Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | UNK | U777688 | — |
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | UNK | Z008265 | — |
A lump of fluid under the skin where it does not belong; Vaxelis and Vaxneuvance given subcutaneously, so it infiltrated and there was a lump of fluid under the skin where it does not belong and it has not gone away in 3 weeks; VAXELIS and VAXNEUVANCE administered incorrectly, given subcutaneously; This non-serious spontaneous safety report with Case ID reference number 02859364 (Interaction number: 02859338) was received by partner on 19-AUG-2025 and forwarded on 20-AUG-2025 from a healthcare professional. Additional information was received on 21-AUG-2025 from partner and forwarded on 22-AUG-2025 from a healthcare professonal. The causal relationship between Vaxelis and the reported event of "VAXELIS and VAXNEUVANCE administered incorrectly, given subcutaneously is not applicable due to the nature of the event while and the reported event of "A lump of fluid under the skin where it does not belong." was assessed as related. This case is considered as off label use due to incorrect route of vaccine administration (subcutaneously instead of intramuscularly). Further information is expected.
Prophylaxis