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 ROTATEQ and VAXELIS after a temperature excursion that occurred on 07MAY2025; This non-serious spontaneous, safety report with reference numbers 02823417 and 02822913 was received by partner, on 17-JUN-2025 and forwarded to agency on 17-JUN-2025 from a healthcare professional. Additional information was received on 20-JUN-2025. Due to the nature of the event, the causality between Vaxelis and the events of "inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion that occurred on 07MAY2025" and "no adverse event" were not applicable. For reference purposes this case is linked to: MCM-008160, MCM-008161, MCM-008162, MCM-008164, and MCM-008169 (same temperature excursion event). No further information is expected.
Prophylaxis