Sex: M
Vaccine: COVID19
Symptoms: Adverse food reaction, Colitis ulcerative, Myalgia
Clinical narrative: ULCERATIVE COLITIS FLARE UP/ATE SOME LETTUCE AND THERE WAS A RECALL DID NOT KNOWN IF THAT CAUSED IT; VACCINE CAUSED MUSCLE ACHES; ULCERATIVE COLITIS FLARE UP/ATE SOME LETTUCE AND THERE WAS A RECALL DID NOT KNOWN IF THAT CAUSED IT; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP/ATE SOME LETTUCE AND THERE WAS A RECALL DID NOT KNOWN IF THAT CAUSED IT) in an adult 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.    There was no reported medical history.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-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. On an unknown date, the patient experienced COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP/ATE SOME LETTUCE AND THERE WAS A RECALL DID NOT KNOWN IF THAT CAUSED IT) (seriousness criterion medically significant), MYALGIA (VACCINE CAUSED MUSCLE ACHES) and ADVERSE FOOD REACTION (ULCERATIVE COLITIS FLARE UP/ATE SOME LETTUCE AND THERE WAS A RECALL DID NOT KNOWN IF THAT CAUSED IT). At the time of the report, COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP/ATE SOME LETTUCE AND THERE WAS A RECALL DID NOT KNOWN IF THAT CAUSED IT), MYALGIA (VACCINE CAUSED MUSCLE ACHES) and ADVERSE FOOD REACTION (ULCERATIVE COLITIS FLARE UP/ATE SOME LETTUCE AND THERE WAS A RECALL DID NOT KNOWN IF THAT CAUSED IT) had resolved.            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  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.   The reporter's causality for the event(s) of ulcerative colitis flare up/ate some lettuce and there was a recall did not known if that caused it unknown onset, vaccine caused muscle aches and ulcerative colitis flare up/ate some lettuce and there was a recall did not known if that caused it unknown onset was not provided.  Company comment. This spontaneous case concerns an adult male patient, in treatment with Adalimumab for Ulcerative colitis, who received two doses of mRNA  1273 vaccine, and experienced the unexpected, serious medically significant event of colitis ulcerative (described as "ulcerative colitis flare up"). Event onset date was not reported; hence latency and temporal association cannot be properly assessed. On an unspecified date, the patient presented an adverse food reaction which could be related to the event. The outcome was recovered. No further details were provided for medical reviewing. Co  suspect product Adalimumab, and Ulcerative colitis (flaring of symptoms is part of the natural course) remains as contributors for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient, in treatment with Adalimumab for Ulcerative colitis, who received two doses of mRNA  1273 vaccine, and experienced the unexpected, serious medically significant event of colitis ulcerative (described as "ulcerative colitis flare up"). Event onset date was not reported; hence latency and temporal association cannot be properly assessed. On an unspecified date, the patient presented an adverse food reaction which could be related to the event. The outcome was recovered. No further details were provided for medical reviewing. Co  suspect product Adalimumab, and Ulcerative colitis (flaring of symptoms is part of the natural course) remains as contributors for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.