Received Aug 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | UNK | — | — |
No adverse event; Inadvertent administration of VAXELIS after a temperature excursion that occurred on 07MAY2025; This non-serious spontaneous safety report, with reference number 02823419 (Interaction Number 02822913), was received by partner on 17-JUN-2025 and forwarded to agency on 17-JUN-2025 from a nurse. Due to the nature of the event, the causality between the event inadvertent administration of VAXELIS after a temperature excursion that occurred on 07MAY2025' and Vaxelis was not applicable. Further information is expected. SIGNIFICANT FOLLOW-UP INFORMATION, was received by agency on 20-JUN-2025 from a nurse. Due to the nature of the event, the causality between the event; "Inadvertent administration of VAXELIS after a temperature excursion that occurred on 07MAY2025" and "No adverse event" and Vaxelis was not applicable. For reference purposes this case is linked to: MCM-008160, MCM-008161, MCM-008162, MCM-008163, and MCM-008169 (same temperature excursion event) No further information is expected.
Prophylaxis