Received Jun 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | — | — |
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | — | — |
third dose was given as an early dose; 2nd dose administered on 16 Jan 2015; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 4-month-old female patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis. Concomitant products included Hepatitis b vaccine. On 06-MAR-2015, the patient received the 3rd dose of Engerix B. On 16-JAN-2015, the patient received the 2nd dose of Hepatitis B vaccine. On 16-JAN-2015, not applicable after receiving Engerix B and an unknown time after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose administered on 16 Jan 2015). On 06-MAR-2015, the patient experienced drug dose administration interval too short (Verbatim: third dose was given as an early dose). The outcome of the 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: 09-JUN-2025 Physician explained that a 10 year old patient received by accident an expired forth dose of a Hepatitis B vaccine (lot number W025817, expiration date 21st May 2025, brand name not provided by the caller, but they mentioned that it was non-GSK product) on 2nd June 2025 since they noticed that their third dose was given as an early dose. First dose of Hepatitis B was given on 5th November 2014, second dose on 16th January 2015 and third dose on 6th March 2015 which led to Drug dose administration interval too short. Physician did not know what the brand name or lot number for any of the 3 prior doses was. Adverse Event report sent as a preventive measure as a potential early third dose of Engerix-B, and potential interchangeability, since the fourth dose was not a GlaxoSmithKline vaccine. Caller decided to end the call when they noticed that the fourth dose was not from GlaxoSmithKline so Medical Information did not have time to ask for consent to follow up with Safety Team. The patient received 2nd dose of Hepatitis B later than the recommended schedule, which led to lengthening of vaccination schedule.
HEPATITIS B VACCINE