Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Sinus disorder, Uveitis
Clinical narrative: Photophobia; Uveitis flare up/blurred vision/redness/floaters in left eyes/dark floating spots/sensitivity to Light/Light sensitivity to eye/Eye pain; Sinus disorder; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (Uveitis flare up/blurred vision/redness/floaters in left eyes/dark floating spots/sensitivity to Light/Light sensitivity to eye/Eye pain) in a 53-year-old 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 product included non-company product ADALIMUMAB (HUMIRA) for Uveitis.    It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient's past medical history included Uveitis flare up (In right eye) on 29-Sep-2021. Concurrent medical conditions included Uveitis.   On 06-Oct-2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 160 milligram. On 13-Oct-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 80 milligram. On 27-Oct-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 16-Nov-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 80 milligram. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In 2021, the patient experienced SINUS DISORDER (Sinus disorder). In October 2021, the patient experienced UVEITIS (Uveitis flare up/blurred vision/redness/floaters in left eyes/dark floating spots/sensitivity to Light/Light sensitivity to eye/Eye pain) (seriousness criterion medically significant). On an unknown date, the patient experienced PHOTOPHOBIA (Photophobia). At the time of the report, UVEITIS (Uveitis flare up/blurred vision/redness/floaters in left eyes/dark floating spots/sensitivity to Light/Light sensitivity to eye/Eye pain) had resolved and SINUS DISORDER (Sinus disorder) and PHOTOPHOBIA (Photophobia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported.  It was reported that  patient was administered with Humira on the abdomen but after pushing the button patient felt pain causing to flinch and the medication spilled out. Patient developed events with 80 mg and 40 mg of  Humira. Treatment details were not reported.  The reporter causality for the events Floaters in eye, Light sensitivity to eye, Blurred vision, Eye pain, Redness, Lack of drug effect , Injection site pain, Inappropriate dose of drug administered, Photophobia, Uveitis flare up with respect to Humira was provided as not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  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 53-year-old female patient with relevant medical history of Uveitis and Uveitis flares, who experienced the unexpected, serious  (medically significant) event of Uveitis (reported as Uveitis flare up) on an unspecified date in the context of having received a dose of mRNA-1273 vaccine.  Onset latency could not be determined as dates of vaccination and onset of event was not reported. Patient experienced symptoms of blurred vision, redness, floaters in eye, sensitivity to light and eye pain for which Adalimumab (Humira) was given. No information on any other doses of COVID-19 vaccination was provided. The relevant medical history of Uveitis and Uveitis flares is confounding to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Follow up document was received and had significant information's. Added events of Floaters in eye, Light sensitivity to eye. Added patient's age, event onset date, dosage information of suspect and co-suspect drug and medical history. On 18-Nov-2021: Follow up document was received with significant information. Added event of Injection site pain On 14-Jan-2022: Follow up document was received with significant information. Added Sinus disorder and hence narrative updated. On 26-Apr-2022: Event Uveitis flare up added. Seriousness of case updated. On 22-Aug-2022: Event Photophobia added. Narrative updated.; Sender's Comments: This spontaneous case concerns a 53-year-old female patient with relevant medical history of Uveitis and Uveitis flares, who experienced the unexpected, serious  (medically significant) event of Uveitis (reported as Uveitis flare up) on an unspecified date in the context of having received a dose of mRNA-1273 vaccine.  Onset latency could not be determined as dates of vaccination and onset of event was not reported. Patient experienced symptoms of blurred vision, redness, floaters in eye, sensitivity to light and eye pain for which Adalimumab (Humira) was given. No information on any other doses of COVID-19 vaccination was provided. The relevant medical history of Uveitis and Uveitis flares is confounding to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.