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:

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 ] 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 ] 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 ] 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:

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

“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

DTAPHE-related death reports to VAERS

January 1 through November 30, 2005

VAERS

Report Received

State Age

Year Sex Vaccine

Date

Symptoms

Date Days

SPT Death

Date Days

Death 231965 1/4/2005 VA 0.2 M 8/26/2004 8/26/2004 0 8/27/2004 1 232015 1/6/2005 CA 0.1 M 12/27/2004 12/27/2004 0 12/27/2004 0 232507 1/19/2005 CA 0.4 M 1/5/2005 1/9/2005 4 1/9/2005 4 233066 1/28/2005 IA 0.4 M 1/10/2005 1/14/2005 4 1/14/2005 4 233419 2/4/2005 IA 0.4 M 1/28/2005 2/1/2005 4 2/2/2005 5 233427 2/7/2005 CA 0.5 M 8/10/2004 8/11/2004 1 8/11/2004 1 235154 3/18/2005 NY 0.2 M 3/14/2005 3/15/2005 1 3/15/2005 1 235456 3/28/2005 SC F 1/20/2005 1/20/2005 0 1/20/2005 0 235675 4/1/2005 GA 0.3 M 1/26/2005 1/27/2005 1 1/27/2005 1 235687 4/1/2005 CA 0.2 F 3/30/2005 3/31/2005 1 3/31/2005 1 236715 4/28/2005 OH 0.2 F 3/8/2005 3/10/2005 2 3/11/2005 3 239722 6/13/2005 TN 0.4 M 5/12/2005 5/16/2005 4 5/16/2005 4 239724 6/13/2005 KY 0.2 M 12/28/2004 1/3/2005 6 1/3/2005 6 240408 6/24/2005 TN 0.2 M 6/17/2005 6/18/2005 1 6/18/2005 1 240945 7/5/2005 WV 0.2 M 6/21/2005 6/27/2005 6 6/27/2005 6 241542 7/20/2005 NJ 0.3 F 6/13/2005 6/14/2005 1 6/14/2005 1 241557 7/20/2005 MN 0.2 M 7/11/2005 7/13/2005 2 242400 8/8/2005 AR 0.4 F 7/20/2005 7/22/2005 2 7/22/2005 2 243253 8/22/2005 AL 0.2 M 8/18/2005 8/19/2005 1 8/19/2005 1 243594 8/30/2005 MO 0.2 M 8/19/2005 8/21/2005 2 8/21/2005 2 244138 9/14/2005 GA 0.3 F 9/12/2005 9/13/2005 1 9/13/2005 1 244255 9/19/2005 IA 0.4 F 9/6/2005 9/7/2005 244917 10/5/2005 CA 0.3 M 9/19/2005 9/19/2005 0 9/19/2005 0 244965 10/5/2005 IL 0.2 M 9/29/2005 10/1/2005 2 10/1/2005 2 245770 10/20/2005 MO 0.4 M 10/11/2005 10/17/2005 6 10/17/2005 6 246641 11/2/2005 MO 0.4 M 6/15/2005 6/21/2005 6 6/21/2005 6 247332 11/14/2005 CT 0.3 F 9/22/2005 9/25/2005 3 9/25/2005 3 247838 11/18/2005 MS 0.3 F 10/18/2005 10/19/2005 1 10/19/2005 1 233746 2/11/2005 TX 0.4 M 2/8/2005 2/8/2005 0 2/8/2005 0 238842 6/1/2005 FL 0.1 F 5/25/2005 5/26/2005 1 5/26/2005 1 238603 5/31/2005 NoInfo

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.

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

6 months or younger



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] 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.



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. [



2007 in focus 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. [ 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

DTAPHE-related death reports to VAERS

January 10 through October 8, 2007

Report Date Vaccinated

Symptoms Experienced

Interim

R 5 Notes 289148 8/1/07 8/2/07 12 hr Baby found dead. Autopsy Diagnosis SIDS 289543 8/9/07 8/10/07 1 d + Respiratory arrest, gaze palsy 290655 8/30/07 9/11/07 12 d Apnea, cyanosis, hypothermia 290672 3/22/07 3/23/07 1 d Baby had pneumonia 3/17-3/19 290781 8/21/07 9/4/07 14 d + Sudden death (Note 1) 290946 9/19/07 9/20/07 1 d + Irritability, cyanosis 280206 4/11/07 4/12/07 <1 d + Warm and irritable then unresponsive 282860 6/25/07 6/25/07 5 hr + Found in crib unresponsive 282926 6/27/07 6/28/07 <1 d + Just over viral infection. Cardiology f/u

283066 6/18/07 6/20/07 2 d + Respiratory arrest, SIDS 284014 6/19/07 6/29/07

10 d + Screening information: Negative 287915 8/2/07 8/6/07 4 d + Ventricular dilatation SIDS 288181 8/3/07 8/9/07 6 d Accidental death, asphyxia

288471 8/16/07 8/17/07

1 d + Respiratory arrest 288921 8/21/07 8/23/07 2 d Cerebral edema, SDH, SAH (Note 2) 289100 8/23/07 8/24/07 1 d + Failure to thrive, microcephaly, A/V block 274046 3/12/07 3/13/07 <1 d Autopsy: SIDS 275756 4/4/07 4/5/07 1 d SIDS – Bronchiolitis 3/20/07 275775 3/22/07 3/23/07

1 d + Mild fever, Bronchopneumonia 277175 2/19/07

2/23/07 4 d Bruises on head, abdomen. COD trauma 278301 4/27/07 5/06/07 9 d + Respiratory arrest. Had diarrhea. 278322 3/21/07 4/19/07 29 d + Autopsy consistent with SIDS 278873 5/4/07 5/5/07 1 d + “unsure adverse event” – Patient died 279405 4/19/07 4/20/07 1d + Death. Sleep disorder. 271451 1/10/07 1/11/07 1d + Autopsy: Sleep disorder, SIDS 271530 1/22/07

1/22/07

0 d Accidental death. (Note 3) 272141 1/18/07

1/25/07 7 d + Mild hydrocephalus. SIDS 272371 2/8/07

2/10/07 2 d No PNC vaccine. SIDS. Co-sleeping parents 272859 2/21/07 2/21/07 0 d + SIDS (Note 4) 272947 1/11/07 2/1/07 21 d + Intestinal infarction and death (Note 5) 273879 2/6/07 2/14/07

8 d + SIDS, cerebral edema (Note 6) 291338 8/9/07 8/10/07 1 d Cause of death undetermined (Note 7) 291476

9/12/07 9/15/07

3 d + SIDS (Note 8) 291677 9/11/07 9/12/07 1 d Patient died within 24 hours 291803 9/21/07 9/22/07 1 d + Ex Preemie. Cardiac arrest. Enlarged heart 293421 10/1/07 10/4/07 3 d + Symptoms: Death 294509 10/8/07 10/9/07 >1 d + Cardio-respiratory arrest, fever



Note 1: Report 290781: This infant was given an additional dose of hepatitis B and IPV vaccines but the report was not flagged by the reporter or the VAERS recorder as a vaccination error



Note 2: Report 288921: This infant had subdural and subarachnoid hemorrhages plus cerebral edema and encephalopathy (described as “encephalitis”). In a medical center with a big “Child Protection Program” budget, these findings would have almost certainly been attributed to abuse by shaking. The private pediatrician evidently did not think so and correctly reported the death as an adverse event to VAERS within 24 hours.



Note 3: Report 271530: “Accidental death, Atrial fibrillation, Atrial flutter, Cardiomegaly. Chest X-ray abnormal. Crying, Dyspnea. Electrocardiogram ST-T change Electrocardiogram abnormal. Encephalopathy. Eye rolling. Heart rate irregular. Hypoventilation. Laboratory test Left ventricular hypertrophy. Lethargy. Myocardial infarction. 6 month old into ER, via aunt’s arms gasping for breath then becoming unresponsive approximately 15 minutes prior to arrival. On admit to ER, patient lethargic with slow shallow respiration weak, crying effort, reported vomiting at home. EKG reported ventricular hypertrophy, rapid irregular rate with PVCS. Patient transferred to a location. Patient coded/died in route to hospital.” The report was filed with VAERS the day after the baby died. One can only wonder why such death was considered, reported and recorded as “accidental”.



Note 4: Report 272859: “Sudden infant death syndrome. Was in apparently vigorous good health and died suddenly within a few hours after leaving clinic visit at which immunizations were administered.” Here again, one must wonder why this infant’s death was considered “unexplained” and why it was diagnosed as SIDS.



Note 5: Report 272947: “Symptoms: Congenital intestinal malformation Death Intestinal infarction Intestinal ischaemia Intestinal obstruction Volvulus. Information has been received from a physician concerning a 3 month old female who, "five weeks ago," on approximately 11-JAN-2007, was vaccinated with a first 2ml oral dose of Rotateq. In the "first week of February," on approximately 01-FEB-2007, the patient died of volvulus. At the time of the report the physician was still awaiting the autopsy report. Unspecified medical attention was sought. No product quality complaint was involved. The patient's experience was considered to be immediately life-threatening by the reporter. Additional information is not expected.” This report is also puzzling. This 3-month-old female infant developed a volvulus with intestinal infarction and died some 3 weeks after receiving the rotavirus vaccine with 3 other vaccines. The reporting physician listed “congenital” intestinal malformation as the first symptom although no “pre-existing conditions” were listed. It is not clear why the reporter concluded that “No product quality complaint was involved.” Hopefully someone at VAERS will review this report more objectively.





Note 6: Report 273879: “Blood pressure Brain death Brain edema — Cerebral ischaemia Coagulopathy Cyanosis. Death Infection — Life support — Metabolic acidosis — Respiratory arrest — Rotavirus test positive — Sudden infant death syndrome. Infant found in crib not breathing and cyanotic, parent began CPR and called 911. Child placed on life support and later declared brain dead. Taken off life support and pronounced dead. Child treated with various medications for infection, blood pressure.” On March 1, 2006, CDC released the Sudden, Unexplained Infant Death Investigation (SUIDI) Reporting Form [ http://www.cdc.gov/SIDS/SUIDHowtoUseForm.htm ]. This infant died in February 2007 one week after he received four pediatric vaccines. The diagnosis of SIDS seems questionable as the death was neither sudden nor unexplained.





Note 8: Report 291476: “Autopsy Peripheral coldness - Sudden death Sudden infant death syndrome - Unresponsive to stimuli- Information has been received from a physician concerning a 17-week-old male who on 12-Sep-2007 was vaccinated with a dose of Rotateq (lot# 656838/0968U). Suspect vaccination included PedvaxHib (manufacturer unknown). Concomitant vaccinations included Pediarix and Prevnar (it was noted that the patient did not receive MMR II and Varivax). On 14-Sep-2007, the parents put the infant to sleep on his back. The infant had a pacifier and no blankets in the crib. At midnight, when the parents checked on him, he was fine. When the parents checked on him at 6am on 15-Sep-2007, he was unresponsive and cold. 911 was called and the baby was coded. The infant was dead on arrival to the hospital. The cause of death was sudden infant death syndrome. No product quality complaint was involved. This is one of several reports from the same reporter. Sudden infant death syndrome was considered to be disabling and life threatening. Autopsy results will be provided when they become available. Additional information has been requested.” The conclusion that “no product quality complaint was involved” is questionable if “additional information has been requested”. The statement “it was noted that the patient did not receive the MMR II and Varivax” makes no sense in a report about a 17-week old infant neither does the description of “peripheral” coldness at autopsy.



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. [



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.



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.



Table III

VAERS reports

DTAPHE, HIBV and PNC vaccines

6 months of age or younger



DTAPHE

HIBVPNC

Introduced20031990 2000

Reports259016,7617,186

Reports /yr*+/- 575+/- 960+/- 960

Males1,371 (53%)8,911 (53%)3,854 (54%)

Premature3722890

Fail to thrive4225

Hospital491 (19%)2,791 (17%)1,301 (18%)

Deaths137 (5.3%)964 (5.8%)388 (5.4%)

SIDS38 (27.7%)565 (58.6%)150 (38.6%)



Convulsion 522189

Seizure82261211

Hemorrhage1 A16 F8 K

Arrest40 B223 G

82 L

Apnea70 B709 H

246 M

CPR12 B9338

Fractures 1 C2 I3

Bruises2 D E

8 J3





* 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



Note G: See results at



Note H: See results at



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



Note K: See results at



Note L: See results at



Note M: See results at



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: Note 7: Report 291338: “Refusal of treatment by relative. Cause of death undetermined at this time. Reported from a doctor with a mother who refused vaccine due to 2 deaths she heard about after children received vaccines - Only information available at this time.” This is a disturbing report and more information is needed. The report suggests that the mother had originally refused to have the baby vaccinated but later agreed. The baby unfortunately died the day after the vaccines were administered.Note 8: Report 291476: “Autopsy Peripheral coldness - Sudden death Sudden infant death syndrome - Unresponsive to stimuli- Information has been received from a physician concerning a 17-week-old male who on 12-Sep-2007 was vaccinated with a dose of Rotateq (lot# 656838/0968U). Suspect vaccination included PedvaxHib (manufacturer unknown). Concomitant vaccinations included Pediarix and Prevnar (it was noted that the patient did not receive MMR II and Varivax). On 14-Sep-2007, the parents put the infant to sleep on his back. The infant had a pacifier and no blankets in the crib. At midnight, when the parents checked on him, he was fine. When the parents checked on him at 6am on 15-Sep-2007, he was unresponsive and cold. 911 was called and the baby was coded. The infant was dead on arrival to the hospital. The cause of death was sudden infant death syndrome. No product quality complaint was involved. This is one of several reports from the same reporter. Sudden infant death syndrome was considered to be disabling and life threatening. Autopsy results will be provided when they become available. Additional information has been requested.” The conclusion that “no product quality complaint was involved” is questionable if “additional information has been requested”. The statement “it was noted that the patient did not receive the MMR II and Varivax” makes no sense in a report about a 17-week old infant neither does the description of “peripheral” coldness at autopsy.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.VAERS reportsDTAPHE, HIBV and PNC vaccines6 months of age or youngerDTAPHEHIBVPNCIntroduced20031990 2000Reports259016,7617,186Reports /yr*+/- 575+/- 960+/- 960Males1,371 (53%)8,911 (53%)3,854 (54%)Premature3722890Fail to thrive4225Hospital491 (19%)2,791 (17%)1,301 (18%)Deaths137 (5.3%)964 (5.8%)388 (5.4%)SIDS38 (27.7%)565 (58.6%)150 (38.6%)Convulsion 522189Seizure82261211Hemorrhage1 A16 F8 KArrest40 B223 G82 LApnea70 B709 H246 MCPR12 B9338Fractures 1 C2 I3Bruises2 D E8 J3* 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 arrestNote 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:

Among 6-month-old or younger infants, males were more likely to have a vaccine adverse event. From 1990 to the end of October 2007, there were 15,471 reports concerning male infants vs. 13,395 reports concerning female infants. [http://tinyurl.com/2e62ef] and [http://tinyurl.com/26b3t2] The percentage of hospitalized infants was about the same for all 3 vaccines. The percentage of infants who died was also about the same. “SIDS” reports following the administration of DTAPHE constituted 27.7% of death reports compared to 38.6% for PNC and 58.6% for HIB, the oldest of the three vaccines. Both DTAPHE and PNC were licensed several years after the “back to sleep” recommendation. Some cases may have been listed as “sudden death” and not retrieved in a search for SIDS. Seizures were mentioned more frequently in DTAPHE-related reports (3.16%) than in HIBV (1.55%) and PNC- related reports (2.9%). Apnea or “arrest” were mentioned in 4.24% of DTAPHE-related reports vs. 5.56% for HIBV and 4.56% for PNC-related reports. Reports mentioning prematurity constituted 1.43% of the total for DTAPHE compared to 1.36% for HIBV and 1.25% for PNC.

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.”