Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19 pneumonia, Colitis ulcerative, Colonoscopy, Feeding disorder, Lethargy
Clinical narrative: COVID-19 pneumonia; Unable to eat; Lethargic; Colitis is back and active; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia), FEEDING DISORDER (Unable to eat), LETHARGY (Lethargic) and COLITIS ULCERATIVE (Colitis is back and active) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.  Concurrent medical conditions included Ulcerative colitis since 2021.  On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In August 2021, the patient experienced FEEDING DISORDER (Unable to eat) (seriousness criterion hospitalization) and LETHARGY (Lethargic) (seriousness criterion hospitalization). On an unknown date, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization and medically significant) and COLITIS ULCERATIVE (Colitis is back and active) (seriousness criterion medically significant). The patient was hospitalized for 65 days until sometime in October 2021 due to COVID-19 PNEUMONIA, FEEDING DISORDER and LETHARGY. At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonia), FEEDING DISORDER (Unable to eat), LETHARGY (Lethargic) and COLITIS ULCERATIVE (Colitis is back and active) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: Colitis was back/active and was mild-severe.. In August 2021, Oxygen saturation: 77.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications were reported. In 2021, patient was hospitalized for sixty five days with COVID-19 Pneumonia. The patient could not eat, oxygen level was 77, lethargic, and colitis was back and active, Humira quit working and stomach hurts with Humira. He was assisted by different physician every seven days. He took three months to learn how to breath and stomach hurts. Colitis medicine was not working. First of this year he was taking four pills a day every day but HUMIRA quit working and colonoscopy colitis was back active and mild severe. He was struggling three months without medicine and enema made it worst. He was still suffering and got deadly ill when he got the first Moderna shot. He was lethargic for two to three days and went to hospital. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported.  Company comment: This spontaneous case concerns a 69-year-old, male patient with pre-existing ulcerative colitis (UC) previously treated with Humira (Adalimumab), who was hospitalized for the unexpected, serious (medically significant) adverse event of special interest COVID-19 pneumonia and for the unexpected events of Feeding disorder and Lethargy. The patient also experienced the unexpected, serious (medically significant) event of Colitis ulcerative, described as worsening of the pre-existing condition. Exact onset dates of events were not specified. On an unknown date, the patient complained persistence of stomach pain despite treatment with Adalimumab, and further worsened by enema. Colonoscopy was done which confirmed UC relapse. The patient then discontinued the medication and has not been on any treatment for 3 months prior to mRNA-1273. Within the same month following the first dose of mRNA-1273, the patient experienced inability to eat, lethargy and decreased oxygen saturation, and was hospitalized. He was later discharged 2 months after the first vaccination. Information was not provided on whether the reported COVID-19 pneumonia, for which the patient was admitted for 65 days, is related to the earlier mentioned hospitalization. There is limited information provided on the timelines, course during hospital stay, diagnostic procedures conducted and treatment details for medical review. The patient's pre-existing condition, given the nature of ulcerative colitis to have periods of remission and relapse, remains a confounder for the exacerbation and could also be contributory to the feeding disorder and lethargy. Additionally, the elderly age of the patient and the prolonged non-medication despite being symptomatic could have contributed to contracting the infection and to the prolonged hospitalization. Adalimumab was cited as co-suspect in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.  This case was linked to MOD-2022-601371 (Patient Link).  Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2022: Follow up contains no new information.; Sender's Comments: This spontaneous case concerns a 69-year-old, male patient with pre-existing ulcerative colitis (UC) previously treated with Humira (Adalimumab), who was hospitalized for the unexpected, serious (medically significant) adverse event of special interest COVID-19 pneumonia and for the unexpected events of Feeding disorder and Lethargy. The patient also experienced the unexpected, serious (medically significant) event of Colitis ulcerative, described as worsening of the pre-existing condition. Exact onset dates of events were not specified. On an unknown date, the patient complained persistence of stomach pain despite treatment with Adalimumab, and further worsened by enema. Colonoscopy was done which confirmed UC relapse. The patient then discontinued the medication and has not been on any treatment for 3 months prior to mRNA-1273. Within the same month following the first dose of mRNA-1273, the patient experienced inability to eat, lethargy and decreased oxygen saturation, and was hospitalized. He was later discharged 2 months after the first vaccination. Information was not provided on whether the reported COVID-19 pneumonia, for which the patient was admitted for 65 days, is related to the earlier mentioned hospitalization. There is limited information provided on the timelines, course during hospital stay, diagnostic procedures conducted and treatment details for medical review. The patient's pre-existing condition, given the nature of ulcerative colitis to have periods of remission and relapse, remains a confounder for the UC exacerbation and could also be contributory to the feeding disorder and lethargy. Additionally, the elderly age of the patient and the prolonged non-medication for UC despite being symptomatic could have contributed to contracting the infection and to the prolonged hospitalization. Adalimumab was cited as co-suspect in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.