DTaP and Tdap Vaccine Product Inserts (plus combination vaccines)
Whooping cough or pertussis is a contagious respiratory disease caused by the B. pertussis bacterium. The disease is spread by coughing or sneezing. Thick mucous builds up in the lungs and clogs air passages, triggering violent coughing spells. It can be quite serious, especially for young infants with tiny air passages. The fatality rate is highest in infants under six months of age. The effects of toxins in the B. pertussis bacteria can produce high fever, convulsions, brain damage and death. Permanent damage can include continuing seizure conditions, mental retardation, learning disabilities, and chronic illness.
Severe cases of whooping cough may require hospitalization, respiratory support, and nutritional and rehydration therapy. There is no medicine to cure whooping cough but antibiotics are often used to reduce the spread of the disease to others as well as treat secondary infections such as pneumonia, bronchitis, and otitis media (inner ear infections). In the past, these secondary infections often caused many of the deaths, which occurred after a child had whooping cough.
A 1982 health bulletin summarized the dangers of whooping cough:
In its early stages, pertussis is indistinguishable from the many colds common in children. However, after one or two weeks, the illness gets progressively worse. Thick mucous builds up in the lungs, triggering severe coughing spells as children try to clear their clogged up airways. Children can cough so long and hard that they literally cannot ‘catch their breath;’. Their faces turn blue when they are unable to get fresh oxygen into their system. As the coughing spell ends, children gasp for their next breath with a characteristic crowing sound, or whoop. These coughing spells can occur up to 40 times a day and can last two to three months.
In 1934, more than 265,000 cases of pertussis were reported in the U.S. with nearly 8,000 deaths. Whooping cough in the underdeveloped Third World countries is still the killer it once was throughout the world in the early part of this century. However, in modern countries, such as Europe and the U.S., today whooping cough is a much more manageable disease that causes death or injury less frequently. This is due to improved sanitation, nutrition, and medical care; the use of antibiotics to control secondary infections; the employment of modern resuscitation methods to start a baby breathing again after choking; and rehydration techniques to counter the loss of body fluids from high fever, vomiting, or diarrhea.
In 1977, Britain had more than 99,000 pertussis cases reported with 23 deaths and no cases of encephalitis, which resulted in a case fatality ratio of approximately 1 in 4,300 cases. A 1985 British report placed the risk of death for infants under 1 year from pertussis at 1 in 69,000.
Today between 2,000 and 10,000 cases of whooping cough are reported to the Centers for Disease Control (CDC) annually. However, there actually may be 40,000 to 100,000 cases each year because the CDC estimates that the disease is underreported in America by as much as 20 times. Since publicity about pertussis vaccine reactions has become more widespread and more physicians are looking for and reporting the disease, periodically there is corresponding publicity about mini-epidemics of whooping cough in different states. The state of Washington reported 162 cases in ten months in 1984; there were no deaths, no cases of brain damage, and 49 percent of the cases aged 3 months to 6 years had been appropriately vaccinated for their age with DPT. In 1993, Cincinnati reported that 40% of children who caught pertussis were vaccinated appropriately for their age.
Because the U.S. has a 95% vaccination rate with pertussis vaccine, it is possible these reported increases are not real increases in the incidence of whooping cough but are simply a result of increased reporting of a portion of the 40,000 to 100,000 pertussis cases may be occurring every year but have historically remained unreported.
The DPT vaccine is given to children to prevent diphtheria, pertussis (whooping cough) and tetanus. The pertussis portion of the DPT shot is composed of killed B. pertussis bacteria, the same bacteria that cause whooping cough. In the bacteria are toxins which are responsible for the neurological complications of both the vaccine and the disease. The DTaP vaccine contains a purified acellular version of the pertussis vaccine and has fewer B. pertussis toxins in it. The DTaP vaccine is associated with fewer reactions but can still cause injuries and death.
Since its development in the mid 1930’s and its widespread use by the late 1950’s, there have been repeated reports by parents and medical researchers that children were dying or being left with medication resistant convulsions, mental retardation, learning disabilities, and physical handicaps after reacting severely to pertussis vaccine. Fifty years of scientific literature in medical journals and books has documented the history of these reports.
Some three and a half million American children receive pertussis vaccine every year and most react mildly. But an unknown number react more severely with high-pitched screaming, persistent crying for 3 or more hours, fever over 103F, excessive sleepiness, convulsions or collapse/shock that may lead to either death or permanent brain damage.
The only large study ever conducted in the U.S. to determine DPT vaccine reaction rates found that 1 in 875 DPT shots is followed by a convulsion or shock/collapse episode. The rate of permanent damage or death following DPT reactions is a hotly debated subject. One study surveying 215,000 Swedish children whom had received DPT shots showed a rate of permanent brain damage or death in 1 in 17,000 children. Many vaccine authorities rely on the 1981 British study that reported that 1 in 110,000 DPT shots results in a serious neurological reaction and that permanent brain damage occurs in 1 in 310,000 shots. (These figures are often misquoted by U.S. physicians as 1 in 110,000 children. This is a significant error because a child may receive 3 to 5 doses of vaccine.) It is misleading to apply these risk estimates to the U.S. population because:
- Britain uses a different whole cell pertussis vaccine that appears to be less potent;
- High risk children were excluded from the study even though these categories of high-risk children are routinely vaccinated in the U.S.
- All reactions were not counted. The study only counted those children who were hospitalized or who had a convulsion lasting 30 minutes or longer. Children can have serious vaccine reactions and not be hospitalized or have convulsions lasting less than 30 minutes and still die or become brain damaged.
Even the study’s authors cautioned against using the reaction rate figures for other countries. It is probable they greatly underestimate the actual risk for American children.
The pertussis vaccine is estimated to be 63% to 94% effective in the DPT shot and 59% to 90% effective in the DTaP shot. Despite a very high vaccination rate in the U.S., thousands of cases occur. CDC officials have stated that a growing number of pertussis cases are occurring in vaccinated adults and older children. Often adults and teenagers can have atypical whooping cough and only exhibit symptoms similar to a bad cold or flu. The undiagnosed adult and teenage carriers of whooping cough, most of who have been fully vaccinated, spread the disease to vulnerable newborn infants and young children.
In 1984, Swedish epidemiologist B. Trollfors concluded that whole cell pertussis vaccines are only effective for 2 to 5 years. He pointed out that even countries with a 90-95 percent vaccination rate (such as the U.S.) could not completely prevent the disease. However, most scientists maintain that if pertussis vaccine is used on a widespread basis in a population, it appears to lessen the overall incidence of the disease and some vaccinated children have less severe cases of whooping cough.
When pertussis vaccination rates fell to about 30 percent in Sweden, West Germany, England, and Japan in the 1970’s, these countries saw major increases in reported cases of the disease within three years of that drop in use. (Epidemiologically it takes three years after a sudden decrease in vaccination rates for a population to lose "herd immunity" and develop real increases in whooping cough cases.) There is good reason to believe that if pertussis vaccine use fell to about 30 percent in the U.S. there would be a substantial increase in cases of whooping cough within three years of that fall in vaccine use.
Until 1982 when WRC-TV in Washington, D.C. aired a documentary on pertussis vaccine reactions, most American parents (and most doctors) were unaware that the vaccine could cause death and permanent brain damage. Few parents were informed about the definition of a high-risk child or a severe reaction.
There are three "official" vaccine policy-making authorities in America making recommendations for the use of vaccines administered to children by physicians. These vaccine policy makers state the official definition of a high-risk child, a severe reaction, and a contraindication to vaccination.
Vaccine Manufacturers. Several private drug companies currently produce and distribute the pertussis vaccine. Each manufacturer includes product information circulars in packages of DPT vaccine containing information on what the manufacturers consider to be severe reactions and contraindications.
American Academy of Pediatrics. The American Academy of Pediatrics (AAP) publishes a Report of the Committee on Infectious Diseases (also referred to as the Red Book) every four years with periodic updates in Pediatrics to serve as a guide for pediatricians in private practice.
The Public Health Service makes recommendations on the use of vaccines for physicians administering vaccines in the public health clinics. Guidelines formulated by the Advisory Committee on Immunization Practices (ACIP) periodically appear in the Morbidity and Mortality Report published by the CDC.
The ACIP considers the following circumstances to put a child at high risk of reacting to the pertussis vaccine and are considered absolute reasons to NOT VACCINATE WITH pertussis vaccine contained in DPT or DTaP:
- An immediate anaphylactic (shock) reaction.
- Encephalopathy (an acute, severe central nervous system disorder occurring within 7 days after vaccination)
The ACIP considers the following events as “PRECAUTIONS” and states that parents and vaccine providers “should evaluate the risks and benefits of administering subsequent doses of a pertussis containing vaccine”:
- Temperature of more than 105 F within 48 hours;
- Collapse or shock-like state within 48 hours;
- Persistent crying lasting more than 3 hours occurring within 48 hours;
- Convulsions with our without fever occurring within 3 days.
The vaccine manufacturers in their products manufacturer inserts list the following circumstances as reasons NOT to vaccinate with the “P” or pertussis vaccine in DTaP:
- Children older than 7 years of age;
- Children who have recovered from culture-confirmed pertussis (whooping cough);
- Hypersensitivity to any component of the vaccine;
- Anaphylaxis (shock) reaction;
- Moderate or severe febrile (fever) illness or acute infection;
- Vaccination with pertussis-containing vaccines during an outbreak of polio;
- Encephalopathy (acute, severe central nervous system disorder within 7 days following vaccination manifested by such signs as coma, decreased level of consciousness, prolonged seizures);
- Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized.
The vaccine manufacturers also list as “Warnings” the same circumstances that are listed as “PRECAUTIONS” by the ACIP above. Are Other Children at High Risk?
There are other circumstances which may put a child at high risk of reacting to the pertussis vaccine but have been cited in the medical literature and reported by researchers and are not officially recognized by the AAP, the ACIP, and vaccine manufacturers. A good library, particularly a medical library at a community hospital or university, will give you access to the medical literature.
Child is ill with anything including a runny nose, cough, ear infection, diarrhea, or has recently recovered from an illness.
Several scientific articles have suggested that serious vaccine reactions are more likely to occur if children have current viral and bacterial infections. One article suggests that as long as "a four week interval between illness and vaccination may be advisable" and warns that while "it is a matter of clinical judgment how long the vaccine should be deferred….in administering the vaccines of any kind care should be taken to exclude the likelihood of infection in the child, his family, or other close contacts." The product information circular accompanying DPT vaccine manufactured by Connaught Laboratories in 1989 stated, "Immunization should be deferred during the course of any acute illness."
In order to insure that your child is healthy at the time of vaccination, make sure a doctor gives your child a careful physical exam before each DPT shot. This should include taking a temperature and a thorough exam of your child’s throat and ears to make sure that there is no infection present.
Be sure to report any illness, however slight, that your child has had in the previous months. Mention any viral or bacterial infections that you or a member of your family may currently have or to which your child may have been exposed.
Child has a family member who has reacted severely to a DPT shot.
In 1946, Werne and Garrow reported the deaths of identical twins within 24 hours of their second diptheria-pertussis shot. The same outcome in identical twins is strong evidence of genetic predisposition to reacting to the vaccine and the possibility of such genetic predisposition has been frequently cited in the scientific literature. Additionally, there have been reports of two, three and four pertussis vaccine damaged children in one family.
Child has a family history of convulsions of neurological disease.
Many European countries including England, the Netherlands, and Sweden have advised that the pertussis vaccine is contraindicated if a member of the child’s immediate family (brother, sister, mother or father) has a history of convulsions or neurological disease. Once again, the reason for this contraindication is based on the genetic predisposition factor. The product information circular accompanying DPT vaccine manufactured by Lederle Laboratories in 1985 state, "Routine immunization with this product should not be attempted if the child has a personal or family history of central nervous system disease or convulsions." The product information circular accompanying DPT vaccine manufactured by Connaught Laboratories in 1989 stated, "Use of this product is also contraindicated if the child has a personal or family history of a seizure disorder.
In 1975, a World Health Organization sponsored international meeting of pertussis vaccine experts recommended that "children from families with a history of neurological disorders should not be vaccinated." In 1977, the Department of Health and Social Security in England stated that children should not be given pertussis vaccine if they have a "family history of epilepsy or other diseases of the central nervous system.
In a 1987 recommendation published in the MMWR, the CDC stated "recent studies suggest that infants and children with a history of convulsions in the first degree family members (i.e. siblings and parents have a 3.2 fold increase risk for neurologic events compared with those without such histories (CDC, unpublished data)." The CDC went on to recommend, however, that these children should receive pertussis vaccine even though the pertussis vaccine is known to cause neurologic events such as convulsions.
Child was born prematurely or with low birth weight.
Babies who are born prematurely may not have neurological, respiratory, and immunological systems that are as fully developed as those who are full-term. A 1994 study of two-month old babies in a special care nursery for premature/low birth weight babies in Dallas showed 19% had either new or increased episodes of apnea (stopped breathing) in the 24-48 hours after being vaccinated with DPT and HIB vaccines and some required oxygen and other support to begin breathing again.
Child has had cerebral irritation in the neonatal period (such as head trauma at birth from a difficult delivery; high-pitched screaming with arching of the back; meningitis).
A child who has had signs of cerebral irritation after birth may be manifesting evidence of a damaged or weakened neurological system that could be especially vulnerable to the effects of the pertussis vaccine. The British department of Health and Social Security states that pertussis vaccination "should not be carried out in children who have … a history of cerebral irritation or damage in the neonatal period."
Child has a personal or family history of severe allergies (such as eczema, asthma and, especially, allergy to cow’s milk.
Throughout the scientific literature dealing with pertussis vaccine during the past 40 years, there have been reports by some researchers that a history of severe allergies in a child or his family may predispose a child to reacting to the pertussis vaccine. In England in past decades, a personal or family history of allergies was considered a contraindication.
Dow Chemical Company’s DPT product insert in the 1960’s stated "fractional doses are recommended in infants with cerebral injury, asthma, a strong family history of allergy …" In 1961, Hopper found that in a group of babies who reacted violently to the pertussis vaccine, there was twice as much eczema, asthma, hay fever, and allergic skin rashes in the child, his brothers and sisters, parents, and grandparents as there was in a control group of the same size. In 1969, Hannik found a positive family history of allergies in a significant proportion of infants who reacted with high-pitched screaming, shock and convulsions.
A 1982 study by Steinman concluded that genetic predisposition may play a role in pertussis vaccine reactions and suggests that a personal or family history of allergies, particularly milk allergy, may be a warning sign. Steinman’s work has been reinforced by reports from parents whose children are allergic to milk and have reacted to the vaccine. An allergy to milk may be manifested by severe constipation, diarrhea, projectile vomiting or frequent spitting up of significant amounts of milk after bottle or breast feeding, persistent crying after feedings (colic), eczema or recurrent skin rashes. Often after baby has been placed on soybean formula or other cow’s milk substitutes, these symptoms will disappear.
It is important for parents to know what constitutes a severe reaction to the DPT or DTaP shot because it is generally agreed by vaccine policy makers that those who react severely should not receive the "P" or pertussis portion of the DPT or DTaP shot again. For subsequent boosters, only the "D" (diphtheria) and "T" (tetanus) portion of the shot should be given.
Many children react to the DPT or DTaP shot to some degree and appear to recover without any permanent effect. A 1979 study reported that more that 50% of DPT vaccine recipients had temperatures of at least 100 F. and another study found that local redness, pain and swelling at the injection site were reported following 37.7%, 40.7% and 50.9% of DPT vaccinations, respectively.
An unknown number of children reacted more severely to a DPT or DTaP shot with temperatures over 103 F., high pitched screaming, excessive sleepiness, persistent crying for more than 3 hours, convulsions, and shock/collapse. In some children these reactions can be followed by permanent brain damage or death. The frequency of more serious pertussis vaccine reactions in America is unknown, as is the rate of death and brain damage associated with severe reactions.
The one large controlled study conducted in the U.S. to determine DPT reaction rates in America was held at UCLA with FDA funding in 1979. The UCLA/FDA study showed that 1 in 875 DPT shots results in a convulsion or collapse/shock reaction. Two babies in the study died following DPT reaction symptoms, but their deaths were classified as sudden infant death syndrome (SIDS or crib death).
Death was the first reaction to be associated with pertussis vaccine. In 1933, the Danish vaccine researcher Madsen described the deaths of two babies within a few hours after they had been vaccinated.
It is not known how many pertussis vaccine deaths occur in the U.S. each year because often the deaths of babies, who receive DPT or DTaP shots and then die shortly after exhibiting classic pertussis vaccine reactions, are misclassified as SIDS. The incidence of SIDS increases after the first month of life, rises to a peak at two and three months, and declines after the age of four months.
One SIDS study concluded that 17 of 23 vaccinated SIDS infants (or about 52%) died within one week of a DPT shot after 6 (or about 11%) died within 24 hours of the shot. Another researcher concluded that a "relationship between SIDS and immunization accounts for less than 6.3% of the total SIDS death." However, a large government sponsored NICHD study concluded that DPT immunization is not a factor in the etiology of SIDS.
The AAP, ACIP and vaccine manufacturers consider the following to be reactions to the pertussis vaccine. As stated previously, in most cases, those children who react severely to a DPT or DTaP shot may be given the DT (diphtheria and tetanus) portion of the shot for future booster doses.
Allergic Hypersensitive Reaction. Most allergic hypersensitive reactions occur within minutes or an hour of the shot and may include hives, sudden swelling of the mouth or throat, difficulty breathing, hypertension and shock. This can be an immediate life threatening reaction which requires immediate medical assistance.
Shock/Collapse. The terms "collapse" and "shock-like episode" and "hypotonic hyporesponsive episode" are used to describe a serious neurological reaction which appears to be peculiar to the pertussis vaccine. British physician George Dick, M.D. described the shock/collapse reaction to a DPT shot in a 1967 study:
"About three hours after inoculation, the baby suddenly becomes marble white, cold and collapsed and remains like this for about 15 to 30 minutes; after recovery, it often remains pale and listless for a few hours. Some mothers have said that their babies become unconscious at the onset of the collapse, others thought their baby was dead. When babies developing this syndrome were followed up a year later, they seemed healthy and appeared to have passed the usual milestones normally. It is, however, difficult to exclude the possibility of permanent damage. On observing these reactions, parents quite naturally urgently summoned a doctor, but by the time he arrived the baby had usually recovered the severe episode and some mothers were quite unable to convince their physicians that anything really serious had happened. Because of the unavoidable delay in getting to the patients, very few doctors have seen the early stage of this syndrome (except in their own infants). It is quite possible that it is more frequent than is generally believed, for it could well pass unobserved even by the mother."
In the 1979 UCLA/FDA study of DPT reactions, the authors described shock/collapse: "All such reactions observed occurred within ten hours of immunization and usually within four hours. Characteristically, the infant or child was pale, hypotonic, and unresponsive to his parents for a period ranging from ten minutes to 36 hours." The authors went on to observe that "Collapse or shock like state following pertussis immunization has been reported on numerous occasions. The majority of these hypotonic hyporesponsive episodes seem to be self-limited with no residue. However, there have been reports of death from apparent shock following pertussis immunization."
If you observe your child having a collapse/shock reaction, you should immediately have your baby examined by your physician in the emergency room of your local hospital.
High Pitched Screaming or Persistent Crying for 3 or More Hours. George Dick, M.D., in his 1967 study stated: the reaction of persistent and uncontrollable screaming comes on about two hours after inoculation. It starts with a bout of screaming and the baby cannot be comforted or quieted. This screaming often lasts for about one hour and usually terminates with a period of exhaustion lasting for about 30 minutes, during which time the baby is restless but quiet. Screaming bouts then commence again and eventually the baby falls into a deep sleep for as long as twelve hours."
The authors of the UCLA/FDA study defined high pitched screaming as "a cry of unusual character, usually described by the parents as a high pitched scream. It was a cry that the parents claimed they had never heard their child produce before.
In a 1980 article, Edward Mortimer, M.D., observed: "Neurologic reactions, particularly in infants, are always worrisome, but two of the four that may be classified as such are really of unknown origin and are only presumed to be neurologic. One is an episode of prolonged, uncontrollable crying that begins within a few hours of the injection and lasts for at least an hour (sometimes for as long as six hours or more); this persistent screaming syndrome has been referred to by some investigators as "high pitched crying" which is reminiscent of the "encephalitic cry" sometimes associated with brain damage, but others have reported that the crying associated with pertussis vaccination is simply protracted."
If your child begins to scream with a high-pitched cry, or cries uncontrollably with a normal pitched cry for several hours, you should immediately have your baby examined by your physician or by a physician in the emergency room of your local hospital.
High Temperature. The product information inserts of one vaccine manufacturer considers a temperature of more than 103 F to be a contraindication and another manufacturer lists 102 F. But the AAP’s Red Book and the ACIP recommendations state that the temperature must be 105 F. (40.5C) or more to be a contraindication to further pertussis vaccine.
You should ask your physician to give you instructions on how to take immediate steps to lower your infant’s high fever if it should occur. A high temperature is of particular concern because in infants and children it can trigger febrile convulsions. If your child runs a prolonged high fever, you should immediately call your physician or your local hospital emergency room. If your child’s fever nears 105 F., your child should be immediately examined by a physician.
Excessive Sleepiness. Children exhibiting this reaction usually lapse into a deep sleep from which they cannot be easily awakened. This has also been referred to as excessive somnolence or a "severe alteration of consciousness." Leonard Rome, M.D., points out that "excessive somnolence, for instance, refers to a state of sleep from which the infant cannot be aroused; a drowsy child who wakes up to eat is not experiencing this reaction."
Convulsions. A convulsion is defined by Webster’s Third International Dictionary as a "spasmodic contraction of the muscles." There are different kinds of convulsions and they can occur with or without a fever: a clonic convulsion is "marked by alternating contracting and relaxing of muscles"; a tonic convulsion is a "prolonged contraction of the muscles"; and a local (or focal) convulsion is "any minor spasm affecting but one muscle or one part of members (of the body).
Petit mal convulsions are "attacks of brief impairment of consciousness often associated with flickering of the eyelids and mild twitching of the mouth" or "a brief loss of consciousness, lasting a few seconds. A few 3-per-second blinks or jerks of eyelids and sometimes arms may be conjoined." Petit mal convulsions may be as subtle as staring episodes with slight drooling.
A generalized grand mal convulsion "begins with a sudden loss of consciousness, a cry, a fall to the ground, tonic then clonic movements of the muscles of the cranium and limbs, sometimes sphincter incontinence, and other autonomic disorders. The motor activity soon terminates, leaving the patient in a state of coma, which lasts for many minutes of even as long as a half-hour. As a coma recedes, mental confusion, drowsiness and headache become evident.
If you suspect your child is suffering a convulsion, you should have your child examined by your physician or by a physician in the emergency room of your local hospital.
Encephalopathy or brain involvement which may lead to mental retardation, learning disabilities, behavior disorders, paralysis, or other mental and physical disability can occur following a severe DPT shot reaction. The Public Health Service ACIP recommendations state that the pertussis vaccine can cause "Encephalopathy, with or without convulsions, manifested by bulging fontanel, changes in the level of consciousness, or focal neurologic signs, the encephalopathic reaction if he or she exhibits the following signs after an encephalopathy may lead to permanent neurologic deficit."
Your baby may be having an encephalopathic reaction if he or she exhibits the following signs after a DPT shot: sudden eye crossing; unusual unresponsiveness to parents, siblings or visual or auditory stimuli; inability to move an arm or leg; strange, repetitive movements of any part of the body; a pronounced, negative change or regression in physical, emotional or intellectual behavior.
If you observe any of these symptoms shortly after your child receives a DPT shot, you should contact your physician immediately and have your child immediately examined by your physician or by a physician in the emergency room of your local hospital. If you have any questions regarding your baby’s unusual behavior in the weeks following a DPT shot, you should consult a pediatric neurologist promptly.
Any time you contact a physician or a hospital about a suspected severe reaction your child may be having to a vaccination, make sure the date and time of the vaccination and the symptoms your child is having are recorded in your child’s medical record. Make sure you do not leave the office or hospital without written record that your child has been examined.
Several reports in the vaccine literature as well as by parents of vaccine damaged children suggest that a severe local reaction or a general systemic reaction may be a warning that the child is at high risk of reacting more strongly to subsequent doses of pertussis vaccine.
Severe Local Reaction. The most common reaction to a DPT shot is a local one which includes mild pain, redness, soreness or swelling around the site of the injection. A 1979 survey of four pediatric practices in Colorado revealed that 72 percent of the children had local reactions, which included redness, swelling and tenderness after DPT shots.
However, some children experience a severe local reaction characterized by a large, red, hard, hot and swollen lump at the site of injection that may remain for several weeks. In the 1980’s in England, "any severe local reaction to a preceding dose" was contraindicated to further pertussis vaccination. There have been reports by parents of vaccine-damaged children that a severe local reaction after a DPT shot was followed by more involved systemic or neurological reactions after a subsequent shot.
General Systemic Reactions have been reported by parents of vaccine-damaged children. They can include a body rash, vomiting or diarrhea within hours of the shot. Or the child may exhibit a sudden unusual decline in health including loss of appetite and weight (failure to thrive), chronic diarrhea, ear and respiratory infections, or the development of new allergies. Children who fail to thrive or are chronically ill for months following a DPT shot should be checked by a physician.
The AAP, ACIP and U.S. vaccine manufacturers do not consider severe local reactions or general systemic reactions as reasons to stop vaccination with pertussis vaccine. However, all symptoms following a DPT shot should be reported to the child’s doctor.
Thrombocytopenia and Hemolytic Anemia are two blood disorders which have been reported to rarely follow DPT shots. Thrombocytopenia means a reduced number of platelets circulating in the blood and can cause "purpura" (blotchy red patches on the child’s body caused by the thinned blood seeping into the tissues beneath the skin).
Diabetes and Hypoglycemia. The body’s glucose (sugar) metabolism is regulated by insulin which is secreted by the pancreas. Researchers have detected increased insulin production in infants injected with pertussis vaccine.
In 1970, Pittman stated "the infant whose blood sugar level is influenced by food intake may be especially vulnerable to vaccine-induced hypoglycemia should a feeding be missed because of a feverish reaction following vaccinations." Hannik and Cohen in 1978 concluded, "infants who show serious reactions following pertussis vaccination suffer from failure to maintain glucose homeostasis." A 1982 study detailed the role the DPT vaccine played in causing diabetes in a sixteen month old girl who was genetically predisposed to diabetes and who suffered from a viral infection that attacked her pancreas.
It cannot be overemphasized that parents should monitor their children carefully day and night for at least 72 hours after each DPT shot is given. The first 24 hour post-vaccination is an especially important time to be alert. Although identifying a severe reaction to the pertussis vaccine is the combined responsibility of parents and doctors, only parents can be with a child 24 hours a day.
If you have any reason to believe that your child may be having a severe reaction, notify your doctor at once and take your child to the nearest hospital emergency room where your child can be immediately examined by either your doctor or a doctor in the emergency room.
While the American Academy of Pediatrics has stressed that it uses 48 hours as the period during which events can be attributed to the vaccine, the time limit has not been sustained scientifically. One large British study found a statistical correlation between DPT vaccination and convulsions occurring within seven days of the shot (particularly within 72 hours). The government requires that all reactions be reported which occur within 30 days of a vaccination given at a public health clinic or private physician’s office.
After your child receives a vaccination, you may request a written record of:
- the date and time of day the vaccine was given;
- the type of vaccine and the dose number;
- the name and title of the person who gave the shot;
- the vaccine manufacturer’s name;
- the vaccine lot number
You should keep information concerning any vaccine given to your child in a permanent vaccination record, plus the details of any reactions that occur. As mentioned previously in this booklet, if any of these events occur after your child gets a DPT shot, immediately arrange for an examination at the doctor’s office, clinic, or emergency room.
Your doctor or public health clinic is required by law to report all adverse events, including injuries and deaths that occur within 30 days after vaccination to federal health authorities. All reports should be made to the Vaccine Adverse Events Reporting System (VAERS). If you know your child’s reaction was not reported, you have the right to report the reaction yourself by calling 800-822-7967. NVIC can provide you with the forms and assist you in reporting the reaction.
It is important for us, as parents, to be equally concerned and knowledgeable about the risks of pertussis disease as we are about the risks of pertussis vaccine. Pertussis disease has the potential to cause seizures, brain damage, and even death, just as the vaccine can. Most of America’s medical community believes that the risk of serious injury or death from pertussis is greater than the risk of injury or death which can be caused by the vaccine.
However, recognition of and concern about the risks of pertussis disease does not diminish our need and responsibility to recognize and be concerned about the risks of the pertussis vaccine. The challenge today is for parents, physicians, scientists, manufacturers and health officials to recognize the risks of both the disease and the vaccine and work to protect the health and well being of each individual child.
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