Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Uveitis, Vaccination site pain
Clinical narrative: Uveitis flare up; Vaccination site pain; Fatigue; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (Uveitis flare up) in a 51-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 and Panuveitis.    The patient's past medical history included Eyelid ptosis (RIGHT EYELID PTOSIS), Eye pain and Blurred vision (Dark floating spots in vision and increased redness to affected eye). Concurrent medical conditions included Photophobia (SENSITIVITY TO LIGHT).   In May 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced UVEITIS (Uveitis flare up) (seriousness criterion medically significant), VACCINATION SITE PAIN (Vaccination site pain), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, UVEITIS (Uveitis flare up) had not resolved and VACCINATION SITE PAIN (Vaccination site pain), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medications was reported. No treatment medications was 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 51-year-old female patient with relevant medical history of Uveitis, who experienced the unexpected, serious  (medically significant) event of Uveitis (reported as Uveitis flare up) on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as date of event onset was not provided. Patient developed dark floating spots in vision, increased eye pain and redness, and  sensitivity to light. Patient was treated with Humira. Patient received 3 doses of mRNA-1273 vaccine consisting of a 2-dose primary series given 19 days apart (Inappropriate schedule of product administration noted), and a third dose approximately 5 months after.  The relevant medical history of Uveitis remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Significant follow up received- Events updated.; Sender's Comments: This spontaneous case concerns a 51-year-old female patient with relevant medical history of Uveitis, who experienced the unexpected, serious  (medically significant) event of Uveitis (reported as Uveitis flare up) on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as date of event onset was not provided. Patient developed dark floating spots in vision, increased eye pain and redness, and  sensitivity to light. Patient was treated with Humira. Patient received 3 doses of mRNA-1273 vaccine consisting of a 2-dose primary series given 19 days apart (Inappropriate schedule of product administration noted), and a third dose approximately 5 months after.  The relevant medical history of Uveitis remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.