Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Hives - urticaria; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives - urticaria) in a 40-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine for an unknown indication. Concurrent medical conditions included Urticaria since 2024. On 26-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 06-Oct-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced URTICARIA (Hives - urticaria). At the time of the report, URTICARIA (Hives - urticaria) was resolving. The patient had no medical history, or risk factor. No concomitant medication was reported. The patient had hives - urticaria for the second year in a row where it was bad. Dermatologist diagnosed the disease. If it was the same as last year, it would be a few months of flare-ups. The patient did not experience any additional symptoms/events. There were no lab data/results available. Patient was taking topical creams to help with the urticaria.; Reporter's Comments: Patient's concurrent medical condition was assessed as strong risk factor for reported event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Urticaria