Received Feb 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 2345B | — |
12 month old patient received an adult dose of Havrix; 12 month old patient received an adult dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 12-month-old male patient who received HAV (Havrix adult) (batch number 2345B, expiry date 02-FEB-2026) for prophylaxis. The patient's past medical history included thrombocytopenia. On 17-FEB-2025, the patient received Havrix adult. On 17-FEB-2025, an unknown time after receiving Havrix adult, the patient experienced accidental overdose (Verbatim: 12 month old patient received an adult dose of Havrix) and adult product administered to child (Verbatim: 12 month old patient received an adult dose of Havrix). 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 The healthcare provider reported that a 12 month old patient received an adult dose of Havrix which led to accidental overdose and adult product administered to child. The reporter mention that patient has history of thrombocytopenia.
Medical History/Concurrent Conditions: Thrombocytopenia