Received Sep 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Administration after a temperature excursion; 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 a 12-month-old male patient who received MMR (Priorix) for prophylaxis. Co-suspect products included HAV (Havrix) for prophylaxis. On 21-AUG-2025, the patient received Priorix. On 22-AUG-2025, the patient received Havrix. On an unknown date, an unknown time after receiving Priorix and Havrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a 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: 28-AUG-2025 A healthcare professional called to report that after 2 excursions, the first one being at 47.3 degree Fahrenheit for 50 minutes and 24 seconds and the second one being at 46.4 degree Fahrenheit for 25 minutes and 50 second, Priorix and Havrix were administered to a patient, which led to incorrect storage of product. This case was one of the twenty-five case reported by the same reporter for different patient.; Sender's Comments: US-GSK-US2025AMR113209:Same reporter US-GSK-US2025AMR113210:Same reporter US-GSK-US2025AMR113211:Same reporter US-GSK-US2025AMR113212:Same reporter US-GSK-US2025AMR113213:Same reporter US-GSK-US2025AMR113214:Same reporter US-GSK-US2025AMR113215:Same reporter US-GSK-US2025111056:Same reporter US-GSK-US2025AMR113217:Same reporter US-GSK-US2025AMR113218:Same reporter US-GSK-US2025AMR113219:Same reporter US-GSK-US2025AMR113220:Same reporter US-GSK-US2025AMR113221:Same reporter US-GSK-US2025AMR113222:Same reporter US-GSK-US2025AMR113223:Same reporter US-GSK-US2025AMR113224:Same reporter US-GSK-US2025AMR113225:Same reporter US-GSK-US2025AMR113226:Same reporter US-GSK-US2025AMR113208:Same reporter US-GSK-US2025AMR113231:Same reporter US-GSK-US2025AMR113230:Same reporter US-GSK-US2025AMR113227:Same reporter US-GSK-US2025AMR113228:Same reporter US-GSK-US2025AMR113229:Same reporter