Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Cataract, Colitis ulcerative, Condition aggravated, Immunisation reaction, Osteopenia
Clinical narrative: Ulcerative colitis flares; Cataract; Reactions to all three COVID 19 vaccine shots with Humira (Adalimumab); Osteopenia; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Ulcerative colitis flares) and CATARACT (Cataract) in an adult 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 products included non-company products ADALIMUMAB (HUMIRA) for Panuveitis and COVID-19 VACCINE for COVID-19 vaccination.    Concurrent medical conditions included Colitis ulcerative and Panuveitis.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient received third dose of COVID-19 VACCINE (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced COLITIS ULCERATIVE (Ulcerative colitis flares) (seriousness criterion medically significant), CATARACT (Cataract) (seriousness criterion medically significant), IMMUNISATION REACTION (Reactions to all three COVID 19 vaccine shots with Humira (Adalimumab)), OSTEOPENIA (Osteopenia) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, COLITIS ULCERATIVE (Ulcerative colitis flares), CATARACT (Cataract), IMMUNISATION REACTION (Reactions to all three COVID 19 vaccine shots with Humira (Adalimumab)), OSTEOPENIA (Osteopenia) and CONDITION AGGRAVATED (Condition aggravated) had not resolved.            No concomitant medication was reported.  The patient had significant flare ups of Ulcerative Colitis including rectal bleeding. The patient felt that flare ups of Ulcerative Colitis began to worsened after first COVID vaccine was administered and had significant reactions to all three COVID 19 vaccine shots. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was reported.   This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.  Company Comment: This is a Spontaneous case reported by a consumer, concerning an adult female patient, with relevant medical conditions of colitis ulcerative and panuveitis, who experienced the unexpected and serious (due to medically significant) events of Colitis ulcerative (reported as ulcerative colitis flares) and Cataract, which occurred on an unknown date after vaccination with the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab for panuveitis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the events had not resolved. Colitis ulcerative can present relapses as part of the natural history of disease, so that confounds the case.  Panuveitis can be a contributory factor for Cataract. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an adult female patient, with relevant medical conditions of colitis ulcerative and panuveitis, who experienced the unexpected and serious (due to medically significant) events of Colitis ulcerative (reported as ulcerative colitis flares) and Cataract, which occurred on an unknown date after vaccination with the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab for panuveitis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the events had not resolved. Colitis ulcerative can present relapses as part of the natural history of disease, so that confounds the case.  Panuveitis can be a contributory factor for Cataract. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.