Received Feb 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (KINRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | D947X | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 42B22 | — |
vaccines probably administered after above temperature excursions/temperature excursion for Kinrix and Engerix-B during 8 minutes with a maximum temperature of 8.63 degree Celsius; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-IPV (Kinrix) (batch number D947X) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number 42B22) for prophylaxis. On an unknown date, the patients received Kinrix and Engerix B. On an unknown date, an unknown time after receiving Kinrix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: vaccines probably administered after above temperature excursions/temperature excursion for Kinrix and Engerix-B during 8 minutes with a maximum temperature of 8.63 degree Celsius). The outcome of the incorrect storage of drug was unknown. 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: 05-FEB-2025 The office manager called to reported that a temperature excursion for Kinrix and Engerix-B during 8 minutes with a maximum temperature of 8.63 degree Celsius which led to, incorrect storage of drug. The reporter also mentioned a prior temperature excursion for those same vaccines of 7 minutes with a maximum temperature of 8.75degreree Celsius already reported in this case. The reporter explained that some of those vaccines were probably administered to patients after the temperature excursions, but she was not sure (no patient details provided by caller).