Received Feb 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
dermatitis/it was located on the shinbone and is about 4 inches by 2 inch and looks like a rash; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS (dermatitis/it was located on the shinbone and is about 4 inches by 2 inch and looks like a rash) in an 80-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine (Flu) for an unknown indication. Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (had taken so far 8 covid vaccines). Past adverse reactions to the above products included No adverse effect with COVID-19 VACCINE. On 16-Nov-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. In February 2026, the patient experienced DERMATITIS (dermatitis/it was located on the shinbone and is about 4 inches by 2 inch and looks like a rash). At the time of the report, DERMATITIS (dermatitis/it was located on the shinbone and is about 4 inches by 2 inch and looks like a rash) had not resolved. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter considered DERMATITIS (dermatitis/it was located on the shinbone and is about 4 inches by 2 inch and looks like a rash) to be not related. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medication was not reported. It was stated that patient had dermatitis and stated it started about a week and a half ago, she did not believe it was caused by the vaccine. It was located on the shinbone and was about 4 inches by 2 inch and looked like a rash now. It was stated that she had done a mammogram, the reason and results were not mentioned, but her HCP had advised her that the vaccine may cause the mammogram results to be skewed. She also added that she had blood tests to rule out vasculitis, and this was done before the mNEXSPIKE dose because her doctor said that mNEXSPIKE might alter the results of blood tests. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.; Reporter's Comments: The event was assessed as not related to suspected vaccine due to lack of temporal association. Patient's advanced age is confounding factor. The benefit-risk relationship of the product is not affected by this report.