Received Aug 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Maladministration of adult dose to a pediatric patient (potential First Dose); Maladministration of adult dose to a pediatric patient (potential First Dose); This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 1-year-old female patient who received HAV (Havrix adult) for prophylaxis. On 29-JUL-2025, the patient received the 1st dose of Havrix adult. On 29-JUL-2025, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: Maladministration of adult dose to a pediatric patient (potential First Dose)) and adult product administered to child (Verbatim: Maladministration of adult dose to a pediatric patient (potential First Dose)). The outcome of the overdose and adult product administered to child were 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: 13-AUG-2025 Registered nurse called to asked about safety concerns on five patients vaccination schedule (potential first dose) with the maladministration of an adult dose of havrix which led to adult product administered to child and overdose. Vaccination dates and partial patient demographics (only gender and age) were obtained in this call. No vaccine detail was obtained in this call. No further information was obtained in this call.; Sender's Comments: US-GSK-US2025104626:same reporter different patient US-GSK-US2025104616:same reporter different patient US-GSK-US2025104628:same reporter different patient