Sex: U
Vaccine: HEP
Symptoms: Hepatitis B, Hepatitis B DNA assay positive, Hepatitis B surface antigen positive, No therapeutic response
Clinical narrative: This case was reported in a literature article and described the occurrence of hepatitis B infection in a unk patient who received Hepatitis B vaccine. Concurrent medical conditions included renal failure (Requiring hemodialysis) and hepatitis B exposure (via another patient at the hemodialysis station). On an unknown date, the patient received Hepatitis B vaccine (unknown). On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced hepatitis B infection (serious criteria GSK medically significant), not responding to therapy and possible vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the hepatitis B infection, not responding to therapy and vaccination failure were unknown. It was unknown if the reporter considered the hepatitis B infection to be related to Hepatitis B vaccine. Additional information: This case was reported in a literature article and it described a case of lack of efficacy in a subject of unknown gender and age who had received hepatitis B vaccinations (manufacturers unknown). The subject's concomitant medical conditions included renal failure that required haemodialysis. No further information on the subject's medical history, concurrent medical conditions or concomitant medication was provided although the authors mentioned that the haemodialysis was the only risk factor that this subject had for hepatitis B. On an unspecified date, the subject received an unknown number of unspecified hepatitis B vaccinations (number of doses, dosage, administration routes and sites unknown; batch numbers not provided). On an unknown date, an unknown period after the administration of the vaccines, the subject failed to respond to the vaccinations according to the authors. Later the subject tested positive for hepatitis B surface antigen in March 2013 and had a hepatitis viral load >1.1 x 108IU/mL in July 2013. This case was assessed as medically serious by GSK. This case was considered as a possible vaccination failure. A serology result was positive for hepatitis B surface antigen in March 2013 and the subject's hepatitis B viral load was more 1.1 x 10E8 IU/mL in July 2013. The subject's hepatitis B virus genome sequence and the sequence of a hepatitis B positive subject who attended the same haemodialysis unit matched 99.9%. Based on this result and the observation of substandard infection control measures in the haemodialysis unit, the authors believed that the transmission of the hepatitis B virus was related to the haemodialysis procedure. Treatment was unknown. At the time of reporting the outcome of the events was unspecified. The authors did not comment on any possible causal relationship between the vaccination and the events. The authors concluded that "This was the first reported haemodialysis-related hepatitis B virus transmission from a subject with reactivation. This case underscored the challenges in identifying haemodialysis subjects who reactivate; it also might have policy implications for expanded hepatitis B virus testing among haemodialysis subjects with resolved infection, particularly those with severe immunosuppression".