Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 5 | 5JX2E | — |
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | 4 | UNK | — |
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | — |
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
accidentally administered an adult dose of Engerix-B to a 19 year old patient; accidentally administered an adult dose of Engerix-B to a 19 year old patient; 1st on August 18th 2005 and 4th on Feb 6 2006; 1st on August 18th 2005 and 3rd on December 5th 2005; 1st on August 18th 2005 and 2nd on October 13th 2005; 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 9-week-old female patient who received HBV (Engerix B adult) (batch number 5JX2E, expiry date 15-DEC-2026) for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis. Concomitant products included HEPATITIS B VACCINE (HEPATITIS B). On 17-FEB-2025, the patient received the 5th dose of Engerix B adult. On 06-FEB-2006, the patient received the 4th dose of Hepatitis B vaccine. On 05-DEC-2005, the patient received the 3rd dose of Hepatitis B vaccine. On 13-OCT-2005, the patient received the 2nd dose of Hepatitis B vaccine. On 13-OCT-2005, an unknown time after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long (Verbatim: 1st on August 18th 2005 and 2nd on October 13th 2005). On 05-DEC-2005, the patient experienced drug dose administration interval too short (Verbatim: 1st on August 18th 2005 and 3rd on December 5th 2005). On 06-FEB-2006, the patient experienced extra dose administered (Verbatim: 1st on August 18th 2005 and 4th on Feb 6 2006). On 17-FEB-2025, the patient experienced adult product administered to child (Verbatim: accidentally administered an adult dose of Engerix-B to a 19 year old patient) and accidental overdose (Verbatim: accidentally administered an adult dose of Engerix-B to a 19 year old patient). The outcome of the adult product administered to child, accidental overdose, extra dose administered, drug dose administration interval too short 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: 17-FEB-2025 The patient received 2nd dose, which was later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose, which was earlier than the recommended interval, leading to shortening of vaccination schedule. The patient received 4th dose of Hepatitis B, which was an extra dose administered. The reporter stated that they accidentally administered an adult dose of Engerix-B to a 19 year old patient, which led to adult product administered to child and accidental overdose. The reporter did not have lot number or expiration date for any of the 4 prior doses, brand name not provided.
HEPATITIS B