Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | UNK | U8313AA | IM / LL |
| MMR | MEASLES + MUMPS + RUBELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | SC |
Provider said that redness at the injection site was normal; Product administered to patient of inappropriate age; sdministered a dose of VAXELIS to a patient outside of the recommended age range as a catch up dose,; This non-serious spontaneous safety report with reference number: 2025SA271176 was received by a partner on 09-SEP-2025 and forwarded to agency on 10-SEP-2025 from other health professional and concerned a person of unknown origin. Case was considered as off-label use due to the reported event of patient being administered Vaxelis at 5-year-old. The reporter did not assess the causal relationship between Vaxelis and Provider said that redness at the injection site was normal,' and due to the nature of the event, the causality between the events 'product administered to patient of inappropriate age', 'administered a dose of VAXELIS to a patient outside of the recommended age range as a catch up dose,' and Vaxelis was not applicable. Further information is expected.
Prophylaxis