Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 80777040060 | IM |
small rash on my left eyelid; hives; They are quite itchy and red.; They are quite itchy and red.; itchy patches/a patch the size of a quarter on my right shoulder at my neck; This spontaneous case was reported by a consumer and describes the occurrence of EYELID RASH (small rash on my left eyelid), URTICARIA (hives), PRURITUS (They are quite itchy and red.), ERYTHEMA (They are quite itchy and red.) and RASH (itchy patches/a patch the size of a quarter on my right shoulder at my neck) in a 66-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 80777040060) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 80777040060) for COVID-19 prophylaxis. On 21-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 24-Oct-2025, the patient experienced EYELID RASH (small rash on my left eyelid), URTICARIA (hives), PRURITUS (They are quite itchy and red.), ERYTHEMA (They are quite itchy and red.) and RASH (itchy patches/a patch the size of a quarter on my right shoulder at my neck). The patient was treated with Fexofenadine hydrochloride (Allegra) on 24-Oct-2025 for Rash, at a dose of 24 hour dose; Fexofenadine hydrochloride (Allegra) ongoing from October 2025 for Rash, at a dose of 12 hour dose and Triamcinolone acetonide (topical) ongoing from 24-Oct-2025 for Itching, at a dose of approximately every three hours. At the time of the report, EYELID RASH (small rash on my left eyelid), URTICARIA (hives), PRURITUS (They are quite itchy and red.), ERYTHEMA (They are quite itchy and red.) and RASH (itchy patches/a patch the size of a quarter on my right shoulder at my neck) had not resolved. The patient had no medical history, concomitant disease or risk factor. No concomitant medication was reported. The patient received the Moderna Covid vaccine on 21-Oct-2025. On 24-Oct-2025, the patient developed a small rash on the left eyelid and a patch the size of a quarter on the right shoulder at the neck. The patient had hives and itchy patches, mainly on the left side of the body, the side of the injection. If that matters, they were on the neck, on the chest, a large hard patch under the chin and around the lips and in the left ear. They had not changed but seemed to be getting a little worse, meaning patients were getting more of them. They were quite itchy and red. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. Once the patient realized it was a rash as it spread to the corner of that left eye, they then got the quarter-sized patch on the right shoulder. The patient put herself on a 12-hour dose of Allegra. The patient also applied a topical cream spelled TRIAMCINOLONE ACETONIDE 0.1%. The patient applied the cream approximately every three hours to relieve itching. The patient took Allegra every 12 hours as 24 hours did not help. The patient also used ice on the rash areas that were painful or itchy so that patient did not scratch. The patient had been taking both from 24-Oct-2025 until the current date, which was 27-Oct-2025. It had not made much difference. It only relieved some itching.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.