Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Haematochezia, Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool / LIGHT BLOOD IN STOOL) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease. Concurrent medical conditions included Crohn's disease. On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced FATIGUE (Fatigue / VACCINE MADE FEEL FATIGUED). On an unknown date, the patient experienced HAEMATOCHEZIA (Blood in stool / LIGHT BLOOD IN STOOL) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal cramp / CRAMPING), DIARRHOEA (Diarrhea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 01Oct2021 and 2nd dose on 08Nov2021). In 2021, FATIGUE (Fatigue / VACCINE MADE FEEL FATIGUED) had resolved. At the time of the report, HAEMATOCHEZIA (Blood in stool / LIGHT BLOOD IN STOOL), ABDOMINAL PAIN (Abdominal cramp / CRAMPING) and DIARRHOEA (Diarrhea) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 01Oct2021 and 2nd dose on 08Nov2021) outcome was unknown. No concomitant medications were provided by the reporter. The patient received HUMIRA (Solution for injection in pre-filled pen)(ADALIMUMAB). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of vaccine made feel fatigued, light blood in stool, diarrhea and cramping unknown onset and diarrhea and cramping unknown onset for HUMIRA(ADALIMUMAB)was not provided. No treatment medications were provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns a male patient aged 33 years with relevant medical history of CROHN'S DISEASE on Humira reported, who experienced the unexpected serious (medically significant) event of Haematochezia on unknown dates in the context of mRNA-1273 vaccine. Additionally Inappropriate schedule of vaccine administered was noted as patient had received initial two doses of mRNA-1273 at an interval of 38 days. He also experienced non-serious events of fatigue, abdominal pain and diarrhoea. No further information on detailed clinical course, investigations, treatment of the event was available in the report.  Outcome of the event was resolved at the time of report. Relevant medical history remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a male patient aged 33 years with relevant medical history of CROHN'S DISEASE on Humira reported, who experienced the unexpected serious (medically significant) event of Haematochezia on unknown dates in the context of mRNA-1273 vaccine. Additionally Inappropriate schedule of vaccine administered was noted as patient had received initial two doses of mRNA-1273 at an interval of 38 days. He also experienced non-serious events of fatigue, abdominal pain and diarrhoea. No further information on detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was resolved at the time of report. Relevant medical history remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.