Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia, Headache, Inappropriate schedule of product administration, Pain in extremity, Stool analysis
Clinical narrative: blood in stool; Pain in arm; Headache; Second moderna dose was administered on 01-Sep-2021, and booster dose was administered on 01-NOV-2021; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (blood in stool) in a 50-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) for Ulcerative colitis.    The patient's past medical history included Ulcerative colitis.   On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third 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) at an unspecified dose. On 01-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), HEADACHE (Headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second moderna dose was administered on 01-Sep-2021, and booster dose was administered on 01-NOV-2021). On an unknown date, the patient experienced HAEMATOCHEZIA (blood in stool) (seriousness criterion medically significant). On 01-Nov-2021, HEADACHE (Headache) had resolved. In November 2021, PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, HAEMATOCHEZIA (blood in stool) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second moderna dose was administered on 01-Sep-2021, and booster dose was administered on 01-NOV-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Stool analysis: Blood in stool.         No concomitant drug was reported. HUMIRA (Solution for injection in pre-filled pen) was used for the indication of moderate to severe ulcerative colitis. No treatment drug was reported. Causality for humira (adalimumab) : the reporter's causality for the event(s) of blood in the stool, pain in arm and headaches was not provided.  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 50 years with relevant medical history of ULCERATIVE COLITIS reported, who experienced the unexpected serious (medically significant) event of Haematochezia on unknown date 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 31 days and the 3rd dose after 2 months. Stool analysis done on unknown date showed Blood in stool.  No further information on detailed clinical course, investigations, treatment of the events was available in the report.  Outcome of the event was not 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.; Sender's Comments: This spontaneous case concerns a male patient aged 50 years with relevant medical history of ULCERATIVE COLITIS reported, who experienced the unexpected serious (medically significant) event of Haematochezia on unknown date 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 31 days and the 3rd dose after 2 months. Stool analysis done on unknown date showed Blood in stool.  No further information on detailed clinical course, investigations, treatment of the events was available in the report.  Outcome of the event was not 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.