Age: 0.16
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Laboratory test abnormal, Sudden infant death syndrome
Clinical narrative: A physician reported that a 2 month old infant received an injection of Prevnar on 9/27/01. Subsequently, the pt was hospitalized and on 10/13/01, the infant died. No further information was available at the date of this report. This is 1 of 2 pts from this facility who died following receipt of Prevnar (lot 475385). Follow-up information received on 12/6/01 from the physician, indicated that the infant was a 2 month old female who received her 1st doses of Prevnar, Tripedia, Comvax and IPOL vaccines on 9/27/01. On 10/14/01, the infant was found not breathing. CPR was initiated and EMS were called. She was seen in an ER where she was pronounced dead. An autopsy was inclusive and the cause of death was reported as Sudden Infant Death Syndrome.  Follow up on 10/22/2003: "This report was received from Wyeth Ayerst for streptococcus pneumoniae vaccine (Prevnar) and assigned manufacturer report number HQ9063804DEC2001 (also noted to be HQ9063504NOV2001, HQ7304118OCT2001 & HQ0646611FEB2002).  This report is concerning a 10 week old female with a history of poor weight gain who on 09/27/2001 was vaccinated with the first dose of Hib conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) IM (Lot # 63944/0776L).  Concomitant vaccinations that same day included the first doses of streptococcus pneumoniae vaccine (Prevnar) (Lot # 476-385 also reported as 475-385) IM, alum, potassium (+) diphtheria toxoid (+), pertussis vaccine (+) tetanus toxoid (Tripedia) (Lot # U0537AB) IM and poliovirus vaccine (IPOL) (Lot # T1390) IM.  On 10/14/2001 the patient was found apneic.  Resuscitation measures were performed by the patient's mother and by emergency personnel prior to transferring the patient to a local ER were she was pronounced dead.  Bacterial CSF, blood and viral culture samples yielded negative results.  A urine culture was negative and white blood cell count was 3000.  An autopsy returned inconclusive results but sudden infant death syndrome was possible.  This was originally reported by a pediatrician.  Follow up information from a physician stated that her practice, "did not have any concerns regarding the Hib conjugate vaccine (+), hepatitis b vaccine recombinant (yeast)".  Additional information from a nurse in the physician's office stated that this patient, who was previously healthy, received Hib conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) (Lot # 639444/0776L).  It was also reported that another infant (WAES # 0203USA00661) also received Hib conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) (Lot # 638216/1591K) and Streptococcus pneumoniae vaccine (Prevnar) and died of SIDS.  The physician's office reported that they did not believe there was any associated with the Hib conjugate vaccine (+) hepatitis b vaccine recombinant (yeast), but that both infants received the same lot of Streptococcus pneumoniae vaccine (Prevnar).  This report was also received from the Center for Biologics and Evaluation and Research and was assigned VAERS ID number 180019.  Follow up information noted that there was no illness at the time of vaccination.  The patient died of apparent SIDS 2.5 weeks after vaccination.  The autopsy report was SIDS vs. asphyxia.  The reporter listed the cause of death as SIDS.  Follow up information received on 12/30/2002 indicated that thte patient's birth weight was 4 lbs, 15 ounces.  It was also reported that the patient was a "second twin", had hyperglycemia, hypebilirubinemia, and was premature at 35 weeks gestation.  Additional follow up information indicated that the medical history previously reported was not correct.  The patient was not a twin and did not have hyperglycemia, hyperbilirubinemia or prematurity.  The patient died on 10/14/2001 at 09:49 and the autopsy was done on 10/15/2001 at 08:20.  The autopsy report showed no significant pathologic abnormality or focus of infection identified.  The petechiae identified "are a specific finding".  Of concern in thsi case is the sleeping position of the infant.  A face down position on an adult who is lying on a couch sets up the potential of an asphyxial or a "re-breathing" event.  The autopsy findings alone cannot distinguish between this type of death and a death due to sudden infant death syndrome.  The manner od eath is therefore certified as "undetermined if injured".  The final pathologic diagnoses are "I.  Undetermined causes-SIDS vs asphyxia with petechiae, thymus pronounced, petechiae few on leural surfaces of lungs and epicardium, prone position sleeping on shoulder of baby sitter next to back of couch" and "II.  Patent foramen ovale".  There was no significant pathologic abnormality or focus of infection identified.  An endotracheal tube is inserted via the mouth which is otherwise free of injury.  Examinationof th eneck reveals no evidence of injury.  The chest is symmetrical and free of external evidence injury.  The upper and lower extremities are normally developed and symmetrical.  No evidence of recent or old trauma is noted.  The back is unremarkable.  External genitalia are those of a female infanct without evidence of trauma.  The anus is patent without dilitation.  The scalp is reflected in the usual fashion disclosing no evidence of injury on the inner table.  A portion of the calvarium is removed and free of skull fractures.  An exam of the soft tissues of the neck discloses no IM hemorrhages of the strap muscles or other evidence of injury.  The myocardium is red-brown and firm without evidence of recent or old injury.  Ventricular chambers are of appropriate size and the walls are not thickened.  There is no obstructive material or aspirated of occluding thromboemboli.  The small and large intestines are continuous and free of obstruction or leasions.  The "calyces, pelves" and ureters are unremarkable.  The splenic capsule is intact.  The thymus weights 23 grams.  Position and location are appropriate.  There is a pronounced pattern of petechiae noted on the anterior and posterior surfaces of the tissue.  The thyroid and adrenal glands are appropriately positioned and unremarkable.  There is no abnormality noted in the bones and muscle encountered in the performance of the autopsy.  Exam of the tissues discloses no histologic abnormality or focus of infection.  There were no drugs identified in the screens, no growth in the bacterial blood culture, no growth in the CSF culture, culture negative for viral organisms and no virus isolated in the cell culture of the nasal swab.  Other business partners numbers are: 7625-2001, U2002-00029, F2002-00145 and PEI 1437-2002.  No other information was reported.  The case is closed."