Received Mar 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| FLU4 | INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Administration after temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis and Flu Seasonal QIV Quebec (FluLaval Tetra) for prophylaxis. On an unknown date, the patient received Boostrix, Infanrix and FluLaval Tetra. On an unknown date, an unknown time after receiving Boostrix, Infanrix and FluLaval Tetra, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-MAR-2025 A licensed practical nurse reported temperature excursions for Boostrix, Infanrix and Flulaval. Healthcare professional mentioned that these excursions occurred since 12th September 2024 until 28th February 2025. During the call, healthcare professional mentioned that probably a couple of these vaccines were used which led to incorrect storage of drug. This is 1 of the 2 cases reported by the same reporter.; Sender's Comments: US-GSK-US2023167156:same reporter