Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Large intestinal ulcer, Malaise, Musculoskeletal stiffness, Tremor
Clinical narrative: Upset stomach; Ulcer in colon; not been feeling well; sometimes hands shaky or get stuck; sometimes hands shaky or get stuck; arm hurt after getting covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LARGE INTESTINAL ULCER (Ulcer in colon) in a 69-year-old 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 products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and IBUPROFEN for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis.   On 29-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) at an unspecified dose and IBUPROFEN (unknown route) at an unspecified dose. In 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (sometimes hands shaky or get stuck), TREMOR (sometimes hands shaky or get stuck) and VACCINATION SITE PAIN (arm hurt after getting covid vaccine). On 10-Sep-2021, the patient experienced MALAISE (not been feeling well). On an unknown date, the patient experienced LARGE INTESTINAL ULCER (Ulcer in colon) (seriousness criterion medically significant) and ABDOMINAL DISCOMFORT (Upset stomach). At the time of the report, LARGE INTESTINAL ULCER (Ulcer in colon), ABDOMINAL DISCOMFORT (Upset stomach), MUSCULOSKELETAL STIFFNESS (sometimes hands shaky or get stuck), TREMOR (sometimes hands shaky or get stuck) and VACCINATION SITE PAIN (arm hurt after getting covid vaccine) outcome was unknown and MALAISE (not been feeling well) was resolving.            No concomitant product reported by reporter. No treatment medication reported by 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 69 year old female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Large intestinal ulcer, unknown days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. She received the first dose about a month ago with no reported adverse events. No information on detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69 year old female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Large intestinal ulcer, unknown days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. She received the first dose about a month ago with no reported adverse events. No information on detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.