Age: 53.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Anal incontinence, Diarrhoea, Ultrasound kidney, Wrong technique in product usage process, X-ray
Clinical narrative: recurrent diarrhea, frequent bathroom visits/no control of bowel movement/Bowel incontinence; recurrent diarrhea, frequent bathroom visits/no control of bowel movement; user error/caps removed straight off/pen was then set down for about 30 seconds/then pick up/button accidentally pressed/heard click/solution dispensed onto kitchen table/Wrong injection technique; This is a spontaneous report from a non-contactable consumer (patient) reporting for himself received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-3917215-00). A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE (TOZINAMERAN), Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 intramuscular on 03Apr2021 at the age of 53-years-old as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA 40MG/0.4ML, Solution for injection in pre-filled pen), subcutaneous from an unspecified date in Feb2021 (Batch/Lot number was not reported) and ongoing, at 40 mg for ulcerative colitis. The patient's medical history included alcohol use, variety, occasionally from 1988, polycystic kidney disease from 1998. kidney transplant on an unspecified date in March 2008, ulcerative colitis from unspecified date, pollen allergy manifestation by sneeze/eye water from unspecified date. The patient was a non-smoker. The patient's concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscularly on 06Mar2021 at the age of 53-years-old as single dose for covid-19 immunisation. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 13May2021, the patient experienced user error/caps removed straight off/pen was then set down for about 30 seconds/then pick up/button accidentally pressed/heard click/solution dispensed onto kitchen table. On 19May2021, the patient experienced recurrent diarrhea, frequent bathroom visits/no control of bowel movement/Bowel incontinence. The patient underwent lab tests and procedures which included ULTRASOUND OF KIDNEY (ultrasound kidney): unknown on an unspecified date, BARIUM X-RAY (x-ray): unknown on 19May2021. The events were reported as non-serious. The action taken in response to the event(s) for adalimumab was dose not changed. The outcome of event, Wrong injection technique was recovered on 13May2021, recurrent diarrhea was recovered on 20May2021 while Bowel incontinence was not recovered.  The reporter's causality for the event(s) of Bowel incontinence (Anal incontinence), Wrong injection technique (Wrong technique in product usage process), Diarrhea recurrent (Diarrhoea) with HUMIRA 40MG/0.4ML (Solution for injection in pre-filled pen) (ADALIMUMAB) was not related. The reporter's causality for the event(s) of of Bowel incontinence (Anal incontinence), Wrong injection technique (Wrong technique in product usage process), Diarrhea recurrent (Diarrhoea) with (BNT162B2) was not related.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events Bowel incontinence and Diarrhea recurrent is assessed to be unrelated.