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
Clinical narrative: It was reported that a 4 month old female was vaccinated with IPOL (lot number W0063) SC in the left leg, HIB/HEP B combined (Recombivax) (lot number 0915M) IM in the right leg, DTaP (lot number DTP2575A2) IM in the right leg, Prevnar (lot number 485-991) IM in the left leg and Synagis (lot number SA2932A (on 11/27/02 at 12:30. About 15 minutes after vaccination, at 12:43, the patient became apneic and bradycardic. Rescue breathing and chest compressions were started on patient by a nurse practitioner. Oxygen was administered. 911 was called and paramedics transferred the patient to the ER. The patient was treated and released from the ER. The patient recovered. Follow up: Upon review of information, it was deemed necessary to change the product coding for HIB/Hepatitis B combined vaccine (changed Recombivax to Comvax). Follow up correspondence received on 12/16/02: Additional therapies that 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 erythromyciin for an ear infection, which was resolved at the time of vaccination. The reporter indicated that the patient became apneic, bradycardic, and had a respiratory arrest within 10-15 minutes of receiving vaccination. The patient was given resuscitation and 911 was called. The patient was transported to ER of a hospital. The patient had no further problem in the ER; he was maintained there for one hour and discharged. The reporter stated the physician's office has bee in contact with the child's parents and he has had no further episodes. The reporter indicated the patient had previously received the same vaccinations at two months of age and had no problems. THe patient's sex, which had previously been reported as female, was confirmed as male. From additional correspondence received on 12/26/02, no new medically significant informaiton was provided, however, their ID number was provided.  *F/UP report on 12/27/02: A medical assistant reported the occurrence of shock in a 4 mt old male who was vax'd w/Infanrix for prophylaxis. Add'l info was received from another medical group. The subject had NKA's. His medical history included Down Syndrome, Klinefelter's syndrome, tracheoesophageal fistula, and trachcomalocia. On 11/27/02, the subject received his 2nd injection of Infanrix. On the same date, he also received injections of Comvax (Hib / Hep B), Ipol, 7-valent pneumococcal conjugate vax, and Palivizumab. The reporting medical assistant stated that 15 mins after receiving his immunizations, the subject became "apneic, bradycardic" and experienced shock 35 mins post-injection. A nurse practitioner administered cardiopulmonary resuscitation, and the subject was transported to the local ER by emergency medical personnel. He recovered and was sent home from the ER after several hrs. The most recent info was received on 12/17/02. Another medical group reported that the vaccine provided stated that she "could not assess which injection caused the event. It is believed that it was a combination of the pain from multiple injections and the infant's pre-existing medical condition." The shock, apnea, and bradycardia in this report are considered medically serious. (OMIC) From additional correspondence received on 1/6/03, additional information was received from MedImmune for palivizumab. The report provided information which confirmed a male infant was given Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant, diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid, and poliovirus vaccine inactivated at the same time. The additoinal information also noted the patient was born weighing 2497 grams at gestational age 37 weeks. It was noted the reporter did not have any information on the patient's birth or the mothers pregnancy. Additional information has been requested. Follow up received on 2/3/03, it was reported that the patient has no siblings. The batch number for diphtheria toxoid (+) tetanus toxoid (+) acellular pertussis vaccine absorbed is DTPA575A2, not DTP257A2 as previously reported. The batch number reported for Synagis is V073. No additional information was provided. This case is closed. From follow up 2/26/03 it was reported: reviewed, no additional information at this time. This case is closed. From additional infomration received on 3/17/03, it was deemed necessary to amend the adverse event coding. The adverse event shock was added adn the codes re-ranked. No no information was provided at this time. This case is closed. From additional information received on 3/31/03, it was reported that the patient went into shock 35 minutes after reciving the vaccines and that the patient fully recovered. This case is closed.