Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Decreased appetite, Urticaria
Clinical narrative: Information has been received from a certified medical assistant concerning a 3 months old infant patient who on 01-APR-2011 in the morning, was vaccinated a dose of RECOMBIVAX HB (lot number: 666601/1315Z, Thimerosal free) (expiration date, dose, site of administration not reported). Secondary suspect vaccine included a dose of ROTATEQ (expiration date, dose and site of administration not reported). On 01-APR-2011, same evening, around 7:00 P.M, the patient experienced hives and loss of appetite. Also the mother reported that the infant's symptoms worsened the next two days. The certified medical assistant for the allergist was requesting a lot check for the two vaccines. The patient was referred to allergy specialist. Follow up information has been received from a licensed visiting nurse who reported the lot number (669083/1450Z, expiration date: 27-AUG-2012) for the ROTATEQ given on 01-APR-2011. It was also noted that the certified medical assistant called back and again reported the lot number for RECOMBIVAX HB as lot # 666601/1315Z and the lot  number for ROTATEQ as lot # 1350Z. Lot# 1350Z is an invalid lot number for marketed ROTATEQ. At the time of the report, the patient's outcome was unknown. A preliminary lot check investigation was performed for ROTATEQ (lot number: 669083/1450Z). To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation. A preliminary lot check investigation was performed for RECOMBIVAX HB (thimerosal free) (lot number: 666601/1315Z). 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 (thimerosal free). Additional information will be provided upon finalization of this manufacturing investigation. A standard lot check investigation has been finalized. All in-process quality checks for the lot 666601/1315Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. A standard lot check has been finalized. All in-process quality checks for the lot number in question (669083/1450Z) were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information has been received from a physician, concerning the two (previously reported as three) months old female baby, with no pre existing allergies, birth defects, or medical conditions and no adverse events prior to vaccination, who on 01-APR-2011 on morning, was vaccinated intramuscularly in the left thigh with the second dose of RECOMBIVAX HB (dose not reported) (lot #: 666601/1315Z). Secondary suspect vaccination received orally included the first dose of ROTATEQ (dose not reported) (Lot #: (669083/1450Z). Concomitant therapy received on the same date on morning, intramuscularly in the right and left thigh respectively, included: the first dose of PENTACEL and the first dose of PREVNAR (Lot #: 914972). There was no illness at the time of vaccination. Physician reported that the baby's mom stated that on 01-APR-2011, the infant broke out in hives from head to toe, that lasted two days and started within the evening after vaccination. No lab/diagnostics studies were performed. Physician reported that on 03-APR-2011, patient recovered from broke out in hives from head to toe. Additional information has been requested.