Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Gastrointestinal disorder, Immunisation reaction, Irritable bowel syndrome, Pain
Clinical narrative: Rheumatoid arthritis flare up; Diabetes; Irritable bowel syndrome; Bowel incontinence/ Could not control bowel movement; Unspecified disorder of intestine/ Bowel issues; Fall/ Fallen and hit head; Upset stomach; Vaccination related malaise/ Felt sick after first covid shot; Pain; Difficulty in walking/ Trouble walking long distances and gets aches/ pains; Diarrhea/ Diarrhea a lot; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and DIABETES MELLITUS (Diabetes) 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 Rheumatoid arthritis.    Patient had no known allergies.  The patient's past medical history included Polypectomy. Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant), IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome), ANAL INCONTINENCE (Bowel incontinence/ Could not control bowel movement), GASTROINTESTINAL DISORDER (Unspecified disorder of intestine/ Bowel issues), FALL (Fall/ Fallen and hit head), ABDOMINAL DISCOMFORT (Upset stomach), IMMUNISATION REACTION (Vaccination related malaise/ Felt sick after first covid shot), PAIN (Pain), GAIT DISTURBANCE (Difficulty in walking/ Trouble walking long distances and gets aches/ pains) and DIARRHOEA (Diarrhea/ Diarrhea a lot). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) was resolving, DIABETES MELLITUS (Diabetes), IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome), ANAL INCONTINENCE (Bowel incontinence/ Could not control bowel movement), ABDOMINAL DISCOMFORT (Upset stomach), PAIN (Pain), GAIT DISTURBANCE (Difficulty in walking/ Trouble walking long distances and gets aches/ pains) and DIARRHOEA (Diarrhea/ Diarrhea a lot) outcome was unknown, GASTROINTESTINAL DISORDER (Unspecified disorder of intestine/ Bowel issues) had not resolved and FALL (Fall/ Fallen and hit head) and IMMUNISATION REACTION (Vaccination related malaise/ Felt sick after first covid shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported.  The reporter causality for the Co-suspect (Humira) for all the Events was not provided.  Patient had biopsy and colonoscopy tests on an unknown date however the results were not provided.   On an unknown date, patient had Polypectomy (polyps removed).  Treatment medications were not 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 is a spontaneous case concerning an elderly female patient with medical history of Rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis and the unexpected, serious (medically significant) event of Diabetes mellitus, after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the events, clinical course, diagnostic tests and treatment details were not provided in the case. At the time of report, the event Rheumatoid arthritis was resolving and the outcome of the event Diabetes mellitus was unknown. Medical history of Rheumatoid arthritis remains a risk factor for the event of Rheumatoid arthritis. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-642610 (Patient Link).; Sender's Comments: This is a spontaneous case concerning an elderly female patient with medical history of Rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis and the unexpected, serious (medically significant) event of Diabetes mellitus, after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the events, clinical course, diagnostic tests and treatment details were not provided in the case. At the time of report, the event Rheumatoid arthritis was resolving and the outcome of the event Diabetes mellitus was unknown. Medical history of Rheumatoid arthritis remains a risk factor for the event of Rheumatoid arthritis. The benefit-risk relationship of mRNA-1273 is not affected by this report.