Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Colitis ulcerative, Diarrhoea, Gastric infection, Palpitations
Clinical narrative: Ulcerative colitis flare ups; Issues with heart after taking covid vaccine; Heart palpitations; Stomach bug; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Ulcerative colitis flare ups) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COLITIS ULCERATIVE (Ulcerative colitis flare ups) (seriousness criterion medically significant), CARDIAC DISORDER (Issues with heart after taking covid vaccine), PALPITATIONS (Heart palpitations), GASTRIC INFECTION (Stomach bug) and DIARRHOEA (Diarrhea). At the time of the report, COLITIS ULCERATIVE (Ulcerative colitis flare ups) had not resolved, CARDIAC DISORDER (Issues with heart after taking covid vaccine), PALPITATIONS (Heart palpitations) and DIARRHOEA (Diarrhea) outcome was unknown and GASTRIC INFECTION (Stomach bug) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Treatment and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Reporter's causality for events heart palpitations and diarrhea was not reported with respect to Humira drug. Reporter's causality for events Issues with heart after taking COVID vaccine, stomach bug and ulcerative colitis flare ups was no reasonable possibility with respect to Humira drug. 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, reported by a consumer, concerning an elderly female patient with relevant medical condition of moderate to severe Ulcerative colitis, who experienced the unexpected serious (medically significant) events of Colitis ulcerative reported as ulcerative colitis flared up, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the vaccination date nor event onset date were provided. The patient also had heart issue, palpitation, diarrhea, and gastric infection. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event Colitis ulcerative was not resolved. The condition of moderate to severe Ulcerative colitis remains as a confounder for ulcerative colitis flared up. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning an elderly female patient with relevant medical condition of moderate to severe Ulcerative colitis, who experienced the unexpected serious (medically significant) events of Colitis ulcerative reported as ulcerative colitis flared up, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the vaccination date nor event onset date were provided. The patient also had heart issue, palpitation, diarrhea, and gastric infection. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event Colitis ulcerative was not resolved. The condition of moderate to severe Ulcerative colitis remains as a confounder for ulcerative colitis flared up. The benefit-risk relationship of mRNA-1273 is not affected by this report.