Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Haemorrhage, Hiatus hernia
Clinical narrative: COULDN'T FIND WHERE WAS BLEEDING; HIATAL HERNIA; THREW UP SOME DARK STUFF; LIGHTHEADED,; FELT ABDOMINAL PAIN; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (COULDN'T FIND WHERE WAS BLEEDING) in an elderly female 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.    Concurrent medical conditions included Colitis ulcerative.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-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) Citrate Free. On an unknown date, the patient experienced HAEMORRHAGE (COULDN'T FIND WHERE WAS BLEEDING) (seriousness criteria hospitalization and medically significant), HIATUS HERNIA (HIATAL HERNIA), DISCOLOURED VOMIT (THREW UP SOME DARK STUFF), DIZZINESS (LIGHTHEADED,) and ABDOMINAL PAIN (FELT ABDOMINAL PAIN). At the time of the report, HAEMORRHAGE (COULDN'T FIND WHERE WAS BLEEDING), HIATUS HERNIA (HIATAL HERNIA), DISCOLOURED VOMIT (THREW UP SOME DARK STUFF), DIZZINESS (LIGHTHEADED,) and ABDOMINAL PAIN (FELT ABDOMINAL PAIN) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Endoscopy: hiatal hernia. On an unknown date, Full blood count: 8.0 and abnormal. On an unknown date, Haemoglobin: 7.6 and abnormal.         No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. After receiving first Covid dose was rough She felt abdominal pain, second dose no problems. The reporter's causality for the event(s) of HOSPITALIZED, FELT LIGHTHEADED and THREW UP SOME DARK STUFF with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of FELT ABDOMINAL PAIN, COULDN'T FIND WHERE WAS BLEEDING, HEMOGLOBIN WAS 7.6, HIATAL HERNIA and COMPLETE BLOOD COUNT WAS 8.0 was not provided. There was no reasonable possibility that the events of HOSPITALIZED, FELT ABDOMINAL PAIN, FELT LIGHTHEADED, THREW UP SOME DARK STUFF, COULDN'T FIND WHERE WAS BLEEDING, HEMOGLOBIN WAS 7.6, HIATAL HERNIA and COMPLETE BLOOD COUNT WAS 8.0 are related to HUMIRA(ADALIMUMAB). No treatment medication was reported. 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 an elderly female patient with concurrent condition of ulcerative colitis, who experienced the unexpected serious (hospitalization, medically significant) event of Haemorrhage, unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient experienced abdominal pain, felt light headed, had dark colored vomiting. So, she underwent endoscopy and was found to have hiatus hernia. The site of bleeding was not mentioned in the report. Her haemoglobin was 7.6. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Concurrent condition of ulcerative colitis and co-suspect adalimumab could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female patient with concurrent condition of ulcerative colitis, who experienced the unexpected serious (hospitalization, medically significant) event of Haemorrhage, unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient experienced abdominal pain, felt light headed, had dark colored vomiting. So, she underwent endoscopy and was found to have hiatus hernia. The site of bleeding was not mentioned in the report. Her haemoglobin was 7.6. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Concurrent condition of ulcerative colitis and co-suspect adalimumab could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.