Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Gastrointestinal infection, Haematochezia, Rectal haemorrhage, Wrong technique in product usage process
Clinical narrative: technique/cap removed/replaced prior to injection; GI infection; Bloody stool; Rectal bleeding; Bloating; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Bloody stool) and RECTAL HAEMORRHAGE (Rectal bleeding) in a 64-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.    Previously administered products included for Drug use for unknown indication: PENICILLIN (penicillin allergy manifested by rash) and APRISO (apriso allergy manifested by rash). Past adverse reactions to the above products included Rash with APRISO and PENICILLIN. Concurrent medical conditions included Type 2 diabetes mellitus, Blood pressure high, Acid reflux (esophageal), Enlarged prostate and Ulcerative colitis. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (esophageal), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (BENICAR HCT) for Blood pressure high, MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for Enlarged prostate, METFORMIN for Type 2 diabetes mellitus.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram once a week. In August 2021, the patient experienced HAEMATOCHEZIA (Bloody stool) (seriousness criterion medically significant), RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant) and ABDOMINAL DISTENSION (Bloating). In September 2021, the patient experienced GASTROINTESTINAL INFECTION (GI infection). On 21-Jan-2022, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (technique/cap removed/replaced prior to injection). In November 2021, GASTROINTESTINAL INFECTION (GI infection) had resolved. At the time of the report, HAEMATOCHEZIA (Bloody stool), RECTAL HAEMORRHAGE (Rectal bleeding) and ABDOMINAL DISTENSION (Bloating) was resolving and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (technique/cap removed/replaced prior to injection) outcome was unknown.            Causality for humira 40mg/0.4ml(Solution for injection in pre-filled injector): the reporter's causality for the event(s) of technique/cap removed/replaced prior to injection was not provided. The reporter's causality for the event(s) of bloody stool, bloating, rectal bleeding and GI infection with humira 40mg/0.4ml(adalimumab) was no reasonable possibility.  No treatment drug was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 64 years with relevant medical history of ULCERATIVE COLITIS reported, who experienced the unexpected serious (medically significant) events of Haematochezia and Rectal haemorrhage on unknown dates (in August 2021) after receiving third dose of mRNA-1273 vaccine. Patient also experienced non serious events of Abdominal distension and Gastrointestinal infection. Patient had received initial two doses of mRNA-1273 at an interval of 28 days. No further information on detailed clinical course, investigations, treatment of the events was available in the report.  Outcome of the events was resolving at the time of report. Relevant medical history remains a confounder to the events. 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 64 years with relevant medical history of ULCERATIVE COLITIS reported, who experienced the unexpected serious (medically significant) events of Haematochezia and Rectal haemorrhage on unknown dates (in August 2021) after receiving third dose of mRNA-1273 vaccine. Patient also experienced non serious events of Abdominal distension and Gastrointestinal infection. Patient had received initial two doses of mRNA-1273 at an interval of 28 days. No further information on detailed clinical course, investigations, treatment of the events was available in the report.  Outcome of the events was resolving at the time of report. Relevant medical history remains a confounder to the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.