Received Jun 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | T9TL9 | — |
Adult dose to a pediatric PX; Overdose; 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 13-year-old female patient who received HAV (Havrix adult) (batch number T9TL9, expiry date 15-DEC-2025) for prophylaxis. Previously administered products included Havrix (1st dose received on 26th June 2023). On 24-MAY-2025, the patient received the 1st dose of Havrix adult. On 24-MAY-2025, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Adult dose to a pediatric PX) and overdose (Verbatim: Overdose). The outcome of the adult product administered to child and overdose 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: 29-MAY-2025 On of our patients well not a patient from us, but we have a mobile unit event, and a young lady was given a Havrix vaccine, the Hep A, she was 13, but she was given the vaccine for 19 and up, which led to adult product administered to child and overdose. HCP reported that the patient received the Havrix vaccine on 24-May-2025. Also, they mentioned that the patient had a prior Hep A vaccine in 26-Jun-2023, but they are not sure if this was also Havrix. So, this is the 2nd Hep A dose that the patient receive Also, HCP mentioned that as this was a mobile event, the place where the patient get the dose was in (they didn't provide any specific.