Age: 0.3
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Bradycardia, Shock
Clinical narrative: Information has been received from a health professional concerning a 3 month old patient with Down's Syndrome, Klinefelter's syndrome, no previous allergies; and history of tracheoesophageal (TE) fistula and tracheolmalacia since birth, who on 11/27/02 was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast)(lot # 644277/0915M). Concomitant therapy given at the same time on 11/27/02 included diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid, poliovirus vaccine inactivated. Streptococcus pneumoniae vaccine, and palivizumab. Additional therapies which the patient has been receiving since birth include metoclopramide hydrochloride 10mg, and lansoprazole. It was also noted, the patient had recently completed a prescription of erythromycin for an ear infection, which was resolved at the time of vaccinations. The reporter indicated that on 11/27/02, the patient was being held in the office for 20 minutes post vaccination only for observation, and within 10-15 minutes of receiving the vaccinations, the patient became apneic, bradycardic, and had a respiratory arrest. The patient was given resuscitation and oxygen, the physician's office called 911, the paramedics arrived and transported the patient to the ER, he was maintained there for one hour and discharged. The reporter stated, the physician office has been in contact with the child's parents and he has had no further episodes. It was noted the reporter did not have any information on the patient's birth or the mother's pregnancy. The reporter indicated the patient had previously received the same vaccinations at two months of age and had no problems. Upon internal review it was determined that the patient becoming apneic, bradycardic and subsequent respiratory arrest were considered to be an other important medical event (OMIC). Additional information has been requested. Reported on 01/14/2003: "Information has been received from a health professional concerning a 16 week-old male patient (also reported as female) with down's syndrome, and klinefelter's syndrome, no previous allergies; and history of tracheoesophageal (TE) fistula and tracheolmalacia since birth, who on 11/27/2002 @ 12:30pm was vaccinated with a second dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast)(lot#644277/0915m), given by intramuscular injection in the right thigh.  concomitant therapy given at the same time on 11/27/2002 @ 12:30 included a second dose of diphtheria toxoid (+) tetanus toxoid(+) acellular pertussis vaccine absorbed (INFANRIX)(Batch #DTPA575A2) given by intramuscular injection in the upper right thigh, a second dose of poliovirus vaccine inactivated (IPOL)(Batch #W0063) given by subcutaneous injection in the left thigh, a second dose of Streptococcus pneumoniae vaccine (PREVNAR)(Batch #485-991) given by intramuscular injection in the left thigh, and palivizumab (SYNAGIS)(Batch #V073).  Additional therapies which the patient has been receiving since birth include metoclopramide hydrochloride (AEOLAN) 10mg, and lansopratole (PREVACID)(the reporter was unable to locate the dosage in the patient's chart).  It was also noted, the patient had recently completed a prescription of erythromycin for an ear infection (dosage and exact dates were not reported), which was resolved at the time of vaccinations.  The reporter indicated that on 11/27/2002, the patient was being held in the office for 20 minutes post vaccination only for observation, and within 10-15 minutes of receiving the vaccinations (also reported as "about 15 minutes after vaccination, at 12:43 pm) the patient became apneic, bradycardic, and had a respiratory arrest; also reported as "went into shock 35 minutes after receiving the vaccines".  The patient was given resuscitation, rescue breathing and chest compressions were started on the patient by a nurse practitioner, and oxygen was administered.  The physician's office called 911, the paramedics arrived and transported the patient to the emergency room of a hospital where the patient was treated.  The reporter indicated the patient had no further problems in the emergency room, he was maintained there for one hour and discharged.  The reporter stated, "the physician office has been in contact with the child's parents and he has had no further episodes".  The patient fully recovered.  It was noted the reporter did not have any information on the patient's birth or the mother's pregnancy.  The reporter indicated the patient had previously received the same vaccinations at two months of age and had no problems.  Upon internal review it was determined that the patient becoming apneic, bradycardic and subsequent respiratory arrest were considered to be an other important medical event.  Additional information was received from Medimmune for palivisumab (SYNAGIS)(manufacturer report number not provided).  The report provided information which confirmed a male infant was given Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast), diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid, and poliovirus vaccine inactivated at the same time.  The additional information also noted the patient was borin weighing 2497 grams (also reported as 4.4 kilograms at gestational age 37 weeks, and the patient does not have siblings.  Additional information has been received from Wyeth with an assigned manufacturer control number of HQ5680004dec2002, and from GlaxoSmithKline with an assigned manufacturer number A0388212A.  Other business partner numbers include U2002-01076 and F2002-03328.  Additional information has been requested.