Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052036 | IM |
plasma cell gingivitis; pemphigoid/pemphigus; pemphigoid/pemphigus; lichen planus; This spontaneous case was reported by a consumer and describes the occurrence of PEMPHIGUS (pemphigoid/pemphigus) and PEMPHIGOID (pemphigoid/pemphigus) in a 72-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052036) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included Pre-filled Syringe injection (batch no. 3052036) for COVID-19 prophylaxis. No Medical History information was reported. On 07-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 19-Sep-2025, the patient experienced PEMPHIGUS (pemphigoid/pemphigus) (seriousness criterion medically significant), PEMPHIGOID (pemphigoid/pemphigus) (seriousness criterion medically significant) and LICHEN PLANUS (lichen planus). On an unknown date, the patient experienced GINGIVITIS (plasma cell gingivitis). At the time of the report, PEMPHIGUS (pemphigoid/pemphigus), PEMPHIGOID (pemphigoid/pemphigus), LICHEN PLANUS (lichen planus) and GINGIVITIS (plasma cell gingivitis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2025, Immunoassay: This had been diagnosed as final diagnosis:plasma cell gingivitis and clinical diagnosis lichen planus versus pemphigoid/pemphigus. The patient had no medical history, concomitant disease or risk factors. The concomitant medication was not reported by the reporter. The patient developed white spots and redness and inflammation on her upper gums in her mouth. The white spots were no longer there, but the inflammation of her gums was still a problem. It was unknown if the patient experienced any additional symptoms or events. There were no additional lab data or results available. The treatment medication was not reported by the reporter.; Reporter's Comments: Gingivitis was assessed as not related, due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.
Test Date: 20251110; Test Name: immunofluorescence test; Result Unstructured Data: This had been diagnosed as final diagnosis:plasma cell gingivitis and clinical diagnosis lichen planus versus pemphigoid/pemphigus