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Shaken Baby Syndrome And VAERS: A Review And Analysis

By: Dr. F. Edward Yazbak

Injuring or killing a child is a terrible crime, and the failure of a physician to recognize child abuse is tragic.

An erroneous diagnosis of "Non Accidental Injury" and specifically the so-called "Shaken Baby Syndrome" (SBS) is just as tragic. The resulting nightmare involving law enforcement agencies, social services and the legal system is beyond description.

Though bruises, subdural hemorrhages, retinal hemorrhages and fractured ribs are often associated with non accidental injuries, their presence singly or in combination may not be proof of guilt, unlike stab wounds, spiral fractures of long bones, depressed skull fractures and intentional drowning, smothering and strangulation.

A syndrome is a group of signs and symptoms that occur together and characterize a particular abnormality (Webster). The National Center on Shaken Baby Syndrome defines SBS as "a term used to describe the constellation of signs and symptoms resulting from violent shaking or shaking and impacting of the head of an infant or small child". Diagnosing SBS on the basis of an isolated finding, such as a retinal hemorrhage, is therefore probably not justified. Retinal hemorrhages can be seen in scurvy (Hess, 1920), in association with subarachnoid hemorrhages (Biousse, 1988), and even in normal newborns, after vaginal delivery (Kaur, 1990). They have been noted after CPR (Goetting, 1990), and following accidental trauma (Elner, 1990), and Hepatitis B vaccination (Devin, 1996). Retinal hemorrhages may be symptoms of coagulation disorders (Nelson 1996) and some autoimmune diseases (Boucher, 1998).

It has become apparent lately that, at times, infants and children with the diagnosis of Shaken Baby Syndrome had developed their first symptoms shortly after receiving one or more pediatric vaccines. The CDC (Center for Disease Control and Prevention) warns that the simple fact that a symptom or a constellation of symptoms occurs shortly after a vaccination is not proof of causation. This argument is often used when MMR and Autism are discussed.  When parents state that their children, who were normal, developed autism shortly after MMR vaccination, the CDC responds that the first symptoms of autism usually become apparent in the second year of life, around the time when MMR is usually administered, and that therefore, any association between the two is casual or temporal, not causal.

Situations where findings may be due to either intentional injury or a vaccine reaction will become increasingly challenging as more vaccines and combination vaccines are introduced. Some recently vaccinated infants will be abused. In these cases, the responsible adult should be held accountable. On the other hand, the physician must evaluate the infant and the situation very carefully to rule out every other possible cause for the findings, before filing a report of child abuse. Punishing an abusive parent and protecting the other children is the right thing to do. Inappropriately removing children to foster homes in the middle of the night and unleashing a cascade of events on an innocent caretaker is not, particularly at such a sad and vulnerable time.  

After reading Dr. Buttram's excellent contribution entitled "Vaccines, Vitamin C Depletion and Shaken Baby Syndrome" (Redflagsdaily SBS On-line Conference), I wondered if there had been reports of SBS to VAERS (Vaccine Adverse Events Reporting System). I did not expect that many had been filed; After all, a physician who has decided that a parent had shaken and injured his or her baby is unlikely to report the case as a vaccine reaction.

One must keep in mind that only around 10% of vaccine adverse events are ever reported to VAERS, in spite of the fact that the CDC frequently reminds health professionals to do so.

The CDC and FDA (Federal Drug Administration) warn about misinterpretation of VAERS reports and data

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.

It is likely that reports to VAERS prompted the decisions to remove the oral polio vaccine (OPV), the diphtheria, tetanus and whole cell pertussis vaccine (DTP) and the rotavirus vaccine from the US market.

I initiated only 3 simple searches:

Shaken, Shaken Baby Syndrome and SBS.

Some reports appeared in more than one search and some were not relevant.

My specific comments on each case are in red.
Search: Symptom     Shaken
Result: 14 reports

For the sake of brevity, only the first report (28754, filed in 1991) will be scrutinized. This case will be referred to as the "index case".                        

Cases 56800 (1993), 77315 (1995) and 112223 (1998) will be discussed in general terms.

VAERS ID 28754 Vaccination Date: 1991-01-31
Age 0.2 Date filed: 1991-03-08  
Sex F Where Administered: PUB
State CO Purchased by: PUB
Life Threatening Illness? Yes
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data: defer to the children’s Hospital, Denver.
Previous Vaccinations:
Other Medications: Tylenol
Preexisting Conditions: NONE Known
  Vaccinations Manufacturer Lot Dose Route Site
1 DTP LEDERLE 289901 0 IM LL
2 HIBV LEDERLE(PRAXIS) M030FC 0 IM RL
3 OPV LEDERLE 0627H 0 PO  
Onset Date: 1991-02-03    Number of Days: 3
Symptoms: CONVULS HEM EYE HEMATOMA SUBDURAL INJURY INTENT SOMNOLENCE VOMIT
Child admitted w/hx of lethargic & vomiting followed by sz. Had retinal hemorrhage & bilateral subdural hematoma. Dx: Shaken baby synd;

For those not acquainted with VAERS, this report states that a 2-month-old baby girl from Colorado received the first dose of DTP vaccine (lot # 289981), the first dose of HIB or Hemophilus type B vaccine (lot # M030FC) and the first dose of OPV (lot # 0627H) on 1/31/1991. Three days later, the baby convulsed and had eye and subdural hemorrhages (which were considered intentional injuries), was somnolent and threw up. The baby was admitted to Children's Hospital in Denver with a history of lethargy and vomiting followed by seizures. She had retinal hemorrhage and bilateral subdural hematoma. The condition was considered life threatening, the patient survived and recovered.

Diagnosis:  Shaken baby Syndrome.

The report was filed on 3/8/1991, 37 days after vaccination.

Legally, the situation described above seems ominous. A parent could have been convicted and served time in prison. He or she may have been beaten or threatened in jail and may be still scorned by neighbors, 12 years later.

The question is: Was that person guilty?

A comprehensive review of the medical chart and of all the facts is not possible because identities are kept confidential. Only information about the vaccine lots is available from VAERS and a "Hot Lot" search was therefore conducted.

Result: Multiple reports have been filed about each of the three vaccine lots.

Unfortunately, it is impossible to properly interpret findings from "Hot Lot" searches, because the size of each lot is never revealed; fifty reports about a small lot may therefore be more significant than 200 reports about a very large lot.

DTP Lot 289901

There were 66 reports filed with VAERS including one (case 28438) describing another infant who had also received both DTP 289901 and HIB M030FC.

VAERS ID 28438 Vaccination Date: 1991-01-18
Age 0.6 Date filed: 1991-03-05  
Sex M Where Administered: PUB
State CO Purchased by: PUB
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: none
Diagnostic Lab Data: spinal tap-neg
Previous Vaccinations:
Other Medications: none
Preexisting Conditions:
  Vaccinations Manufacturer Lot Dose Route Site
1 DTP LEDERLE 289901 1   LL
2 HIBV LEDERLE(PRAXIS) M030FC 0   RL
3 OPV LEDERLE 619D 1 PO  
Onset Date: 1991-01-19    Number of Days: 1
Symptoms: CONVULS FEVER INFECT
child recvd DTP/OPV/HBOC on 18Jan, @ 3 am 19Jan woke up. Had seizures took to ER-was admitted, needed Valium to stop seizures. T increased 104.8 /p seizures. Cultured RSV

This 6-month old baby boy was also from Colorado. He was vaccinated on 1/18/1991, less than two weeks before the index case and reacted with a high fever and seizures a few hours after vaccination. The report was filed 3 days before the index case.

Where there any reports of a brain hemmorhage with DTP lot 289901?

Search: Lot number 289901            Symptom hemorrhage

Result: Two reports:

Our index case: (28754) and another from Washington state (27445): a 2-month old female infant who was vaccinated almost two month earlier and developed major problems 24 hours after vaccination.

VAERS ID 27445 Vaccination Date: 1990-12-03
Age 0.2 Date filed: 1991-01-21  
Sex F Where Administered: UNK
State WA Purchased by: UNK
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes (days in hospital: )
    Prolonged Hospitalization? No
Current Illness:
Diagnostic Lab Data: CT scan reveals intracranial hemorrhage;hosp course from 14Dec90;problem#1-fluids,electrolyte,nutrition:serum Na+-125;hyponatremic.Problem #2-respiratory rate 20-40.Problem#3-cardiovascular myocardial damage requiring ICU.
Previous Vaccinations:
Other Medications:
Preexisting Conditions: Dx small ventricular septal defect, inguinal hernia surgery preformed doing well
  Vaccinations Manufacturer Lot Dose Route Site
1 DTP LEDERLE 289901 0    
2 HIBV LEDERLE(PRAXIS) M190SD 0    
3 OPV LEDERLE 291966 0    
Onset Date: 1990-12-04    Number of Days: 1
Symptoms: APNEA CARDIOVASC DIS COAGUL DIS CONVULS DYSPNEA HEART FAIL HEM INTRACRAN HYPONATREM KIDNEY FAIL SWEAT
24 hrs after DTP/OPV/HIB given, pt had sweating & difficulty breathing, taken to ER where pt had cardio-resp failure, intubated & hospitalized had sz&renal fail,DX of disseminated intravascular coagulation, CAT scan- intracranial hemorrhage

.

The baby had cardio-respiratory failure, renal failure, disseminated intravascular coagulation, myocardial damage and intracranial hemorrhage. Her condition was certainly life threatening and should have been listed as such.

The case was filed as a straightforward vaccine adverse event within a month

Where there any deaths reported with DTP lot 289901?

Search: Lot number 289901                        Symptom Death

Result: 2 reports.

Both infants were 2-months old, were also vaccinated in the last 10 days of January 1991 and in both instances, the cause of death was listed as SIDS (Sudden Infant Death Syndrome). The first baby, from Washington, died 6 days after vaccination; the second, from South Carolina, died some 48 hours after receiving a dose of DTP lot 289901 and OPV.

VAERS ID 29345 Vaccination Date: 1991-01-28
Age 0.2 Date filed: 1991-03-29  
Sex M Where Administered: OTH
State WA Purchased by: UNK
Life Threatening Illness? No
Died? Yes (date died: 1991-02-03)
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data:
Previous Vaccinations: NA
Other Medications:
Preexisting Conditions:
  Vaccinations Manufacturer Lot Dose Route Site
1 DTP LEDERLE 289901 0 IM RL
2 HIBV LEDERLE(PRAXIS) M730FE 0 IM LL
3 OPV LEDERLE 289945 0 PO  
Onset Date: 1991-02-03    Number of Days: 6
Symptoms: SIDS
Crib Death- SIDS;

VAERS ID 29754 Vaccination Date: 1991-01-22
Age 0.2 Date filed: 1991-04-10  
Sex F Where Administered: PUB
State SC Purchased by: PUB
Life Threatening Illness? No
Died? Yes (date died: 1991-01-24)
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
  Vaccinations Manufacturer Lot Dose Route Site
1 DTP LEDERLE 289901 0 IM  
2 OPV LEDERLE 283943 0 PO  
Onset Date: 0000-00-00    Number of Days:
Symptoms: SIDS
infant death-pending autopsy

Were there possibly more deaths in infants who had received DTP 289901?

(This time, instead of listing death under symptom, I simply clicked yes after Died?)

Search: Lot 289901               Died? Yes

Result: Four reports.
The first two are 29345 and 29754 (above).
The last two (29756 and 29769) are incomplete and cannot be interpreted, but they are still relevant to this discussion. Case 29756 is a 4 ms-old baby girl who received DTP / OPV on 1/8/1991 and died 2/2/1991. Case 29769 is a 7 ms-old baby boy, who was vaccinated (DTP / HIB) on 3/4/1991 and expired on 3/23/1991.

Both cases were from South Carolina just like case 29754, and all 3 cases were reported to VAERS on the same day, 4/10/1991. Obviously, causation cannot be implied, simply because 3 reports arrived from the same state on the same day describing 3 infants who died suddenly, shortly after receiving a vaccine from the same lot.

 

HIB Lot M030FC

There were 58 reports to VAERS. One, case 27451, described a 3 months old male infant from Oregon who died 9 days post vaccination. The diagnosis listed was SIDS.

VAERS ID 27451 Vaccination Date: 1990-11-20
Age 0.3 Date filed: 1991-01-21  
Sex M Where Administered: PVT
State OR Purchased by: PVT
Life Threatening Illness? No
Died? Yes (date died: 1990-11-29)
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: None
Diagnostic Lab Data: SIDS investigation & autopsy done
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
  Vaccinations Manufacturer Lot Dose Route Site
1 DTP CONNAUGHT LABS 0L11101 1   LL
2 HIBV LEDERLE(PRAXIS) M030FC 0   RL
3 OPV LEDERLE 0619L 1 PO  
Onset Date: 1990-11-29    Number of Days: 9
Symptoms: SIDS
Dx sudden infant death syndrome died 29Nov90
 

Seizures after vaccination with HIB lot M030FC were reported 4 times: cases 27166, 27648, 28438 and 29464. In one case, 27648, MMR was administered concomitantly. In the other 3, the patient also received DTP. Seizures occur more frequently after DTP and MMR than after HIB vaccination.

There were 11 reports of hospitalization following vaccination with HIB lot M030FC: Cases 26275, 27274, 27444, 27648, 28434, 28438, 28754, 28815, 29132, 30437 and 54162. In 4 cases, 27224, 27444, 27648 and 28438, the child had invasive HIB disease. In case 29132, the diagnosis was Guillain Barre Syndrome, a possible vaccine complication.

 

Polio Lot 0627H

There were 28 cases reported where vaccines from this particular lot had been administered. Six of them were hospitalized and all had convulsions: Cases 30013, 36382, 36397, 36726, 38019 and the index case. Here again, it must be stressed that oral polio vaccination alone rarely if ever causes seizures. One case (36726) will be reviewed because the infant also received DTP 289901.

VAERS ID 36726 Vaccination Date: 1991-02-05
Age 0.3 Date filed: 1991-12-05  
Sex M Where Administered: PUB
State CO Purchased by: PUB
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes (days in hospital: 7)
    Prolonged Hospitalization? No
Current Illness: NONE
Diagnostic Lab Data: MRI, Sp tap, Blood work, EEG’s, Cat Scan all neg/normal;
Previous Vaccinations:
Other Medications:
Preexisting Conditions: NONE
  Vaccinations Manufacturer Lot Dose Route Site
1 DTP LEDERLE 289901 1    
2 OPV LEDERLE 0627H 1    
Onset Date: 1991-02-25    Number of Days: 20
Symptoms: CONVULS GRAND MAL
Had a grandmal sz last for 50 min was transported to Hosp in ICU for 3 days; had a Cat Scan, sp tap & blood work all normal; no fever; was put on Dilantin @ that time; Was referred to a neurologist which are still seeing; is now on Depakote

.

This 3-month old baby from Colorado received the same lot DTP and Polio vaccines five days after our index case. He had a grand mal seizure lasting 50 minutes, was in ICU for 3 days, and in a pediatric ward for another 4 (possibly in the same children's hospital as the index case). He developed epilepsy, was prescribed Depakote and is under the care of a neurologist. I consider a 50-minute grand mal seizure in a 3-month old infant a life-threatening event.

Medico-legal remark I: In 1991, this case would have been compensated through the vaccine injury compensation program as an adverse event after DTP. Now, it is not considered a "table injury" because of the 20 days interval.

Medico-legal remark II: Two infants from the same state received two identical vaccinations

(Same dose, same product, same manufacturer and same lot number) five days apart. They both developed problems shortly thereafter. The family of the first infant became embroiled in a legal nightmare; the second family was eligible for compensation.

Cases 56800, 77315 and 112223.

VAERS ID 56800 Vaccination Date: 1993-09-16
Age 0.8 Date filed: 1993-11-01  
Sex M Where Administered: PUB
State ID Purchased by: PUB
Life Threatening Illness? Yes
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes (days in hospital: 4)
    Prolonged Hospitalization? No
Current Illness:
Diagnostic Lab Data: EEG, Ct Scan, MRI all nl;
Previous Vaccinations:
Other Medications:
Preexisting Conditions: mom drank ETOH during pregnancy
  Vaccinations Manufacturer Lot Dose Route Site
1 DTPH LEDERLE 353905 2    
Onset Date: 1993-09-22    Number of Days: 6
Symptoms: AGITATION CONVULS HEM RETINAL HYPERTONIA STUPOR
6 days p/vax pt had stiffness, eyes fixed & staring to side, irritable cry; adm to hosp pt had shaken baby synd w/retinal hemorrhages; altered consciousness for 1 more day; began seizing;

DTPH is a combination of DTP and HIB.

The fact that a mother drank alcohol during pregnancy, regardless of circumstances and frequency, is damning with Social Services but may be irrelevant to this case.

I do not condone drinking alcohol during pregnancy.

Altered consciousness and seizures may be due to many causes, including vaccines. Head MRI and CT-scan did not reveal any structural changes suggesting direct injury to the brain. The diagnosis of SBS in this case may have been based on the retinal hemorrhages.

There were 45 reports to VAERS with DTPH lot 353905. Five children were hospitalized and one died, case 57614. This 3-month old male infant from Oregon was also vaccinated (DTPH +OPV) in the fall of 1993. He developed symptoms within 24 hours and died a day later. Though he had fever, petechiae and hemorrhages, SIDS was listed as the diagnosis.

  77315 Vaccination Date: 1995-01-30
Age 0.2 Date filed: 1995-09-18  
Sex M Where Administered: PVT
State MN Purchased by: PVT
Life Threatening Illness? Yes
Died? No
Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes (days in hospital: )
    Prolonged Hospitalization? No
Current Illness: recent hosp liver malfunct w/protime ane
Diagnostic Lab Data: 14FEB95 gross, blood CSF; CT 14FEB95 hydrocephalis; MRI 4MAR95 massive brain/retinal bleed;
Previous Vaccinations: unk
Other Medications: NONE
Preexisting Conditions: recent hospitlaization liver malfunct w/prolonged protime anemia-esophog bleed;
  Vaccinations Manufacturer Lot Dose Route Site
1 DTPH LEDERLE 384977 0    
2 HEP UNCLASSIFIED   1    
nset Date: 1995-02-13    Number of Days: 14
Symptoms: CRY ABNORMAL CSF ABNORM EYE DIS HEM CEREBR HEM RETINAL HYDROCEPHALUS INJURY INTENT SOMNOLENCE
parents c/o pt lethargic, one eye wandered, fussy, no appetite; hospitalized 13FEB95; high pitched scream noted by MD CT documented hydrocephalus-(retroactive reading brain bleed present); dx shaken baby;

Note: In VAERS reports, the first dose of a vaccine is referred to as dose 0. The second dose becomes dose 1 and so on.

This 2-month old male infant was "at risk" when he received the first dose of DTPH and the second dose of Hepatitis B vaccine on 1/31/1995. He had recently been in the hospital where he was found to have liver disease, and prolonged prothrombin time, both potential causes of bleeding. Indeed he had esophageal bleeding, a very serious event at any age and more so, under the age of 2 months. Bleeding problems have been described after Hepatitis B vaccination. In this case, the findings prior to 1/30/1993 could have been related to the first Hepatitis B vaccination. Lot numbers for both doses of the vaccine are not listed and further review is not possible.

Two weeks after receiving DTPH and a second Hepatitis B vaccine, the baby crashed. A diagnosis of SBS was listed because the infant had a high-pitch cry (an accepted reaction to DTP) and, by CT scan, a bleed in the brain and hydrocephalus. A CT scan is not a good tool to detect the "age" of a brain hemorrhage. A post-mortem autopsy may be the only way to prove conclusively whether the bleed is old (It could have occurred at the time of the esophageal bleeding), new or a re-bleed (A recent bleeding superimposed on an old one). Both the history and findings do not seem to support a diagnosis of SBS.

Medico-legal comment: If the family had a good attorney and a knowledgeable expert witness, it would be unlikely that an informed judge or jury would return a guilty verdict in this case today. I actually believe, that in a civil litigation, the preponderance of evidence would probably be in favor of the parents. Knowing the lot numbers of the hepatitis B vaccines would be helpful. 

DTPH lot 384977: There were 99 reports and 3 deaths (75164, 76307, 77681).

Case 76307 had also received a Hepatitis B vaccine and had petechiae.

VAERS ID 112223 Vaccination Date: 1998-03-18
Age 0.2 Date filed: 1998-07-01  
Sex U Where Administered: OTH
State   Purchased by: OTH
Life Threatening Illness? Yes
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: unk
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: unk
Preexisting Conditions:
  Vaccinations Manufacturer Lot Dose Route Site
1 DTAP LEDERLE 447831 0    
2 HEP UNCLASSIFIED        
3 HIBV LEDERLE(PRAXIS)   0    
4 OPV LEDERLE   0 PO  
Onset Date: 1998-03-19    Number of Days: 1
Symptoms: BRAIN SYND ACUTE HEM CEREBR INFARCT CEREBR INJURY INTENT
1 days p/vax pt devel focal hemorrhages in subdural area;the reporter, ped neurologist eval pt & stated that looks like pt is a subject of child abuse & dx shaken baby synd;A defense attorney allegedly attributes this event to Acel-immune;

The pediatrician who knew the family and saw this baby on 3/18/1998 did not suspect child abuse or else he would/should have called the police and social services, instead of administering four vaccines and handing the baby back to the parents.

The baby developed major problems a day later.

A diagnosis of SBS, based only on a finding of "focal hemorrhages in the subdural area" without any other evidence of trauma, is debatable and should be easily challenged in court. In all likelihood, the neurologist who diagnosed SBS only met the parents for a few minutes. Most people would probably agree with the defense attorney in this case.

Note: Parents, like everyone else, react differently to stress and threatening situations. Their comportment, whatever it is, can suggest guilt to their accusers. If they are screaming and  crying, they are "acting" because they are guilty. If they are quiet and composed, they "must be guilty" because they are not appropriately upset. 

DTAP lot 447831: 4 other reports (106181,111216, 111870, 111437) were filed. Two infants had high-pitch screaming. One had questionable minor seizures. The last infant (see below) had no pre-existing conditions. He vomited, became agitated and had trouble breathing hours after receiving 4 vaccines. He now has cerebral palsy and seizures.

VAERS ID 114337 Vaccination Date: 1998-03-18
Age 0.2 Date filed: 1998-09-24  
Sex M Where Administered: PVT
State NJ Purchased by: UNK
Life Threatening Illness? No
Died? No
Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes (days in hospital: 10)
    Prolonged Hospitalization? No
Current Illness: seizures
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
  Vaccinations Manufacturer Lot Dose Route Site
1 DTAP LEDERLE 447831 0    
2 HEP MSD 1186E 1    
3 HIBV LEDERLE(PRAXIS) 0162H      
4 IPV CONNAUGHT LTD N0292 0    
Onset Date: 1998-03-19    Number of Days: 1
Symptoms: AGITATION ANOMALY CONGEN CNS ANOREXIA CONVULS DYSPNEA GI DIS MENTAL RETARD PALLOR REACT AGGRAV SYNCOPE VISION ABNORM WEIGHT DEC
started vomiting @ approx 6AM p/bottle;had a sz & then lost consciousness;began crying;seemed to have trouble breathing;head was ice cold & was very pale;bein dx for cerebral palsy

*          *          *

How many cases of Shaken Baby Syndrome were filed with VAERS in 10 years?

Search: Shaken Baby Syndrome

Result: 5 reports

The case in the first report (130604) is so tragic that it will be discussed separately.

VAERS ID 164275 Vaccination Date: 2000-11-07
Age 0.4 Date filed: 2001-01-02  
Sex M Where Administered: PUB
State SC Purchased by:  
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes (days in hospital: 45)
    Prolonged Hospitalization? No
Current Illness: NONE
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions: NONE
  Vaccinations Manufacturer Lot Dose Route Site
1 DTAP UNCLASSIFIED DTAP917A2   IM LL
2 HIBV UNCLASSIFIED     IM  
3 IPV UNCLASSIFIED        
Onset Date: 2000-11-13    Number of Days: 6
Symptoms: CONVULS INJURY ACCID REACT UNEVAL THROM
No data provided. 60 day follow-up states the pt has seizures. Discharge summary states diagnosis is shaken baby syndrome, inferior vena cava thrombus
Not enough information is available to discuss this report adequately. It is not clear why a diagnosis of SBS was made. The 4 months old male infant had no pre-existing conditions prior to vaccination. He developed seizures 6 days after receiving 3 vaccines and spent 45 days in the hospital. The interval between vaccination and seizures is appropriate and seizures have been reported after DTP, DTP-containing vaccines and DTAP. There is no relationship between seizures and inferior vena cava thrombosis Accidental injury is mentioned under symptoms, but no details are given. Thrombosis of the inferior vena cava is a very serious event, which may be due to direct trauma to the abdomen but no such trauma in mentioned. Interestingly, it is sometimes associated with another SBS: Short Bowel Syndrome.
 
  166388 Vaccination Date: 2000-10-23
Age 0.2 Date filed: 2001-03-06  
Sex M Where Administered: OTH
State MI Purchased by: OTH
Life Threatening Illness? No
Died? No
Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes (days in hospital: 28)
    Prolonged Hospitalization? No
Current Illness: Respiratory infection on antibiotics
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Antibiotics
Preexisting Conditions: 5 weeks premature; respiratory infection, on antibiotics
  Vaccinations Manufacturer Lot Dose Route Site
1 DTP UNCLASSIFIED     IM  
2 HEP MSD     IM  
3 IPV       SC  
Onset Date: 2000-10-24    Number of Days: 1
Symptoms: APNEA BLIND BRAIN SYND ACUTE CONVULS DEAF ECCHYMOSIS EDEMA TONGUE INJURY INTENT PETECHIA SCREAMING SYND
The pt’s grandmother reported that a 2 month old male pt received vaccines on 10/23/00. Reportedly, the next day, the pt developed continuous crying, seen in physician’s office. The pt was hospitalized on 11/22/00 due to respiratory failure, bruising around the mouth, petechia and swollen tongue. Pt was discharged on 12/20/00 with a dx of Shaken Baby Syndrome with brain damage, blind and deaf. Pt is on feeding tube and Phenobarbital for seizures. No further info is available. Upon internal review, seizures
This infant, who was 5 weeks premature, was sick and on antibiotics when he was vaccinated at the age of 2 months. The screaming syndrome and convulsions are known reactions to DTP. He had an anoxic hypoxic episode and respiratory failure with resulting brain damage, inability to swallow, blindness and deafness. The petechiae, bruising around the mouth and swollen tongue were caused, in all likelihood, by rough resuscitative efforts.  Lot numbers were not listed and cannot be checked. The information provided does not seem to support a diagnosis of Shaken Baby Syndrome.

VAERS ID 168563 Vaccination Date: 1995-07-12
Age 0.3 Date filed: 2001-04-12  
Sex M Where Administered: PVT
State OH Purchased by:  
Life Threatening Illness? Yes
Died? No
Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes (days in hospital: 14)
    Prolonged Hospitalization? No
Current Illness: NONE
Diagnostic Lab Data: MR-showed cerebral palsy and cortical visual impairment.
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: 3 months premature at birth; healthy
  Vaccinations Manufacturer Lot Dose Route Site
1 DTAP LEDERLE 390969 2 IM  
2 HIBV LEDERLE 010LD 2 IM  
3 UNK UNCLASSIFIED 722H1 2    
Onset Date: 1995-07-20    Number of Days: 8
Symptoms: AGITATION ANOMALY CONGEN CNS COMA CONVULS GRAND MAL HEM INTRACRAN HEM RETINAL INFECT INJURY ACCID RESPIRAT DIS STUPOR VISION ABNORM
Became fussy and took to doctor. He said it was a virus. Child became worse; went back to the doctor and he had a grand mal seizure and stopped breathing in the waiting room. He was taken to the hospital and almost died from seizures. MR showed cerebral palsy and cortical visual impairment. The 60 day follow-up states cerebral palsy. Diagnosis from hospital: shaken baby syndrome with intracranial hemorrhage, retinal hemorrhage, Traumatic Stupor - Coma

This baby was born 3 months before term. He was "healthy" when at age 3 months he received 3 vaccines. He developed symptoms 8 days after vaccination and was evaluated. He did not have any evidence of injury and was sent home with a diagnosis of a viral illness. He was brought back to the doctor's office where he convulsed and stopped breathing. He became permanently damaged. The circumstances as described do not suggest abuse.  The timing of the severe seizures is compatible with a vaccine reaction. There were 8 other reports to VAERS for DTaP lot 390969: 66129, 75239, 76157, 76167, 76476, 76860, 86318, 94563. Case 76476 had a seizure. There were 42 reports to VAERS with HIB lot 010LD  (actually M010LD). Seven infants were hospitalized and one expired (case 77666),
VAERS ID 178960 Vaccination Date: 2001-11-28
Age 3.0 Date filed: 2001-12-13  
Sex M Where Administered: PUB
State MO Purchased by: PUB
Life Threatening Illness? No
Died? Yes (date died: 2001-11-28)
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data: NONE
Previous Vaccinations:
Other Medications: Phenobarbital; Baclofen; Robinul; Extendryl; Zyrtec Syrup; Nasonex Spray; Senocot Children’s Syrup; NaFl; Acetaminophen Solution; Atrovent Neb
Preexisting Conditions: Shaken baby syndrome at 5 weeks of age; Blind; CA; Seizures; 13 weeks premature; Disorder microcephaly; NPO with G-tubes
  Vaccinations Manufacturer Lot Dose Route Site
1 FLU WYETH 4018041 4 IM RA
Onset Date: 2001-11-28    Number of Days: 0
Symptoms: INJURY INTENT
The pt had no problems immediately after injection or prior to being discovered dead in crib at 05:45 on 11/28/01. On the last check of pt at 03:00 on 11/28/01, he was laughing and playing. Death certificate indicates the child died from shaken baby syndrome (suffering from this since 5 weeks old according to the dept of health).

This 3 year-old boy (ex-13 weeks premature) died hours after receiving a flu vaccine. It is difficult to understand how a 1998 diagnosis of shaken baby syndrome can be listed as the cause of a sudden death in 2001, particularly when the child had "no problems" in the doctor's office immediately after he received the flu vaccine and even later at home, before he died. In 2001, the same flu vaccine was used for children and adults. The dose was ¼ cc for children under the age of 3 and ½ cc for adults and children over 3. It is more than likely that an infant with all the problems listed, who is only fed by gastrostomy tube, was small in stature and weighed much less than an average 3-year old. Under the circumstances, many pediatricians would have scaled the dose down to a ¼ cc. It is not known whether this was done. The limited information available suggests that several causes other than intentional injury could have caused the baby's problems at age 5 weeks. Listing the cause of death as shaken baby syndrome is not justified. Three other reports were filed with Flu vaccine lot number 4018041.  All 3 patients were adults. Two, 181314 and 181315, concerned females vaccinated in the same day and in the same facility in NY. The last was from Maryland.  In all probability, all 3 received the same dose as the baby.
VAERS ID 130604 Vaccination Date: 1998-11-03
Age 0.1 Date filed: 1999-11-12  
Sex M Where Administered: PVT
State NY Purchased by: OTH
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes (days in hospital: 8)
    Prolonged Hospitalization? No
Current Illness: NONE
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: pt recv pedvax HIB by MERCK given 9/13/98;
Preexisting Conditions: club foot-left;
  Vaccinations Manufacturer Lot Dose Route Site
1 DTAP CONNAUGHT LABS 0962260 0 IM RL
2 HBHEPB MSD   0    
3 HIBV MSD 0907H 1 IM LL
4 IPV CONNAUGHT LTD N0597 0 SC RL
Onset Date: 1998-11-12    Number of Days: 9
Symptoms: AGITATION CONVULS CRY ABNORMAL HEM RETINAL HEMATOMA SUBDURAL
p/vax pt devel constant crying;pt exp a sz;pt hosp x 8 days;dxed w/ retinal hemorrhages & subdural hematomas. Follow up received 5/3/01 states the baby’s problem was "shaken baby syndrome" with intercranial hemorrhages, not a reaction to shots. No further information available regarding the pt or this case. 15-day follow up received 5/15/01 states the baby’s problem was "shaken baby syndrome" with intracranial hemorrhages not a reaction to the shots. The pt’s father has been convicted and is in jail for sha

The tone and "language" of the original report suggest that it was a professional rather than a parent. The baby's clubfoot could have been due to oligohydramnios, or reduced amniotic fluid, a condition that may have caused other problems in the fetus.

Constant crying and seizures 8 or 9 days after vaccination are accepted vaccine reactions. Retinal hemorrhage has been described after Hepatitis B vaccination.

In the report, 0907H is listed as a HIBV lot number. It is not. It is a HBHEPB lot number. 

HBHEPB is a combination vaccine containing HIB and Hepatitis B vaccine. If indeed the baby received a dose of HBHEPB vaccine and a dose of a vaccine from lot 0907H, as reported, he actually would have received TWO doses of the same HBHEPB vaccine or two HIB and two Hepatitis B vaccines on the same day. In addition, the baby was under 2 months of age on 11/3/98 (listed as age 1 month). He should not have received a PedvaxHIB (a HIB vaccine) on 9/13/1998, shortly after birth. The first dose of HIB vaccine is usually administered around 2 months of age and usually with other vaccines. It is the first dose of hepatitis B vaccine, which is recommended shortly after birth.

The original report was filed on 11/12/1999, one year after the event.

Two statements to the effect that this was Shaken Baby Syndrome and not a vaccine reaction were added some 18 months later (5/3/2001 and 5/15/2001).

Because of these inconsistencies the complete medical record should be carefully reviewed.

The following information about DTAP lot 0962260 and HBHEPB lot 0907H is relevant:

There were 89 reports to VAERS with DTAP lot 0962260.

Four infants had convulsions: Reports 120168, 120302, 151191 and 170393:

There were two reports of death: 132111 and 170393, both somewhat relevant to the discussion. 

VAERS ID 132111 Vaccination Date: 1999-11-26
Age 0.4 Date filed: 1999-12-10  
Sex M Where Administered: PUB
State TX Purchased by: PVT
Life Threatening Illness? Yes
Died? Yes (date died: 1999-11-28)
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: resp distress, pneumothonax, PDA, Apnea, anemia, thrombocytopenia, hypotension;
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions: resp distress, pneumothrax, PDA, Apnea, Anemia, thrombocytopenia, hypotens, candida UTi, penumonia;
  Vaccinations Manufacturer Lot Dose Route Site
1 DTP CONNAUGHT LABS 0962260 0 IM  
2 HEP MSD 1522J 0 IM  
3 HIBV LEDERLE(PRAXIS) 458728 0 IM  
4 IPV CONNAUGHT LTD P02422 0 SC  
Onset Date: 1999-11-27    Number of Days: 1
Symptoms: FEVER
p/vax pt devel fever, initially low grade, then 104 by 11/29/99 AM;APAP q 4hr beginning w/vax;
This infant had documented thrombocytopenia or low platelet count. Symptoms seen with reduced platelets include bruising, bleeding without obvious injury and non-clotting
VAERS ID 170393 Vaccination Date: 1999-01-08
Age 0.7 Date filed: 2001-05-31  
Sex M Where Administered: PVT
State FL Purchased by: PUB
Life Threatening Illness? Yes
Died? Yes (date died: 1999-01-09)
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes (days in hospital: 2)
    Prolonged Hospitalization? No
Current Illness: Gastroenteritis and vomiting for 1 day
Diagnostic Lab Data:
Previous Vaccinations: ;UNK. DTAP;;2.00;In Sibling
Other Medications: Tylenol
Preexisting Conditions: NONE
  Vaccinations Manufacturer Lot Dose Route Site
1 DTAP CONNAUGHT LABS U0962260 0 IM LL
2 HEP SMITHKLINE ENG626A 0 IM RL
3 HIBV LEDERLE(PRAXIS) M240RL 0 IM LL
4 OPV LEDERLE 45084607 0 PO  
Onset Date: 1999-01-08    Number of Days: 0
Symptoms: ANAPHYL APNEA BONE FRACT SPONTAN CONVULS ECCHYMOSIS EDEMA BRAIN ENCEPHALITIS EYE DIS HEM INTRACRAN HEM RETINAL HEM SUBARACHNOID HEMATOMA SUBDURAL INJURY ACCID PNEUMONIA SCREAMING SYND SKIN DIS SOMNOLENCE
Convulsion, caused eye contusion, E.T.C.; lethargic en-route to hospital, E.T.C.; Encephalitis, high pitched screaming, E.T.C., pneumonitis, apnea, anaphylaxis, sclerosis.

This report is very important.

Shortly after receiving the 4 listed vaccinations, this seven months old infant had all of the following: convulsions, apnea (stopped breathing), injury/fracture, brain edema, retinal, subarachnoid and subdural hemorrhages, encephalitis and pneumonia and died. The uninformed could have interpreted all these symptoms as evidence of SBS. The pediatrician was right to report the case as a vaccine reaction.

There were 8 reports to VAERS concerning HBHEPB 0907H, including one death (case 130608), which interestingly was reported on the same day as case 130604.

VAERS ID 130608 Vaccination Date: 1999-10-01
Age 1.0 Date filed: 1999-11-12  
Sex F Where Administered: PUB
State KY Purchased by: PUB
Life Threatening Illness? No
Died? Yes (date died: 1999-10-13)
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data: chemistry-BUN 36, CR 0.8, aGT 162, LDH 4054;aridocid 9.1;paltelets 90,000;PT/PTT 18.1/39.4;abrinogan 382;bil 1.8;
Previous Vaccinations: NONE
Other Medications: NONE
Preexisting Conditions: NONE
  Vaccinations Manufacturer Lot Dose Route Site
1 HBHEPB MSD 0907H 3 IM LL
2 OPV LEDERLE 0998H 2 PO  
Onset Date: 1999-10-13    Number of Days: 12
Symptoms: ABDO ENLARGE APNEA BUN INC CYANOSIS FEVER HEART ARREST INFECT LAB TEST ABNORM PAIN PROTHROMBIN DEC THROMBOCYTOPENIA THROMBOPLASTIN DEC
pt adm to hosp 10/13/99 w/fever, leg pain, abd distention & leg purple; dx Beta-hem, streptococci group A invasion.-transported to hosp; complications; cardiopulmonary arrest;

12 days after vaccination, this one-year old girl from Kentucky developed thrombocytopenia and coagulopathies, with pain and purple discoloration of the legs, abdominal distention, renal involvement, breathing difficulty, cyanosis and cardio-respiratory arrest. She died within 24 hours. The beta-hemolytic streptococcus group A sepsis was probably the result of "immune paralysis" a rare vaccine reaction Similar cases of sepsis after HIB vaccination were described earlier in this review with HIB M030FC (27224, 27494, 27648, 28438).

*          *          *

Lastly, how many reports with SBS were there?

Search: SBS

Result: 2 cases

In the first case (103221), SBS was a typographical error, because it referred to FBS (Fasting Blood Sugar). The second is case 188855 (below), which is important because of the report of multiple rib fractures.   

VAERS ID 188855 Vaccination Date: 2002-05-01
Age 0.4 Date filed: 2002-08-14  
Sex M Where Administered: PVT
State CA Purchased by: OTH
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes (days in hospital: 4)
    Prolonged Hospitalization? No
Current Illness: Stuffy, congested, heavy breathing
Diagnostic Lab Data:
Previous Vaccinations: Excessive crying;Hep B (unknown mfr);1;0;In Patient
Other Medications: NONE
Preexisting Conditions: NONE
  Vaccinations Manufacturer Lot Dose Route Site
1 DTAP AVENTIS PASTEUR, DO546AA      
2 HIBV AVENTIS PASTEUR, UA482AA      
3 IPV AVENTIS PASTEUR, U0824      
4 PNC LEDERLE LABORATO 425997      
Onset Date: 2002-05-06    Number of Days: 5
Symptoms: AGITATION ANOREXIA FEVER HEM MONILIA ORAL RHINITIS SCREAMING SYND SOMNOLENC    E VASODILAT
1st shot 3/8/02, HEB 1, congested, irritable, fussy. 2nd shot 5/1/02, IPV/OPV, DTaP, DTP, DT/TD, HIB, PPV, very congested, irritable, high pitch cry, fever, hot and cold flashes, cold sores-thrash, sleepy, no eating well. No solutions. Doctors say baby has "SBS." Subdural heamtoma, non-accidental trauma, multiple rib fractures.

This baby reacted to his first hepatitis B vaccine with excessive crying. He had a cold when he received 4 vaccines together on 5/1/2002. Irritability, high-pitch cry and fever suggest a vaccine reaction. Hot and cold flashes, cold sores and congestion are symptoms related to the pre-existing viral illness. It is not known whether the so-called subdural hematoma was old or new or old and new, a re-bleed. A detailed description of the MULTIPLE rib fractures would have been helpful; unfortunately it is not available. Evidence of other trauma and severe injury to the chest wall and lungs should have been noted if multiple ribs were broken all together. If the fractures were at different stages of healing, intentional trauma would be less likely. The suggestion that a parent can break his infant's ribs, only one rib at a time every few days, without inflicting any other injury, or being noticed, is far fetched. In an infant, "fractured" ribs "healing at different stages of callus formation" may represent sequential spontaneous bleeds under the periosteum due to a metabolic disorder or sub-clinical scurvy.

The fate of the caretaker is not known. It is possible that he or she is still in jail in California.

Vaccines review:

DTAP lot DO546AA: This case was the only one reported.

HIB lot UA482AA: There were 4 reports. The other 3 were reactions at the injection site.

IPV UO824: 6 reports filed. None was relevant to this discussion.

PNC (Pneumococcal vaccine) lot 425997: This case was the only one reported.

*          *          *         

Discussion

A simple search of VAERS data yielded several reports of "Shaken Baby Syndrome".

After careful review, it is clear that in most cases the diagnosis of SBS was questionable and the possibility of a vaccine reaction more likely.

Local and state police may have hesitated in filing charges if they had seen the preceding information.    

It is unlikely that a judge or jury would have rendered a guilty verdict in any of the discussed cases. An appeal should be considered if a parent is still incarcerated as a result of these reviewed reports.

Even at this late stage, evaluation of the records and evidence in the cases by the respective "State Board of Medical Review" may help vindicate the parents.

Child protective agencies will get involved and actually remove the infant and his or her siblings to foster care for extended periods of time if they suspect abuse, whether criminal charges are filed or not. Trying to extricate the family from this situation can be very difficult. Parents should remain calm, cooperative and courteous at all times. Locking horns with the young social worker on the case or her powerful supervisor is useless and often counter-productive. Hopefully in time, the family's innocence will be recognized and things will be allowed to return to normal.

The employees of the department of children and families have stressful jobs and very heavy caseloads. They are forever reminded about the few unfortunate situations when infants were returned to abusive parents only to be injured a short time later. Their position "to be rather safe than sorry" is understandable, though at times unjustified.

Parents need to become very knowledgeable about vaccines, so that their consent is truly  "informed" every time; they should gather all available information and not be afraid to ask questions. An infant with any problem, past or present, could be at-risk for an adverse event.

Because several vaccines are often administered together, their reactions may be difficult to assess. Sorting events and responsibility will become more of a challenge. If the vaccines are new on the market, some of their after-effects may not have been fully understood or reported as yet. 

If a baby develops any symptoms following vaccination, the parent/caretaker should inform the physician at once and go on "high alert".

It is advisable to keep the private physician or pediatrician involved in the case, even if the infant is hospitalized. His or her knowledge of the situation can be helpful particularly in discussions of family dynamics.

Should the empathic attitude of the hospital staff change or should someone bring up the subject of shaken baby syndrome or child abuse, the "suspected parent/caretaker" should remain non confrontational. He/she should ask a lot of questions and write long notes about what is being said and done, describing signs, symptoms and tests in great detail. This will be very difficult under the circumstances, but could be of great help later on.

An attorney should be contacted early rather than late and if possible, a consultation by a medical specialist should be requested as a second opinion. If the baby's pediatrician is not on the case, he or she should be also notified and asked to help.

The parents should promptly file a report with VAERS if the symptoms and timing suggest a vaccine reaction. The toll free number is (800) 822 7967

All efforts must be directed towards saving the affected baby. Nothing else is as important.

If the infant expires, a medical examiner's report should be considered incomplete if it does not include a discussion of all recent vaccinations.

Conclusions

A parent or a caretaker who is out of control may shake or hit an infant against a hard surface. It is imperative that all children are protected and that the abusive adult is punished.

On the other hand, as this review suggests, some accused parents whose children were thought to have "Shaken Baby Syndrome" were probably innocent.

A diagnosis of Shaken Baby Syndrome must not be made lightly. It should only be entertained when all other causes for the findings, vaccines included, have been thoroughly examined and ruled out. 

Any future research on child abuse and specifically Shaken Baby Syndrome must include a discussion of recent vaccinations.

PS: Compliments to Nick Regush for considering the topic of Shaken Baby Syndrome and initiating this scientific discussion.

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