The
Doctor's Corner Multiple
Vaccinations And the Shaken Baby Syndrome
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
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:
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:
“DTAPHE” is the official abbreviation of the 5 in 1 vaccine (DTaP + HePB + IPV) in VAERS and “PNC” is the official abbreviation of the heptavalent pneumococcal conjugate vaccine. The HIB conjugate vaccine is usually listed as “HIBV”. The 2005 VAERS Search 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
The 2007 VAERS Search 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. All DTAPHE-related Death
Reports 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] 2007 in focus 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. Table II
Review of findings The updated December 2007 VAERS search revealed that there were thirty seven (37) reported deaths of infants 6 months old or younger who had been vaccinated during a period of 279 days in 2007 (Jan 10-Oct.8) with an average of one death a week. Thirty-six (36) infants had received the DTAPHE, HIBV and PNC vaccines and one had received DTAPHE and HIBV only. Twenty-five (25) infants had also received the new rotavirus vaccine. [http://tinyurl.com/39p3c9] At least 8 of the 37 infants (22%) died within hours of vaccination; 21 infants (64%) died by the end of the following day. 31 infants (84%) died within a week. The cause of death was listed as SIDS, or sudden death or sudden infant death syndrome in 12 reports in spite of the fact that some of them had such findings as cerebral edema, cerebral ischemia, a coagulopathy, encephalopathy, and cardiac and pulmonary abnormalities. http://tinyurl.com/3x7wc7] There were several reports of infants “not breathing". Such is often the presentation of infants supposedly “shaken” or “shaken and slammed”. One infant (Report 288921) had findings two days following vaccination that would have surely been interpreted by some as SBS (Note 2). In spite of their terrible loss, these parents should consider themselves lucky that the case was reported to VAERS – as it should have been- and not to Child Protective Services and the police. A general VAERS search, vaccine by vaccine, was also initiated on December 7, 2007. It was focused on general data and certain symptoms. It should be noted that the same case reports could have been retrieved for each vaccine. The majority of children receiving DTAPHE, the latest licensed vaccine, will have also usually received HIB V and PNC on the same day - at different sites, as previously mentioned. The search was also limited to infants who were 6 month-old and younger and the results are listed in Table III.
* Number of yearly reports calculated on the bases of 4.5 years for the 5 in 1 vaccine, 17.5 years for the conjugate HIB vaccines and 7.5 years for the pediatric pneumococcal vaccine. Note A: Report 216480: This infant developed an encephalopathy, retinal and subdural hemorrhages 8 days post- vaccination. They were all presumed to be due to “inflicted trauma”. Note B: The same infants could have been listed under CPR, apnea and arrest Note C: Report 216239: This 3-month-old male infant from Georgia had alpha thalassemia, gastro-esophageal reflux (GER) and a hernia repair. He presented 20 days following vaccination (DTAPHE, HIBV and PNC) with acidosis, multiple spontaneous bone fractures, cerebral edema, hydrocephalus and intracranial hematomas. Temporary Brittle Bone Disease (TBBD) and Vitamin C were mentioned in the report. The baby’s head circumference had increased from the 5th to the 90th percentile before the vaccination. The VAERS report was filed six weeks after death. Note D: Report 277175 (also see Table II): This 5-month old male infant expired 4 days following DTAPHE, HIBV and PNC vaccination. He had a history of asthma. “Baby was DOA at hospital. Death certificate listed bruises found on head and cause of death as traumatic injuries of head and abdomen.” No further details are available. It appears that because the infant was dead on arrival, he had no hematological investigations. (Also see Note F below) Many physicians including some pathologists are not aware that the PIVKA II (Protein Induced by Vitamin K Absence) test is a reliable coagulation test that can be done post-mortem. Note E: Report 291825: This 3-month old male infant from Indiana received his second set of DTAPHE, HIBV and PNC on 9/13/07 when he “had a mild runny nose, loose stools”. Past history revealed that he was born at 25 weeks gestation and had a grade II intraventricular bleed and apnea of prematurity. There was a family history of hemophilia. On 9/16/07, he was admitted with sepsis, gastroenteritis and thrombocytopenia. His platelet count went down to 14,000 and he received a platelet transfusion. Petechiae were noted on the upper extremities, mainly around IV sites. Note F: See results at http://tinyurl.com/yo7pp3 Note G: See results at http://tinyurl.com/2xb7dk Note H: See results at http://tinyurl.com/ys8es6 Note I: Report 216239 previously discussed. Report 188855: This 4-month-old male from California who received DTAP, HIB, IPV and PNC on 5/1/2002 was found to have a subdural hematoma and multiple rib fractures 5 days later and diagnosed as Shaken Baby Syndrome. Note J: See results at http://tinyurl.com/2bdsgf Note K: See results at http://tinyurl.com/3xdove Note L: See results at http://tinyurl.com/ytmga7 Note M: See results at http://tinyurl.com/37cwm9 Note N: Reports 216239 and 188856 were previously discussed. Report 192933:4 month-old female infant from Kansas who received DTAP, IPV and PNC on 8/9/2002 and was found unresponsive in her swing 5 days later. She was found to have cerebral edema, retinal and subdural hemorrhages and spontaneous fractures, suspected to have been due to “intentional injuries”. *** Because two or all three vaccines reviewed are usually administered concomitantly, few conclusions can be reasonably drawn. The following is just a listing of the information:
Sudden Infant Death Syndrome 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. Discussion 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. In the cases of alleged abuse by shaking /slamming that I reviewed, extreme crankiness was not reported. Frequently, the Apparent Life Threatening Event (ALTE) followed a bath or a feeding, two pleasant and relaxing experiences. The surroundings were usually quiet and most often the adult in attendance was doing something else when he or she first noticed the baby “gasping for air”, seizing or not breathing. Often, the accused adult had been alone with the infant for just a very short time, and not long enough for him or her to “lose it” — even if the infant was screaming his head off. It is also rather unreasonable to think that a mother who knows that her baby has been extra-irritable following several vaccinations or colic or gas or whatever, would suddenly decide to go to the mall shopping and leave him alone with Dad. In every one of my reviews, the behavior of the adult in attendance when the baby crashed was very appropriate. He or she did exactly what was supposed to be done: they stimulated and suctioned the baby, called 911 and attempted resuscitation. In every case, the EMTs who responded to the 911 call and who arrived in record time, reported no suspicious behavior on the part of the adult, and no visible evidence of inflicted trauma, such as bruises, burns or deformities. Because of their open skull sutures and fontanels, infants can remain asymptomatic even when they have substantial intracranial hemorrhages. They are usually only checked after they arrest, convulse, or become unconscious. When a CT-Scan of the head reveals a subdural hemorrhage, child abuse is immediately suspected, particularly if the baby has a retinal hemorrhage or a “fracture” somewhere. Multi-generational intracranial hemorrhages and specifically acute and chronic subdural hematomas, are likely to be interpreted by a biased expert as “proof” of repeated shaking when in fact, such finding may very well be an argument against abuse. It is surely far-fetched to think that a father can decompensate and shake his small baby causing a first subdural bleed, calm down when mother returns home and act as if nothing happened, wait for a few days until she decides to go out again, lose his temper and become a monster a second time, re-shaking the baby violently enough to cause a second subdural hemorrhage and even a third. Besides, if the “abuse experts” truly believe that pediatric vaccines cause severe irritability and parents shake infants who become extremely agitated, shouldn’t vaccine manufacturers and vaccine promoters, including pediatricians, make it very clear to ev |