Received Mar 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | 2 | — | — |
No adverse event; HCP called to report a TE for GARDASL 9, ROTATEQ, MMR II, RECOMBIVAX, and VAXELIS syringes. Caller reported excursions occurred between 9/22/2025 and 11/23/2025 and product had been administered to multiple patients.; This non-serious spontaneous Safety Report was received with reference number: 02910607 (Interaction number: 02910596) by partner on 24-NOV-2025 and forwarded to agency on 24-NOV-2025 from a Health Professional. Due to the nature of the event, HCP called to report a TE for GARDASL 9, ROTATEQ, MMR II, RECOMBIVAX, and VAXELIS syringes. Caller reported excursions occurred between 9/22/2025 and 11/23/2025 and product had been administered to multiple patients was not applicable. This case is considered nonvalid due to no patient identifiers provided. Further information expected. SIGNIFICANT FOLLOW-UP INFORMATION was received from an HCP on 02-DEC-2025. The case becomes valid. Due to the nature of the events, the causality between the events 'HCP called to report a TE for GARDASL 9, ROTATEQ, MMR II, RECOMBIVAX, and VAXELIS syringes. Caller reported excursions occurred between 9/22/2025 and 11/23/2025 and product had been administered to multiple patients' and 'No adverse event' and Vaxelis was not applicable. No further information expected.
Prophylaxis
PREVNAR 20; RSV VACCINE; ROTATEQ