Age: 1.51
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody
Clinical narrative: Information has been received from an office manager concerning an approximately 18 year old male patient who on an unspecified date 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 5). The patient was administered at least one dose of RECOMBIVAX HB, lot #603895/0748V. The patient required a fourth dose of the vaccine. The hepatitis B surface antibody was repeated a month after the fourth dose was given to the patient and the result was greater than 1000. 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 30-SEP-1992 (approximately at the age of 23 weeks) 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 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 a physician who reported that a current 18 year old, no smoker with no pre-existing allergies, birth defects or medical conditions, that at the age of 23 week, on 24-AUG-1992 was vaccinated with a first dose of RECOMBIVAX HB in the left leg (route unspecified, lot number: 603897/0750V). On the same day the patient received a second dose of DTaP, poliovirus vaccine, Hib conj vaccine (unspecified carrier) (LEDERLE) in the right leg (route unspecified, lot number:318-908), second dose of poliovirus vaccine, Hib conj vaccine (unspecified carrier) (LEDERLE) in the right leg (lot number: 320-9320653A), orally and a second dose of hepatitis B vaccine, recomb (PRAXIS) (route unspecified, lot number:M130JB) in the right leg. On 30-SEP-1992, the patient was vaccinated with a second dose of RECOMBIVAX HB in the left leg (route unspecified, lot number: 603895/0748V) in the left leg. On 22-OCT-1993, the patient received the third dose (route unspecified, lot number: 607248/0451W). On 13-MAY-2010 the patient underwent a hepatitis B surface antibody which was <5 mIU/L (not have immunity to hepatitis B virus). On 02-JUN-2010, the patient received a fourth dose of RECOMBIVAX HB (manufacturer unknown). On 09-JUL-2010, the patient's hepatitis B surface antibody which was > 1000 mIU/L (immunity to hepatitis B virus). This is one of several reports received from the same source. In the AE screen the event of overdose was deleted. Additional information is not expected.