Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia, Uveitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (Uveitis flare up) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 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) at an unspecified dose once a week. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose every two weeks. In 2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever). On an unknown date, the patient experienced UVEITIS (Uveitis flare up) (seriousness criterion medically significant). In 2021, FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) had resolved. At the time of the report, UVEITIS (Uveitis flare up) had not resolved. No concomitant medication were not reported. The patient experienced uveitis flare up. Patient uveitis condition was not getting better with Humira. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication were not 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 reported by a consumer, concerns a 61 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Uveitis (Uveitis flare up), unknown days after receiving the 3 dose of mRNA-1273 vaccine in the COVID 19 vaccination series, along with other non serious events. Patient had previously received two primary doses with Moderna vaccines, unknown days prior to the 3 dose, with no adverse events reported. On an unknown date, the patient had received ADALIMUMAB (Humira) for Uveitis. It was reported that the event was not getting better with Humira, which could be considered as a confounder. No further clinical information on comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event had not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case reported by a consumer, concerns a 61 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Uveitis (Uveitis flare up), unknown days after receiving the 3 dose of mRNA-1273 vaccine in the COVID 19 vaccination series, along with other non serious events. Patient had previously received two primary doses with Moderna vaccines, unknown days prior to the 3 dose, with no adverse events reported. On an unknown date, the patient had received ADALIMUMAB (Humira) for Uveitis. It was reported that the event was not getting better with Humira, which could be considered as a confounder. No further clinical information on comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event had not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.