1. rfd 2003 12 04 a not so perfect vaccine the dtp dtap vaccines an investigation

A Not-so-Perfect Vaccine
The Diphtheria, Tetanus and Acellular Pertussis Vaccine: An Investigation

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. In this paper, both DTP and DPT refer to the
same product: Diphtheria and Tetanus toxoids plus whole-cell Pertussis vaccine.
The following statements are true about whooping cough and whooping cough
vaccination
1. The incidence of whooping cough in the United States had decreased before the
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 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 infants…Adverse
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. (2)
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 3. Unless the vaccine is properly prepared and refrigerated, its potency and
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 where 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. 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)
Vaccination is not compulsory in Japan.
[In this presentation, the Diphtheria, Tetanus and acellular Pertussis Vaccine will be
referred to as DTAP (not DTaP).]
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

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
Adverse Event
Time Interval
C. Any acute complication or sequela (including death) of above events II. Pertussis antigen-containing vaccines C. Any acute complication or sequela (including death) of above events
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.

The aim of this presentation is to refute this presumption by carefully reviewing,
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 § 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 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. All Reports
% of total
% of total
% of deaths
Life Threat
Hospitalized
Under age 1
Under age 1
Seizures
Under age 1
Under age 1
Under age 1
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
Other vaccines
administered
DPTA917A2
Not listed
HBHEPB, IPV
DTAP9121A2
HBHEPB, IPV
HBHPV, IPV
HBHEPB, IPV
HEP, HIB, IPV
HBHEPB, IPV
HEP, HIB, IPV
HEP, HIB< IPV
HBHEPB, IPV
HEP, HIB, IPV
HBHEPB, IPV
HBHEPB, IPV, PNC
HBHEPB, IPV, PNC
HEP, HIB, IPV

Notes
Comments (in bold)
a. 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.
b. 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!
c. 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.
d. 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?
e. 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.
f. 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.
g. 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.
h. Case 151867: Premature. Twin A.
Comment: Infant at risk.
i. 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.
j. 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.
k. 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!
l. 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.
m. 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.
n. Case 159003: “Past history: Mother has history of smoking during pregnancy.”
Comment: Mother’s smoking? Seven antigens 24 hours before death?
o. 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”. p. 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
Report / Case Number
DPTA917A2
Not listed
DTAP9121A2
Pt. + 151619 (1) +152001 (2)
Pt. +158477 (3)
Pt. + 162748 (4)
Pt. + 127341 (5) +128054 (6) +
132820 (7)
Pt. +151748 (8) +161853 (9)
Patient + 151867 above
Pt. +160877 (below) +161164
(10) + 166213 (11)
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.
6. Case 128054: F, 2m, MS, 4 days. Post vaccine syndrome. Cause of 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 that 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 study 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
1. 2. Vaccination against whooping-cough. Efficacy versus risks. Stewart GT. Lancet 1977 Jan29;1(8005):234-7 Stewart GT. Scott Med J. 1979 Jan;24(1):47-52. 4. Whooping cough and pertussis vaccine: a comparison of risks and benefits in Britain during the period 1968-83. Stewart GT. Dev Biol Stand. 1985;61:395-405. 5. 6. 7. The true story of pertussis vaccination: a sordid legacy? Geier D., Geier M. J Hist Med Allied Sci. 2002 Jul;57(3):249-84. 8. 9. Epidemiology and Prevention of Vaccine-Preventable Diseases, 5th Edition Editors: Atkinson W, Humiston S, Wolfe C, Nelson R. (CDC /D HHS) 10. Physicians Desk Reference 2003, page 812 11.12. Mortality and Morbidity Weekly Report (MMWR) December 1, 20Injury%20Statistics%20and%20Incidence%20Rates 14. 15. Mortality and Morbidity Weekly Report (MMWR) July 19, 2002/51(28);616-618 16. 17. MMWR September 22, 2000/49(9):1-26 18. Acellular and whole-cell pertussis vaccines in Japan. Report of a visit by US scientists. Noble GR, Bernier RH, Esber EC, Hardegree MC, Hinman AR, Klein D, Saah AJ. JAMA. 1987 Mar 13;257(10):1351-6. ======================= F. Edward Yazbak, MD, FAAP Falmouth, Massachusetts E-Mail:

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