Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 69-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS; for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First vaccine series (Dose 1)) and PFIZER BIONTECH COVID-19 VACCINE (First vaccine series (Dose 2)). Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and Spikevax NOS. On 25-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In August 2025, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2025, SARS-CoV-2 test: Positive. No concomitant medication was reported. It was reported that the patient was never really reacted to the Moderna. The patient had first vaccine series with Pfizer, then switched to Moderna. The patient was diagnosed with COVID-19 in late August 2025. Diagnosis was based on positive testing result, symptoms and doctor visit. No hospitalization required. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-790047, US-MODERNATX, INC.-MOD-2025-790050 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790047:Patient 02 US-MODERNATX, INC.-MOD-2025-790050:Patient 01
Test Date: 202508; Test Name: COVID-19 test; Test Result: Positive