: Blood clots/Vaccination site thrombosis; Felt sick; Injection site reaction; Histamine reaction; Welts at injection site; Fever; Rectal bleeding; Gall bladder removal; 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-163-4469352-00.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GALLBLADDER DISORDER (medically significant) with onset May2022, outcome "recovered" (2022), described as "Gall bladder removal"; PYREXIA (non-serious) with onset Jun2022, outcome "recovered" (2022), described as "Fever"; RECTAL HAEMORRHAGE (medically significant) with onset Jun2022, outcome "recovered" (2022), described as "Rectal bleeding"; VACCINATION SITE THROMBOSIS (medically significant), outcome "recovered", described as "Blood clots/Vaccination site thrombosis"; MALAISE (non-serious), outcome "recovered", described as "Felt sick"; VACCINATION SITE REACTION (non-serious), outcome "recovered with sequelae", described as "Injection site reaction"; HISTAMINE ABNORMAL (non-serious), outcome "unknown", described as "Histamine reaction"; VACCINATION SITE URTICARIA (non-serious), outcome "recovered with sequelae", described as "Welts at injection site". The patient underwent the following laboratory tests and procedures: Histamine level: Abnormal. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of gallbladder disorder.  The reporter's assessment of the causal relationship of "gall bladder removal", "rectal bleeding", "fever", "injection site reaction", "histamine reaction" and "welts at injection site" 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 and "blood clots/vaccination site thrombosis", "felt sick", was reported as possible.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of gall bladder removal, COVID vaccine reaction/blood clots/felt sick unknown onset, COVID vaccine reaction/blood clots/felt sick unknown onset, fever and rectal bleeding with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of injection site reaction/histamine reaction and welts at injection site unknown onset and injection site reaction/histamine reaction and welts at injection site unknown onset with Humira (Adalimumab) was a reasonable possibility.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information in the case the reported events Vaccination site thrombosis , Malaise, Pyrexia, Vaccination site reaction , Histamine abnormal, Vaccination site urticaria are assessed as related to suspect drug . Based on available information in the case the reported event Gallbladder disorder , Rectal haemorrhage assessed as unrelated to suspect drug  and more likely related to intercurrent/ underlying medical condition 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.