Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Herpes zoster, SARS-CoV-2 test, Tooth infection, Uveitis
Clinical narrative: UVEITIS BREAKTHROUGHS; Tooth infection; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (UVEITIS BREAKTHROUGHS) in a 70-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.    Concurrent medical conditions included Uveitis and Cataract.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-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. In January 2021, the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced UVEITIS (UVEITIS BREAKTHROUGHS) (seriousness criterion medically significant) and TOOTH INFECTION (Tooth infection). In November 2021, HERPES ZOSTER (Shingles) had resolved. At the time of the report, UVEITIS (UVEITIS BREAKTHROUGHS) and TOOTH INFECTION (Tooth infection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive.         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  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.  The reporter's causality for the event(s) of tooth infection, uveitis breakthroughs, and shingles with Humira(adalimumab) was a reasonable possibility.  Company comment: This is a spontaneous case reported by a consumer. A 70-year-old female patient in treatment with ADALIMUMAB (HUMIRA) for Uveitis, received 2 doses of mRNA-1273 vaccine and experienced medically significant event of Uveitis flare up. Onset date of the event was not provided, latency cannot be assessed. In addition, patient experienced non serious events of tooth infection and herpes zoster. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Uveitis can flare as part of its natural history. Adalimumab could be a contributory factor for developing infections including herpes zoster. Uveitis flare up, tooth infection and herpes zoster were considered not related to mRNA-1273 per the reporter's assessment. 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. A 70-year-old female patient in treatment with ADALIMUMAB (HUMIRA) for Uveitis, received 2 doses of mRNA-1273 vaccine and experienced medically significant event of Uveitis flare up. Onset date of the event was not provided, latency cannot be assessed. In addition, patient experienced non serious events of tooth infection and herpes zoster. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Uveitis can flare as part of its natural history. Adalimumab could be a contributory factor for developing infections including herpes zoster. Uveitis flare up, tooth infection and herpes zoster were considered not related to mRNA-1273 per the reporter's assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.