Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Bleeding in bowel movement; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (Bleeding in bowel movement) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose of Pfizer last March 21,2021 administered in his Left arm.) on 21-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd dose of Pfizer last April 21 and2021 administered in his Left arm.) on 21-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Allergy to antibiotic (experienced reaction with Amoxicillin), Allergy to antibiotic (got sick with CIPRO) and Ulcerative colitis (Patient have ulcerative colitis since 1987) since 1987. Concomitant products included MESALAMINE and MERCAPTOPURINE for an unknown indication.   In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2022, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced GASTROINTESTINAL HAEMORRHAGE (Bleeding in bowel movement) (seriousness criterion medically significant). On 03-Feb-2022, EXTRA DOSE ADMINISTERED (Extra dose administered) outcome was unknown. At the time of the report, GASTROINTESTINAL HAEMORRHAGE (Bleeding in bowel movement) outcome was unknown.            Patient reported concomitant medication as Curcumin with Bioterine 100mg once daily.  Patient received his 1 dose of Pfizer vaccine on 21 March 2021 and 2 dose of Pfizer vaccine on 21 April 2021, both received intramuscularly on his left arm. Patient received 3 dose of Moderna vaccine on Aug 2021 on his left arm and Booster dose of Moderna on 3 Feb 2022 on his left arm. Patient experienced bleeding in bowel movement and not yet reported it to his physician. Patient asked if there any reports similar to his case who had ulcerative colitis and experienced bleeding.  No treatment medication was reported by patient.  Company comment: This case concerns a 62-year-old male patient with relevant medical history of ulcerative colitis who experienced the unexpected serious event of Bleeding in bowel movement (Seriousness Criterion-medically significant). The events occurred unspecified days after the booster dose of mRNA-1273 Vaccine. Patient received extra dose of mRNA-1273 vaccine. Medical history of ulcerative colitis can be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-475739 (Patient Link).; Sender's Comments: This case concerns a 62-year-old male patient with relevant medical history of ulcerative colitis who experienced the unexpected serious event of Bleeding in bowel movement (Seriousness Criterion-medically significant). The events occurred unspecified days after the booster dose of mRNA-1273 Vaccine. Patient received extra dose of mRNA-1273 vaccine. Medical history of ulcerative colitis can be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.