Sex: M
Vaccine: HEP
Symptoms: Nausea, Pain, Serum ferritin increased, Toxicologic test normal, Transaminases
Clinical narrative: Suspected vaccination failure; acute hepatitis B virus (HBV) infection; Nausea; Vomiting; Jaundice; Body aches; Abdominal pain; worsening lethargy; right upper quadrant abdominal pain; This case was reported in a literature article and described the occurrence of vaccination failure in a 32-year-old male patient who received Hepatitis B vaccine for an unknown indication.   The patient's past medical history included homosexual (unprotected sexual intercourse with male partners). Concurrent medical conditions included depression. Concomitant products included venlafaxine.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), acute hepatitis b (serious criteria hospitalization and GSK medically significant), nausea (serious criteria hospitalization), vomiting (serious criteria hospitalization), jaundice (serious criteria hospitalization), general body pain (serious criteria hospitalization), abdominal pain (serious criteria hospitalization), lethargy (serious criteria hospitalization) and upper abdominal pain (serious criteria hospitalization). The patient was treated with acetylcysteine (N-Acetylcysteine). On an unknown date, the outcome of the vaccination failure, acute hepatitis b, nausea, vomiting, jaundice, general body pain, abdominal pain and upper abdominal pain were unknown and the outcome of the lethargy was recovered/resolved.   The reporter considered the vaccination failure, acute hepatitis b, nausea, vomiting, jaundice, general body pain, abdominal pain, lethargy and upper abdominal pain to be related to Hepatitis B vaccine.  Additional details were provided as follows: This case was reported in a literature article and described the suspected vaccination failure in a 32-years old male patient, who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown) for prophylaxis. The patient had past medical history of depression. The patient was taking venlafaxine. The patient denied having unprofessional tattoos, IV drug use, heavy alcohol use, recent acetaminophen use, ingestion of non-commercial mushrooms or herbal supplements, but reported unprotected sexual intercourse with male partners. Family history was notable for hemochromatosis in his father. On an unspecified date, the patient received unspecified hepatitis B virus (HBV) vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after the vaccination, the patient was transferred to the hospital, for escalation of care, after presenting with 4-day history of nausea, vomiting, jaundice, body aches, abdominal pain, and worsening lethargy. Upon arrival, his lethargy resolved, but jaundice and right upper quadrant (RUQ) abdominal pain persisted. Initial labs showed elevated aspartate aminotransferase/alanine aminotransferase (AST/ALT) of 3075/4895 IU, respectively, bilirubin of 16.3 mg/dL, international normalized ratio (INR) more than 2 and ferritin levels 17,000 ng/ml. Ceruloplasmin levels and alpha-1 antitrypsin clearance were within normal limits. Blood toxicology ruled out acetaminophen, alcohol, and salicylate toxicity. Evaluation for Hereditary Hemochromatosis showed a heterozygous H63D-mutation of HFE. However, Viral Hepatitis panel was positive for HBsAg, anti-HBc IgM, HBeAg, and negative for anti-HBs and a Viral Hep B DNA of 579000 copies. Hepatitis D Antigen and cytomegalovirus (CMV) evaluations were inconclusive. The patient was improved over a few days with supportive care and N-acetylcysteine, until his transaminase levels dropped below 1000. No tenofovir or entecavir were required. The patient was then discharged with outpatient follow up. This case has been considered as suspected vaccination failure being the time to onset was unknown. This case has been considered as serious due to suspected vaccination failure. The authors commented, "There is limited literature in regards to viral Hepatitis B infection in previously vaccinated individuals. To our knowledge many of the acute hepatitis B infections occur in unimmunized individuals and individuals with primary or secondary immunodeficiency despite vaccination. Appropriate immune response to the viral Hepatitis-B vaccine is defined as having anti-HBs of at least 10 IU/L. 10% of adults only achieve levels below 10 IU/L which puts them at risk of future infection. Studies demonstrated the rate of seroconversion following HBV vaccination to be around 90%. 87% of non-responders developed anti-HBV titers after a booster dose. In initial responders, there is evidence of an enduring protection against HBV. Furthermore, in subjects with anti-HBV that titers were considered below a protective level, an anamnestic response developed to an HBV booster, suggestive of a long-term immune memory from the HBV vaccine. To identify non-responder's post- vaccine testing (PVT) is needed, but not routinely performed, except in Healthcare workers." The authors concluded, "Viral Hepatitis B infection should still be considered in high risk patients despite previous immunization. PVT could help identify vaccine Non-responders who could benefit from a booster dose." This article corresponding to this case is not available for regulatory submission due to copyright restriction.