Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Ear disorder, Inappropriate schedule of product administration, Uveitis
Clinical narrative: Uveitis in retina; Ear disorder; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (Uveitis in retina) in a 61-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 Ankylosing spondylitis.    The patient's past medical history included Erythema ear in 2008. Concurrent medical conditions included Anxiety attack since 2008 and Ankylosing spondylitis (Flare ups created every 3 months) since 2014.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, received second 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. On an unknown date, the patient experienced UVEITIS (Uveitis in retina) (seriousness criterion medically significant), EAR DISORDER (Ear disorder) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, UVEITIS (Uveitis in retina) was resolving and EAR DISORDER (Ear disorder) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  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 male patient aged 61 years with relevant medical history of Ankylosing spondylitis reported, who experienced the unexpected serious (medically significant) event of Uveitis that occurred on an unknown date (2021) in the context of mRNA-1273 vaccination. Additionally Inappropriate schedule of vaccination was noted as patient had received initial two doses of mRNA-1273 at an interval of 4 months. No further information on clinical course, investigations and treatment received was available in the report. Outcome of the event Uveitis was resolving at the time of report. Relevant medical history remains a confounder to the event Uveitis. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a male patient aged 61 years with relevant medical history of Ankylosing spondylitis reported, who experienced the unexpected serious (medically significant) event of Uveitis that occurred on an unknown date (2021) in the context of mRNA-1273 vaccination. Additionally Inappropriate schedule of vaccination was noted as patient had received initial two doses of mRNA-1273 at an interval of 4 months. No further information on clinical course, investigations and treatment received was available in the report. Outcome of the event Uveitis was resolving at the time of report. Relevant medical history remains a confounder to the event Uveitis. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.