Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | Z5434 | — |
Adult dose to a pediatric patient; he got the 1 ml dose instead of the 0.5 mL; Havrix late second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 17-year-old male patient who received HAV (Havrix adult) (batch number Z5434) for prophylaxis. Previously administered products included Hepatitis A vaccine (First dose was received on 14-Nov-2011 and did not know the brand name of the product). On 22-SEP-2025, the patient received the 2nd dose of Havrix adult 1 ml. On 22-SEP-2025, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Adult dose to a pediatric patient), overdose (Verbatim: he got the 1 ml dose instead of the 0.5 mL) and drug dose administration interval too long (Verbatim: Havrix late second dose). The outcome of the adult product administered to child, overdose and drug dose administration interval too long 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: 22-SEP-2025 After the 2nd Hepatitis A vaccine, the healthcare professional informed that the patient did not have any adverse event.