Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Gastro intestinal hemorrhage associated with chronic gastritis; Chronic gastritis; Nurse reports patient has fallen twice since being home; Abdominal pain; Acute Kidney Injury (found during hospital workup); Seven weeks and 3 days between shots; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (Gastro intestinal hemorrhage associated with chronic gastritis), CHRONIC GASTRITIS (Chronic gastritis), FALL (Nurse reports patient has fallen twice since being home), ABDOMINAL PAIN (Abdominal pain) and ACUTE KIDNEY INJURY (Acute Kidney Injury (found during hospital workup)) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Seven weeks and 3 days between shots). On an unknown date, the patient experienced GASTROINTESTINAL HAEMORRHAGE (Gastro intestinal hemorrhage associated with chronic gastritis) (seriousness criteria hospitalization and medically significant), CHRONIC GASTRITIS (Chronic gastritis) (seriousness criterion hospitalization), FALL (Nurse reports patient has fallen twice since being home) (seriousness criterion hospitalization), ABDOMINAL PAIN (Abdominal pain) (seriousness criterion hospitalization) and ACUTE KIDNEY INJURY (Acute Kidney Injury (found during hospital workup)) (seriousness criterion medically significant). The patient was hospitalized from 23-Mar-2021 to 02-Apr-2021 due to ABDOMINAL PAIN, CHRONIC GASTRITIS, FALL and GASTROINTESTINAL HAEMORRHAGE. On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Seven weeks and 3 days between shots) had resolved. At the time of the report, GASTROINTESTINAL HAEMORRHAGE (Gastro intestinal hemorrhage associated with chronic gastritis), CHRONIC GASTRITIS (Chronic gastritis), FALL (Nurse reports patient has fallen twice since being home), ABDOMINAL PAIN (Abdominal pain) and ACUTE KIDNEY INJURY (Acute Kidney Injury (found during hospital workup)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Nurse reported history of fall, non-compliant with cane use. Supra-therapeutic INR, watchman procedure was scheduled on 15-Apr-2021. Nurse reports patient had fallen twice since being home.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.