Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
tested positive on Sept 14; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive on Sept 14) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 07-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 14-Sep-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced COVID-19 (tested positive on Sept 14). At the time of the report, COVID-19 (tested positive on Sept 14) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2025, SARS-CoV-2 test: Positive. No concomitant medication was reported. The patient had vaccine on 7-Jun-2025 and tested positive on 14-Sep-2025. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789367 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789367:Husband case
Test Date: 20250914; Test Name: Covid-19 test; Test Result: Positive