Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052155 | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
rash around the neck and upper abdomen up to under the breasts, like a heat rash, not itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash around the neck and upper abdomen up to under the breasts, like a heat rash, not itchy) in an elderly female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052155) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX NOS; for Drug use for unknown indication: penicillin and Sulpha. Past adverse reactions to the above products included Drug allergy with Sulpha and penicillin; and No adverse effect with SPIKEVAX NOS. Concurrent medical conditions included Sulfonamide allergy (sulpha drug) and Penicillin allergy. On 26-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 26-Sep-2025, the patient experienced RASH (rash around the neck and upper abdomen up to under the breasts, like a heat rash, not itchy). On 28-Sep-2025, RASH (rash around the neck and upper abdomen up to under the breasts, like a heat rash, not itchy) had resolved. The patient always received the Moderna COVID vaccines in the past. The concomitant medication was not reported by the reporter. On Friday, 26-Sep-2025, the patient received a dose of mNEXSPIKE and Flu shot. It was reported that within less than 12 hours of the vaccination, she developed a rash around the neck and upper abdomen, extending up to under the breasts. The rash looked like a heat rash and was not itchy. The symptoms were resolved by Sunday night, on 28-Sep-2025, after about two days. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter.; Reporter's Comments: Flu vaccine was assessed as confounding factor for reported event of RASH. The benefit-risk relationship of product is not affected by this report.
Penicillin allergy; Sulfonamide allergy (sulpha drug)