Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Headache, Mouth ulceration, Myalgia
Clinical narrative: Mouth ulcers; Fatigue; Headaches; Panuveitis flare up; Second/Booster vaccine caused bone pain; Second/Booster vaccine caused muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (Panuveitis flare up) in a 46-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) solution for injection for Panuveitis.    Concurrent medical conditions included Panuveitis (Non-infectious intermediate, posterior and panuveitis).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Aug-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) at an unspecified dose. In 2021, the patient experienced BONE PAIN (Second/Booster vaccine caused bone pain) and MYALGIA (Second/Booster vaccine caused muscle pain). In December 2021, the patient experienced UVEITIS (Panuveitis flare up) (seriousness criterion medically significant). On an unknown date, the patient experienced MOUTH ULCERATION (Mouth ulcers), FATIGUE (Fatigue) and HEADACHE (Headaches). At the time of the report, UVEITIS (Panuveitis flare up), BONE PAIN (Second/Booster vaccine caused bone pain), MOUTH ULCERATION (Mouth ulcers), MYALGIA (Second/Booster vaccine caused muscle pain) and HEADACHE (Headaches) had resolved and FATIGUE (Fatigue) was resolving.            No concomitant medication was reported.  The co-suspect Humira formulation was reported as Solution for injection in pre-filled pen. On 01-Aug-2021, the patient received the booster dose of Moderna COVID-19 vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for the event panuveitis flare up, fatigue, mouth ulcers, second/booster vaccine caused muscle pain, second/booster vaccine caused bone pain, pressure in eye and headaches with co-suspect Humira was not provided.  The symptom Ocular discomfort has been manifested under Uveitis.  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 is a Spontaneous case reported by a consumer, concerning a 46-year-old female patient, with relevant medical condition of panuveitis, who experienced the unexpected and serious (due to medically significant) event of Uveitis (reported as panuveitis flare up), which occurred approximately 4 months after the third dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for panuveitis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had resolved. Panuveitis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 46-year-old female patient, with relevant medical condition of panuveitis, who experienced the unexpected and serious (due to medically significant) event of Uveitis (reported as panuveitis flare up), which occurred approximately 4 months after the third dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for panuveitis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had resolved. Panuveitis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.