Age: 0.71
Sex: M
Vaccine: HEP
Symptoms: Anti-HBs antibody negative
Clinical narrative: Information has been received from an office manager concerning an 18 year old male patient who on 12-JUL-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number unspecified). The office manager reported that after the three doses of RECOMBIVAX HB were given to the patient, all blood work (hepatitis B surface antibody) came back negative, not immune (lab was 8). The patient had been vaccinated with at least one dose of lot# 603895/0748V. The patient required a fourth dose of the vaccine, on 12-JUL-2010 (lot number unspecified). At the time of the report the patient had not had follow up laboratories yet. The patient did not develop hepatitis B. No other adverse experience was reported. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The office wanted to know if lot# 603895/0748V was associated with failed immunity. Follow up information has been received from the office manager who reported that on 23-OCT-1992 (at the age of 8 months) the patient was vaccinated with a dose of RECOMBIVAX HB (lot number lot# 603895/0748V) (adult dose vaccine, actual dose not reported), as an infant. The office manager could not confirm if the vaccine was stored correctly back in 1992. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation. Follow-up information has been received from an office manager who indicated that the currently 18 year old patient non-smoker with no pre-existing allergies or medical conditions on 08-SEP-1992 was vaccinated with a first dose of RECOMBIVAX HB (Lot# 603897/0750V). On 23-OCT-1992 the patient was vaccinated with a second dose of RECOMBIVAX HB (Lot# 603895/0748V). Concomitant vaccination included a fourth dose of B-CAPSA 1 (Lot# M015J2) administered in his left arm on 20-MAY-1993. On 02-SEP-1993 the patient was vaccinated with a third dose of ENGERIX-B (Lot# 1198A2) in his right arm, a fourth dose of TRIPEDIA (Lot# 3L71093) in his left arm and on 20-MAY-1993, the patient was vaccinated with a third oral dose of ORIMUNE (Lot# 3509430682K) in the left arm. On 09-JUN-2010 a Hepatitis B surface antibody (quant.) test was performed, with a result of 8. The result was verified by repeat analysis. It was reported that the patient did not have immunity to hepatitis B virus. That same day a varicella-Zoster virus IgG antibody test was performed, with a result of 2.44. On 18-JUN-2010 the reporter spoke to the patient's mom, who indicated that the patient was well. On 12-JUL-2010 the patient was vaccinated with a fourth dose of ENGERIX-B. On an unknown date another Hepatitis B surface antibody (quant.) test was performed, results were pending. The reporter considered the events to be non-serious. This is one of several reports received from the same source. Additional information is not expected. The patient had laboratory work (hepatitis B surface antibody quantitative).