Age: 0.2
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Body temperature increased, Chills, Pyrexia, Ultrasound scan, Urinary tract infection bacterial
Clinical narrative: Information has been received from the father of the patient (a "doctor") and a physician concerning the reporter's 2 month old son who on 17-NOV-2007 was vaccinated with a dose of PEDVAXHIB (Lot # 656522/0437U).  Concomitant vaccination on 17-NOV-2007 included a dose of INFANRIX (Lot # AC71B130114).  The patient's father  reported that within 24 hours of vaccination with PEDVAXHIB, his son developed an unusually high fever (104.7 F by rectal measurement) and shaking chills.  The physician had noted, as reported by the father, "that under normal circumstances, only 20% of infants would develop a fever as a reaction to this vaccine.  Yet the fever associated should not rise beyond 102 F."  It was reported that the patient's "fever rose beyond 102 F and was in fact extremely high".  The patient was immediately referred to the emergency room for assessment and treatment.  "Later, he was diagnosed as having an upper Urinary Tract Infection (UTI), which resulted in the extremely high fever and chills."  The emergency room discharged record dated 20-NOV-2007 indicated that the patient was positive for urinary tract infection ("+ UTI - UA with LF").  Emergency room records indicated that the patient was treated with a shot of CEFTRIAXONE, IM x 1 dose and prescribed SUPRAX, 2.5 mL (1/2 tsp) orally, once daily before bedtime X 9 days.  Also recommended that patient be given TYLENOL, 1ml every 4 hours with a temp greater than 100.4.  In addition, the patient was to follow up with pediatrician on 20-NOV-2007 at 10AM.  The father reported that prior to the vaccination date, and confirmed by the physician on 17-NOV-2007 prior to vaccinations, the baby "showed no sign of UTI".  The father also stated the following:  "In view of the timing of the occurrence, as well as the fact that the shot sites are close to the urinary tracts, I have strong reason to believe (his son's) UTI was caused by the direct injection of the contaminated [MSD] vaccine, causing a disseminated infection of which the bacteria traveled into his upper urinary tracts via bloodstream".  The father also stated the following:  "My son, being only 2-month old at the time, suffered substantially from high fever and chills, hospital treatment at the ER, multiple clinic visits, 3 weeks of antibiotic medication, ultrasonic as well as x-ray examination, besides the suffering and monetary loss that me and my wife had incurred.  While [the patient] was not found to have developed structural problem in his urinary tracts after this incidence, he now belongs to a higher risk group that is more prone to a recurrent UTI, which could possibly lead to permanent kidney damage and other complications such as high blood pressure at a later stage in life".  On an unspecified date, the patient recovered from upper urinary tract infection (bacterial).  The patient's father felt that upper urinary tract infection (bacterial) was related to therapy with PEDVACHIB.  Lot# 656522/0437U was recalled from the market.  A standard lot check investigation was performed.  All in process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  Additional information has been requested.