Multiple Vaccinations and the Shaken Baby Syndrome

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."

There is no argument with the last sentence but it should be noted that:

1.On July 16, 1999, the manufacturer of RotaShield ®, a rotavirus vaccine, suspended further distribution and administration of the vaccine "until more data on the potential association between vaccine administration and intussusception became available. The action was taken in consultation with the Food and Drug Administration following a recommendation from the Centers for Disease Control and Prevention to postpone administration because of reports to the Vaccine Adverse Events Reporting System (VAERS) of a possible association between the use of RotaShield and the development of intussusception." The vaccine was withdrawn from the market on October 15, 1999.

http://www.fda.gov/cber/recalls/rota101599.htm

2.On September 30, 2005, the FDA and CDC alerted consumers and health care providers to five reports of Guillain Barre Syndrome (GBS) following administration of a new Meningococcal Conjugate Vaccine A, C, Y, and W135. Because of the serious nature of the adverse events, the two agencies asked anyone with knowledge of any possible cases of GBS occurring after vaccination "to report them to the Vaccine Adverse Event Reporting System (VAERS) to help the agencies further evaluate the matter."

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01238.html

3.In testimony on May 18, 1999, in front of a Congressional sub-committee, Susan Ellenberg PhD, Director of the Biostatistics and Epidemiology Division of the Center for Biologics Evaluation and Research of the FDA stated that "Although VAERS has methodological limitations inherent in passive surveillance systems, VAERS is essential to the U.S. vaccine safety monitoring system. It is the only surveillance system which covers the entire U.S. population and includes the largest number of case reports of events temporally associated with vaccination in the U.S. It provides timely availability of data from a geographically diverse population, allowing rapid detection of possible new, unusual or rare adverse events. Such detection generates hypotheses that may then be tested in other databases."

http://www.fda.gov/ola/1999/vaers.html

4.Researchers from the FDA, the CDC and the NIH (The National Institutes of Health) have repeatedly published research papers based on VAERS findings in peer-reviewed medical journals.

It would certainly be a colossal loss of funds and effort if the valuable information revealed by this, the best-supervised post-marketing surveillance program in the world, is discounted, just because of a small percentage of clearly flawed reports. Those of us who are well-acquainted with the program and who regularly review submitted reports have no difficulty interpreting the information and identifying any errors.

Relative to this investigation, reports to VAERS have the following limitations:

1.Only a small proportion of adverse events is ever reported;

2.The parents of the "SBS victim" are usually too busy defending themselves and very often not aware of the potential role of the recent vaccinations;

3.The physicians involved in the care of the "shaken" infants:

Rarely inquire about recent vaccinations and or promptly discount any role they could have played.

Usually jump to the conclusion that every subdural or retinal hemorrhage and every fracture or pseudo-fracture must have been due to shaking and abuse and refuse to consider other plausible causes or differential diagnoses.

Tend to be less informed about the adverse events of pediatric vaccines than about their benefits.

Are therefore most unlikely to take the time to complete a VAERS report.

The first-conducted VAERS search was limited to reports received during the first 334 days of 2005 (January1 through November 30). There were few reports related to vaccinations administered in 2004 and several adverse events occurring in 2005 but only reported in 2006 were not included. Most often DTAPHE, HIB V and PNC were administered at the same time but in separate syringes.

As previously noted, it would have been difficult to find reliable information on the post-vaccinal incidence of retinal and subdural hemorrhages, the two findings that are considered by many as pathognomonic of SBS. The search was therefore focused on other findings often seen in alleged "child abuse by shaking", namely apnea, cardio-respiratory arrest, convulsions and deaths.

A total of 659 reports to VAERS concerning DTAPHE were filed in the first 11 months of 2005. In 486 (74%) of the cases, the infant had received HIB and PNC on the same day.

There were 31 death reports related to the administration of DTAPHE. In 28 cases (90%), the infant had received all three vaccines. In two cases, the babies had received DTAPHE and HIB, and in one case, just DTAPHE. (See Table I below.)

There were 22 reports of apnea, 45 reports of seizures and two reports of encephalopathy (reports 233066 and 233419). Ten reports cited SIDS as the cause of death.

In summary, there were approximately two reports per day of events following DTAPHE vaccination alone or with other vaccines. One "SIDS" death and two other infant deaths were reported each month, on average.

Table I
DTAPHE-related death reports to VAERS
January 1 through November 30, 2005

Days SPT: Number of days between vaccination and symptoms
Days Death: Number of days between vaccination and demise
Cases 233746 and 238603 received DTAPHE and HIB.
Case 283603 received DTAPHE alone.
All other cases (28) received DTAPHE, HIB and PNC.
Four infants were vaccinated in 2004.
There were five deaths in California, three in Missouri and two in Iowa.
One case had insufficient data. Of the other 30 infants, 20 were boys and 10 were girls. Four infants died the day they were vaccinated; eleven died the following day.
Half of all the deaths occurred within two days of vaccination.
More deaths were reported following the first set of vaccines at age 2 months.

Because of the serious implications of the above findings, a general search of all reports related to the 5 in 1 vaccine since its introduction and a more focused 2007 search were conducted starting December 7, 2007. The searches were limited to death reports of infants 6 months of age or younger; they did not include reports of infants who had received their third dose of vaccine late. In almost all cases, the infant had received other vaccines at the same time.

One hundred and thirty seven (137) death reports of infants 6 month-old or younger who had received DTAPHE were filed between July 21, 2003 and September 30, 2007. Eighty four (84) of the infants were males and fifty three (53) were females. [http://tinyurl.com/347npw]

The first 10 death reports described infants who had received DTAPHE + HIBV + PNC. Five infants (50%) died within 48 hours [Reports 206796, 207832, 209326, 211047 and 216572], one infant [Report 207831] died three days and another [Report 211877] five days following vaccination.

There were 37 reports of "SIDS" related to the administration of DTAPHE with other vaccines. A duplicate report and three others, where the infant died beyond 30 days, were excluded. Twenty six of the 33 remaining infants or 79% died within a week of vaccination; 16 infants (46%) died within 48 hours of vaccination.

Five infants diagnosed as SIDS died a few hours after vaccination (Reports 232015, 235456, 244917, 268567, 268705), five died the following day and six within two days. http://tinyurl.com/3dqkm9

Table II is a listing of VAERS reports of infant deaths related to the administration of DTAPHE, most often with HIBV and PNC, between January 10 and October 8, 2007. It is likely that this is an incomplete listing and that other reports of infants vaccinated during that 279-day-period will be filed later. http://tinyurl.com/39p3c9

A recently-licensed Rotavirus vaccine is presently part of the "routine" pediatric vaccination program. This vaccine is also administered at 2, 4 and 6 months of age and its VAERS code is "ROTHB5". In Table II, a "+" in the R 5 column will identify the infants who received that vaccine.

One must keep in mind that the intervals between vaccination and death are calculated by date. An infant vaccinated in the afternoon and expiring the following morning would be listed as having a one-day interval when indeed he died less than 24 hours after vaccination. The interval is listed in hours when exact times were provided.

Many professionals who report adverse events and most VAERS recorders seem convinced that a diagnosis of SIDS — even when death occurred hours or a day or two after vaccination — exonerates the vaccine and safeguards the sanctity and future of the U.S. vaccine initiatives. They are evidently unaware of an important 1998 research paper by Ridgway [Disputed Claims for Pertussis Vaccine Injuries Under the National Vaccine Injury Compensation Program. J Investig Med 1998; 46: 168–74.]

In that report, Ridgway reviewed all 786 claim-disputes from the start of the U.S. National Vaccine Injury Compensation Program (VICP) in 1988 through June 1996. 107 of the 786 claims were DTP-related adverse events where early death occurred. The plaintiffs in 73 (68%) of the 107 cases were awarded compensation because the preponderance of evidence suggested the deaths were somehow due to the vaccination. In 50 of the 73 (68.5%) compensated claims, the findings at autopsy had been "interpreted" as SIDS. Clearly the Special Masters of the U.S. Court of Claims disagreed and considered the diagnosis of SIDS unjustified.

There is no reason to think that things have significantly changed in the last twenty years. If that is so, then it is entirely possible that up to two thirds of the SIDS deaths following the concomitant administration of the three vaccines discussed in this report would be found to be vaccine-injury related justifying their compensation under U.S. law by the VICP.

Any discussion of SIDS and SBS is not complete without the mention of two pioneers: Archie Kalokerinos who proposed that a relative vitamin C deficiency predisposed to both SIDS and SBS and found that IV supplementation of the vitamin was protective and Alan Clemetson who reported that blood histamine increased when vitamin C reserves decreased and recommended that blood histamine and serum ascorbate levels be measured whenever SBS was suspected.

Many SBS "experts" especially those employed by "Child Protection" programs, continue to claim that loving parents with no past history of aggression or abuse and experienced and devoted babysitters and day care workers, suddenly lose their tempers when babies cry and shake them to death or near death.

The fact is that babies have always cried; they are supposed to. As a pediatrician, nothing concerned me more than a mother telling me "He is so good. He never cries."

From the beginning of time, and before we knew there was a "Shaken Baby Syndrome", babies have cried and parents have consoled them …without killing them: If they were hungry, they were put to the breast; if they were wet, their diapers were changed; and if they just needed a hug, they were hugged. If they were really upset, we carried them for a while or took them for a short car ride. No one held babies by the arms or legs and shook them to death and no one slammed them on a bed or a couch either. Parents loved their babies whether they were placid or not.

When confronted with the fact that SBS symptoms often followed vaccination at 2 and 4 months of age, many of the same SBS "experts" proposed that the vaccinations caused excessive crying and the caretaker "could not take it anymore." According to them, this is when the previously very loving and caring father, mother or babysitter "lost it" and started shaking and shaking the infant causing subdural and retinal hemorrhages, brain damage and even death.

The CDC will be well advised to conduct its own investigation and review of the above data. Particular attention should be paid to the following:

A. More infant deaths occurred in a shorter period of time following the administration of the same three vaccines in 2007 than in 2005.

B. Almost two thirds of the 2007 deaths occurred within a day or two of the vaccinations

The risks and benefits of simultaneous multiple pediatric vaccinations should be clearly explained to parents. Saving the infant the pain of an extra injection or the parents the trouble of a second trip to the doctor or clinic are worthless arguments when compared to the infant’s death.

The history of recent vaccinations must be recorded, reviewed and critically considered before anyone starts screaming "Shaken Baby Syndrome" or calling the authorities.

Like SIDS deaths, infant deaths attributed to SBS and occurring within 30 days of a vaccination should be reported to VAERS and carefully reviewed by a specialized team.

The diagnosis of "Shaken Baby Syndrome" has been questioned and challenged in the last few years. It is time to put it to rest.

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Just after this report was submitted for publication, I was consulted about a fifth infant who died two weeks after he was vaccinated. The two-month-old baby boy, a second twin, had received the same three vaccines discussed above, in addition to the new rotavirus vaccine. His father has been charged with "reckless homicide".

A few days later, the following news item from Idaho was brought to my attention. http://www.spokesmanreview.com/tools/story_breakingnews_pf.asp?ID=12892

Shot in the dark