Sex: F
Vaccine: DTAPHEPBIP, HEP, HEP, HIBV
Symptoms: Extra dose administered, Hepatitis B antibody negative, Product administered to patient of inappropriate age
Clinical narrative: Caller stated her daughter's titer was checked and she is at the non protective antibody level (her level is less than 0.15mcg) after receiving PEDVAXHIB.; Caller stated her daughter received the first two doses as recommended per the prescribing information, but the third dose was administered 5 months too early (when the patient was only 7 months old).; Extra dose administered; This spontaneous report was received from a consumer refers to a 3-years-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (reported as: at birth), the patient was vaccinated with the first dose in the series of hepatitis b vaccine rhbsag (yeast)(ENGERIX B) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis (reported as: hepatitis b and Haemophilus b). On unknown date(reported as: at 1 month), the patient was vaccinated with the second dose in the series of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis (reported as: hepatitis b and Haemophilus b). On unknown date, (reported as: at 2 months) the patient was vaccinated with the third dose in the series of diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis (reported as: hepatitis b and Haemophilus b). On unknown date (reported as: months lates), the patient was vaccinated with the last dose in the series of diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis (reported as: hepatitis b and Haemophilus b). On unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis (reported as: hepatitis b and Haemophilus b). Caller was unable to provide exact dates of vaccines administration.  The patient's mother stated that her daughter should have only received 3 doses, but instead received 4 doses (extra dose administered). The reporter also stated that her daughter was not properly vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB). It was reported that her daughter received the first two doses as recommended per the prescribing information, but the third dose was administered 5 months too early (when the patient was only 7 months old) (product administered to patient of inappropriate age).  On unknown date, the patient experienced Hepatitis B antibody negative. The reporter stated that stated her daughter's titer was checked and she was at the non-protective antibody level (her level was less than 0.15mcg) after receiving haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB). The outcome of hepatitis b antibody negative was unknown.   The causality assessment was not provided.