Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal haemorrhage
Clinical narrative: blood transfusion due to GI bleed after Moderna covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (blood transfusion due to GI bleed after Moderna covid-19 vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Blood transfusion (blood transfusion due to GI bleed after Moderna covid-19 vaccine) in April 2022.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced GASTROINTESTINAL HAEMORRHAGE (blood transfusion due to GI bleed after Moderna covid-19 vaccine) (seriousness criterion medically significant). At the time of the report, GASTROINTESTINAL HAEMORRHAGE (blood transfusion due to GI bleed after Moderna covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  HCP Pharmacist called with a question about contraindications for a second (Moderna) booster for a patient who had a recent blood transfusion (in April 2022).  No treatment medication was reported.  Company comment: This spontaneous case concerns a female patient aged 70 years with no medical history reported, who experienced the unexpected serious (medically significant) event of Gastrointestinal haemorrhage that occurred on an unknown date(approximately 4 months) after third dose of mRNA-1273 vaccination in covid-19 vaccination series. Patient had received blood transfusion in April 2022 due to GI bleed after Moderna covid-19 vaccine. No further clinical course, lab reports or treatment details were reported.  Outcome of the event was unknown at the time of report. Patient had received 1st and 2nd dose of mRNA-1273 vaccine at an interval of 28 days. Elderly age of the patient could be a  risk factor. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 70 years with no medical history reported, who experienced the unexpected serious (medically significant) event of Gastrointestinal haemorrhage that occurred on an unknown date(approximately 4 months) after third dose of mRNA-1273 vaccination in covid-19 vaccination series. Patient had received blood transfusion in April 2022 due to GI bleed after Moderna covid-19 vaccine. No further clinical course, lab reports or treatment details were reported.  Outcome of the event was unknown at the time of report. Patient had received 1st and 2nd dose of mRNA-1273 vaccine at an interval of 28 days. Elderly age of the patient could be a  risk factor. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement