Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | — | OT |
I got my last year only got the one dose, didn't get the second; I got my last year only got the one dose, didn't get the second; This non-serious initial spontaneous safety report was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00427) and concerns an individual of unspecified age and sex who reported experiencing "I GOT MY LAST YEAR ONLY GOT THE ONE DOSE, DIDN'T GET THE SECOND" (Incomplete course of vaccination) and "I GOT MY LAST YEAR ONLY GOT THE ONE DOSE, DIDN'T GET THE SECOND" (off label use) on an unspecified date in 2024 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) in 2024. At the time of the report, the outcome of the Incomplete course of vaccination, Off label use was Recovered/Resolved. A discrepancy was identified in the source document: For the event of Incomplete course of vaccination and Off label use, event onset year was captured as the year of vaccine administration and event cessation was captured to match the event start date with an outcome of recovered/resolved as it is a special situation event.; Sender's Comments: This Female of an unspecified age experienced Incomplete course of vaccination and Off label use after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events 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.