Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | T9TL9 | — |
accidentally administered an adult presentation of Havrix to a 12 month old patient on February 21st 2025; accidentally administered an adult presentation of Havrix to a 12 month old patient on February 21st 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 12-month-old female patient who received HAV (Havrix adult) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis. On 21-FEB-2025, the patient received the 1st dose of Havrix adult. On 21-FEB-2025, an unknown time after receiving Havrix adult, the patient experienced accidental overdose (Verbatim: accidentally administered an adult presentation of Havrix to a 12 month old patient on February 21st 2025) and adult product administered to child (Verbatim: accidentally administered an adult presentation of Havrix to a 12 month old patient on February 21st 2025). The outcome of the accidental 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: 21-FEB-2025 Licensed practical nurse stated that they accidentally administered an adult presentation of Havrix to a 12 month old patient, which led to accidental overdose, adult product administered to child. The reporter refused to provide initials and date of birth of the patient. The vaccine administration facility was the same as primary reporter.