Sex: U
Vaccine: HEP
Symptoms: Death, Haemodialysis, Hepatitis B DNA assay negative, Hepatitis B core antibody negative, Hepatitis B surface antibody negative
Clinical narrative: Death (Cause of Death No Stated); Hepatitis B Surface Antibody Negative; Hepatitis B Surface Antigenaemia; Initial Report Received 07-Sep-2023  This report was retrieved from the following publication:   A 41-year-old man developed hepatitis B surface antigenaemia (HBsAg) following vaccination with adjuvanted-Hepatitis-B vaccine-(Recombinant)-Dynavax for hepatitis B immunisation.  Medical history included alcoholic hepatic cirrhosis and worsening chronic kidney disease from hepatorenal syndrome.  Concomitant medications included intravenous pressors, intravenous albumin, rifaximin, lactulose, and packed red blood cells (PRBCs) which were admitted during hospitalization.  On an unspecified date, in the summer of 2022, the patient was admitted unresponsive. Laboratories included a serum creatinine was 5.64 mg/dL (normal range not specified). Treatment included unspecified intravenous pressors, intravenous albumin, rifaximin, lactulose, and packed red blood cells (PRBCs).  The patient underwent repeated paracentesis. The patient was transferred to a large metro area hospital for a liver transplant, however, he could not be listed and subsequently started haemodialysis (HD). Pre-dialysis Hepatitis B Virus (HBV) tests were negative.   On an unspecified date, nine days after starting HD, hepatitis B virus (HBV) vaccine [HEPLISAV-B] 20 mcg/0.5mL (Lot # 937234) and a hepatitis A virus (HAV) vaccine were administered.   Four days after vaccination with HEPLISAV-B, the patient was transferred back to the previous admitting institution.  Repeat screening tests confirmed HBsAg but was negative for quantitative and qualitative HBV surface antibodies and negative for HBV core antibody. The patient had no new symptoms.  Aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase, and bilirubin were unchanged or normal.  The publication noted that the patient's HBsAg was attributed to HEPLISAV-B. The patient had no symptoms. Infectious disease was consulted.  Thirteen days following HEPLISAV-B vaccination, HBV DNA quantification test by PCR was undetected. A few weeks later, the patient reportedly died.  The cause of death was not specified.    Company Comment: The hepatorenal syndrome represents the end-stage of a sequence of reductions in kidney perfusion induced by increasingly severe hepatic injury, and is associated with a poor prognosis. Although the cause of death was not specified, possibly contributing factors include the patient's medical history of alcoholic hepatic cirrhosis and worsening chronic kidney disease from hepatorenal syndrome. The event of death is unlisted per HEPLISAV-B SmPC, SPC and listed per HEPLISAV-B IB and agency. The events of hepatitis B surface antibody negative and hepatitis B surface antigen positive are listed per HEPLISAV-B IB, agency, SmPC and SPC.; Sender's Comments: The hepatorenal syndrome represents the end-stage of a sequence of reductions in kidney perfusion induced by increasingly severe hepatic injury, and is associated with a poor prognosis. Although the cause of death was not specified, possibly contributing factors include the patient's medical history of alcoholic hepatic cirrhosis and worsening chronic kidney disease from hepatorenal syndrome. The event of death is unlisted per HEPLISAV-B SmPC, SPC and listed per HEPLISAV-B IB and USPI. The events of hepatitis B surface antibody negative and hepatitis B surface antigen positive are listed per HEPLISAV-B IB, agency, SmPC and SPC.; Reported Cause(s) of Death: Cause of Death No Stated