Received Nov 11, 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 67-year-old male 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 24-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. On 17-Oct-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, patient and his wife both received this vaccine and subsequently caught COVID on or around 17-Oct-2025. Two weeks later, they were still very sick and coughing up mucus. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790809 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790809:Original Case Number : MOD-2025-790809/ wife's case