Received Oct 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 5 | 9LK2G | — |
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | 4 | UNK | — |
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | 3S54K | — |
Extra dose administered; underdose; Adult use of a child product; Extra doses; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 44-year-old female patient who received HAV (Havrix pediatric) (batch number 3S54K, expiry date 02-MAR-2025) for prophylaxis. Co-suspect products included HBV (Engerix B pediatric) (batch number 9LK2G, expiry date 14-SEP-2025) for prophylaxis and Hepatitis B vaccine for prophylaxis. Previously administered products included Havrix (The patient received a full series (2 doses) of Hepatitis A in 2007) and Engerix b (4 doses of Hepatitis B between 2002 and 2007). On 26-SEP-2024, the patient received the 3rd dose of Havrix pediatric and the 5th dose of Engerix B pediatric. On an unknown date, the patient received the 4th dose of Hepatitis B vaccine. On 26-SEP-2024, an unknown time after receiving Havrix pediatric and Engerix B pediatric and not applicable after receiving Hepatitis B vaccine, the patient experienced underdose (Verbatim: underdose), adult use of a child product (Verbatim: Adult use of a child product) and extra dose administered (Verbatim: Extra doses). On an unknown date, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the underdose, adult use of a child product, extra dose administered and extra dose administered 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: 25-SEP-2025 A patient over 18 year old but may have gotten a pediatric dose of hepatitis a (HAVRIX) and hepatitis b (ENGERIX-B) on 26-Sep-2024. Documentation was conflicting as the documented NDC and expiration dates did not match the lot number. For HAVRIX the documented NDC number was 58160-0825-43 and for ENGERIX B the documented NDC number was 58160-0820-43. The patient received a full series (2 doses) of Hepatitis A in 2007 (Brand unknown when asked) and 4 doses of Hepatitis B between 2002 and 2007 (brand unknown when asked). When asked for reason why patient received these doses in 2024, healthcare professional stated that the patient did call and there was a note in her chart that she was requesting a hep an and hep b vaccine and healthcare professional stated it could be for work which was typically the case when patients call requesting vaccines.