Received Aug 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | — | OT |
She had never been vaccinated previously with any other Covid vaccine, and she only ever got one dose of the Novavax Covid vaccine in March 2025; She had never been vaccinated previously with any other Covid vaccine, and she only ever got one dose of the Novavax Covid vaccine in March 2025; This non-serious initial spontaneous report from withheld was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00601) and concerns a 47- year-old Female who reported "She had never been vaccinated previously with any other covid vaccine, and she only ever got one dose of the Novavax covid vaccine in march 2025" (Incomplete course of vaccination) and "She had never been vaccinated previously with any other covid vaccine, and she only ever got one dose of the Novavax covid vaccine in march 2025" (Off label use) after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on 22-Mar-2025. At the time of reporting, the outcome of the Incomplete course of vaccination and Off label use was Recovered/Resolved.; Sender's Comments: This 47-year-old Female experienced Incomplete course of vaccination and Off label use after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Incomplete course of vaccination and Off label use were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Incomplete course of vaccination and Off label use is considered Possible.