Received May 21, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | 2 | — | — |
This situation is pre-assessed as an off-label (intentional by HCP) use as per local labelling due to administration of VAXELIS in patients over 4 years of age; This non-serious spontaneous Safety Report was received with reference number: IN-260402-88194 (Interation number: 02857745) by Partner on 01-APR-2026 and forwarded on 02-APR-2026 from a healthcare professional. Due to the nature of the event the causal relationship between the event of This situation is pre-assessed as an off-label (intentional by HCP) use as per local labelling due to administration of VAXELIS in patients over 4 years of age' and Vaxelis is not applicable. This case is considered off-label use. Further information expected. SIGNIFICANT FOLLOW-UP INFORMATION received from healthcare professional on 05-APR-2026 and forwarded on 05-APR-2026. Due to the nature of the event the causal relationship between the event of This situation is pre-assessed as an off label (intentional by HCP) use as per local labelling due to administration of VAXELIS in patients over 4 years of age' and Vaxelis is not applicable. No further information expected.
Prophylaxis
Medical History/Concurrent Conditions: Low weight
HEP A IN VAC; HPV VACCINE; MMR