V.A. Soldatenkova and F.E. Yazbak/Medical Veritas
4 (2007) 1414–14211414
An investigation of infant deaths following initial hepatitis B vaccinationbased on the Vaccine Adverse Event Reporting System (VAERS), 1992-2002
Valentina A. Soldatenkova
, MS; and F. Edward Yazbak
, MD, FAAP
3282 Walnut St. #C
TL Autism ResearchLos Alamos, NM 87544 70 Viewcrest DrivePhone: +1 505 661 8078 Falmouth, MA 02540Fax: +1 505 665 4817 Phone: +1 508 540 5060 Fax: +1 508 457 9814Email: email@example.com Email: TLAutStudy@aol.com
To examine Sudden Infant Death Syndrome (SIDS) and hepatitis B neonatal vaccination.
170 reports related to neonatal hepa-titis B vaccination were filed with the Vaccine Adverse Event Reporting System (VAERS) during 1992-2002. Of the 38 (22.4%) death reports, 29were unexplained; 24 were classified as SIDS in the United States National Vital Statistics, and 4 were attributed to unknown causes.
Asystematic review of neonatal SIDS and other unexpected infant deaths following the initial dose of hepatitis B vaccination should be undertaken atthe international level.© Copyright 2007 Pearblossom Private School, Inc.–Publishing Division. All rights reserved.
SIDS, sudden death, vaccines
death in infancy and early childhood wasdefined prior to 1969 as “the death of a child who was thoughtto be in good health or whose terminal illness appeared to be somild that the possibility of a fatal outcome was not anticipated.” Such definition was usually applied to children under 2years of age [1,2]. Before 1963 and the First International Con-ference on Causes of Sudden Death in Infants , few profes-sionals other than forensic pathologists were aware of this phe-nomenon.It was only at the Second International Conference onCauses of Sudden Death in Infants in 1969 that “Sudden InfantDeath
or SIDS, was first defined as “the suddendeath of an
infant which was unexpected by history and inwhich a thorough
postmortem examination failed to demon-strate an adequate cause
of death.” Until then sudden
causeswere mixed with truly sudden and
deaths .Since 1989 SIDS has been
defined in the United States as“the sudden death of an infant under 1 year of age which
re-mains unexplained after a thorough case investigation, includ-ing
performance of a complete autopsy, examination of thedeath
scene, and review of the clinical history.” There
was no code for SIDS in International Classification of Diseases (ICD) before 1973
, although related ICD-7 andICDA-8 codes and causes of sudden
deaths were published elsewhere [8,9]. SIDS has been housed in ICD chap-ter “Symptoms, Signs, and Ill-Defined Conditions” since 1973and coded 795.0 under ICDA-8, 798.0 under ICD-9, and R95under ICD-10. ICDA-8 and ICD-9 were used in the U.S. in1968-78  and in 1979-1998 , respectively. ICD-10 wasimplemented in the U. S. since 1999 .
A SIDS investigative and autopsy protocol was publishedand recommended for medical examiners and coroners in 1976, but was not mandated at the state and local levels. It never re-quired review of the vaccination history .In California, the SIDS protocol required an autopsy since1974, and an inquiry about administered vaccines since 1990[12,13].The Centers for Disease Control and Prevention (CDC) andthe National Institute of Child Health and Human Development(NICHHD) released a generic protocol of the Sudden
Infant Death Investigation Report Form (SUIDIRF) in1996. Only California, Minnesota, Missouri, and New Mexicohad written SUID investigation protocols before 1996 .Although the form required taking a vaccination history, its usewas never enforced [15,16].In 2006 the CDC reported that “some SUIDs are not investi-gated and, when they are, cause-of-death data are not collectedand reported consistently.”  The CDC and other organiza-tions revised the 1996 form and released a new Sudden
Investigation (SUIDI) Reporting Form thatrequires taking the vaccination history on
March 1, 2006 .
2. SIDS and vaccine injury compensation
In order to protect the vaccine manufacturers and health care providers, the U.S. Congress passed the National ChildhoodVaccine Injury Act (NCVIA) in 1986.Amendments to the act established the National VaccineInjury Compensation Program (NVICP) in 1988 . The Foodand Drug Administration (FDA) and the CDC launched theVaccine Adverse Event Reporting System (VAERS) in July1990 in response to NCVIA .Ridgway  reviewed 786 claim disputes from the start of the NVICP in 1988 through June 1996. Of the 786 claims, 107(13.6%) resulted from DTP-related adverse events that led toearly death and 73 (68.5%) of those were awarded compensa-tion. In 50 of those 73 compensated claims, autopsy findingswere interpreted as SIDS; 9 cases had “non-specific findings”, 4had “other specific diagnosis”, 3 had pneumonia, 1 had en-cephalitis, and 6 were not autopsied.