Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM / RA |
itching; hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and URTICARIA (hives) in a 76-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 29-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 29-Sep-2025, the patient experienced PRURITUS (itching) and URTICARIA (hives). The patient was treated with Vitamin e at a dose of Oil/Cream. At the time of the report, PRURITUS (itching) and URTICARIA (hives) was resolving. No concomitant medication was reported. The patient had hives appearing on her right hand on the evening of 29-Sep-2025 and a shot was received on the upper right arm & on 08-Nov-2025, the itching had decreased but she was still sensitive to using warm water and any article of material that touches her right hand. Of course, scratching the affected area did not help, but very cold water or ice pack helped tremendously to control the itching and vitamin E Oil/Cream was used to heal. The affected area was wrapped with non-adherent pads held on with an elastic conforming bandage. It was unknown if the patient experienced any additional symptoms/events.