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A Not-So-Perfect Vaccine: The Diphtheria, Tetanus And Acellular Pertussis Vaccine: An Investigation

By: Dr. F. Edward Yazbak

The Disease

Pertussis or Whooping Cough is an acute infectious disease caused by Bordetella pertussis.  The disease has been described for centuries; the organism was first isolated in 1906. Whooping cough is transmitted through the respiratory route usually by droplets of secretions.

The incubation period is usually 7 to 14 days but may be as short as 5 days and as long as 21 days. The disease evolves in three phases. Patients are most contagious during the initial catarrhal stage consisting usually of minor cold symptoms and a slight nocturnal cough. During the paroxysmal stage, which may last for several weeks, the patient has the more characteristic coughing spells, which culminate in an inspiratory whoop and are often followed by vomiting. There is usually a marked leucocytosis (increased white count) and lymphocytosis (increased lymphocyte count). In newborns and young infants, whooping cough may present as apnea and cyanotic spells. During the convalescent stage, the paroxysms subside; the patient coughs less and clinical improvement becomes evident.

Erythromycin is the antibiotic of choice for the treatment of whooping cough. If given early, it shortens the course of the illness and reduces its severity. Because it also eradicates the organism from the secretions, it decreases spread and communicability.

Erythromycin or trimeththoprim-sulfamethoxazole prophylaxis is of value for close contacts and is recommended regardless of vaccination status.

According to the Centers for Disease Control and Prevention (CDC) “Since widespread use of the vaccine, incidence (of whooping cough) has decreased more than 98%, to an average of about 3700 cases per year since 1980... Whole-cell pertussis vaccine is composed of the suspension of formalin–inactivated B. pertussis cells. It was developed in the 1930s, and used widely in clinical practice by the mid 1940s”.

Until lately, the whole cell pertussis vaccine was available in combination with diphtheria and tetanus toxoids as DTP and contained thimerosal, a mercury derivative. The vaccine was also sometimes referred to as DPT.  Both DTP and DPT refer here to the same product: Diphtheria and Tetanus toxoids plus whole-cell Pertussis vaccine.

The following statements are basic to whooping cough and whooping cough vaccination:

  1. The incidence of whooping cough in the United States had decreased before the introduction of the pertussis vaccine
  2. It has continued to decrease since the vaccine has been in use.
  3. Whooping cough may be a serious and potentially fatal illness in young and vulnerable infants. 
  4. DTP vaccination has been associated with many severe and permanent adverse events including encephalopathy, brain damage, seizures, and even death. The reactions have been attributed to the pertussis component.

An excellent resource on the subject of DTP vaccine reactions is the website of the National Vaccine Information Center (1).

Of 253 infant deaths cases awarded more than 61 million dollars by the US Court of Federal Claims in the 1990s, 224, or 86%, were attributed to vaccination with DTP.  The cause of death had originally been listed as Sudden Infant Death Syndrome (SIDS) in 90 of these cases or 40%. It should be noted that relatively few vaccine injury cases are ever filed in the United States and that, in only a small percentage of those cases, are the plaintiffs compensated. 

There were sporadic reports of serious neurological complications and death following DTP vaccination in the fifties and sixties

In 1977, G. T. Stewart (United Kingdom) published an important study in the Lancet titled “Vaccination against whooping-cough. Efficacy versus risks”(2).

Calculations based on the mortality of whooping cough before 1957 predict accurately the subsequent decline and the present low mortality. Notifications of incidence, though variable and incomplete, follow the same pattern of steady decline in the United Kingdom and are unaffected either by small-scale vaccination beginning about 1948 or by nationwide vaccination beginning in 1957… attack-rates may be lower and complications fewer in vaccinated children… No protection by vaccination is demonstrable in infantsAdverse reactions and neurotoxicity following vaccinations were studied in 160 cases. In 79, the relationship to pertussis vaccine was strong. In 14 of these cases, reaction was transient but characteristic of a syndrome of shock and cerebral disturbance, which, in the other 65 cases, was followed by convulsions, hyperkinesis, and severe mental defect. It seems likely that most adverse reactions are unreported and that many are overlooked. Precise information about the efficacy and safety of this vaccine is lacking, because existing provisions, national and international, for epidemiological surveillance and evaluation are inadequate. The claim by official bodies that the risks of whooping-cough exceed those of vaccination is questionable, at least in the U.K.”

In 1979, Stewart reported in the Scottish Medical Journal (3):

“Herd infections, especially in children, are strongly influenced epidemiologically by social and demographic factors which have contributed favorably to a general decline in incidence and mortality during the past 50 years or more. Intervention procedures such as immunization cannot be evaluated or planned realistically except against these background factors. Assessed in this way, immunization against diphtheria and poliomyelitis was unequivocally effective in reducing incidence and morbidity of these diseases. By comparison, pertussis vaccine has a very limited protective effect, the value of which, as morbidity decreases, may be offset by the intrinsic toxicity of the vaccine and by the possibility of infrequent but severe brain damage in some children. “

In 1982, William C. Torch, MD, Director of Child Neurology, University of Nevada School of Medicine presented a study at the 34th American Academy of Pediatrics (AAP) Meeting and stated: “These data show that DPT vaccination may be a generally unrecognized major cause of sudden infant and early childhood deaths, and that the risks of immunization may outweigh its potential benefits.  A need for a reevaluation and possible modification of current vaccination procedures is indicated by this study."               The Torch study findings were criticized as anecdotal.

In 1983, Baraff et al. reported a DTP-Sudden Infant Death Syndrome (SIDS) temporal association in the Journal of Pediatric Infectious Diseases.  They reviewed cases of SIDS recorded in Los Angeles County and interviewed 145 families. The authors reported that there was a statistically significant excess of deaths in the first day and first week after DTP, a “temporal association”. The authors rejected the need to use a “Control Group” relying on the assumption that “there should be no temporal association between DTP immunization and SIDS, were there no causal relationship between these two events.” 

In 1985, Professor G. T Stewart published another review article (4) titled “Whooping cough and pertussis vaccine: a comparison of risks and benefits in Britain during the period 1968-83”, in which he stated:

 “Deaths of infants with whooping cough have decreased steadily since 1900 [i.e. before the isolation of the causative bacteria and the development of the vaccine] , the rate since 1975 being the lowest ever. Active epidemiological surveillance in Glasgow, with a population of 216,000 children and 13,000 births annually, shows that outbreaks and severe cases requiring admission to hospital were concentrated consistently in a few areas of deprivation… There were no deaths attributable to proven or suspected infections with Bordetella pertussis during the period 1972-1983. No cases of encephalopathy, permanent brain damage or lung damage were detected in a follow up of all cases notified, surveyed or admitted to hospital between 1975 and 1982. Collectively, these national and local data provided estimates of the frequency of infection, complications of infection, admission to hospital and death in children with whooping cough for comparison with local, national and published estimates of the frequency and severity of adverse reactions, encephalopathy, permanent brain damage and death after injections of pertussis vaccine. It is concluded that, in children living in non-deprived circumstances in Britain, the risk of pertussis vaccine during the period 1970-83 exceeded those of whooping cough. In some deprived sectors, the risks from whooping cough might have been marginally higher but there was no evidence that this was associated with any increase in deaths or permanent disabilities.”

A multidisciplinary workshop on the Neurologic Complications of Pertussis and Pertussis Vaccination was held in the fall of 1989 in Warrenton Virginia.                 Professors J. H. Menkes and M. Kinsbourne, both renowned neurologists and accepted experts in the field, published the report of that workshop which can be found in its entirety on the National Vaccine Information Center (NVIC) web site. To this day, the report remains the most careful and unbiased reference on the subject and the following information is gratefully reproduced.

About the disease: " Pertussis mortality in the US is 2-3/1000 cases. Seizures occur in 1.9% of cases, and encephalopathy in 0.3%.  It appears likely that a combination of one or more bacterial toxins, asphyxia, CO2 retention and loss of cerebral vascular autoregulation is responsible for the neurologic symptoms.  The timing of the encephalopathy, suggests that it results from increased lysis of bacteria and release of endotoxin. The encephalopathy is not confined to the paroxysmal phase.

About the DTP vaccines: In evaluating side reactions to the vaccine, the following must be kept in mind:

  1. Vaccines are not standardized between manufacturers
  2. For a given manufacture, vaccines are not standardized from one batch to another.
  3. Unless the vaccine is properly prepared and refrigerated, its potency and reactivity vary with shelf life.

In fact, the whole question of vaccine detoxification has never been systematically investigated.

Listed in order of increasing severity, observed adverse reactions include irritability, persistent, unusually high pitch crying, somnolence, seizures, a shock-like “hypotensive, hyporesponsive” state, and encephalopathy.  Since the neurologic picture is not specific for pertussis vaccination, its temporal relationship to the vaccination is that critical variable for determining causation.

Menckes and Kinsbourne went on to say that although the majority of seizures following pertussis vaccination were associated with fever, it was the consensus of the neurologists attending the workshop, that they did not represent febrile convulsions but that they were in fact non-benign convulsions.

The incidence of post-vaccine encephalopathy was difficult to ascertain. Quoting a British study by Miller published in the British Medical Journal in 1981, Menkes and Knsbourne stated: “…The relative risk of a previously normal infant for the onset of an illness leading to permanent encephalopathy was 4.2 times greater during the first 72 hours following DPT vaccination than in controls.  From this study, the risk of permanent brain damage following DPT has been calculated as 1:310,000 doses….”

 (Please note that the authors referred to “doses”. If each child actually received the recommended primary series (3 doses) and boosters (2 doses), then potentially, permanent brain damage from the DTP vaccine could be as frequent as 1:60,000 children)

It was the consensus of the workshop, and in particular, the participating neurologists, that although the vaccine may possibly accelerate neurologic signs or symptoms in some children, and a small proportion of apparent complications may be coincidental, there was no inherent difficulty in assigning cause and effect to the vaccine and subsequent neurologic residua…. In summary, it was the consensus that there is sufficient experimental data to implicate both endotoxin and PT (Pertussis Toxin) in adverse neurologic reactions to pertussis vaccine.”

Menkes & Kinsborne also reviewed the findings in 20 cases of seizures and encephalopathy following DTP vaccination seen by Prof. Jean Aicardi (Hopital des Enfants Malades, Paris).  In all cases symptoms started within 72 hours, and usually within 24 hours of pertussis vaccination.  Fifteen of the 20 patients developed symptoms within 12 hours of the vaccination. There was frequently change in consciousness or coma of several days duration, followed by an abrupt developmental arrest.  Seizures presented as myoclonic epilepsy or status epilepticus. The EEG was originally normal in 75% of the cases but seriously deteriorated with time. The examination of the cerebrospinal fluid usually revealed normal findings.

 

The Japanese Experience

There were 37 infant deaths and 57 “temporally related severe events” after DTP vaccination in Japan between 1970 and 1974. Because of a boycott by physicians and parents, the government stopped the vaccination program in 1975 to examine the situation. It then recommended resumption of DTP vaccination starting at 24 months of age. In the period that followed, there were only TWO reports of children older than 2 filed for vaccine compensation but not a single infant death and Japan’s infant mortality rate (IMR) dropped from 17th to lowest in the world. [The United States ranked 23rd highest in infant mortality among the 29 industrialized countries in 1995. (8) In 2000, Japan had the lowest IMR among the G7 nations with 3.9 infant deaths per 1000 live birth; The US had the highest, with 6.8 per 1000.]

After a while and because of an increase in the number of cases of whooping cough, the vaccine authorities in Japan gave parents the choice to start their children’s DTP vaccination between 3 and 48 months of age.(Vaccination is not compulsory in Japan.)  According to Hiroshi Nishida, the rate of Sudden Infant Death Syndrome (SIDS) increased by 371% from 0.07% in 1980 to 0.33% in 1992, in spite of the fact that starting in 1981, DTaP (Diphtheria and Tetanus toxoids with acellular pertussis vaccine) which caused fewer reactions, was used exclusively in Japan. Presently, according to the World Health Organization (WHO), the recommendation for the DTaP primary series in Japan is two injections between 3 and 90 months and a third between 6 and 90 months of age (6)

U.S. Concerns

In “The true story of pertussis vaccination: a sordid legacy?” Geier and Geier discussed the DTP experience in detail. (7) Their article is a superior review of the subject.

A special committee of the Institute of Medicine (IOM) held repeated meetings on DTP vaccination and its problems. It reported the following:

In 1985: There is the highest priority to switch to acellular pertussis vaccine

In 1990: There is sufficient evidence that whole-cell pertussis vaccine causes acute encephalopathy but the evidence is not conclusive enough that the vaccine causes brain damage.

In 1993: Whole-cell pertussis vaccine causes brain damage.  

[Also in 1993, the British National Childhood Encephalopathy Study (NCES) group conceded that whole-cell pertussis vaccine caused permanent brain damage]

In 1994: Whole-cell. pertussis vaccine was more likely than not responsible for causing encephalitic reactions with a reasonable degree of medical certainty for up to 7 days after immunization in previously normal children.

 

The DTAP Vaccine

[Here, I’ll refer to the vaccine as DTAP, instead of DTaP]

The Federal Drug Administration (FDA) approved the use of DTAP for booster doses in 1991 and for all doses in 1996. All DTP and DTAP products used in the US contained thimerosal, a mercury derivative. In 1999, the AAP and FDA recommended that thimerosal be removed from pediatric vaccines.

Several acellular pertussis vaccines were developed and licensed in the United States. They contained different purified inactivated components of B. pertussis in varying concentrations and were always combined with diphtheria and tetanus toxoids. No single antigen pertussis vaccine has been available commercially for sometime. According to the CDC:

“Contraindications to further vaccination with DTP or DTAP are severe allergic reactions to a prior dose of vaccine or vaccine component and encephalopathy, not due to another identifiable cause, within 7 days of vaccination…Certain infrequent adverse events following pertussis vaccination will generally contraindicate subsequent doses of pertussis vaccine. These adverse events are: Temperature to 105°F within 48 hours, not due to another identifieable cause, Collapse or shock-like state (hypotensive-hyporesponsive episode) within 48 hours, Persistent, inconsolable crying lasting 3 hours or more and Convulsions with or without fever occurring within 3 days…Acellular pertussis vaccine should not be substituted in children who have a valid contraindication to whole cell pertussis vaccine. If a valid contraindication or precaution exists, DT should be used for the remaining doses on the schedule.” (9)

The manufacturer of one of the still available DTAP products lists the same contraindications as those of the CDC; specifically that encephalopathy (not due to other identifiable causes) within 7 days of vaccination is a contraindication for further pertussis vaccination. According to that manufacturer, encephalopathy consists of major alterations of consciousness, unresponsiveness, generalized or focal seizures that persist for more than a few hours and failure to recover within a few hours. (10)

Interestingly, and most unfortunately, as shown in the box below, filing for “on-table” vaccine compensation is allowed only if encephalopathy has occurred in the 72 hours following vaccination with a pertussis antigen-containing vaccine (11)

National Childhood Vaccine Injury Act
Vaccine Injury Table

Effective August 26, 2002

Vaccine

Adverse Event

Time Interval

I.    Tetanus toxoid-containing vaccines (e.g., DTaP, DTP-Hib, DT; Td, or TT)

A. Anaphylaxis or anaphylactic shock

0-4 hours

B. Brachial neuritis

2-28 days

C. Any acute complication or sequela (including death) of above events

Not applicable

II.   Pertussis antigen-containing vaccines (e.g., DTaP, DTP, P, DTP-Hib)

A. Anaphylaxis or anaphylactic shock

0-4 hours

B. Encephalopathy (or encephalitis)

0-72 hours

C. Any acute complication or sequela (including death) of above events

Not applicable

It seems strange that under a banner saying Helping America Heal, the vaccine injury table limits compensation to those cases where encephalopathy or encephalitis occurred within 72 hours of vaccination when the CDC, a special committee of the IOM and the vaccine manufacturer state that encephalopathy can occur within 7 days of vaccination with a pertussis antigen.

It is imperative to note that all pertussis antigen-containing vaccines including DTaP are accepted as potential causes of encephalopathy and not only DTP.

Many physicians and indeed many lawyers are under the impression that “all pertussis vaccine problems” have disappeared with the DTP. The CDC and the vaccine manufacturers have encouraged such feeling of safety and security.

Let’s then carefully review, possibly for the first time, the DTAP-associated problems, including SIDS deaths, reported to the Vaccine Adverse Event Reporting System (VAERS).

 

Pertussis Deaths

The Perspective.

There were 92 deaths due to whooping cough in the United States between 1980 and 1995 or on average of 6 cases a year.

In comparison:

  • In the same 15 years, there were 266 deaths due to tetanus, an average of 18 cases a year. (9)
  • During July-August 1998, eleven children died because they were entrapped in the trunk of a car. (12)
  • According to the National Safe KIDS Campaign, falls killed 112 children in 1997 alone and about 18 children die annually after falling from windows. (13)
  • 53 children died in drowning accidents in 1999 in the state of Georgia alone (14)

Of the 36 children whose cases were reviewed, 4 had drowned in a bathtub at home.

The vaccine authorities were extremely concerned in 2000 because there had been an increase in the number of cases of pertussis and 17 deaths (15). All infants who died were under 4 months of age.

In Scandals-07/26/02, Sandy Gottstein Mintz discussed those 17 deaths in relation to the DTAP reports to VAERS. (16)

  • There were 57 DTAP-associated deaths in 1998 (reported by the end of 2000)
  • If indeed only 10% of cases are ever reported to VAERS, then possibly 570 deaths actually occurred shortly after DTAP vaccination, most often with other vaccines.
  • There were 23 reports of infants expiring by the day following vaccination. Even without factoring in any under-reporting to VAERS, the number of infants reported to have died by the day following DTaP vaccination in 1998 is still more than the number who died as a result of whooping cough in the year 2000

Vaccination rates are not uniform nationwide. The perspective of the Mintz analysis becomes even more disturbing when one looks at the proportion of infants who had actually been vaccinated according to the CDC recommendations. From January to December 1998, only 7 (seven) states achieved the 90% vaccination goal for four doses of the combined diphtheria, tetanus and pertussis vaccines. (17)

DTP, DTAP and VAERS

Between 1990 through the end of 2002 the following reports were filed with VAERS.     In most of them, multiple vaccines were administered at the same time.

   

DTP

DTAP

All Reports

 

26,581

18,484

Deaths

All

942

416

 

% of total

3.5

2.2

SIDS

All

568

243

 

% of total

2.1

1.3

 

% of deaths

60.3

58.4

Life Threat

All

561

348

Hospitalized

All

3,518

1,721

 

Under age 1

2,481

1,087

Apnea

All

953

331

 

Under age 1

784

264

Seizures

All

193

275

 

Under age 1

116

170

Stupor

All

1,760

701

 

Under age 1

1,253

425

Fever

All

5,617

2,839

 

Under age 1

3,122

1,130

Table I

A comparison between DTP and DTAP reports to VAERS is not possible because as DTP was phased out, DTAP was gradually introduced during the 1990’s. In addition, neither the number of doses distributed nor the size of the different vaccine lots is available

DTAP in VAERS

As mentioned earlier, the US Court of Federal Claims agreed that DTP vaccination was responsible for 224 infant deaths in the 1990s and awarded compensation to the plaintiffs. In 90 of these infants or 40%, the cause of death had originally been listed as SIDS.

A careful VAERS search was conducted to examine SIDS reports after DTAP vaccination in a small and hopefully representative sample. The first 25 consecutive reports of infants who received DTAP in 2000 and died within 72 hours were reviewed. The 72-hour period was selected because of the time limitation on the vaccine injury table. All the selected reports can be found in pages 40 to 48 of the 84 pages of death reports after DTAP. In 23 cases, the infant had received other vaccines.

HBHEPB is a combination of Hepatitis B and HIB vaccines.
HEP is Hepatitis B vaccine
HIB is Hemophilus Influenzae B vaccine
IPV is Inactivated Polio Vaccine
PNC is the pneumococcus-7 vaccine.

Case

Age

Sex

State

Other vaccines administered

Inter-

val to

Death

DTAP

Lot #

Cause Death Notes

134070

6m F

OH

None

3 d

DPTA917A2

SIDS   a

150474

3m M

MT

HIB, IPV

1 d

467675

            b

150475

5m M

IL

None

2 d

Not listed

SIDS

150874

3m M

TX

HIB, IPV

< 1 d

1004R

SIDS   c

150931

2m F

MA

HIB, IPV

1 d

40040CA

            d

151190

3m M

OR

HBHEPB, IPV

3 d

DTAP9121A2

SIDS

151618

2m M

PA

HBHEPB, IPV

2 d

91682

            e

151620

3m M

LA

HBHPV, IPV

< 1 d

A919A2

SIDS   f

151621

2m M

CT

HIB, IPV

1 d

U0045BA

SIDS   g

151867

2m M

GA

HBHEPB, IPV

1 d

U0137BA

SIDS   h

152213

2m M

AR

HEP, HIB, IPV

1 d

462354

            i

152301

2m M

OH

HBHEPB, IPV

< 1 d

467673

SIDS

152417

2m M

OH

HIB, IPV

3 d

7389AA

SIDS

152502

1m M

AL

IPV

1 d

UA475AA

            j    

153392

2m M

NV

HEP, HIB, IPV

< 1 d

469396

            k     

154522

??  M

FL

HIB, PNC

3 d

920A2

            l

155423

3m M

MI

HEP, HIB< IPV

2 d

918A2

SIDS

156329

2m M

MS

HBHEPB, IPV

1 d.

U0056FA

SIDS

156370

2m M

TX

HEP

< 1 d

UD173CA

           m

156861

3m M

AL

HEP, HIB, IPV

3 d.

D009

SIDS

158477

2m. F

NM

HBHEPB, IPV

1 d.

U0137BA

SIDS

159003

2m. M

?

HBHEPB, IPV, PNC

1 d.

467674

SIDS   n

159916

3m. F

TX

HBHEPB, IPV, PNC

3 d.

U0317BB

            o

160417

2m F

KY

HEP, HIB, IPV

2 d

467010

SIDS

160877

2m M

VA

HEP, PNC

3 d

U0317BB

            p

                      

Table II

Notes

Comments (in bold)

  1. Case 134070: Past history of Respiratory Distress Syndrome and seizures.                             
    Comment: Patient at risk. There is at least a warning (if not a contra-indication) listed concerning administering a pertussis antigen-containing vaccine to infants with seizures. 
  2. Case 150474: Past history: Negative. Symptoms: Apnea.  
    Cause of death: “Accidental suffocation 24 hours post vaccination.”                  
    Comment: It is difficult if not impossible to comment on such a statement!
  3. Case 150874: Past history: On amoxicillin till 3 days prior to vaccination. “Autopsy shows pulmonary vascular congestion, pulmonary edema, tracheobronchitis with bronchiolotis and peri-bronchiolar pulmonary inflammation, generalized visceral congestion, sudden infant death”                                                                        
    Comment: The infant was sick and on antibiotics 3 days before receiving 3 vaccines and died within 24 hours from vaccination. The autopsy revealed findings suggesting infection. Such “immune paralysis” has been described after vaccination. It simply means that while the baby’s immune system is busy dealing with the vaccine, it is overwhelmed by an intercurrent infection. A limited and specific form, Hemophilus Influenzae B
    invasive disease, is eligible for compensation as a vaccine injury if it occurs within 7 days of HIB vaccination. For the sake of completion, reports to VAERS with the same HIB lot number (512453A) were reviewed. There were 30 reports in all and one other death (case 131636): A 4-month old baby girl from NY who died within 24 hours of vaccination and who had had urological surgery 1 month earlier. The autopsy revealed a large abscess of the urinary bladder.
  4. Case 150931: Symptoms: Apnea. “Pt was well and went to sleep at approximately 10:30 pm. Found at 6:00 am not breathing. Pt had been put to sleep on her side but was found on stomach.
    Comment: Did this baby expire because she was on her stomach or because she had received 5 antigens one day earlier?
  5. Case 151618: Patient was on Augmentin. Preexisting Conditions: History of otitis media, bronchiolitis, colic, gas, seborrhea. “ Per mother’s report, infant experienced diarrhea, nasal congestion, no fever was noted. Autopsy states cause of death as interstital pneumonitis. Autopsy shows also pulmonary edema, focal intrapulmonic hemorrhage’
    Comment: In this case, the suggestion is that the baby had an infection, which resulted in his death 2 days after he received 6 antigens. It is well known that Augmentin can cause diarrhea. 
  6. Case 151620: Preexisting Conditions: Prematurity at 26 weeks, agenesis of corpus callosum. Patient was on medication for gastro-esophageal reflux and gas.
    Comment: This baby had problems and was at risk. He was probably still very small at 3 months of age. He received six antigens (and possibly 50 micrograms of mercury) less than 24 hours before death.
  7. Case 151621: Symptoms:Apnea, Heart Arrest, SIDS. “Found apneic and asystolic, tied up in blankets 24 hours after vax. Autopsy shows final cause of death as sudden infant death syndrome”
    Comment: “Tied up in blankets” or 24 hours after 6 antigens.
  8. Case 151867: Premature. Twin A.
    Comment: Infant at risk.
  9. Case 152213: Symptoms: Agitation. “Mother reports infant fussy night of 03/30/00. Laid infant on stomach and patted his back. Infant and mother fell asleep. Mother woke up and infant not breathing. Mother called 911”. Autopsy done. No report.
    Comment: Sleep position? Interval 24 hours.
  10. Case 152502: Past history: Cleft palate, hypospadias. “Post vax, infant was in bed with parents - found with mucus and blood in mouth early in the morning on 12/07. 911 was called. Unable to resuscitate. Both parents smoke. Moved into new trailer recently.”
    Comment: Smoking, Trailer, Sleeping with parents? Interval 24 hours, baby not 2-month old yet.    
  11. Case 153392: “Pt did not wake up the morning after shots were given. Autopsy gives cause of death as positional asphyxia”
    Comment: “Positional asphyxia” ? Interval less than 24 hours!
  12. Case 154522: Past history: Prematurity, Bronchopulmonary dysplasia and failure to thrive. “Three days post vax the pt died of unknown cause most likely related to severe BPD, prematurity and failure to thrive.”
    Comment: Infant at risk. The death is attributed to “unknown causes” plus pre-existing risk factors not to vaccines plus pre-existing risk factors.
  13. Case 156370: Symptoms: Acidosis, Anemia, Cardiovascular disease, Encephalopathy, Heart arrest, Hyperkalemia, Hypoxia, Infection, Bacterial pneumonia. “Pt found asystolic and pulseless in the field. Received epinephrine x 4 with heart rate obtained. Transferred to ICU, intubated but no respirations, fixed pupils, no corneal reflexes. Initial PH: 6.5; pt died about 15 hours after arrival with cardiopulmonary arrest.”
    Cause of death: Hypoxic Ischemic Encephalopathy (HIE) with disseminated intravascular coagulopathy, probably due to viral infection.
    No pre-existing conditions were reported. Under laboratory results, the reporter states: ”Initial hemoglobin was normal then dropped to <5. Initially severe acidosis, never corrected: potassium increased to 8.6”.
    Comment: It is hard to believe that anyone can think that a healthy 2-month old baby experienced all these catastrophic events and died because of a viral illness within 24 hours of DTAP and Hepatitis B vaccination. Interestingly, just three weeks ago, I was asked to comment on a similar situation. A 2-month old girl developed seizures and “HIE” within 48 hours from vaccination (DTAP, HIB, IVP and PNC) and is now permanently brain damaged. The treating neurologist reported the case to Social Services as possible child abuse or neglect and effectively destroyed the life of two innocent young parents as well.
  1. Case 159003: “Past history: Mother has history of smoking during pregnancy.”
    Comment
    : Mother’s smoking? Seven antigens 24 hours before death?
  2. Case 159916: Past history: Apnea, cyanosis, heart arrest “On 9/14/00, the baby was found blue and not breathing at 12:30 PM. Baby had been put to sleep at 10:30 am. Paramedics were unable to intubate due to rigor mortis. Taken to the ER and pronounced dead on arrival as pt was in asystole”. 
  3. Case 160877: Past history: Status post stage I surgery for Hypplastic Left Heart Syndrome. Other medications: Phenobarb, Lasix, Digoxin “20 hours post vax, the pt had a fever of 100. 72 hours post vax, the pt arrived unresponsive to ER and died during resuscitative efforts. A blood culture grew pneumococcus. Child was status post stage I surgery for hypoplastic left heart syndrome”. 
    Comment: This baby was at high risk when he was vaccinated. He was born with an underdeveloped left side of the heart and had been through the first stage of corrective surgery. Immune paralysis may have contributed to his death. It would have been helpful to know the type of the pneumococcus grown in his blood. There were 57 VAERS reports of “Sepsis” after administration of the pneumococcal vaccine (PNC). In several reports, blood cultures were positive for Streptococcus pneumoniae (pneumococcus). In many of those cases PNC was the only vaccine administered. Another infant, a 2-month old female from Pennsylvania (case 161299) received a dose of PNC from the same lot number (473809) on 10/25/2000 and died on 10/27/2000. She had DTAP and HIB on the same day. Cause of death was listed as SIDS.

*          *          *

DTAP Hot Lot Search

The DTAP lot number was not reported in case 150475. All other DTAP lots used were reviewed. Two patients received vaccines from lot U0137BA and another two received vaccines from lot U0317BB. These two lots were evidently produced in succession by the same manufacturer.

DTAP Lot Number Total Reports Death Reports Death                                       Report / Case Number
DPTA917A2 1 1 Patient
467675 28 1 Patient
Not listed      
1004R 1 1 Patient
40040CA 3 1 Patient
DTAP9121A2 1 1 Patient
91682 1 1 Patient
A919A2 44 3 Pt. + 151619 (1) +152001 (2)
U0045BA 8 1 Patient
U0137BA 58 2 Pt. +158477 (3)
462354 24 2 Pt. + 162748 (4)
467673 36 1 Patient
7389AA 88 4 Pt. + 127341 (5) +128054 (6) + 132820 (7)
UA475AA 1 1 Patient
469396 38 1 Patient
920A2 38 1 Patient
918A2 36 3 Pt. +151748 (8)  +161853 (9)
U0056FA 46 1 Patient
UD173CA 1 1 Patient
D009 1 1 Patient
U0137BA 58 2 Patient + 151867 above
467674 37 1 Patient
U0317BB 29 4 Pt. +160877 (below) +161164 (10) + 166213 (11)
467010 38 1 Patient
U0317BB 29 4 Pt. +159916 above + 161164 (above) + 166213 (above)

Table III

The following information will be provided about the 14 other cases listed in table II:  Sex (M. or F.). Age, State, Interval between vaccination and demise, Relevant History, Diagnosis. Each patient received DTAP with other vaccines unless specified.

  1. Case 151619: M, 2m, CA, 7 days. Patient had had surgery for pyloric stenosis. He developed vomiting and diarrhea, became dehydrated and hyperkalemic and went on to multiple organ failure and cardiac arrest.
  2. Case 152001: F, 2m, ME, 5 days. SIDS.
  3. Case 158477: F, 2m, NM, 1 day. SIDS.
  4. Case 162748: F, 2m, MI, 36 hours. Patient was 32 weeks premature. Pneumonia.
  5. Case 127341: M, 2m. OH, 2 days. Premature (35 weeks), single kidney. SIDS. (Sleeps with parents)
  6. Case 128054: F, 2m, MS, 4 days. Post vaccine syndrome. Cause of death consistent with vaccine related death.
  7. Case 132820: M, 2m, IL, 1 day: SIDS (History of shaking? Seizures)
  8. Case 151748: M, 3m, PA, 26 days. SIDS.
  9. Case 161853: M, 2m, MS, 6 days. Premature twin. SIDS.
  10. Case 161164: M, 2m, MN, 4 days. SIDS.
  11. Case 166213: M, 5m, NM. Interval between vaccination and demise not listed. Patient was 35 weeks premature and had “resolved bronchiolitis’. Cause of death is listed as Probable Asphyxia.                          

 

Discussion

When DTP was used exclusively, many studies were published regularly to convince physicians and parents that the vaccine was quite safe. The fact is that the DTP vaccine was not safe and it had to be replaced by the DTAP vaccine.

Now, the CDC and vaccine manufacturers consistently downplay the side effects of DTAP vaccination. Indeed, though minor reactions following DTAP are fewer than with DTP, more serious reactions occur in rather disturbing numbers. This is supported by a report that was issued by a committee of US Scientists and published in 1987 in the Journal of the American Medical Society (JAMA). In “Acellular and whole-cell pertussis vaccines in Japan. Report of a visit by US scientists”, the authors stated:

 “Since the introduction of acellular pertussis vaccines in Japan late in 1981, more than 20 million doses have been administered, mostly to children 2 years of age and older. Clinical studies indicate that mild local and febrile reactions are less frequent after administration of acellular pertussis vaccines than after whole-cell vaccines. Serious adverse events with sequelae occurred in 2-year-old children at approximately the same low rate during the period 1975 through August 1981, when whole-cell vaccines were used, and during August 1981 through 1984, when acellular vaccines were used exclusively.”  At least one of the authors of the report is still with the CDC.

Clearly multiple reports of serious DTAP-associated reactions have been filed with VAERS. Again, one must keep in mind that less than 10% of adverse events after vaccination are ever reported.

Two of the 25 infants whose reports were reviewed, a 5-month old male and a 6-month old female received the DTAP vaccine alone, 2 and 3 days before their demise. The cause of death in both cases was listed as SIDS.

Earlier, we only administered DTP and polio vaccines at the same time. Today, several vaccines are routinely administered together at 2, 4, and 6 months of age and again when boosters are recommended. A 2-month-old infant receiving DTAP, HBHEPB, IPV and PNC is actually receiving 7 antigens.

The CDC and vaccine lobby have agreed that it is perfectly acceptable to administer 5 to 7 antigens or attenuated live virus vaccines together, to the enchantment of HMOs. They have succeeded in convincing themselves, physicians and many parents that this is actually safe. This investigation does not support such feeling of comfort.

60% of the babies (15 of 25) in the group were two months old (or younger) when they succumbed shortly after they received the first series of recommended vaccinations.

Only five of the 25 cases were girls. There were 3 cases from Texas, 2 from Alabama and 2 from Ohio. The remaining 18 cases came from 18 different states.

Eighteen (72%) of the 25 deaths occurred in the 48 hours after vaccination. Nine babies died on the day following vaccination and 4 within hours and less than one day after they were vaccinated.

The cause of death was listed as SIDS in 15 (60%) of the 25 cases in Table II. SIDS (Sudden Infant Death Syndrome) is by definition the sudden and unexpected death of an apparently healthy infant, whose death remains unexplained after the performance of an adequate postmortem investigation including (1) an autopsy, (2) investigation of the scene and circumstances of the death and (3) exploration of the medical history of the infant and family.

Seven other cases (150474, 150931, 152213, 152502, 153392, 154522, 159916) were found in full cardio-respiratory arrest and died. In each case, some environmental factor was mentioned to “explain” the event. Many or all of the seven deaths could have been labeled as SIDS by other observers raising the incidence of SIDS following DTAP vaccination in this sample to 88%.

It is not known how many infants were exposed to the following risk factors: Living in trailers, Sleeping with parents, Entanglement in blankets, Cigarette smoking and Positional asphyxia in early 2000. Neither is it known how many of them died of SIDS in the 78 hours BEFORE they were scheduled to receive 3 to 7 antigens at the same time.

In addition, SIDS was listed as the cause of death in 7 (64%) of the 11 reports reviewed  in Table III.

The CDC insists that vaccines do not cause SIDS and that any association between the two is temporal or casual but not causal. Many believe, as Baraff did 20 years ago, that: “there should be no temporal association, were there no causal relationship between the two events.” 

This limited review shows that 9 (36%) of the infants in the main series had known risk factors when they were vaccinated. Pneumograms, apnea monitors and medication for apnea were not mentioned in any of the 25 reports. It would be reasonable to assume, as proposed by Scheibner, that babies who already have A & Bs (apnea and bradycardia) may be at a higher risk of developing respiratory and cardiac arrest AFTER multiple vaccinations. Premature infants are more likely to have abnormal pneumograms and to need monitoring and medication.

Vaccine manufacturers were ordered to remove Thimerosal from all pediatric vaccines in 1999. It is not known how many of the 25 children in this study actually received vaccines containing the mercury derivative as a preservative. The latest available VAERS post-DTAP death reports (Fall of 2002) were quickly reviewed for comparison and appeared casually similar to those of early 2000.

 It is difficult to draw any conclusions from the fact that that there were more infant deaths reported than life-threatening events after both DTP and DTAP: 942 deaths vs. 561 life-threatening complications for DTP and 415 deaths vs. 348 life-threatening events after DTAP vaccination. This could mean that the vaccine reactions are very severe. It could also simply be due to the fact that infants’ deaths, within 30 days of vaccination, including SIDS, are more carefully reported and get the attention of the local health authorities, while serious reactions of surviving infants do not.

In one case, the complication that culminated in the infant’s demise could have been caused, not by the DTAP, but by another vaccine. 

Careful studies that criticize any aspect of the vaccination programs are rarely published in medical journals. Pro-vaccine papers on the other hand, are often accepted without difficulty. It is not surprising therefore, that most physicians are more aware of the vaccine “benefits” than they are of adverse events

.

Conclusions

VAERS reports provide valuable information.

Many serious adverse events including death are occurring shortly after DTAP vaccination. This review suggests causation and eligibility for compensation.

The question of SIDS after vaccination deserves renewed attention. It is simplistic to attribute these deaths to chance.

References

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