Age: 1.5
Sex: F
Vaccine: HEP, HEP
Symptoms: Ultrasound abdomen abnormal, Vaccination failure, Vertical infection transmission
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a 9-year-old female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B Immune Globulin. On an unknown date, the patient received the 4th dose of Hepatitis B vaccine, the 3rd dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine, the 1st dose of Hepatitis B vaccine and Hepatitis B Immune Globulin at an unknown dose and frequency. On an unknown date, 7 years after receiving Hepatitis B vaccine and 8 years after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), chronic hepatitis B (serious criteria hospitalization and GSK medically significant), unknown cause of death (serious criteria death and GSK medically significant), hepatomegaly (serious criteria hospitalization), abdominal pain (serious criteria hospitalization), scleral icterus (serious criteria hospitalization), palmar erythema (serious criteria hospitalization), microcytic anemia (serious criteria hospitalization), hepatocellular carcinoma (serious criteria hospitalization and GSK medically significant), edema of lower extremities (serious criteria hospitalization), hepatic cirrhosis (serious criteria hospitalization and GSK medically significant), multi-organ failure (serious criteria hospitalization and GSK medically significant), respiratory failure (serious criteria hospitalization and GSK medically significant), hepatopulmonary syndrome (serious criteria hospitalization and GSK medically significant), acute renal failure (serious criteria hospitalization and GSK medically significant), inappropriate schedule of drug administration and vertical infection transmission. On an unknown date, the outcome of the vaccination failure, chronic hepatitis B, hepatomegaly, abdominal pain, scleral icterus, palmar erythema, microcytic anemia, hepatocellular carcinoma, edema of lower extremities, hepatic cirrhosis, multi-organ failure, respiratory failure, hepatopulmonary syndrome, acute renal failure, inappropriate schedule of drug administration and vertical infection transmission were unknown and the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the vaccination failure, chronic hepatitis B, unknown cause of death, hepatomegaly, abdominal pain, palmar erythema, microcytic anemia, hepatocellular carcinoma, edema of lower extremities, hepatic cirrhosis, multi-organ failure, respiratory failure, hepatopulmonary syndrome, acute renal failure, inappropriate schedule of drug administration and vertical infection transmission to be related to Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. The reporter considered the scleral icterus to be related to Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of vaccination failure in a 9-year-old female patient who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown). The patient was a previously healthy female. The patient's mother's prenatal records revealed that she was HBsAg positive during her pregnancy. She was unaware of her diagnosis and denied receiving any further testing or treatment. At the birth hospital, the patient was born full term via Caesarean section due to failure to progress. The patient was never breastfed. The patient did not have any other identified risk, either via blood-borne or sexual exposure, for hepatitis B virus infection by history. No information on patient's concurrent condition or concomitant medication was provided. On unspecified dates, on day 1 of life, at the age of 3, 5 and 18-month, the patient received 4 doses of unspecified HBV vaccine (administration route and site unspecified; batch number not provided). The patient also received hepatitis B immune globulin (HBIG) on day 1 of life. There were no records of an evaluation for hepatitis B infection, including HBsAg and anti-HBs testing after the patient completed her vaccination series. On an unspecified date at the age of 9 years, an unknown period after the last dose of vaccination, the patient initially presented to an outside institution where she was noted to have marked hepatomegaly. Subsequently, the patient was admitted to the other hospital with 2 weeks and 2 days of pronounced scleral icterus. The patient's examination was notable for an ill-appearing child with a pulse of 144 beats per minute and respiratory rate of 48 breaths per minute. She had a non-tender, but distended, abdomen with a firm liver edge palpable 5 cm below the right costal margin. She had non-pitting oedema in both lower extremities and palmar erythema. Laboratory studies revealed a microcytic anaemia (haemoglobin 9.1 g/dl, mean corpuscular volume 76 fL, elevated transaminases (aspartate aminotransferase 419 U/L, alanine aminotransferase 78 U/L, and hyper-bilirubinemia (total bilirubin 5.5 mg/dL). Serum a-fetoprotein was markedly elevated at 100000 ng/mL. Abdominal ultrasound demonstrated a large, right-sided hepatic mass. Contrast-enhanced computed tomography (CT) scan was notable for a nodular liver, a large mixed density mass measuring 15 cm x 12 cm x 18 cm within the right hepatic lobe, multiple smaller hepatic lesions, splenomegaly, and diffuse pulmonary nodules concerning for metastatic disease. The patient underwent open wedge livery biopsy, which revealed a well-differentiated hepatocellular carcinoma (HCC) with active micronodular cirrhosis that was HBsAg positive. A-Fetoprotein immunostaining was positive in the tumour cells. Investigation for an underlying ethology revealed positive serum HBsAg without any detectable hepatitis B surface antibody (anti-HBs). Hepatitis B virus (HBV) DNA was detected in the blood at 100000 IU/mL and she was hepatitis B envelope antigen (HBeAg) positive. Her HBV genotype was type A with a P120T surface antigen mutation. Testing was negative for HIV-1, hepatitis C virus, and inherited cholestatic diseases that could predispose her to HCC. Subsequently, the final diagnosis of hepatocellular carcinoma secondary to chronic hepatitis B infection was made. The patient rapidly deteriorated post-biopsy progressing to multisystem organ failure. She developed respiratory failure requiring endotracheal intubation and had echocardiogram findings consistent with hepato-pulmonary syndrome. She developed acute renal failure. Her liver disease decompensated with a total bilirubin increasing to a peak of 16 mg/dL with a predominant direct component, which precluded even palliative treatment of her malignancy. On hospital day 16, the patient died. The cause of death was unknown. It was not reported if the autopsy was performed. This case has been considered serious due to vaccination failure/hospitalisation/death. The authors stated, "Our patient developed chronic hepatitis B infection despite receiving adequate immunoprophylaxis. This scenario suggests that her virus, with its P120T surface antigen mutation, may have been a vaccine escape mutant." The authors concluded that "Increased awareness of vaccine escape mutant viruses should encourage strict adherence to current screening and treatment guidelines. However, clinicians should be cognizant that a few infants remain at risk of acquiring hepatitis B infection even if the provider has adhered closely to the guidelines."