Received Sep 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052586 | IM / LA |
itchy hives on left & right hands, right underarm & upper arm, right side/torso between hips and ribs, left collarbone, left hip and groin area; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (itchy hives on left & right hands, right underarm & upper arm, right side/torso between hips and ribs, left collarbone, left hip and groin area) in a 46-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052586) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer BioNTech COVID-19 vaccine (Dose 1, Lot: EW0150, Site: Left deltoid, Time: 10:10) on 06-Apr-2021, Pfizer BioNTech 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, Lot: 3032707) on 24-Nov-2023, Spikevax 2024-2025 formula (Dose 6 and Lot: 3043259) on 21-Sep-2024. Past adverse reactions to the above products included No adverse effect with DTP, Hep B, Influenza vaccine, MMR, Moderna bivalent, Pfizer BioNTech COVID-19 vaccine, Pfizer BioNTech COVID-19 vaccine, Pfizer booster, Spikevax 2024-2025 formula and Spikevax XBB.1.5. On 20-Sep-2025, the patient received seventh dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 21-Sep-2025 at 12:30 AM, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced URTICARIA (itchy hives on left & right hands, right underarm & upper arm, right side/torso between hips and ribs, left collarbone, left hip and groin area). On 21-Sep-2025 at 7:00 AM, URTICARIA (itchy hives on left & right hands, right underarm & upper arm, right side/torso between hips and ribs, left collarbone, left hip and groin area) had resolved. Concomitant medication was not provided. The patient had no medical history, concomitant disease or risk factor. It was reported that the patient had woken up at 12.30 am eastern time on 21-sep-2025 with itchy hives on left and right hands, right underarm and upper arm, right side or torso between hips and ribs, left collarbone, left hip and groin area. The dose had been administered on the patient's left upper arm. Hives had resolved by the time the patient woke up at 7 am on 21-sep-2025. She would monitor whether hives continued to occur. There were no lab data or results available. It was unknown if the patient experienced any additional symptoms or events. It was stated that the hives had not been treated. Reporter causality was not reported. This case was linked to MOD-2025-789550 (Patient Link).