Received Nov 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
COVID; mNEXSPIKE 25-26 does not work; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) and VACCINATION FAILURE (mNEXSPIKE 25-26 does not work) in a 71-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 17-Sep-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. In October 2025, the patient experienced COVID-19 (COVID) and VACCINATION FAILURE (mNEXSPIKE 25-26 does not work). At the time of the report, COVID-19 (COVID) had not resolved and VACCINATION FAILURE (mNEXSPIKE 25-26 does not work) outcome was unknown. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) were reported as unknown. No concomitant medication was reported. It was reported that mNEXSPIKE 25-26 did not work. The patient and her husband both received this vaccine and subsequently caught COVID on or around 17-Oct-2025. Two weeks later, they were still very sick and were coughing up mucus It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. This case was linked to MOD-2025-790818 (E2B Linked Report).; Reporter's Comments: Company Comment: The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: MOD-2025-790818:Original Case Number : MOD-2025-790809