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

* 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]