Age: 0.6
Sex: M
Vaccine: HEP
Symptoms: Anti-HBs antibody negative, Antibody test positive
Clinical narrative: Information has been received from an office manager concerning an 18 year old male patient with a birth twin who on 14-JUN-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 less than 5); requiring a fourth dose of the vaccine. The patient received lot# 603895/0748V but it was unknown which dose. At the time of the report, no follow up laboratories had been performed yet. The patient did not develop hepatitis B. No other adverse experience was reported. 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 02-DEC-1992 (at the age of 7 months) the patient was vaccinated with a dose of RECOMBIVAX HB (lot number lot# 603895/0748V) (adult dose) 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 was received from the office manager who reported that  the non smoker male patient on 11-MAY-1992, was vaccinated with the first dose of RECOMBIVAX HB (lot number not available). On 11-JUN-1992, the patient received the second dose of RECOMBIVAX HB (lot number 603481/0584V) and on 02-DEC-1992; the patient received the third dose of RECOMBIVAX HB (lot number 603895/0748V) into the left leg. Concomitant vaccine given on 20-NOV-1992 included the third dose of ACEL-IMUNE (lot # 330910) into the left leg and the third dose of HIBTITER (lot # MOZQJE) into the right leg. On 25-JAN-2010 an anti-HBs titer was performed which was less than 5. The patient did not have immunity to hepatitis B virus at that moment. On the same day, a varicella zoster virus AB (IGG) was done which was 2.56 (positive). On 14-JUN-2010, the patient received a fourth dose of RECOMBIVAX HB (lot # AHBVB789AA) -manufacturer unknown). On 04-AUG-2010, a hepatitis B surface antibody test was performed which was less than 5. The patient did not have immunity to hepatitis B virus at that moment. On 23-AUG-2010, the patient received a fifth dose of RECOMBIVAX HB (lot # AHBVB789BA). At the time of the report, the outcome of the patient was unknown. This is one of several reports received from the same source. 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.