Received Apr 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052583 | IM |
large hives covering the body from the neck down/hives became painful; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (large hives covering the body from the neck down/hives became painful) in a patient of an unknown age and gender who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052583) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052583) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX 2023-2024 PFS (lot number 3031280) in 2023 and SPIKEVAX 2024-2025 PFS (lot number 8080748) in 2024. Past adverse reactions to the above products included No adverse effect with SPIKEVAX 2023-2024 PFS and SPIKEVAX 2024-2025 PFS. On 03-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced URTICARIA (large hives covering the body from the neck down/hives became painful). In October 2025, URTICARIA (large hives covering the body from the neck down/hives became painful) had resolved. Concomitant medication was not provided. It was reported that the patient received a SPIKEVAX (Moderna) COVID-19 vaccine and approximately 36 hours after vaccination, the patient developed a significant adverse reaction. It was reported that the hives recurred intermittently over a period of five days and was so bad that the hives became painful. Due to the absence of prior reactions, concern was expressed regarding possible differences in the composition, formulation, or manufacturing process of the Oct-2025 vaccine. The patient reportedly requested information regarding any changes that could potentially explain the reaction. It was also reported that, following this experience, the patient felt apprehensive about receiving future COVID-19 vaccinations and requested guidance regarding the safety of future doses, as well as any recommended precautions or alternative options. It was unknown if the patient experienced any additional symptoms or events. It was reported that Benadryl was the only antihistamine that provided some relief to the patient.