Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Depressed mood, Feeling abnormal, Gastrointestinal pain, Haematochezia
Clinical narrative: feeling lousy; Pain; Upset; intestinal cramping and gripping; sick; cold sweat; Nausea; Vomiting; started to bleed rectally; blood in stool; This spontaneous case was reported by an other health care professional and describes the occurrence of RECTAL HAEMORRHAGE (started to bleed rectally) and HAEMATOCHEZIA (blood in stool) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 041L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced RECTAL HAEMORRHAGE (started to bleed rectally) (seriousness criterion medically significant), HAEMATOCHEZIA (blood in stool) (seriousness criterion medically significant), PAIN (Pain), DEPRESSED MOOD (Upset), GASTROINTESTINAL PAIN (intestinal cramping and gripping), ILLNESS (sick), COLD SWEAT (cold sweat), NAUSEA (Nausea) and VOMITING (Vomiting). On 01-Nov-2021, the patient experienced FEELING ABNORMAL (feeling lousy). At the time of the report, RECTAL HAEMORRHAGE (started to bleed rectally), HAEMATOCHEZIA (blood in stool), FEELING ABNORMAL (feeling lousy), PAIN (Pain), DEPRESSED MOOD (Upset), GASTROINTESTINAL PAIN (intestinal cramping and gripping), ILLNESS (sick), COLD SWEAT (cold sweat), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: normal (normal) everything was fine.. On an unknown date, Electrocardiogram: normal (normal) other things were fine..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.  The patient stated that she reviewed what she had eaten and thought maybe it was bad mushrooms she had and does not remember how long the bleeding lasted, and also there was blood going down her leg.  Company Comment: This case concerns a 70 year old female patient with no relevant medical history, who experienced the serious unexpected events of rectal hemorrhage and hematochezia. The events occurred on an unknown date after the booster dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 70 year old female patient with no relevant medical history, who experienced the serious unexpected events of rectal hemorrhage and hematochezia. The events occurred on an unknown date after the booster dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.