Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Colitis
Clinical narrative: went to the hospital Aug 4 to the 5th 2022 was there for 5 days for stomach, for colitis; went to the hospital Aug 4 to the 5th 2022 was there for 5 days for stomach; This spontaneous case was reported by a patient and describes the occurrence of COLITIS (went to the hospital Aug 4 to the 5th 2022 was there for 5 days for stomach, for colitis) and ABDOMINAL DISCOMFORT (went to the hospital Aug 4 to the 5th 2022 was there for 5 days for stomach) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0214, 032b21a and 040a21a) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy and Drug allergy (Allergic to amodion and a blood pressure medication). Concomitant products included ONDANSETRON, METOPROLOL, LACTOBACILLUS [LACTOBACILLUS NOS], ATORVASTATIN CALCIUM, SPIRONOLACTONE, PANTOPRAZOLE SODIUM, LOSARTAN POTASSIUM, TRAZODONE, TRAMADOL, FLUOXETINE, ESTRADIOL and IBUPROFEN for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLITIS (went to the hospital Aug 4 to the 5th 2022 was there for 5 days for stomach, for colitis) (seriousness criterion hospitalization) and ABDOMINAL DISCOMFORT (went to the hospital Aug 4 to the 5th 2022 was there for 5 days for stomach) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to ABDOMINAL DISCOMFORT and COLITIS. At the time of the report, COLITIS (went to the hospital Aug 4 to the 5th 2022 was there for 5 days for stomach, for colitis) and ABDOMINAL DISCOMFORT (went to the hospital Aug 4 to the 5th 2022 was there for 5 days for stomach) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       On 22-Oct-2021, patient took first booster dose of Moderna COVID-19 Vaccine.  Patient went to the hospital on 04-Aug-2022 to 05-Aug-2022 and was there for 5 days for stomach and colitis.  Treatment information was not provided. Company comment: This spontaneous case concerns a 70-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Hospitalization) events of Colitis and Abdominal discomfort. The exact date of administration of a dose of mRNA-1273 and onset of the events was not specified, hence latency could not be assessed. The initial two doses of mRNA-1273 were given approximately 6 months prior to the third dose, the interval between the two doses is 29 days, the fourth dose of mRNA-1273 was given 10 months later. It has been reported that the patient was hospitalized for 5 days due to abdominal pain and Colitis. Details of concomitant medications, medical history, clinical course and treatment were not provided. The events have not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.   This case was linked to MOD-2022-630481 (Patient Link).; Sender's Comments: This spontaneous case concerns a 70-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Hospitalization) events of Colitis and Abdominal discomfort. The exact date of administration of a dose of mRNA-1273 and onset of the events was not specified, hence latency could not be assessed. The initial two doses of mRNA-1273 were given approximately 6 months prior to the third dose, the interval between the two doses is 29 days, the fourth dose of mRNA-1273 was given 10 months later. It has been reported that the patient was hospitalized for 5 days due to abdominal pain and Colitis. Details of concomitant medications, medical history, clinical course and treatment were not provided. The events have not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.