Age: 30.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Impaired driving ability, Uveitis
Clinical narrative: Impaired driving ability; Headache; Uveitis flare up; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (Uveitis flare up) in a 30-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 Panuveitis.    The patient's past medical history included Light sensitivity to eye, Impaired driving ability and Headache.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, received third 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) Citrate Free. In November 2021, the patient experienced UVEITIS (Uveitis flare up) (seriousness criterion medically significant). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (Impaired driving ability) and HEADACHE (Headache). In February 2022, UVEITIS (Uveitis flare up) had resolved. At the time of the report, IMPAIRED DRIVING ABILITY (Impaired driving ability) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Company comment: This spontaneous case concerns a 30-years-old female patient with condition aggravated of medical history of Panuveitis, who experienced the unexpected serious (medically significant) event of Uveitis (Uveitis flare up) that occurred in context to the third dose of mRNA-1273 vaccine. Patient had received Co-suspect product of non-company product ADALIMUMAB (HUMIRA) for Panuveitis on unspecified day after the current vaccination. The Clinical course and treatment details were not provided, and the event outcome had resolved. Patient's Co-suspect product of non-company product ADALIMUMAB (HUMIRA) for Panuveitis remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a 30-years-old female patient with condition aggravated of medical history of Panuveitis, who experienced the unexpected serious (medically significant) event of Uveitis (Uveitis flare up) that occurred in context to the third dose of mRNA-1273 vaccine. Patient had received Co-suspect product of non-company product ADALIMUMAB (HUMIRA) for Panuveitis on unspecified day after the current vaccination. The Clinical course and treatment details were not provided, and the event outcome had resolved. Patient's Co-suspect product of non-company product ADALIMUMAB (HUMIRA) for Panuveitis remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.