Sex: M
Vaccine: HEP
Symptoms: Condition aggravated, Diabetic foot, Dialysis, Hepatitis B surface antigen positive, Hepatitis B virus test
Clinical narrative: Hepatitis B surface antigen positive; This case was reported in a literature article and described the occurrence of hepatitis b surface antigen positive in a 65-year-old male patient who received Hepatitis B vaccine for prophylaxis.   Concurrent medical conditions included end stage renal disease, diabetes and diabetic foot ulcer.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, 14 days after receiving Hepatitis B vaccine, the patient experienced hepatitis b surface antigen positive (serious criteria GSK medically significant). On an unknown date, the outcome of the hepatitis b surface antigen positive was unknown.   The reporter considered the hepatitis b surface antigen positive to be related to Hepatitis B vaccine.  Additional details were provided as follows: This case was reported in a literature article and described the occurrence of hepatitis B surface antigen positive in a 65-year-old male patient who was vaccinated with unspecified hepatitis B vaccine (manufacturer unknown) for prophylaxis. The case corresponds to patient 2 reported in this literature article. The patient had underlying condition of end-stage kidney disease (EKSD), diabetes and diabetic foot ulcer. No information on patient's family history or concomitant medication was provided. On an unspecified date, 2 weeks prior to admission, the patient received booster dose of unspecified hepatitis B vaccine (administration route and site unspecified; dosages unknown; batch number not reported). It was reported that, detailed information on administration vaccination revealed by patient's dialysis unit. [The current advisory committee on immunization practices guidelines recommend hepatitis B vaccination series for All ESKD patient's preceded by serologic testing and followed by post vaccination confirmation of immunity]. The age at vaccination was not provided, but it could be 64 or 65 years. On an unspecified date, 2 weeks after receiving the booster dose of vaccination, the patient with ESKD was admitted to the hospital for a diabetic foot ulcer. Patient's routine hospital testing for hepatitis B surface antigen (HBsAg) was positive, and the patient was dialyzed with isolation practice while awaiting results of an acute hepatitis B panel. The patient was irate about faulty vaccination, stating that he was told his recent vaccination would help to prevent hepatitis B infection, not cause it. Treatment was unknown. The outcome was not reported. The authors did not comment on relationship between the event hepatitis B surface antigen positive and unspecified hepatitis B vaccine. The authors stated "The current advisory committee on immunization practices guidelines recommend hepatitis B vaccination series for all ESKD patient's preceded by serologic testing and followed by post vaccination confirmation of immunity'' This is 1 of the 2 valid cases reported in the same literature article. This article is not available for regulatory submission due to copyright restriction.      Lab Comments: Lab test done on an unknown date.