Received Aug 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | UNK | U7392AA | IM / LL |
Administration of VAXELIS to a patient more than 5 years of age; This non-serious spontaneous, safety report with reference numbers 2025SA165307 and 02550786 was received by partner on 09-JUN-2025 and forwarded to agency on 10-JUN-2025 from a heathcare professional. Due to the nature of the event, the causality between Vaxelis and the reported event of "Administration of VAXELIS to a patient more than 5 years of age" 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
PREVNAR 20; MMR; VARICELLA VACCINE