Sex: F
Vaccine: HEP
Symptoms: Hepatitis B, Hepatitis B DNA increased, Hepatitis B e antigen positive, Hepatitis B surface antigen positive, Vaccination failure
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a infant female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B Immunoglobulin. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and Hepatitis B Immunoglobulin at an unknown dose and frequency. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), hepatitis B (serious criteria GSK medically significant) and vertical infection transmission. On an unknown date, the outcome of the vaccination failure, hepatitis B and vertical infection transmission were unknown. The reporter considered the vaccination failure and hepatitis B to be related to Hepatitis B vaccine. It was unknown if the reporter considered the vertical infection transmission to be related to Hepatitis B vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of suspected vaccination failure in a female infant who was vaccinated with Hepatitis B virus (HBV) vaccine (manufacturer unknown). The patient's mother had a medical history of HBeAg-positive chronic hepatitis B with pre-treatment baseline HBV DNA level of 110 million copies per mL. The patient's mother was 28 at the time of delivery. The patient was delivered by an emergent caesarean section due to prolonged labour. No information on patient's medical history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received HBV vaccination (administration route and site unspecified; dosages unknown; batch number not provided). (In this study, the patient's mother was recommended to schedule standard active and passive immune-prophylaxis with hepatitis B immunoglobulin and hepatitis B vaccination for the patient to be administered within 12 hours of birth followed by additional two doses to complete the vaccination series). On an unspecified date, an unknown period after vaccination with HBV vaccine, the patient was noted to have the presence of hepatitis B surface antigen (HBsAg) and high levels of HBV deoxyribonucleic acid (DNA). Subsequently, the patient was diagnosed with HBV infection. This case was considered as suspected vaccination failure being full schedule and time to onset was unknown. This case was considered serious due to suspected vaccination failure. Treatment was unknown. On follow up, the patient remained clinically stable in the immune tolerant phase with high levels of HBV DNA and positive HBeAg. The patient had been undergoing hepatoma surveillance every 6 months. It was reported that antiviral therapy for the patient will be considered later in life if indicated. The authors did not comment on the relationship between the event of HBV infection and HBV vaccination. However, the authors stated that mother-to-child transmission (MTCT) was not preventable despite the institution of comprehensive active and passive immunoprophylaxis for the birth of the patient. The authors concluded that "The current standard of active and passive immune-prophylaxis is thought to be 95% effective in preventing transmission of HBV from mother to her child; however, data suggest this may be an overestimation, especially in certain clinical scenarios. This ambiguity is especially difficult for patients who are already aware of their hepatitis B status and who wish not to pass down HBV infection to their new born children."