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Multiple Vaccinations and the Shaken Baby Syndrome

F. Edward Yazbak, MD, FAAP

Child abuse is a terrible crime and the failure to recognize it is unforgivable. An erroneous diagnosis of inflicted head trauma is just as tragic and the resulting destruction of a family is one of the gravest injustices of modern times. Many have recently questioned the existence of the so-called “Shaken Baby Syndrome” and the concept that the last caretaker must have been guilty. Careful reviews often uncover relevant findings that were missed or ignored. Recent pediatric vaccinations have been suspected as precipitating factors. A recent combination of seven antigens is the focus of this investigation.

The problem
I have recently reviewed several pediatric records in order to determine whether infants diagnosed with “Shaken Baby Syndrome” (SBS) had underlying medical conditions that could explain the findings attributed to inflicted trauma.

The similarity between four cases intrigued me and prompted this investigation. Although geographically distant, the four infants (two boys and two girls) had much in common. They all had complicated past histories and medical conditions that could have very well explained their pathological findings. They had not been abused as far as I could tell and they had received the same three vaccines within three weeks of their apparent life-threatening event (ALTE).

The three vaccines in question were

  • A 5 in 1 vaccine combination
  • A HIB conjugate vaccine
  • A 7-valent pediatric pneumococcal vaccine

The 5 in 1 vaccine combination was licensed in the United States in December 2002. It contains the diphtheria, tetanus and acellular pertussis vaccines in addition to the hepatitis B and the inactivated-polio-virus vaccines. Infants receiving the recommended dose of vaccine at 2, 4 and 6 months of age, after the neonatal dose of hepatitis B vaccine, would be receiving four doses of hepatitis B vaccine. The pentavalent vaccine is thimerosal-free but contains more aluminum per dose than any other vaccine. The patient information pamphlet published in 2004 states that “Brain or nervous system disease, collapse or periods of unconsciousness or lack of awareness and seizures have occurred with other pertussis-containing vaccines. Other serious events including death have occurred after vaccinations; however, these risks are extremely small…

Both the DTaP and Hepatitis B components of the vaccine had been previously licensed and used in the United States. The IPV component had been used in several European countries since 1996 but had not been approved or licensed by the FDA.

The HIB (Haemophilus influenzae B) vaccines available in the United States since 1990 are produced by several manufacturers. They are conjugate vaccines prepared by adding a diphtheria-, meningococcal-, or tetanus-related component to the HIB polysaccharide vaccine to improve immunogenicity. For the purpose of this report, they will not be further identified because they differ ever so slightly and are, in fact, interchangeable. The HIB vaccine primary series is administered at 2, 4 and 6 months of age.

The 7-valent pneumococcal conjugate vaccine was licensed in the U.S. in early 2000 and the primary series is also usually administered at 2, 4 and 6 months of age.

The thimerosal-free mega-combination contains 1200 mcg of aluminum salts as an adjuvant (850 mcg in the 5 in 1 vaccine, 225 mcg in the HIB vaccine and 125mcg in the pneumococcal vaccine). It is presently recommended for the primary series because it provides seven antigens in only three injections.

According to the FDA, “Chapter 21 of the US Code of Federal Regulations [610.15(a)] limits the amount of aluminum in biological products, including vaccines, to 0.85 mg/dose.” [http://tinyurl.com/2eou96]

The Investigation
Two VAERS searches were conducted and the findings were carefully tabulated.

The Vaccine Adverse Event Reporting System (VAERS) is a cooperative project of the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). It is essentially a post-marketing surveillance program, collecting information about side effects that occur after the administration of U.S. licensed vaccines.

VAERS provides a “nationwide mechanism by which adverse events following immunization may be reported, analyzed and made available to the public. It also provides a vehicle for disseminating vaccine safety-related information to parents/guardians, healthcare providers, vaccine manufacturers, state vaccine programs and other constituencies.”

The FDA and the CDC point out that “When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. VAERS is interested in all potential associations between vaccines and adverse events. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.”

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