Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Everything hurt; teeth ache; Does not feel well/ Unpleasant; Fever; Chills; Muscle aches; Nauseated; Vomiting; Got sick again; Intestinal cramping and  Gripping Worse she ever had; put me in a cold sweat; Started to bleed rectally; Major side effects/ All the side effects on the list/ Has every side effect; This spontaneous case was reported by a nurse and describes the occurrence of RECTAL HAEMORRHAGE (Started to bleed rectally) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 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. In February 2021, the patient experienced PAIN (Everything hurt), TOOTHACHE (teeth ache), MALAISE (Does not feel well/ Unpleasant), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches), NAUSEA (Nauseated) and VOMITING (Vomiting). In 2021, the patient experienced RECTAL HAEMORRHAGE (Started to bleed rectally) (seriousness criterion medically significant), VACCINATION COMPLICATION (Major side effects/ All the side effects on the list/ Has every side effect), ILLNESS (Got sick again), GASTROINTESTINAL PAIN (Intestinal cramping and  Gripping Worse she ever had) and COLD SWEAT (put me in a cold sweat). In February 2021, PAIN (Everything hurt), TOOTHACHE (teeth ache), MALAISE (Does not feel well/ Unpleasant), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches), NAUSEA (Nauseated) and VOMITING (Vomiting) had resolved. In 2021, RECTAL HAEMORRHAGE (Started to bleed rectally) had resolved. At the time of the report, VACCINATION COMPLICATION (Major side effects/ All the side effects on the list/ Has every side effect), ILLNESS (Got sick again), GASTROINTESTINAL PAIN (Intestinal cramping and  Gripping Worse she ever had) and COLD SWEAT (put me in a cold sweat) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: normal (normal) everything was fine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment medication were provided.  Company Comment This case concerns a  70 year old female patient with no relevant medical history, who experienced the serious unexpected event of rectal hemorrhage. The event occurred on an unknown date after the second dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-373657 (Patient Link).; Sender's Comments: This case concerns a  70 year old female patient with no relevant medical history, who experienced the serious unexpected event of rectal hemorrhage. The event occurred on an unknown date after the second dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.