Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Eye inflammation, Headache, Uveitis, Vaccination site pain
Clinical narrative: The patient had inflammation in her left eye in the retinae; The patients eye closed during uveitis flare ups; Pain in her left arm for 3 days; Headache for 3 days; This spontaneous case was reported by a patient and describes the occurrence of UVEITIS (The patients eye closed during uveitis flare ups) in a 49-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.     No medical history was provided by the reporter.  Concomitant products included TIMOLOL for Sensation of pressure in eye.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced UVEITIS (The patients eye closed during uveitis flare ups) (seriousness criterion medically significant). On an unknown date, the patient experienced EYE INFLAMMATION (The patient had inflammation in her left eye in the retinae), VACCINATION SITE PAIN (Pain in her left arm for 3 days) and HEADACHE (Headache for 3 days). At the time of the report, UVEITIS (The patients eye closed during uveitis flare ups) and EYE INFLAMMATION (The patient had inflammation in her left eye in the retinae) outcome was unknown and VACCINATION SITE PAIN (Pain in her left arm for 3 days) and HEADACHE (Headache for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also included 2 shots of Steroids in her eyes, Steroid eye drops. No treatment details were reported. The patient received her first Moderna Covid-19 vaccine in May of 2021. Since July 2021 the patient had several problems with her left eye.  She had an increased eye pressure, and pain in her left eye.  The patient could not see out of her eye because it was sensitive to light.  The patients eye closed during uveitis flare ups.  The patient had inflammation in her left eye in the retinae. The patient had pain in her left arm for 3 days and a headache for 3 days.  Company Comment: This spontaneous case concerns a 49-year-old, female patient receiving Timolol eye drops as concomitant medication who experienced the unexpected, serious (medically significant) event of Uveitis flare up which occurred approximately 2 months after receiving the first dose of mRNA-1273. The event was described as appearance of white spots on the left eye accompanied by left eye pain, sensation of pressure in eye and photophobia. The clinical course, diagnostic evaluation and treatment details were not reported. Concomitant use of Timolol eye drops is suggestive of an underlying concurrent eye disorder which remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-630466 (Patient Link).; Sender's Comments: This spontaneous case concerns a 49-year-old, female patient receiving Timolol eye drops as concomitant medication who experienced the unexpected, serious (medically significant) event of Uveitis flare up which occurred approximately 2 months after receiving the first dose of mRNA-1273. The event was described as appearance of white spots on the left eye accompanied by left eye pain, sensation of pressure in eye and photophobia. The clinical course, diagnostic evaluation and treatment details were not reported. Concomitant use of Timolol eye drops is suggestive of an underlying concurrent eye disorder which remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.