Age: 60.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache, Inflammation, Uveitis
Clinical narrative: PANUVEITIS FLARE UP; MORE INFLAMMATION AFTER RECEIVING MODERNA COVID; HAD A HEADACHE AFTER RECEIVING MODERNA COVID VACCINE with HUMIRA; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (PANUVEITIS FLARE UP) in a 60-year-old 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 Panuveitis.    Concurrent medical conditions included Panuveitis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced UVEITIS (PANUVEITIS FLARE UP) (seriousness criterion medically significant), INFLAMMATION (MORE INFLAMMATION AFTER RECEIVING MODERNA COVID) and HEADACHE (HAD A HEADACHE AFTER RECEIVING MODERNA COVID VACCINE with HUMIRA). At the time of the report, UVEITIS (PANUVEITIS FLARE UP) had not resolved and INFLAMMATION (MORE INFLAMMATION AFTER RECEIVING MODERNA COVID) and HEADACHE (HAD A HEADACHE AFTER RECEIVING MODERNA COVID VACCINE with HUMIRA) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that on unknown dates, the patient experienced panuveitis flare up, more inflammation after receiving moderna covid vaccine and had a headache after receiving moderna covid vaccine. It was unknown if patient was enrolled in a covid-19 vaccine trial. patient received moderna covid-19 vaccine. 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 a 60-year-old male patient with medical history of uveitis, who experienced the unexpected, serious (medically significant) event of uveitis an unknown time after a dose of mRNA-1273. The event was described as a flare up. Uveitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old male patient with medical history of uveitis, who experienced the unexpected, serious (medically significant) event of uveitis an unknown time after a dose of mRNA-1273. The event was described as a flare up. Uveitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.