Sex: F
Vaccine: HEP
Symptoms: Hepatitis B e antigen negative, Hepatitis B surface antibody negative, Hepatitis B surface antigen positive, Hepatitis E antibody positive, International normalised ratio normal
Clinical narrative: Suspected vaccination failure; Chronic Hepatitis; This case was reported in a literature article and described the occurrence of vaccination failure in a 27-year-old female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and chronic hepatitis b (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the chronic hepatitis b was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and chronic hepatitis b to be related to Hepatitis B vaccine.     Additional Information: GSK receipt date: 29 April 2022 Author comment: The patient was born in another country and did not receive the HBV vaccination in childhood. The patient reported 2 heterosexual partners in her lifetime. The patient had no history of other sexually transmitted infections, blood transfusions, needlestick injuries, or intravenous drug use. The patient was without pertinent medical history presented with elevated transaminase levels and a positive hepatitis Bsurface antigen (HBsAg) test result. Because of elevated liver enzymes and lack of anti-HBs following vaccination, further serologic testing was performed. At presentation, the patient was asymptomatic. Physical examination findings were unremarkable. This patient's elevated transaminase levels and birth in a country with high HBV prevalence prompted serum HBsAg testing. A false-positive HBsAg test result is unlikely, particularly in the context of the positive IgG anti-HBc and hepatitis B e antibody (anti- HBe) test results. The patient's negative IgM anti-HBc and HBeAg test results, in addition to transaminase levels being below a value that was 2 times the upper limit of "normal" values, supported the diagnosis of chronic inactive HBV infection, characterized by little or no HBVreplication, minimal or no liver inflammation, normal liver enzyme serum levels, absence of HBeAg, presence of anti-HBe, and undetectable or low levels of serumHBVDNA. Resolution of HBV infection is characterized by a negative HBsAg test result with positive anti-HBs and IgG anti-HBc test results and therefore was unlikely in this patient. The patient was informed of her chronic hepatitis B diagnosis and the need for regular monitoring, at least annually, of serum HBV DNA and alanine transaminase levels to assess viral replication and candidacy for HBV treatment. Liver ultrasonography and elastography findings did not show fibrosis or focal masses.  Additional supportive information: This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule and time to onset were unknown. This article corresponding to this case is not available for regulatory submission due to copyright restriction.