Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MEN, PNC, RV5, DTAPHEPBIP, HIBV, MEN, PNC, RV5, TTOX
Symptoms: Cyanosis, Death, Dyspnoea, Granulocyte count, Haematocrit decreased
Clinical narrative: This male subject was enrolled in the prophylactic open study 110870 (MenACWY-TT-057).  On 4 April 2008, he received the 1st dose of HIB-MENCY-TT (IM L thigh) and of PEDIARIX (IM R thigh).  The subject received concomitantly PREVNAR (IM) and ROTATEQ vaccines (po).  Medical conditions at the time of the event included apnea.  Concomitant medications included PREVACID and KEPPRA.  On 08 June 2008, 65 days after the 1st dose of PEDIARIX, 65 days after the 1st dose of HIB-MENCY-TT, this four-month-old subject developed seizure.  The subject was hospitalized and the event was disabling and clinically significant (or requiring intervention).  The subject died, cause of death is unknown.  The investigator considered there was a reasonable possibility that the seizure may have been caused by PEDIARIX and HIB-MENCY-TT.  The subject was withdrawn from the study due to the SAE.  Investigator Comments: 06/10/2008 aware of patient in hospital awaiting medical records.  06/11/08.  Medical records received.  Chemistry and hematology done.  Patient was admitted on 06/08/2008 for seizures.  Pt will be monitored and placed on seizure precautions.  06/30/2008.  Negative for any electrolyte abnormalities during admission.  06/21/2008. CRP 21.0 mg/L, CBC (RBC 4.14 m/ul, Polys % 64%) 06/28/2008. CRP 0.4mg/L, CBC (Platelet 562 K/ul), CXR (bilateral perihilar infiltrates, concerning for viral or bacterial pneumonia.)  Apnea monitor downloads still pending from last week to present.  06/30/2008. Discharge summary received.  Patient admitted after the mother describing an "apneic episode" where the patient stopped breathing and turned blue and not on the apnea monitor when it occurred.  Admitted to PICU and then moved to a video monitored room the rest of the stay and there was no bradycardia, apnea, hypoxia, or seizure-like activity.  Problems with gaining weight and placed on a 24 calorie/ounce formula and started gaining weight gain.  Weight at discharge was 11 pounds 7.8 ounces.  A febrile and discharged on apnea monitor with follow-up for weight check and immunizations.  06-20-2008. Office Visit.  Weight 11 pounds 12 ounces, immunizations given (hold DTP vaccine component).  06-21-2008. Office visit, temperature, 98.5 mother reports fever of 102 and 2 episodes of cyanosis since 06-20-08.  Suspect fever is cause of apnea/seizures episodes.  To use TYLENOL next 24hrs for fever, F/u next week for re-check or f/u if apnea worsens.  06-28-2008.  Office visits.  F/U after ER visit earlier for apnea approximately 90 seconds.  Went home with labored breathing and low grade fever per mother.  Complex long history without diagnosis, PE normal, URI by history, but not obvious here.  Call later in the evening by mom with report of "another spell" plans to admit for monitoring/observation.  06-30-2008.  Discharge summary received no apneic episodes reported during 48 hours hospitalization and to follow up with PCP of notification of infants death on 07-02-08.  Results pending and separate SAE completed to sponsor of this.