Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Colonoscopy, Computerised tomogram, Diverticulum, Nausea
Clinical narrative: Atrial Fibrillation; cholelithiasis; diverticulosis; abdominal discomfort; bloating; change in bowel activity; nausea; Ulcerative Colitis; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): US-MODERNATX-MOC20231207000015.  A 72-year-old male patient received bnt162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for Covid-19 immunization. The following information was reported: COLITIS ULCERATIVE (caused and prolonged hospitalization, disability, medically significant) with onset 2021, outcome "not recovered", described as "Ulcerative Colitis"; ABDOMINAL DISCOMFORT (caused and prolonged hospitalization, disability, medically significant) with onset 2021, outcome "not recovered"; ABDOMINAL DISTENSION (caused and prolonged hospitalization, disability, medically significant) with onset 2021, outcome "not recovered", described as "bloating"; BOWEL MOVEMENT IRREGULARITY (caused and prolonged hospitalization, disability, medically significant) with onset 2021, outcome "not recovered", described as "change in bowel activity"; NAUSEA (caused and prolonged hospitalization, disability, medically significant) with onset 2021, outcome "not recovered"; ATRIAL FIBRILLATION (caused and prolonged hospitalization, disability, medically significant) with onset Oct2021, outcome "not recovered"; CHOLELITHIASIS (caused and prolonged hospitalization, disability, medically significant) with onset Oct2021, outcome "not recovered"; DIVERTICULUM (caused and prolonged hospitalization, disability, medically significant) with onset Oct2021, outcome "not recovered", described as "diverticulosis". The patient underwent the following laboratory tests and procedures: Colonoscopy: (Jun2022) Ulcerative Colitis; Computerised tomogram: (Oct2021) cholelithiasis; (Oct2021) diverticulosis. Therapeutic measures were taken as a result of colitis ulcerative, cholelithiasis, diverticulum.  Clinical course: Received first vaccine in Feb2021. Second dose in Mar2021. Approximately 6 weeks after second vaccine began having abdominal discomfort, including bloating, change in bowel activity and nausea. In Oct2021, the patient experienced new onset atrial Fibrillation and was also diagnosed by CT scan with cholelithiasis and diverticulosis. A colonoscopy in Jun2022, the patient was diagnosed with ulcerative colitis. He was treated for both and was on medications for both. He continued to suffer from U.C even with medications Mesalamine and Budesonide. It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Is Moderna authorized to communicate with the patient / your healthcare provider was yes. Events caused or prolonged hospitalization and was having disabling or incapacitating due to events.  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 the available information the events COLITIS ULCERATIVE , ABDOMINAL DISCOMFORT , ABDOMINAL DISTENSION , BOWEL MOVEMENT IRREGULARITY , NAUSEA , ATRIAL FIBRILLATION, CHOLELITHIASIS are considered to be related to the suspect drug. 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.