Age: 22.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative, Culture stool, Inappropriate schedule of product administration, Salmonellosis, Sluggishness
Clinical narrative: salmonella infection; On 20Jan2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 01Feb2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer; ulcerative colitis flare ups and area sluggish; ulcerative colitis flare ups and area sluggish; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4087012-00.  A 22-year-old male patient (also the reporter) received bnt162b2 (BNT162B2), intramuscular, administration date 01Feb2021 (Batch/Lot number: unknown) at the age of 22 years as dose 2, single for COVID-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous since 28Jan2021 (Batch/Lot number: unknown) at 40 mg (citrate free) and second regimen subcutaneous (ongoing) (Batch/Lot number: unknown) for MODERATE TO SEVERE ULCERATIVE COLITIS. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Mesalamin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (first dose), administration date: 20Jan2021, when the patient was 22 years old, for covid-19 immunisation. The following information was reported: SALMONELLOSIS (hospitalization) with onset 01Sep2021, outcome "recovering", described as "salmonella infection"; COLITIS ULCERATIVE (medically significant), SLUGGISHNESS (non-serious) all with onset 2021, outcome "unknown" and all described as "ulcerative colitis flare ups and area sluggish"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Feb2021, outcome "unknown", described as "On 20Jan2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 01Feb2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer". The patient was hospitalized for salmonellosis (start date: 16Sep2021, discharge date: 20Sep2021, hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: culture stool: (03Sep2021) positive. The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available reported information, the causal association between the events salmonellosis, colitis ulcerative, sluggishness and inappropriate schedule of product administration and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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.