Multiple Vaccinations And the Shaken Baby Syndrome - OAWHealth

Multiple Vaccinations And the Shaken Baby Syndrome

Multiple Vaccinations And the Shaken Baby Syndrome...

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."

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.

"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

No
Info

             

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]

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
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 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.

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.


Table III
VAERS reports
DTAPHE, HIBV and PNC vaccines
6 months of age or younger

 

DTAPHE

HIBV

PNC

Introduced

2003

1990

2000

Reports

2590

16,761

7,186

Reports /yr*

+/- 575

+/- 960

+/- 960

Males

1,371 (53%)

8,911 (53%)

3,854 (54%)

Premature

37

228

90

Fail to thrive

4

22

5

Hospital

491 (19%)

2,791 (17%)

1,301 (18%)

Deaths

137 (5.3%)

964 (5.8%)

388 (5.4%)

SIDS

38 (27.7%)

565 (58.6%)

150 (38.6%)

Convulsion

5

22

189

Seizure

82

261

211

Hemorrhage

1 A

16 F

8 K

Arrest

40 B

223 G

82 L

Apnea

70 B

709 H

246 M

CPR

12 B

93

38

Fractures

1 C

2 I

3

Bruises

2 D E

8 J

3

* 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:

1.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 

2.The percentage of hospitalized infants was about the same for all 3 vaccines.

3.The percentage of infants who died was also about the same.

4."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.

5.Seizures were mentioned more frequently in DTAPHE-related reports (3.16%) than in HIBV (1.55%) and PNC- related reports (2.9%).

6.Apnea or "arrest" were mentioned in 4.24% of DTAPHE-related reports vs. 5.56% for HIBV and 4.56% for PNC-related reports.

7.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."

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 everyone concerned that the irritability following the vaccination will be so intense that the caretaker may actually decompensate, shake the infant to death and land in jail for the rest of his life?

Shouldn’t there be a black box warning on the CDC’s vaccine information statement: "The administration of this vaccine may predispose to Shaken Baby Syndrome".

In 2004, pathologist-hematologist and SBS expert Michael Innis summarized the beliefs of many of us when he wrote:

"I have proved that immunization within this period is a cause, repeat A cause, of these haemorrhages (with or without fractures) in susceptible children …

They will have successfully demolished my explanation if they can document a SINGLE case of Shaken Baby Syndrome or "inflicted shaking/impact injury" (as they prefer to call it) which occurred outside the 21 day period and in which a disorder of Haemostasis, Nutrition, or Liver disease was convincingly excluded.

I repeat, the diagnosis of Shaken Baby Syndrome or Inflicted Shaking/Impact Injury is a proven figment of the imagination of some in the Medical Profession and should be relegated to scrap heap of history before it causes any more shame to the profession and disaster to innocent families."

[http://bmj.bmjjournals.com/cgi/eletters/328/7442/719#57790] Recently, Dr. Michael Pollanen, Ontario’s top forensic pathologist has suggested that "the deaths of 142 Ontario babies since 1986 were attributed to a cause many scientists now believe has been discredited shaken baby syndrome."

http://www.theglobeandmail.com/servlet/story/LAC.20071206.GOUDGE06/EmailTPStory/TPNational

Conclusions

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.

Dr. Michael Innis has proposed that the constellation of findings now perceived by some to be "typical" of the "Shaken Baby Syndrome" be called, more appropriately the "Clemetson-Kalokerinos Syndrome". I fully agree.

Parting advice

Until the CDC and independent international committees further investigate the role of pediatric vaccinations in the causation of the so-called "Shaken Baby Syndrome", parents of infants who have received multiple vaccinations including the 3 vaccines discussed in this report, should exercise extreme caution. They should watch the babies very carefully for a month after each set of vaccinations and report even the slightest problem to their pediatricians – documenting in writing the timing, the findings and the conversation. This is particularly crucial if the pregnancy and delivery were complicated or if the baby was born prematurely or had ongoing health problems. Other considerations are serious infections requiring multiple antibiotics, a recent illness and the baby not being in perfect health at the time of vaccination.

A young parent would be well advised to NEVER be alone with the baby in the immediate post-vaccination period. The presence of a friend, a neighbor or a relative when the baby arrests or convulses can make the difference between a simple interrogation and a full-blown "crime scene investigation". The inconvenience of having a guest, including a mother-in-law, pales in comparison to what I have seen happen to innocent people because some doctor decided that there was a "Shaken Baby Syndrome".


F. Edward Yazbak MD, FAAP
Falmouth, Massachusetts
tlautstudy@aol.com

—————

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

Heartbroken woman wonders if vaccines killed her infant son

By JoNel Aleccia | Staff writer | December 23, 2007

Federal health officials are reviewing whether routine immunizations contributed to the deaths of as many as three North Idaho babies this fall, a spokesman for the Centers for Disease Control and Prevention said this week.

The agency has requested autopsy reports and medical records for at least two children and could seek them for a third Kootenai County infant, all of whom died in September and October, apparently within days of receiving recommended vaccines.

There's no clear link between the vaccines and the deaths, which were classified as Sudden Infant Death Syndrome, or SIDS, said Curtis Allen, a spokesman for the CDC. "There is nothing so far to indicate that there is a particular problem other than these children died in the same city," Allen said.

But the mother of one of the children said it's no coincidence that her 4-month-old son died within days of receiving injections to prevent serious childhood illnesses, including diphtheria, tetanus, pertussis, hepatitis B, polio, rotavirus and invasive pneumococcal disease.

"My baby was so healthy," said Shelly Walker, 39, of Hayden. "He was extremely full of life, energy and vitality."

Nevertheless, early on the morning of Sept. 15, less than three days after Vance Vernon Walker received a round of vaccines at Lakeside Pediatric and Adolescent Medicine in Coeur d'Alene, his mother awoke to a nightmare.

"It was about 5:15 a.m. I woke up and thought, 'He's not making any noise!' " Walker recalled. "I went to pick him up and then I screamed."

Her 16 1/2-pound boy was warm and his lips were still pink, but he wasn't moving. Blood was crusted beneath his eyes, and his clothes and toys were covered with a bloody froth.

As her husband, Brian, 46, called 911, Walker worked frantically to resuscitate their child. But in the emergency room at Kootenai Medical Center, doctors said Vance had been dead for several hours.

"I grabbed my baby in my arms and held him up and I screamed, 'How in the hell did this happen?' " Walker said. "Was it the vaccines?"

Medical officials from the CDC and the federal Food and Drug Administration are working to answer that question for the Walkers and for families of two other babies who died within six weeks of each other.

Two of the deaths have been logged in the voluntary Vaccine Adverse Event Reporting System –VAERS – jointly operated by the CDC and FDA, agency officials said. But Dr. Robert West, the Kootenai County coroner, confirmed that three infants died this fall within days of immunization.

Parents of the other babies could not be reached for comment.

Autopsies failed to detect any specific vaccine reactions, West said, forcing a determination of SIDS – a "diagnosis of exclusion," he noted.

He said he welcomes the federal review. "It is a little bit unusual but not totally unheard of," West said. "It deserves the investigative clout of the CDC."

Walker confirmed that her son's death was one of the Idaho cases reported to VAERS. The other reported child likely was also under the care of the Coeur d'Alene pediatric group, Allen said. That raises the possibility the children received vaccines from the same batch.

If the CDC receives three reports of deaths or 10 reports of serious non-fatal injuries related to the same lot of a vaccine, it launches a review, Allen said.

In Vance Walker's case, the immunizations included a dose of Pediarix, a combined vaccine that contains DTaP, hepatitis B and inactivated polio vaccines. His mother's records indicate the lot number of the vaccine manufactured by GlaxoSmithKline was AC21B124B.

He also received a dose of Prevnar, lot number B54007C, a vaccine manufactured by Wyeth Pharmaceuticals.

Allen, of the CDC, said it would be up to the medical practice to decide whether to suspend use of the vaccine. Dr. Brian Hickok, the pediatrician for Walker's son, did not return calls about the issue. A representative for the medical practice declined to comment.

Those two vaccines are the most likely to be implicated in any adverse events, said David Terzian, a Virginia lawyer who specializes in vaccine injury cases. Terzian said the Walkers have a good chance of receiving compensation for their son's death through a federal program because it occurred so soon after immunization, well within the 72 hours required by federal rules.

Information provided by drug manufacturers and attached to the vaccines reports low numbers of associated deaths. In 14 clinical trials of Pediarix, five deaths were reported among 8,088 recipients of the vaccine, including two cases of SIDS.

In a study of more than 34,000 children in which about half received Prevnar and half received a control vaccine, a dozen deaths, including five SIDS deaths, occurred in the Prevnar group. By contrast, 21 deaths occurred in the control group, including four SIDS deaths, according to manufacturer data.

Immunization specialists acknowledge that any death following vaccination is a tragedy. But they emphasize that far more children died or fell ill in the era before vaccinations.

"For the most part, disease is always going to be more risky than getting a vaccine," said Nicole Pender, health educator for the immunization program at the Washington state Department of Health.

That is no comfort to Shelly Walker. She hopes her experience inspires parents to educate themselves about the risks of vaccines and prompts them to monitor any reaction, however slight. She plans to file a claim through the National Vaccine Injury Compensation Program, which provides a maximum of $250,000 after a vaccine-related death.

In return, all records related to her son's injury and death will be sealed by the drug manufacturers. Walker is optimistic that they'll use the data to improve product safety so other families won't experience her tragedy.

"My hope is they're compiling data and statistics to make things better," she said. "I'm trying to believe in the inherent goodness of something here."

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