Received Sep 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 6 | 3043259 | — |
started breaking out with hives at bedtime almost every night, mostly on the tops of my hands and feet, torso, and back; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (started breaking out with hives at bedtime almost every night, mostly on the tops of my hands and feet, torso, and back) in a 46-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043259) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (Dose 1, Lot: EW0150, Site: Left deltoid, Time: 10:10) on 06-Apr-2021, Pfizer COVID-19 Vaccine (Dose 2, Lot: EW0176, Site: Left deltoid, Time: 5.59 pm) on 30-Apr-2021, Pfizer booster (Dose 3, Lot: FJ8757) on 14-Dec-2021, MMR, Influenza vaccine, Hep B and DTP; for COVID-19 prophylaxis: Moderna bivalent (Dose 4, Lot: 021H22A) on 18-Nov-2022, Spikevax XBB.1.5 (Dose 5 and Lot: 3032707) on 24-Nov-2023. Past adverse reactions to the above products included No adverse effect with DTP, Hep B, Influenza vaccine, MMR, Moderna bivalent, Pfizer COVID-19 Vaccine, Pfizer COVID-19 Vaccine, Pfizer booster and Spikevax XBB.1.5. On 21-Sep-2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In 2025, the patient experienced URTICARIA (started breaking out with hives at bedtime almost every night, mostly on the tops of my hands and feet, torso, and back). At the time of the report, URTICARIA (started breaking out with hives at bedtime almost every night, mostly on the tops of my hands and feet, torso, and back) outcome was unknown. Concomitant medication was not provided. The patient had no medical history, concomitant disease or risk factor. It was reported that over the previous summer (July/August 2025), the patient had started breaking out with hives at bedtime almost every night, mostly on the tops of her hands and feet, torso and back. The patient mentioned that icepacks had helped her to prevent or relieve them. There were no lab data or results available It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. Reporter causality was not reported. This case was linked to MOD-2025-789549 (Patient Link).