Received Aug 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | UNK | U7788AA | — |
Nurse reported that they have given a VAXELIS dose to a 5 year old patient; This non-serious spontaneous, safety report with reference numbers 2025SA186558 and 02574248 was received by partner on 30-JUN-2025 and forwarded to agency on 01-JUL-202 from a nurse practitioner. Due to the nature of the event, the causality between Vaxelis and the reported event of "Nurse reported that they have given a VAXELIS dose to a 5 year old patient" was not applicable. This case is considered an instance of off-label use, due to Vaxelis being administered to patient of inappropriate age. Further information is expected.
Prophylaxis