Received Aug 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | OT |
SARS-CoV-2 infection post vaccine; This serious initial Spontaneous (Literature) safety report was received by Novavax on 04-Aug-2025 from a Consumer or other non-health professional. An individual of an unspecified age (65 year or older) and unspecified gender was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (Intramuscular) (Lot number was not provided in the report), on an unspecified date. No medical history was reported. No concomitant medications were reported. On an unspecified date after vaccination, the patient experienced "SARS-CoV-2 infection post vaccine" (Breakthrough COVID-19) (Serious: Caused/Prolonged Hospitalization). At the time of reporting, the event outcome of Breakthrough COVID-19 was Unknown.; Sender's Comments: This individual of an unspecified age (65 year or older) and unspecified gender experienced Breakthrough COVID-19 after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The event Breakthrough COVID-19 was reported as serious. Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Breakthrough COVID-19 is considered Possible.