Multiple Vaccinations And the Shaken Baby Syndrome

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http://www.nvic.org/doctors_corner/ed_yazbak_shaken_baby_syndrome.htm

see webpage for better graphs

The Doctor's Corner

National Vaccine Information Center

Multiple Vaccinations And the Shaken Baby Syndrome

F. 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.

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[]

The HIB (Haemophilus influenzae 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>http://tinyurl.com/2eou96]

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[]

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>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>http://www.fda.gov/bbs/t\

opics/NEWS/2005/NEW01238.html]

3.In testimony on May 18, 1999, in front of a

Congressional sub-committee, 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>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.<http://www.nvic.org/doctors_corner/ed_yazbak_shaken_baby_syndrome.htm#\

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[]

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”.

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[]

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.

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[]

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.

<http://www.nvic.org/doctors_corner/ed_yazbak_shaken_baby_syndrome.htm#TOP>

[]

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%5D>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>http://tinyurl.com/3dqkm9]

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[]

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>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.

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[]

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

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[]

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>http://www.cdc.gov/SIDS/SUIDHowto\

UseForm.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.

<http://www.nvic.org/doctors_corner/ed_yazbak_shaken_baby_syndrome.htm#TOP>

[]

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>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.

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[]

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

<http://www.nvic.org/doctors_corner/ed_yazbak_shaken_baby_syndrome.htm#TOP>

[]

* 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.

<http://www.nvic.org/doctors_corner/ed_yazbak_shaken_baby_syndrome.htm#TOP>

[]

Note F: See results at <http://tinyurl.com/yo7pp3>http://tinyurl.com/yo7pp3

Note G: See results at <http://tinyurl.com/2xb7dk>http://tinyurl.com/2xb7dk

Note H: See results at <http://tinyurl.com/ys8es6>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>http://tinyurl.com/2bdsgf

Note K: See results at <http://tinyurl.com/3xdove>http://tinyurl.com/3xdove

Note L: See results at <http://tinyurl.com/ytmga7>http://tinyurl.com/ytmga7

Note M: See results at <http://tinyurl.com/37cwm9>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”.

***

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[]

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>http://tinyurl.com/2e62ef]

and [<http://tinyurl.com/26b3t2>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.

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[]

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.

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[]

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?

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[]

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

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>http://bmj.bmjjourn\

als.com/cgi/eletters/328/7442/719#57790]

Recently, Dr. 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/EmailTPStor\

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

/EmailTPStory/TPNational]

<http://www.nvic.org/doctors_corner/ed_yazbak_shaken_baby_syndrome.htm#TOP>

[]

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. 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.

<http://www.nvic.org/doctors_corner/ed_yazbak_shaken_baby_syndrome.htm#TOP>

[]

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. Yazbak MD, FAAP

Falmouth, Massachusetts

<mailto:tlautstudy@...>tlautstudy@...

---------------

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>http://\

www.spokesmanreview.com/tools/story_breakingnews_pf.asp?ID=12892