Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
inflammation; My skin turned really dark; Rash around my stomach/right around my waistline and groin area/rash on my arms/ itching my body; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation), SKIN DISCOLOURATION (My skin turned really dark), RASH PRURITIC (Rash around my stomach/right around my waistline and groin area/rash on my arms/ itching my body) and FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine for an unknown indication. No Medical History information was reported. In 2025, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. In October 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 2025, the patient experienced INFLAMMATION (inflammation), SKIN DISCOLOURATION (My skin turned really dark), RASH PRURITIC (Rash around my stomach/right around my waistline and groin area/rash on my arms/ itching my body) and FATIGUE (fatigue). At the time of the report, INFLAMMATION (inflammation), SKIN DISCOLOURATION (My skin turned really dark), RASH PRURITIC (Rash around my stomach/right around my waistline and groin area/rash on my arms/ itching my body) and FATIGUE (fatigue) outcome was unknown. The concomitant medication was not reported by the reporter. Patient received the flu vaccine 10 days before the Spikevax 2025-2026. The patient got the Moderna vaccine. She did not have any reaction, but a week later she developed a rash around her stomach. Her skin turned really dark. She wondered if it was from the injection. The patient had some inflammation. She was not certain and was not 100 percent sure that it was from that, but that was the only thing she could think of. She had right around her waistline and groin area. She itched her body. She had a rash on her arms. A week or 10 days before that, she had received the flu vaccine. She ended up going to a dermatologist because of the itching and the rash around her waist. She also felt fatigued. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter.