Sex: F
Vaccine: HEP, HEP, HEP, HEP, HEP
Symptoms: Expired product administered, Extra dose administered, Hepatitis B antibody negative, Inappropriate schedule of product administration, Therapeutic response decreased
Clinical narrative: they requested Hepatitis B immunity, but after doing a test patient had low titers; they accidentally administered an expired dose of Engerix-B (20 mcg); given 4th dose; given 3rd dose on October 14th 2005; given 2nd dose on 9th August 2005; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 19-year-old female patient who received HBV (Engerix B adult) (batch number 25K3M, expiry date 02-JUN-2024) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 17-JUN-2024, the patient received the 5th dose of Engerix B adult. On 25-AUG-2006, the patient received the 4th dose of Engerix B. On 14-OCT-2005, the patient received the 3rd dose of Engerix B. On 09-AUG-2005, the patient received the 2nd dose of Engerix B. On 17-JUN-2005, the patient received the 1st dose of Engerix B. On 09-AUG-2005, not applicable after receiving Engerix B adult, Engerix B, Engerix B and Engerix B, an unknown time after receiving Engerix B and not applicable after receiving Engerix B adult, Engerix B, Engerix B and Engerix B, the patient experienced drug dose administration interval too long (Verbatim: given 2nd dose on 9th August 2005). On 14-OCT-2005, the patient experienced drug dose administration interval too short (Verbatim: given 3rd dose on October 14th 2005). On 25-AUG-2006, the patient experienced extra dose administered (Verbatim: given 4th dose). On 17-JUN-2024, the patient experienced expired vaccine used (Verbatim: they accidentally administered an expired dose of Engerix-B (20 mcg)). On an unknown date, the patient experienced therapeutic response decreased (Verbatim: they requested Hepatitis B immunity, but after doing a test patient had low titers). The outcome of the drug dose administration interval too long, drug dose administration interval too short, extra dose administered, therapeutic response decreased and expired vaccine used were unknown.   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-JUN-2024 The nurse accidently administered an expired dose of Engerix B (20 mcg), which led to expired vaccine used. The patient received 4th and 5th doses of Engerix B, which led to extra dose administered. They mentioned this was the fifth Hepatitis B vaccine received by the patient and this last dose indicated because the patient would start colleague and they requested Hepatitis B immunity but after doing a test patient had low titers, the physician suggested revaccination. The reporter did not know why a fourth dose was administered even if Engerix B indication was three doses on patients from birth, which led to extra dose administered. The fourth dose was not administered at their facility. The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Engerix B earlier than recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up.