Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Colonoscopy, Cough, Fatigue, Gastrointestinal disorder
Clinical narrative: Lung disorder/ Lungs issues; Respiratory disorder/ Breathing issues; Coughing; Fatigue; Colitis ulcerative aggravated; Colopathy/ found two spots in colonoscopy; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Colitis ulcerative aggravated) in an elderly 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.    The patient's past medical history included Fatigue in 2018, Lung disorder (MANIFESTED BY RASH) in 2018, Sleep apnea in 2018 and Motor vehicle accident on 06-Oct-2018. Previously administered products included for Drug use for unknown indication: LISINOPRIL. Past adverse reactions to the above products included Rash with LISINOPRIL. Concurrent medical conditions included Ulcerative colitis, Drug allergy (MANIFESTED BY RASH), Non-tobacco user and Abstains from alcohol. Concomitant products included MESALAMINE for Ulcerative colitis.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Aug-2021, received third 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) 1 dosage form. In March 2022, the patient experienced GASTROINTESTINAL DISORDER (Colopathy/ found two spots in colonoscopy). On an unknown date, the patient experienced COLITIS ULCERATIVE (Colitis ulcerative aggravated) (seriousness criterion medically significant), LUNG DISORDER (Lung disorder/ Lungs issues), RESPIRATORY DISORDER (Respiratory disorder/ Breathing issues), COUGH (Coughing) and FATIGUE (Fatigue). At the time of the report, COLITIS ULCERATIVE (Colitis ulcerative aggravated) and COUGH (Coughing) outcome was unknown and GASTROINTESTINAL DISORDER (Colopathy/ found two spots in colonoscopy), LUNG DISORDER (Lung disorder/ Lungs issues), RESPIRATORY DISORDER (Respiratory disorder/ Breathing issues) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, Colonoscopy: Found 2 spots in the colon.         The patient took HUMIRA 40MG/0.4ML(40 Milligram, Solution for injection in pre-filled pen)(ADALIMUMAB). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were 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 male patient with relevant medical history of Ulcerative colitis, who experienced the unexpected, serious  (medically significant) event of Colitis ulcerative (reported as Colitis ulcerative aggravated) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of event onset was not provided. Patient received 3 doses of mRNA-1273 vaccine consisting of a 2-dose primary series given 33 days apart, and a third dose approximately 5 and a half months after.  The relevant medical history of Ulcerative colitis remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2022: Live significant follow up received included medical history and event added, lab test date was added.; Sender's Comments: This spontaneous case concerns an elderly male patient with relevant medical history of Ulcerative colitis, who experienced the unexpected, serious  (medically significant) event of Colitis ulcerative (reported as Colitis ulcerative aggravated) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of event onset was not provided. Patient received 3 doses of mRNA-1273 vaccine consisting of a 2-dose primary series given 33 days apart, and a third dose approximately 5 and a half months after.  The relevant medical history of Ulcerative colitis remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.