Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal lymphadenopathy, Abdominal pain, Computerised tomogram, Diarrhoea
Clinical narrative: had swollen left mesentery lymph nodes which caused blockage in intestine; abdominal swelling dissension; had swollen left mesentery lymph nodes which caused blockage in intestine; inflammatory response which resulted in abdominal surgery; started throwing up and had projectile vomiting; diarrhea; couldn't go to the bathroom because of intestinal blockage; intermittent pain in belly; This spontaneous case was reported by a consumer and describes the occurrence of INTESTINAL OBSTRUCTION (had swollen left mesentery lymph nodes which caused blockage in intestine), ABDOMINAL DISTENSION (abdominal swelling dissension), ABDOMINAL LYMPHADENOPATHY (had swollen left mesentery lymph nodes which caused blockage in intestine), INFLAMMATION (inflammatory response which resulted in abdominal surgery), VOMITING PROJECTILE (started throwing up and had projectile vomiting), DIARRHOEA (diarrhea) and GAIT DISTURBANCE (couldn't go to the bathroom because of intestinal blockage) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013ML0A and 026620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INTESTINAL OBSTRUCTION (had swollen left mesentery lymph nodes which caused blockage in intestine) (seriousness criteria hospitalization prolonged, medically significant and life threatening), ABDOMINAL DISTENSION (abdominal swelling dissension) (seriousness criteria hospitalization prolonged, medically significant and life threatening), ABDOMINAL LYMPHADENOPATHY (had swollen left mesentery lymph nodes which caused blockage in intestine) (seriousness criteria hospitalization prolonged and medically significant), INFLAMMATION (inflammatory response which resulted in abdominal surgery) (seriousness criteria hospitalization prolonged and medically significant), VOMITING PROJECTILE (started throwing up and had projectile vomiting) (seriousness criteria hospitalization prolonged and medically significant), DIARRHOEA (diarrhea) (seriousness criteria hospitalization prolonged and medically significant), GAIT DISTURBANCE (couldn't go to the bathroom because of intestinal blockage) (seriousness criteria hospitalization prolonged and medically significant) and ABDOMINAL PAIN (intermittent pain in belly). The patient was hospitalized for 14 days due to ABDOMINAL DISTENSION, ABDOMINAL LYMPHADENOPATHY, DIARRHOEA, GAIT DISTURBANCE, INFLAMMATION, INTESTINAL OBSTRUCTION and VOMITING PROJECTILE. The patient was treated with POLYCARBOPHIL CALCIUM (FIBER) ongoing since an unknown date for Pain abdominal, at a dose of UNK, qd; PARACETAMOL (TYLENOL [PARACETAMOL]) for Belly ache, at an unspecified dose and frequency; Surgery (Abdominal Surgery) for Abdominal distension and Surgery (Abdominal Surgery) for Inflammation. At the time of the report, INTESTINAL OBSTRUCTION (had swollen left mesentery lymph nodes which caused blockage in intestine), ABDOMINAL DISTENSION (abdominal swelling dissension), ABDOMINAL LYMPHADENOPATHY (had swollen left mesentery lymph nodes which caused blockage in intestine), INFLAMMATION (inflammatory response which resulted in abdominal surgery), VOMITING PROJECTILE (started throwing up and had projectile vomiting), DIARRHOEA (diarrhea), GAIT DISTURBANCE (couldn't go to the bathroom because of intestinal blockage) and ABDOMINAL PAIN (intermittent pain in belly) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) abdominal swelling dissension.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered INFLAMMATION (inflammatory response which resulted in abdominal surgery) to be related. No further causality assessments were provided for INTESTINAL OBSTRUCTION (had swollen left mesentery lymph nodes which caused blockage in intestine), ABDOMINAL DISTENSION (abdominal swelling dissension), ABDOMINAL LYMPHADENOPATHY (had swollen left mesentery lymph nodes which caused blockage in intestine), VOMITING PROJECTILE (started throwing up and had projectile vomiting), DIARRHOEA (diarrhea), GAIT DISTURBANCE (couldn't go to the bathroom because of intestinal blockage) and ABDOMINAL PAIN (intermittent pain in belly).    Concomitant medication was not provided. Patient did not have any Past Medical History and did not took any medication prior to vaccination.   This case was linked to MOD-2022-465089 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Follow up received: Added new reporter, suspect drug administration dates and batch number of dose 1 and 2 and treatment medication.; Sender's Comments: This spontaneous case concerns a 55-year-old, male patient with no medical history reported, who experienced the unexpected, serious events of intestinal obstruction, abdominal distension, abdominal lymphadenopathy, inflammation, vomiting projectile, diarrhoea and gait disturbance, and the unexpected, non-serious event of abdominal pain after administration of the second dose of the Moderna mRNA-1273 vaccine on an unspecified date. The start dates of the events were not provided. The events intestinal obstruction and abdominal distension were assessed as life-threatening. All events were assessed as medically significant and resulted in hospitalization, except for the event abdominal pain. The report stated that 4 days after vaccination, the patient experienced an inflammatory response which resulted in abdominal surgery. He had swollen left mesentery lymph nodes which caused intestinal obstruction. The patient was at work when he started vomiting which was described as 'projectile vomiting'. He also had diarrhea and could not go to the bathroom because of the 'intestinal blockage'. The patient sought consult at the hospital. CT scan showed 'abdominal swelling dissension' and an abdominal surgery was performed. The reporter stated that the doctors mentioned that the cause of the inflammatory response was secondary to the vaccine. No other medication utilized in the hospital for treatment was reported. The patient was hospitalized for almost 2 weeks and was out of work for 3 months. He is now taking fiber daily and unspecified pain medication for the intermittent abdominal pain. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.