Text Size:



tetanus vaccine

Quick Facts

Tetanus

  • Tetanus, often referred to as lockjaw, is caused by the Clostridium tetani bacteria and can be found in soil, manure, and even in the digestive tracts of animals and humans. Tetanus has also been reported in contaminated heroin as well as on skin surfaces.1 Tetanus is not contagious and cannot be transmitted from person to person.2 Tetanus bacteria can enter the body when a person sustains a deep cut, or even a burn3 and can also occur following abortions, elective surgeries, ear infections, pregnancy, dental infections, animal bites, and crush wounds.4
  • Tetanus bacteria do not survive in the presence of oxygen, however, the bacteria are quite resistant to most chemicals and even heat.5 Puncture wounds, which do not bleed very much and are protected by tissue and skin from direct exposure to oxygen, can be the perfect environment for tetanus bacteria to multiply and cause infection.6
  • The incubation period for tetanus infection, from time of exposure to appearance of the first symptoms, ranges from three days to three weeks.7 Initial symptoms include muscular stiffness of the jaw and neck, headache, seizures, changes in heart rate and blood pressure, fever, and chills. Complications include fractures, vocal cord spasms, impaired breathing, pulmonary embolism, pneumonia, infections acquired in the hospital during the course of treatment, and death.8
  • Between 2009 and 2015, there were 197 reported cases of tetanus and 16 tetanus related deaths. All reported deaths occurred in persons over the age 55.  During this time period, persons with diabetes accounted for 13 percent of all reported tetanus cases and 25 percent of all tetanus related deaths. Intravenous drug users accounted for 6 percent of all cases.9
  • In 2015, there were 29 tetanus cases reported with two related deaths.10 Neonatal death from tetanus, which primarily occurs in underdeveloped countries where newborns are exposed to tetanus for unsanitary conditions during the birth process, especially when the umbilical cord is cut, is virtually nonexistent in the U.S.11

Tetanus Vaccine 

  • There are 12 different tetanus-containing vaccines licensed for use in the United States with 8 tetanus combination vaccines available for use in infants and children. These combination vaccines may contain one or more of the following vaccines: pertussis, diphtheria, hepatitis B, Hib, polio, and/ or polio. For adults, there are 4 tetanus combination vaccines available with 2 vaccines containing both tetanus and diphtheria toxoids approved for use in adults and children ages 7 years and older and 2 vaccines containing tetanus and diphtheria toxoid and acellular pertussis approved for use in children and adults ages 10 years and older.12
  • According to the CDC, common tetanus vaccine reactions include injection-site redness, pain, and swelling at the site of the injection. Sometimes, however, the pain and swelling is significant and extends from the shoulder to the elbow. If this occurs, the CDC warns that additional tetanus toxoid vaccine doses should not be administered more frequently than every 10 years.13 Additional serious reported side effects following tetanus toxoid vaccination include anaphylaxis,14 15 brachial neuritis,16 Guillain-Barre Syndrome,17 18 acute disseminated encephalomyelitis (ADEM),19 arthritis20 21 and myocarditis.22
  • As of March 1, 2019 there had been 5,861 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following vaccination with tetanus or tetanus-containing vaccines combined with additional vaccines, including 864 deaths and 4,997 serious injuries.
  • Using the MedAlerts search engine, as of January 30, 2019, there have been 182,116 adverse events reported to the Vaccine Adverse Events Reporting System (VAERS) in connection with tetanus and tetanus-containing vaccines combined with additional vaccines since 1990. Over 60 percent of tetanus vaccine-related adverse events occurring in children six years old and under. Of these tetanus-vaccine related adverse event reports to VAERS, 3,139 were deaths, with over 87 percent of the deaths occurring in children under six years of age. Reported tetanus vaccine adverse events reported to VAERS include redness, swelling and pain at the injection site; headache; fatigue, sore and swollen joints; muscle weakness; fever; chills; nausea; shock; neuropathy; convulsions; encephalopathy; paralysis; Guillain-Barre Syndrome (GBS); death;

NVIC “Quick Facts” is not a substitute for becoming fully informed about Tetanus and the Tetanus vaccine. NVIC recommends consumers read the more complete information following the "Quick Facts", as well as the vaccine manufacturer product information inserts, and speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child.

Food & Drug Administration (FDA) 

  • Infanrix, a 3 in 1 combination shot containing diphtheria, tetanus toxoids, and acellular pertussis vaccine for children under 7 years of age. It is manufactured by GlaxoSmithKline.
  • Daptacel, a 3 in 1 combination shot containing diphtheria and tetanus toxoids and acellular pertussis vaccine for children under 7 years of age. It is manufactured by Sanofi Pasteur Ltd.
  • Pediarix, a 5 in 1 combination shot containing diphtheria and tetanus toxoids and acellular pertussis, hepatitis B recombinant and inactivated poliovirus vaccines for children under 7 years of age. It is manufactured by GlaxoSmithKline.
  • Kinrix, a 4 in 1 combination vaccine containing diphtheria and tetanus toxoids, acellular pertussis and inactivated poliovirus vaccines for children 4 to 6 years old. It is manufactured by GlaxoSmithKline.
  • Quadracel, a 4 in 1 combination vaccine containing diphtheria and tetanus toxoid, acellular pertussis and inactivated poliovirus vaccine for children 4 to 6 years old. It is manufactured by Sanofi Pasteur
  • Pentacel, a 5 in 1 combination shot containing diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus and Haemophilus b conjugate (tetanus toxoid conjugate) vaccines for children under four years old. It is manufactured by Sanofi Pasteur Ltd.
  • VAXELIS, a 6 in 1 combination shot containing diphtheria and tetanus toxoids and acellular pertussis, inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine for children 6 weeks through 4 years of age. It is manufactured by MCM Vaccine Company
  • Diphtheria and Tetanus Toxoids Adsorbed, a 2 in 1 combination shot containing diphtheria and tetanus toxoid vaccine for children under 7 years of age. It is manufactured by Sanofi Pasteur Inc
  • Adacel, a 3 in 1 combination booster shot containing tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine for those 10 years or older. It is manufactured by Sanofi Pasteur Ltd.
  • Boostrix, a 3 in 1 combination booster shot containing tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine for those 10 years or older. It is manufactured by GlaxoSmithKline.
  • TDVAX, a 2 in 1 combination vaccine containing tetanus and diphtheria toxoid for those 7 years of age and older. It is manufactured by MassBiologics.
  • TENIVAC, a 2 in 1 combination vaccine containing tetanus and diphtheria toxoid for those 7 years of age and older. It is manufactured by Sanofi Pasteur Ltd

Centers for Disease Control (CDC)

National Institute of Allergy & Infectious Diseases (NIAID)

Vaccine Reaction Symptoms & Ingredients

Our Ask 8, If You Vaccinate webpage contains vaccine reaction symptoms and more.

Search for Vaccine Reactions

NVIC hosts MedAlerts, a powerful VAERS database search engine. MedAlerts examines symptoms, reactions, vaccines, dates, places, and more.

Reporting a Vaccine Reaction

Since 1982 NVIC has operated a Vaccine Reaction Registry, which has served as a watchdog on VAERS. Reporting vaccine reactions to VAERS is the law. If your doctor will not report a reaction, you have the right to report a suspected vaccine reaction to VAERS.

IMPORTANT NOTE: NVIC encourages you to become fully informed about Tetanus and the Tetanus vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

« Return to Vaccines & Diseases Table of Contents

What is Tetanus?

Tetanus (lockjaw) disease is caused by Clostridium tetani (C. tetani), an anerobic, gram-positive, bacteria with the ability to develop into a spore. Tetanus spores can be found in soil, manure, and in the digestive tracts of animals and humans. Additionally, tetanus has also been reportedly found in contaminated heroin and on skin surfaces.23  

The tetanus bacteria, C. tetani, produces two exotoxins, tetanolysin and tetanospasmin. At this time, the exact function of tetanolysin is unknown, however, the tetanospasmin exotoxin has been determined to be the neurotoxin responsible for the clinical symptoms of tetanus.24

Tetanus bacteria do not survive in the presence of oxygen, however, are quite resistant to most chemicals and even heat.25 Puncture wounds, which do not bleed very much and are protected by tissue and skin from direct exposure to oxygen, can be the perfect environment for tetanus bacteria to multiply and cause infection.26

When tetanus enters the body, the tetanus spores can multiply in low oxygen conditions, producing toxins that spread throughout the body. The incubation period for tetanus infection, from time of exposure to appearance of the first symptoms, ranges from three days to three weeks.27 Initial symptoms include muscular stiffness of the jaw and neck, headache, seizures, changes in heart rate and blood pressure, fever, and chills. Complications include fractures, vocal cord spasms, impaired breathing, pulmonary embolism, pneumonia, infections acquired in the hospital during the course of treatment, and death.28

There are four recognized forms of tetanus disease. The most common form of tetanus is referred to as generalized tetanus and is responsible for approximately 80 percent of cases. The initial sign of generalized tetanus usually involves muscle spasms of the jaw, frequently referred to as “lockjaw”. Muscle spasms involving the extremities, neck, and trunk may also occur. Complications of generalized tetanus can include severe muscle spasms and neurological abnormalities, resulting in prolonged hospital stays and even death. Localized tetanus, a less common form of the disease, involves muscle spasms in close proximity to a wound. While considered a mild form of the disease and often associated with persons previously vaccinated against tetanus, it has the potential to progress into generalized tetanus. Cephalic tetanus, a rare but serious form of the disease, is associated with ear infections or head wounds. Cephalic tetanus typically presents as a cranial nerve palsy and may progress to localized or even generalized tetanus. Neonatal tetanus, while nearly non-existent in the United States, continues to be a threat to infants born in developing countries. Neonatal tetanus results primarily when childbirth occurs in unsanitary conditions and the umbilical cord becomes contaminated. Symptoms typically develop within one week, with infants noted to be irritable, difficult to feed, and may have rigidity with spasms.29

Treatment for tetanus includes immediate hospitalization and the use of human tetanus immune globulin (TIG). Additional measures include wound management, medications to control muscle spasms, airway management, and antibiotics.30 Complete recovery from tetanus disease may take several months.31

There are no laboratory findings to confirm tetanus and a diagnosis is based clinical symptoms. Additionally, only about 30 percent of wounds in patients diagnosed with tetanus are found to be positive for the tetanus bacteria.32

Tetanus became a nationally notifiable disease in 194733 and in 1948, 601 tetanus cases were reported, the highest number ever reported.34 However, since 1947, the incidence of tetanus in the United States has declined by more than 95 percent and deaths from the disease have decreased by over 99 percent.35 In 2015, there were 29 cases of tetanus and 2 deaths reported in the U.S.36 Tetanus is a much more serious problem in underdeveloped countries, especially among newborn babies born in unsanitary conditions whose umbilical cords can become infected with tetanus.37

Is Tetanus contagious?

Tetanus cannot be spread from person to person. It is a disease that is contracted when a person becomes exposed to the tetanus bacterium (Clostridium tetani) through a break in the skin.38 As tetanus is unable to survive in the presence of oxygen, tetanus spores can only develop in the absence of oxygen.39 Wounds that do not bleed very much and are protected by tissue and skin from direct exposure to oxygen are more favorable environments for tetanus bacteria to multiple and spread throughout the body.40

Puncture wounds, wounds contaminated with saliva, feces or dirt, crush wounds, burns, and injuries that result in tissue death are most frequently associated with tetanus.41

Less commonly, a person can be exposed to tetanus from surgical wounds, compound fractures, intramuscular injections, intravenous drug use, insect bites, dental infections, chronic sores, and superficial wounds.42

Tetanus is most commonly found in the soil as well as in the intestines of both animals and humans. Tetanus disease can occur anywhere in the world, however, it is more commonly found in regions that are hot, damp, highly populated, and have soil rich in organic matter. Tetanus disease occurs more frequently during the summer or wet season.43

What is the history of Tetanus in America and other countries?

The first clinical description of tetanus disease dates back to records from 5th century BC, however it was 1884 before experiments with tetanus were published and reported on within the medical community. In 1884, two Italian scientists were able to cause tetanus infections in animals by injecting them with pus originating from a case of fatal human tetanus disease.44 Also in 1884, German physician Arthur Nicolaier induced tetanus in mice by injecting them with tetanus contaminated soil.45

In 1889, Japanese bacteriologist and physician Kitasato Shibasaburo isolated the tetanus bacteria from a human victim of the disease, confirmed its ability to cause the disease when injected into animals, and proved that the bacteria could only reproduce in environments that did not contain oxygen.46 47

Following isolation of the tetanus bacteria, pharmaceutical companies began developing anti-serums against tetanus. By the early 1900’s, several pharmaceutical companies had tetanus anti-serums available for use against tetanus. Anti-serums were often produced in horses, and when antibodies developed, the horses were bled to harvest the serum antitoxins for use in the treatment of tetanus disease. 48

In World War I, soldiers were often administered tetanus anti-serums for both the prevention of as well as for the treatment of tetanus disease. World War I battles were frequently fought in fields and trenches, and soldiers often sustained shrapnel wounds which enhanced the risk of tetanus disease. Due to the significant risk of tetanus disease among enlisted men, military physicians felt it necessary to use tetanus anti-toxins and even experimented on soldiers using varying strengths and numbers of doses in the hopes of both treating and preventing tetanus disease in the battlefield. As a result, many soldiers suffered from serum sickness and even allergic reactions from the use of tetanus anti-serums.49 The first vaccine targeting tetanus disease, the tetanus toxoid (TT), was developed in 192450 but did not become commercially available until 1938.51

Significant decreases in mortality rates from tetanus disease in the United States have been noted by public health officials since the early 1900’s, however, the disease did not become nationally notifiable until 1947.52 In 1948, there were 601 cases of tetanus reported in the U.S., the highest number of cases ever reported in a single year.53 After the 1940s, the incidence of tetanus disease declined steadily and by the mid-1970s, an average of 50–100 cases (~0.05 cases per 100,000) were reported annually.54

Between 1982 and 1984, there were a total of 253 reported tetanus cases in the United States. Of the 224 reported cases where age demographic information was provided, 159 cases (71 percent) occurred in adults 50 years of age and older, while 56 cases (25 percent) occurred in adults 20 to 49 years of age. 6 cases were reported in persons under the age of 19, including 3 cases of neonatal tetanus. 26 percent of individuals who developed tetanus died and all deaths occurred in persons over the age of 30, with the majority of deaths (52 percent) occurring among adults 60 years and older. 11 individuals who developed tetanus disease had previously received at least three doses of tetanus toxoid vaccine. Of the 56 individuals who received wound debridement following the injury but prior to the onset of tetanus, 55 were considered candidates to receive both the tetanus immune globulin (TIG) and the recommended tetanus-diphtheria (Td) vaccine, yet healthcare providers failed to administer the recommended TIG in all cases and administered Td vaccine in only 40 percent of the cases.55

In 1987 and 1988, there were 101 reported cases of tetanus disease (48 cases in 1987 and 53 in 1988). Age demographics were reported in 99 cases, with 67 cases occurring in adults 50 years of age and older and 6 cases reported in children under 20 years of age. The case fatality rate was reported at 21 percent. Of the 48 cases where vaccine status was known, 29 reported no prior tetanus vaccination. In the tetanus cases involving persons under the age of 20, half (3 out of the 6 cases) had received at least 3 doses of tetanus toxoid vaccine. In the 14 cases where wounds were serious enough to warrant wound debridement, health care providers failed to administer the recommended tetanus immune globulin (TIG) in all cases and administered Td vaccine in only 8 cases (57 percent).56

Between 2001 and 2008, there were a total of 233 reported cases of tetanus disease (average of 29 cases per year). Of the 197 cases where outcomes were known, 26 (13.2 percent) were fatal. Vaccination status was known for 92 out of the 233 cases (39.5 percent). 55 individuals (59.3 percent) reported receiving at least one dose of a tetanus toxoid vaccine (TT), with 24 (26.1 percent) reported having received at least 4 or more doses. Of the 195 cases where medical information was known, 30 cases (15.4 percent) occurred in individuals with diabetes. In 176 cases where data was known in regards to injection drug use, 27 cases (15.4 percent) involved injection drug users. One third of persons with an acute wound sought medical treatment, however, fewer than 4 percent received the recommended treatment protocol of either tetanus toxoid (TT) vaccine or TT vaccine in combination with TIG.57

From 2009 through 2015, there were an average of 28 tetanus cases and less than 3 deaths each year. Tetanus cases occurred most frequently among adults between the ages of 20 and 29, however all tetanus related deaths were reported in persons over the age of 55.58 In 2018, there were 20 cases of tetanus reported in the United States.59

According to the World Health Organization (WHO), there were 12,476 reported cases of tetanus worldwide in 2017.60 Of these reported cases, 2,266 were reported as neonatal tetanus. Neonatal tetanus can occur during a childbirth that takes place under unsanitary conditions and neonatal tetanus fatality rates are much higher, especially in developing countries.61

Can Tetanus cause injury and/or death?

Tetanus is a very serious disease requiring hospitalization and medical treatments. Symptoms of tetanus include:62

  • Headache
  • Fever and sweating
  • Jaw cramping
  • Muscle spasms, commonly involving the stomach
  • Painful muscle stiffness throughout the entire body
  • Difficulty swallowing
  • Seizures
  • Blood pressure and heart rate changes

Complications of tetanus include:63

  • Bone fractures
  • Vocal cord spasms
  • Infections acquired in the hospital during the course of treatment
  • Pulmonary embolism
  • Pneumonia
  • Breathing difficulties
  • Death

Tetanus is a rare disease in the United States and rates of the disease have decreased by 95 percent. Since 1947, tetanus associated fatalities have declined by 99 percent.64 While most people who develop tetanus recover fully from the disease, full recovery can take between 2 and 4 months.65

Who is at highest risk for getting Tetanus?

Individuals most at risk for developing tetanus include:66 67 68

  • Those injured with an item that may be contaminated with tetanus
  • Persons who undergo medical treatments in unsanitary conditions
  • Anyone who inject themselves with drugs, including diabetics
  • Intravenous (IV) drug users
  • Persons who are immunocompromised
  • Heroin users, as the growth of tetanus may be supported by the use of quinine, often used to dilute heroin.

Persons who sustain superficial wounds may also be at a high risk for developing tetanus if the wound is not properly cared for.69

Who is at highest risk for suffering complications from Tetanus?

Individuals who are more likely to have complications include:70

  • Those who experience a disease onset within 2 days
  • Persons who have a tetanus incubation period of less than one week
  • A narcotics addiction
  • A diagnosis of generalized tetanus
  • Individuals who sustained tetanus through surgical wounds, abortion, burns, compound fractures, and intramuscular injection
  • Newborns who develop tetanus by means of their umbilical stump
  • Persons who develop fever greater than 104 F (40 C)
  • Individuals, including newborns, who experience elevated heart rates (tachycardia)

Cephalic and neonatal tetanus are considered the most serious and life-threatening forms of the disease and individuals who require mechanical ventilation as a result of tetanus have been noted to be at higher risk of death from the disease.71

Can Tetanus be prevented and are there treatment options?

Prevention

Proper wound care is essential to preventing tetanus. If wounds are dirty or deep, prompt medical attention is recommended. Unclean wounds should not be covered with bandages as this may enhance the risk of wound infection by tetanus or other bacteria.72 Medical treatment options for serious wounds where the presence of tetanus bacteria may be higher include: thorough wound care to remove any foreign objects, dirt or dead tissue; administration of human tetanus immune globulin (TIG); and vaccination with a tetanus toxoid containing vaccine. While antibiotics are not recommended for use against tetanus, they can be used if a wound appears to be infected.73 A person who has sustained a wound considered to be at high risk for tetanus should receive a single dose of human TIG administered by intramuscular injection as quickly as possible. Human tetanus immune globulin (TIG), however, may only be effective at preventing tetanus if the tetanus toxin has not yet bonded to nerve endings.74

All wounds should be completely rinsed out with water and thoroughly washed with soap. Topical antibiotics can also be applied to the wound to prevent bacterial growth. Wounds can be covered with a bandage to keep out bacteria, however, wounds may heal quicker if they remain exposed to air. Any bandage that is applied should be changed at least one time per day or if it becomes dirty or wet. Medical attention is advised if debris is present or in the event that there are concerns about the wound.75

Treatment

Any person suspected of having tetanus requires hospitalization and immediate treatment with human tetanus immune globulin (TIG). Additional treatments of tetanus include wound care, antibiotics, and medications to control muscle spasms. Mechanical ventilation and sedation may also be required.76

Vitamin C may also be an effective treatment option to reduce tetanus mortality rates. A 2013 Cochrane review reported on one study from Bangladesh that found a 100 percent reduction in tetanus-related deaths among children between the ages of 1 and 12 years, and a 45 percent reduction in tetanus-related deaths among persons between the ages of 13 and 30 years of age. While study authors cautioned the use of vitamin C based on this study, they did recommend that further research should be conducted on the use of vitamin C as a treatment option for tetanus disease.77

What is Tetanus vaccine?

In the U.S. today, tetanus vaccine is administered only in a combination shot (DTaP, DT, Tdap, Td) that contains vaccines for tetanus (T), diphtheria (D) and possibly pertussis (whooping cough) (P). The CDC’s Advisory Committee on Immunization Practices (ACIP) currently recommends administration of a tetanus containing vaccine (DTaP) at two, four, and six months old; between 15 and 18 months old; and between four and six years old. Another booster dose is recommended at 11-12 years of age (Tdap). After a booster dose of Tdap vaccine, booster doses with tetanus - diphtheria toxoid vaccine (Td) are recommended every ten years throughout a person’s life.78  While the ACIP also recommends that pregnant women receive a dose of Tdap vaccine during each pregnancy, between 27 and 36 weeks gestation, regardless of a previous history of Tdap vaccine,79 this recommendation contradicts the information provided by the vaccine manufacturers. Boostrix vaccine is approved to be administered only as a single dose80 and the Adacel product insert states that a second dose of Adacel vaccine may be administered if there has been at least an 8 year interval between the first Tdap dose.81 The product insert of both Boostrix and Adacel, the two available FDA licensed Tdap vaccines, also state that there are “no adequate and well-controlled studies” on the use of Tdap vaccine in pregnant women.82 83

The tetanus toxoid vaccine (TT) was developed in 192484 and became commercially available for use in the United States in 1938. Prior to 1960, the tetanus toxoid (TT) was primarily used, however in the 1960’s, the use of the combination tetanus- diphtheria toxoid vaccine (Td) became more prevalent. In 2013, the single antigen tetanus toxoid vaccine (TT) was discontinued in the United States.85 The tetanus toxoid vaccine is available only in combination with other routinely administered vaccines and most frequently combined with diphtheria (DT, Td) and acellular pertussis vaccines (DTaP, Tdap). It can also be found in combination with vaccines for polio, haemophilus influenzae B (HIB), and hepatitis B (see below for descriptions).

Tetanus Toxoid Vaccines Licensed for Use in the U.S.

The U.S. Food and Drug Administration has approved twelve different combination vaccine that include tetanus toxoid vaccine. There are different rules for use of these vaccines by different aged groups.

Following is a list of currently available vaccine combination shots that contain tetanus toxoid vaccine with links to the manufacturer product inserts (click on the name of the product):

  • Infanrix, a 3 in 1 combination shot containing diphtheria, tetanus toxoids, and acellular pertussis vaccine for children under 7 years of age. It is manufactured by GlaxoSmithKline.
  • DAPTACEL, a 3 in 1 combination shot containing diphtheria and tetanus toxoids and acellular pertussis vaccine for children under 7 years of age. It is manufactured by Sanofi Pasteur Ltd.
  • Pediarix, a 5 in 1 combination shot containing diphtheria and tetanus toxoids and acellular pertussis, hepatitis B recombinant and inactivated poliovirus vaccines for children under 7 years of age. It is manufactured by GlaxoSmithKline.
  • Kinrix, a 4 in 1 combination vaccine containing diphtheria and tetanus toxoids, acellular pertussis and inactivated poliovirus vaccines for children 4 to 6 years old. It is manufactured by GlaxoSmithKline.
  • Quadracel, a 4 in 1 combination vaccine containing diphtheria and tetanus toxoid, acellular pertussis and inactivated poliovirus vaccine for children 4 to 6 years old. It is manufactured by Sanofi Pasteur
  • Pentacel, a 5 in 1 combination shot containing diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus and Haemophilus b conjugate (tetanus toxoid conjugate) vaccine for children under four years old. It is manufactured by Sanofi Pasteur Ltd.
  • VAXELIS, a 6 in 1 combination shot containing diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, Haemophilus b conjugate, and hepatitis B recombinant vaccine for children under 5 years of age. It is manufactured by MCM Vaccine Company. (Not currently available for use)
  • Diphtheria and Tetanus Toxoid Adsorbed, a 2 in 1 combination shot containing diphtheria and tetanus toxoid for children under seven years old. It is manufactured by Sanofi Pasteur Ltd
  • Adacel, a 3 in 1 combination booster shot containing tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine for those 10 years or older. It is manufactured by Sanofi Pasteur Ltd.
  • Boostrix, a 3 in 1 combination booster shot containing tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine for those 10 years or older. It is manufactured by GlaxoSmithKline.
  • TDVAX, a 2 in 1 combination shot containing tetanus and diphtheria toxoid for those 7 years of age or older. It is manufactured by MassBiologics
  • TENIVAC, a 2 in 1 combination shot containing tetanus and diphtheria toxoid for those 7 years of age or older. It is manufactured by Sanofi Pasteur

Combination Vaccines

There are some doctors who limit the numbers of vaccines given simultaneously on the same day and will work as partners with parents to choose certain vaccine products and develop individualized schedules for vaccination. If you want your child to receive tetanus vaccine but would prefer a 3 in 1 combination shot (diphtheria, tetanus, and pertussis) rather than a 4 in 1 or 5 in 1 combination shot, talk with your doctor.

If your doctor or the nurse administering vaccines refuses to have a discussion with you about vaccine products or schedules, you may want to consider consulting one or more other trusted health care professionals before making a vaccine decision.

Not all tetanus-containing vaccines have been studied in clinical trials to prove the safety and effectiveness of giving the shot simultaneously with other licensed vaccines. Check the product inserts for more information about administering vaccines at the same time with other vaccines.

About Infanrix Vaccine in Brief

  • Ages: Infanrix is a 3 in 1 shot (diphtheria, tetanus, acellular pertussis vaccine) given to children under age 7 (see GlaxoSmithKline product insert for recommended schedule and other indications).
  • Vaccine ingredients: Aluminum hydroxide, sodium chloride, polysorbate 80 (Tween 80), formaldehyde, modified Stainer-Scholte liquid medium, glutaraldehyde, fenton medium containing a bovine extract, modified Latham medium derived from bovine casein.
  • Estimated Efficacy: Efficacy of tetanus toxoid in Infanrix was based on immunogenicity (blood immune response) and tested in only 45 infants one month following the completion of 3 doses of Infanrix vaccine. At this time, 100 percent of infants had a blood immune response to Infanrix
  • Use with Other Vaccines: In clinical trials, Infanrix was given with HIB, pneumococcal, hepatitis B, inactivated polio or MMR vaccines. There is no information in the product insert about the safety or effectiveness of giving Infanrix simultaneously with inactivated or live influenza, rotavirus, varicella or hepatitis A vaccines.
  • Commonly Reported Adverse Events: Pain, redness, and swelling at the site of the injection; drowsiness; irritability/fussiness; loss of appetite.
  • Other Serious Reported Adverse Events: Hypotonic-hyporesponsive (collapse) episode; persistent cry for 3 or more hours; high fever, and convulsions (seizures). After licensure (post-marketing), reported adverse events included bronchitis, cellulitis, respiratory tract infection, lymphadenopathy, thrombocytopenia, anaphylactic reaction, encephalopathy, headache, hypotonia, ear pain, apnea, cough, angiodema, pruritus, rash, fatigue and Sudden Infant Death Syndrome (SIDS).
  • Contraindications and precautions (Some reasons Infanrix should not be given to a child – See GlaxoSmithKline product insert for complete list):
    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination;
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination;
    • Serious allergic reaction to a previous pertussis vaccination;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • Children with a progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy;
    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Infanrix vaccine product insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination;
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering Infanrix vaccine;
    • The tip caps of prefilled Infanrix syringes contain latex and may cause an allergic reaction in persons sensitive to latex.

NVIC NOTE: Some doctors only vaccinate children who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Infanrix. It is also not known whether Infanrix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Infanrix has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About DAPTACEL Vaccine in Brief

  • Ages: DAPTACEL is a 3 in 1 shot (diphtheria, tetanus, acellular pertussis vaccines) given to children under age 7 (see Sanofi Pasteur product insert for recommended schedule and other indications).
  • Vaccine ingredients: Aluminum phosphate, formaldehyde, ammonium sulfate, modified Mueller-Miller casamino acid medium without beef heart infusion, glutaraldehyde, 2-phenoxyethanol, Stainer-Scholte medium, casamino acids, dimethyl-beta-cyclodextrin, Mueller’s growth medium.
  • Estimated Efficacy: In a U.S study of children who received four doses of DAPTACEL vaccine at 2, 4, 6 and 15-17 months, after administration of the third dose of vaccine (at 6 months of age), 100 percent of vaccine recipients were found to have blood antibody levels indicative of protection. Following administration of the fourth dose of DAPTACEL, 98.8 percent of children sampled were found to have levels of blood antibodies considered to be protective against tetanus disease.
  • Use with Other Vaccines: In clinical trials, DAPTACEL was given with HIB, inactivated polio (IPV), hepatitis B, pneumococcal, and MMR or varicella vaccines. There is no information in the product insert about the safety or effectiveness of giving DAPTACEL simultaneously with inactivated or live influenza, rotavirus, or hepatitis A vaccines. DAPTACEL has been noted to reduce meningococcal antibody responses to Menactra when administered one month after Menactra. In cases where DAPTACEL and Menactra are to be administered, the vaccines were recommended to be given at the same time or else one month apart, with Menactra administered first.
  • Commonly Reported Adverse Events: injection site soreness, tenderness, redness, and increase in arm circumference; fussiness/irritability; inconsolable crying; decreased activity/lethargy.
  • Other Serious Reported Adverse Events: Convulsions (seizures), including infantile spasms; bronchiolitis; pneumonia; meningitis; sepsis; irritability; unresponsiveness. After licensure (post-marketing), reported adverse events have also included cyanosis, nausea, diarrhea, cellulitis, and allergic reaction.
  • Contraindications and precautions (Some reasons DAPTACEL should not be given to a child – See Sanofi Pasteur product insert for complete list):
    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination;
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination;
    • Serious allergic reaction to a previous pertussis vaccination;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy).
    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. DAPTACEL vaccine product insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination;
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering DAPTACEL vaccine.

NVIC NOTE: Some doctors only vaccinate children who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with DAPTACEL. It is not known whether DAPTACEL can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. DAPTACEL has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Pediarix Vaccine in Brief

  • Ages: Pediarix is a 5 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated polio and recombinant hepatitis B vaccines) given to children under age 7 (see GlaxoSmithKline product insert for recommended schedule and other indications).
  • Vaccine Ingredients: Aluminum hydroxide, aluminum phosphate, aluminum salts, sodium chloride, polysorbate 80 (Tween 80), neomycin sulfate, polymyxin B, yeast protein, VERO cells, a continuous line of monkey kidney cells, calf serum and lactalbumin hydrolysate, fenton medium containing a bovine extract, modified Latham medium derived from bovine casein, formaldehyde, glutaraldehyde, modified Stainer-Scholte liquid medium.
  • Estimated Efficacy: Antibody responses to tetanus were tested one month following 3 doses of Pediarix administered in concomitantly with Hib vaccine and PCV7 (Prevnar 7) vaccine at 2, 4, and 6 months. At this time, 100 percent of vaccine recipients were found to have blood antibody levels considered to be protective against tetanus.
  • Use with Other Vaccines: In clinical trials, Pediarix was given with HIB conjugate vaccine (no longer licensed in the U.S.) or pneumococcal vaccines (PCV7). There is no information in the product insert about the safety or effectiveness of giving Pediarix simultaneously with inactivated or live influenza, rotavirus, or hepatitis A vaccines.
  • Commonly Reported Adverse Events: Local injection site reactions (pain, redness, or swelling); fussiness, high fever (Pediarix is associated with higher rates of fever relative to separately administered vaccines. The prevalence of fever was highest on the day of vaccination and the day following vaccination).
  • Other Serious Reported Adverse Events: High fever that required medical attention (In a safety study that evaluated medically attended fever after Pediarix or separately administered vaccines when co-administered with 7-valent pneumococcal and Hib conjugate vaccines, infants who received Pediarix had a higher rate of medical encounters for fever within the first 4 days following the first vaccination); febrile and afebrile convulsions (seizures); gastroenteritis, bronchiolitis; asthma, diabetes mellitus, and chronic neutropenia; anaphylactic reactions (hives, swelling, difficulty breathing, hypotension or shock), demyelinating diseases.
  • Contraindications and precautions (Some reasons why Pediarix should not be given to a child – See GlaxoSmithKline product insert for complete list):
    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination;
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination;
    • Serious allergic reaction to a previous pertussis vaccination;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy);
    • Sensitivity to any component of Pediarix, including yeast or neomycin and polymyxin B (antibiotics);
    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Pediarix vaccine product insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination;
    • The tip caps of prefilled Pediarix syringes contain latex and may cause an allergic reaction in persons sensitive to latex;
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering Pediarix vaccine.

NVIC NOTE: Some doctors only vaccinate children who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Pediarix. It is not known whether Pediarix can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Pediarix has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Kinrix Vaccine in Brief

  • Ages: Kinrix is a 4 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated polio vaccines) given to children 4 to 6 years old (see GlaxoSmithKline product insert for recommended schedule and other indications).
  • Vaccine Ingredients: Aluminum hydroxide, VERO cells, a continuous line of monkey kidney cells, calf serum, lactalbumin hydrolysate, fenton medium containing a bovine extract, modified Latham medium derived from bovine casein, formaldehyde, modified Stainer-Scholte liquid medium, glutaraldehyde, sodium chloride, polysorbate 80 (Tween 80), neomycin sulfate, polymyxin B.
  • Estimated Efficacy: The efficacy of the tetanus toxoid component of Kinrix is estimated to be equal to that of Infanrix.
  • Use with Other Vaccines: In clinical trials, Kinrix was administered simultaneously with the second dose of MMR or MMR and Varicella vaccine. There is no information in the product insert about the safety or effectiveness of giving Kinrix simultaneously with inactivated or live influenza, hepatitis B, or hepatitis A vaccines.
  • Commonly Reported Adverse Events: Injection site pain, including redness, swelling and increase in arm circumference; drowsiness; fever; loss of appetite.
  • Other Serious Reported Adverse Events: Gastroenteritis, dehydration, and cellulitis. After licensure (post-marketing) reported adverse event reports have also included apnea, collapse or shock-like state (hypotonic-hyporesponsive episode), convulsions (with or without fever), injection site vesicles; pruritus (intense itching); allergic reactions, including anaphylaxis; urticaria; angioedema; lympadenopathy, and thrombocytopenia.
  • Contraindications and precautions (Some reasons why Kinrix should not be given to a child – See GlaxoSmithKline product insert for complete list):
    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination;
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination;
    • Serious allergic reaction to a previous pertussis vaccination;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy);
    • Severe allergic reaction to any component of Kinrix, including neomycin and polymyxin B (antibiotics);
    • The tip caps of prefilled Kinrix syringes contain latex and may cause an allergic reaction in persons sensitive to latex;
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering Kinrix vaccine.

NVIC NOTE: Some doctors only vaccinate children who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Kinrix. It is not known whether Kinrix can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Kinrix has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Quadracel Vaccine in Brief

  • Ages: Quadracel is a 4 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated polio vaccines) given to children 4 to 6 years old (see Sanofi Pasteur product insert for recommended schedule and other indications).
  • Vaccine Ingredients: Aluminum phosphate, Stainer-Scholte medium, casamino acids, dimethyl-beta-cyclodextrin, MRC-5 cells, normal human diploid cells, CMRL 1969 medium supplemented with calf serum, modified Mueller’s growth medium, ammonium sulfate, modified Mueller-Miller casamino acid medium without beef heart infusion, formaldehyde, 2-phenoxyethanol, polysorbate 80, glutaraldehyde, neomycin, polymyxin B sulfate.
  • Estimated Efficacy:  The efficacy of the tetanus toxoid vaccine component of Quadracel is estimated to be equal to that of DAPTACEL.
  • Use with Other Vaccines: In clinical trials, Quadracel was administered simultaneously with the MMR and varicella. There is no information in the product insert about the safety or effectiveness of giving Quadracel simultaneously with inactivated or live influenza, hepatitis A, or hepatitis B vaccines.
  • Commonly Reported Adverse Events: Injection site pain, including redness, swelling and increase in arm circumference; malaise; muscle pain; headache.
  • Other Serious Reported Adverse Events: After licensure (post-marketing) reported adverse event reports have also included cyanosis; convulsions (with or without fever); injection site abscess; injection site cellulitis; pallor; screaming; allergic reactions, including anaphylaxis; urticarial, and dyspnea.     
  • Contraindications and precautions (Some reasons why Quadracel should not be given to a child – See Sanofi Pasteur product insert for complete list):
    • Serious allergic reaction following administration of a pertussis, tetanus, diphtheria, or polio containing vaccine or any ingredient of Quadracel vaccine;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy);
    • Seizures within 3 days of a previous pertussis vaccination;
    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering Quadracel vaccine.

NVIC NOTE: Some doctors only vaccinate children who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Quadracel. It is not known whether Quadracel can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Quadracel has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Pentacel Vaccine in Brief

  • Ages: Pentacel is a 5 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated polio and haemophilus influenzae b conjugate vaccines) for children under age 5 (see Sanofi Pasteur product insert for recommended schedule and other indications).
  • Vaccine Ingredients: Aluminum phosphate, polysorbate 80, sucrose, formaldehyde, glutaraldehyde, bovine serum albumin, 2-phenoxyethanol, MRC-5 cells (a line of normal human diploid cells), CMRL 1969 medium supplemented with calf serum, Medium 199 without calf serum, modified Mueller and Miller medium, neomycin, polymyxin B sulfate, modified Mueller’s growth medium, ammonium sulfate, modified Mueller-Miller casamino acid medium without beef heart infusion, Stainer-Scholte medium, casamino acids, dimethyl-beta-cyclodextrin.
  • Estimated Efficacy: Antibody responses to tetanus were tested one month following 3 doses of Pentacel at 2, 4, and 6 months. At this time, 99.7 percent of vaccine recipients were found to have blood antibody levels considered to be protective against tetanus. Following a booster dose of Pentacel at 15-16 months, 100 percent of vaccine recipients were noted to have blood antibody levels considered protective against tetanus.
  • Use with Other Vaccines: In clinical trials, Pentacel was given with hepatitis B, pneumococcal, MMR or varicella vaccines. There is no information in the product insert about the safety or effectiveness of giving Pentacel simultaneously with inactivated or live influenza, rotavirus, or hepatitis A vaccines
  • Commonly Reported Adverse Events: Systemic reactions that occurred in clinical trials in more than 50 percent of participants following any dose included fussiness/irritability and inconsolable crying; fever; injection site reactions, including tenderness, abscess and increase in arm circumference. Cases of encephalopathy and death occurred in clinical trials but were not causally attributed to Pentacel vaccine by investigators.
  • Other Serious Reported Adverse Events: After licensure (post marketing), there have been reports of febrile and afebrile convulsions (seizures); bronchiolitis, gastroenteritis, dehydration, pneumonia, lethargy/somnolence; hypotonic/hyporesponsive episode (collapse); apnea, cyanosis, asthma.
  • Contraindications and precautions (Some reasons why Pentacel should not be given to a child – See Sanofi Pasteur product insert for complete list):
    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination;
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination;
    • Serious allergic reaction to a previous pertussis vaccination;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy);
    • Severe allergic reaction to any component of Pentacel, including neomycin and polymyxin B (antibiotics);
    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Pentacel vaccine product insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination;
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering Pentacel vaccine.

NVIC NOTE: Some doctors only vaccinate children, who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Pentacel. It is not known whether Pentacel can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Pentacel has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About VAXELIS Vaccine in Brief

  • Ages: VAXELIS is a 5 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated poliomyelis, haemophilus influenzae b (Meningococcal Protein Conjugate) and Hepatitis B (recombinant) vaccines) for infants and children between 6 weeks through 4 years of age (prior to the 5th birthday) (see MCM company product insert for recommended schedule and other indications).
  • Vaccine Ingredients: Aluminum, polysorbate 80, glutaraldehyde, formaldehyde, bovine serum albumin, neomycin, streptomycin sulfate, polymyxin B sulfate, yeast protein, ammonium thiocyanate, Mueller’s growth medium, Mueller-Miller casamino acid medium without beef heart infusion, ammonium sulfate, aluminum phosphate, Stainer-Scholte medium, Vero cells, extract of yeast, soy peptone, dextrose, amino acids, mineral salts, amorphous aluminum hydroxyphosphate sulfate.
  • Estimated Efficacy: Tetanus antibodies measured one month following administration of three doses of VAXELIS were found to be at 99.9 percent.
  • Use with Other Vaccines: In clinical trials, VAXELIS was given with pneumococcal (Prevnar 13) and rotavirus (RotaTeq) vaccines. There is no information in the product insert about the safety or effectiveness of giving VAXELIS simultaneously with inactivated or live influenza, hepatitis A, measles, mumps, rubella (MMR), varicella, or measles, mumps, rubella and varicella (MMR-V) vaccines.
  • Commonly Reported Adverse Events: Systemic reactions that occurred in clinical trials following any dose included injection site redness, swelling, and pain, fever, crying, decreased appetite, irritability, vomiting, and somnolence.
  • Other Serious Reported Adverse Events: In the two U.S. clinical trials, 6 deaths were reported but were determined not to be attributed to VAXELIS by trial investigators. These deaths included sepsis, asphyxia, hydrocephalus, unknown cause, and two cases of sudden infant death syndrome (SIDS). As VAXELIS is not currently available for use in the United States, post-marketing data on serious adverse events are limited to those events considered to have a causal link to the vaccines containing the antigens of VAXELIS. These include anaphylaxis, hypersensitivity, seizures, including febrile seizures, and excessive swelling of the injected limb.
  • Contraindications and precautions (Some reasons why VAXELIS should not be given to a child – See MCM Vaccine Company product insert for complete list):
    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination;
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination;
    • Serious allergic reaction to a previous dose of VAXELIS, any ingredient found in VAXELIS, or any other tetanus toxoid, diphtheria toxoid, pertussis-containing vaccine, hepatitis B vaccine, inactivated poliovirus vaccine, or H. influenzae type b vaccine;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy);
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering VAXELIS vaccine;
    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision to vaccinate an infant born prematurely should be careful based on both the possible benefits and potential risks of vaccination.

NVIC NOTE: Some doctors only vaccinate children, who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with VAXELIS. It is not known whether VAXELIS can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. VAXELIS has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Diphtheria and Tetanus Toxoid Adsorbed Vaccine in Brief

  • Ages: Diphtheria and Tetanus Toxoid Adsorbed is a 2 in 1 shot (diphtheria and tetanus) for children 6 weeks to 6 years of age (see Sanofi Pasteur product insert for recommended schedule and other indications). It is used in cases where pertussis vaccine should not be administered.
  • Vaccine Ingredients: aluminum phosphate, isotonic sodium chloride, uracil, inorganic salts, vitamins, dextrose, formaldehyde, casein, cystine, maltose.
  • Estimated Efficacy: Efficacy of tetanus toxoid in Diphtheria and Tetanus Toxoid Adsorbed was based on immunogenicity (blood immune response) and tested in 137 infants only 2 months following the completion of 3 doses of the vaccine (given at 2, 4, and 6 months). 100 percent of infants were noted to have blood antibody levels considered protective against tetanus, two months following three doses of the vaccine.
  • Use With Other Vaccines No clinical trials examined the safety or effectiveness of administering the vaccine with any other U.S. licensed vaccine.
  • Commonly Reported Adverse Events: In pre-licensure clinical trials, pain, redness, and swelling at the injection site, loss of appetite, crying, and fever. Adverse events were noted for only 24 hours following vaccination. In clinical trials, the Diphtheria and Tetanus Toxoid Adsorbed vaccine contained thimerosal (mercury).
  • Other Serious Reported Adverse Events:  After licensure (post marketing) adverse event reports have included injection site pain, swelling and hypersensitivity; syncope; convulsion; somnolence; headache; rash; pallor; itching; lymphadenopathy;
  • Contraindications and precautions (Some reasons why Diphtheria and Tetanus Toxoid Adsorbed should not be given to a child – See Sanofi Pasteur product insert for complete list):
    • Serious allergic or hypersensitivity reaction to a previous shot, or to any diphtheria or tetanus toxoid vaccine;
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering Diphtheria and Tetanus Toxoid Absorbed vaccine;
    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision to vaccinate an infant born prematurely should be careful based on both the possible benefits and potential risks of vaccination.

NVIC NOTE: Some doctors only vaccinate children and adults, who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you or your child are sick and do not want to get vaccinated but your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Diphtheria and Tetanus Toxoid Adsorbed. It is not known whether Diphtheria and Tetanus Toxoid Adsorbed can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Diphtheria and Tetanus Toxoid Adsorbed has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Adacel in Brief:

  • Ages: Adacel is a 3 in 1 shot (tetanus, diphtheria, and acellular pertussis) used as a booster dose (Tdap) for children and adults 10 years and older (see Sanofi Pasteur product insert for recommended schedule and other indications).
  • Vaccine Ingredients: Aluminum phosphate, formaldehyde, 2-phenoxyethanol, Stainer-Scholte medium, casamino acids, ammonium sulfate, modified Mueller’s growth medium, dimethyl-beta-cyclodextrin, glutaraldehyde, modified Mueller-Miller casamino acid medium without beef heart infusion.
  • Estimated Efficacy: Blood antibody responses to tetanus toxoid vaccine were tested one month following administration of a single booster dose of Adacel in persons between the ages of 11 and 64 years. 100 percent of vaccine recipients were found to have blood antibody levels considered protective against tetanus disease.
  • Use with Other Vaccines: In clinical trials, Adacel was given with hepatitis B or inactivated influenza vaccine. There is no information in the product insert about the safety or effectiveness of giving Adacel simultaneously with live influenza, meningococcal, HPV, MMR, varicella, hepatitis A, inactivated polio or other vaccines.
  • Commonly Reported Adverse Events: In clinical trials, most common reactions were pain at the injection site, including swelling; fever (especially in adolescents); headache; body aches/muscle weakness; fatigue; chills, sore and swollen joints; nausea, lymph node swelling.
  • Other Serious Reported Adverse Events: After licensure (post-marketing), adverse event reports have included severe injection site swelling, bruising, sterile abscess; facial palsy; convulsion; syncope (fainting); parasthesia; Guillain-Barre syndrome; myelitis; anaphylactic reaction; hypersensitivity reaction (angioedema, rash, hypotension); urticaria; muscle spasm; myocarditis.
  • Contraindications and precautions (Some reasons why Adacel should not be given to a child or adult – See Sanofi Pasteur product insert for complete list):
    • Moderate or severe acute illness (with or without fever) until the illness resolves;
    • Serious allergic or hypersensitivity reaction to a previous shot;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • In adolescents, a progressive neurologic disorder, including progressive encephalopathy or uncontrolled epilepsy (convulsions);
    • In adults, an unstable neurologic condition, such as cerebrovascular events and acute encephalopathic conditions;
    • Severe allergic reaction to any component of Adacel;
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering Adacel vaccine;
    • Anyone who has experienced an Arthus-type hypersensitivity reaction following a previous dose of a tetanus toxoid vaccine should not receive Adacel more frequently than every 10 years;
    • The tip caps of prefilled Adacel syringes contain latex and may cause an allergic reaction in persons sensitive to latex.

There are no adequate and well-controlled studies on the administration of Adacel in pregnant women in the United States. It is not known whether Adacel vaccine components are excreted in human milk and there is no available data on the effect of administrating Adacel on breast-fed infants or on milk production/excretion. Adacel has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility.

About Boostrix Vaccine in Brief

  • Ages: Boostrix is a 3 in 1 shot (tetanus, diphtheria, and acellular pertussis) used as a booster dose (Tdap) for children and adults 10 years and older (see GlaxoSmithKline product insert for recommended schedule and other indications).
  • Vaccine ingredients: Aluminum hydroxide, sodium chloride, polysorbate 80, modified Latham medium derived from bovine casein, Fenton medium containing a bovine extract, formaldehyde, modified Stainer-Scholte liquid medium, glutaraldehyde.
  • Estimated Efficacy: Antibody responses to tetanus were tested one month following administration of a single booster dose of Boostrix in adolescents between the ages of 11 and 18 years was found to induce blood antibody levels considered protective against tetanus in 100 percent of vaccine recipients. When tested one month following administration in persons between 19 and 64 years of age, 99.6 percent of vaccine recipients were noted to have blood antibody levels considered to be protective against tetanus.
  • Use with Other Vaccines In clinical trials, Boostrix was given with inactivated influenza vaccine (Fluarix) and the meningococcal vaccine (Menactra). In both clinical trials the antibody level for the pertussis component was determined to be lowered. There is no information in the product insert about the safety or effectiveness of giving Boostrix simultaneously with live influenza, MMR, varicella, HPV, hepatitis B, hepatitis A, inactivated polio or other vaccines.
  • Commonly Reported Adverse Events: In pre-licensure clinical trials, pain, redness, and swelling at the injection site, increase in arm circumference of injected arm; headache; fatigue; gastrointestinal symptoms.
  • Other Serious Reported Adverse Events: One case of diabetes developed after Boostrix administration in clinical trials. After licensure (post marketing) adverse event reports have included extensive inflammation, swelling of injected limb, nodule, itching; encephalitis (brain inflammation); convulsion; facial palsy; lymphadenitis; lymphadenopathy; myocarditis; arthralgia; back pain; myalgia; urticaria; Henoch-Schonlein purpura.
  • Contraindications and precautions (Some reasons why Boostrix should not be given to a child or adult – See GlaxoSmithKline product insert for complete list):
    • Serious allergic or hypersensitivity reaction to a previous shot;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • In adolescents and adults, a progressive neurologic disorder, including progressive encephalopathy or uncontrolled epilepsy (convulsions);
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering Boostrix vaccine;
    • Anyone who has experienced an Arthus-type hypersensitivity reaction following a previous dose of a tetanus toxoid vaccine should not receive Boostrix more frequently than every 10 years;
    • The tip caps of prefilled Boostrix syringes contain latex and may cause an allergic reaction in persons sensitive to latex.

NVIC NOTE: Some doctors only vaccinate children and adults, who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you or your child are sick and do not want to get vaccinated but your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Boostrix. It is not known whether Boostrix can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Boostrix has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About TDVAX Vaccine in Brief

  • Ages: TDVAX is a 2 in 1 shot (tetanus and diphtheria) for persons over the age of 7 (see MassBiologics product insert for recommended schedule and other indications).
  • Vaccine Ingredients: Thimerosal, aluminum phosphate, formaldehyde, modified Mueller's media which contains bovine extracts.
  • Estimated Efficacy: Efficacy of tetanus toxoid in TDVAX was based on immunogenicity (blood immune response) of 16 vaccine recipients tested after 3 doses of TDVAX were given as a primary series. All vaccine recipients were noted to have blood antibody levels considered protective against tetanus. When administered as a booster dose, all 36 vaccine recipients tested were noted to have blood antibody levels believed to be protective against tetanus.
  • Use with Other Vaccines: No clinical trials examined the safety or effectiveness of administering the vaccine with any other U.S. licensed vaccine.
  • Commonly Reported Adverse Events: There is no pre-licensing clinical trial data on adverse events following TDVAX in the vaccine product insert.
  • Other Serious Reported Adverse Events:  After licensure (post marketing) adverse event reports have included injection site pain, swelling, warmth, itching and hypersensitivity; fever; cellulitis; nausea; rash; joint and muscle pain; dizziness; convulsion; malaise; headache.
  • Contraindications and precautions (Some reasons why TDVAX should not be given to a child or adult – See MassBiologics product insert for complete list):
    • Serious allergic or hypersensitivity reaction to a previous shot, or to any diphtheria or tetanus toxoid vaccine;
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering TDVAX vaccine;
    • Anyone who has experienced an Arthus-type hypersensitivity reaction following a previous dose of a tetanus toxoid vaccine should not receive TDVAX more frequently than every 10 years.

NVIC NOTE: Some doctors only vaccinate children and adults, who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you or your child are sick and do not want to get vaccinated but your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with TDVAX. It is not known whether TDVAX can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. TDVAX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About TENIVAC Vaccine in Brief

  • Ages: TENIVAC is a 2 in 1 shot (tetanus and diphtheria) for persons over the age of 7 (see Sanofi Pasteur product insert for recommended schedule and other indications).
  • Vaccine Ingredients: Aluminum phosphate, formaldehyde, ammonium sulfate, sodium chloride, modified Mueller-Miller casamino acid medium without beef heart infusion, water.
  • Estimated Efficacy: Efficacy of tetanus toxoid in TENIVAC was based on evaluation of immunogenicity (blood immune response) in 17 vaccine recipients tested after two and three doses of TENIVAC given as a primary series. All vaccine recipients were noted to have blood antibody levels considered to be protective against tetanus four weeks following the third dose of TENIVAC. When administered as a booster dose, 100 percent of persons between the ages of 11-59 years and 96.1 percent of adults 60 years of age and older were noted to have blood antibody levels believed to be protective against tetanus.
  • Use with Other Vaccines: No clinical trials examined the safety or effectiveness of administering the vaccine with any other U.S. licensed vaccine.
  • Commonly Reported Adverse Events: In pre-licensure clinical trials, pain, redness, and swelling at the injection site; fever; muscle weakness; joint pain; malaise; headache.
  • Other Serious reported Adverse Events:  In pre-licensing clinical trials, serious adverse events included asthma, localized infection, stroke, chest pain, colonic polyp, cellulitis, angina pectoris, hip and wrist fracture, and cholecystitis. Three deaths occurred following administration of TENIVAC. Deaths were reported as cardiopulmonary arrest; myocardial infarction and septic shock; and unknown cause. After licensure (post marketing) adverse event reports have included Guillain-Barre Syndrome (GBS), injection site pain, swelling, warmth, itching, cellulitis and hypersensitivity; fever; lymphadenopathy; vomiting; dizziness; paresthesia; syncope; fatigue; peripheral edema; rash; joint and muscle pain; allergic and anaphylactic reactions.
  • Contraindications and precautions (Some reasons why TENIVAC should not be given to a child or adult – See Sanofi Pasteur product insert for complete list):
    • Serious allergic or hypersensitivity reaction to a previous shot, or to any diphtheria or tetanus toxoid vaccine;
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, careful assessment of the possible risks and potential benefits should be completed prior to considering TENIVAC vaccine;
    • Anyone who has experienced an Arthus-type hypersensitivity reaction following a previous dose of a tetanus toxoid vaccine should not receive TDVAX more frequently than every 10 years;
    • The tip caps of prefilled TENIVAC syringes contain latex and may cause an allergic reaction in persons sensitive to latex;
    • Administering TENIVAC vaccine more frequently than prescribed may result in an increased incidence and severity of adverse reactions.

NVIC NOTE: Some doctors only vaccinate children and adults, who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you or your child are sick and do not want to get vaccinated but your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with TENIVAC. It is not known whether TENIVAC can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. TENIVAC has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

What is the history of Tetanus vaccine use in America?

The protective effect of utilizing passive tetanus antitoxin (tetanus anti-serum) in the treatment of tetanus resulted from the combined research and work of Edmond Nocard, Emil von Bering, and Shibasaburo Kitasato. Experimentation on the use of tetanus anti-serum for both the prevention and treatment of tetanus occurred among soldiers serving in World War I, as fatality rates from the disease were high and soldiers were considered to be at high risk of disease development related to field battles and shrapnel wounds. Hundreds of soldiers administered varying doses of tetanus anti-serums developed adverse reactions that included both acute allergic reactions and serum sickness.86

In the mid- 1920’s, vaccine researchers developed a tetanus toxoid vaccine by inactivating the tetanus toxin using both formaldehyde and heat.87 Two individuals were injected with the tetanus toxoid and then exposed themselves to tetanus on at least two separate occasions. Prior to exposing themselves, their blood antibody levels were tested and reported to be 0.01 and 0.007 of American units of Tetanus toxoid per ml. Neither injected individual developed tetanus after exposure. In 1950, the World Health Organization (WHO) determined that a minimum blood antibody level of 0.01 IU/mL following the administration of the tetanus toxoid vaccine could be considered protective against tetanus disease.88

The first tetanus toxoid vaccine became commercially available in 1938 and in the mid 1940’s, the tetanus toxoid was combined with diphtheria toxoid to create the tetanus- diphtheria (Td) toxoid vaccine and additionally combined with whole cell pertussis to create the diphtheria-tetanus-pertussis vaccine (DTP).89 The newly created DTP combination vaccine was then absorbed onto aluminum salts when researchers discovered aluminum’s ability to enhance blood immune responses to both diphtheria and tetanus.90  Numerous companies held licenses for tetanus toxoid vaccines in the mid 1940’s, however, product licensing was not indicative of product endorsement. Safety, purity, and potency (if tests were available to determine potency) were tested as part of licensing approval, however, product efficacy was not, and not required for product licensing. Companies that held tetanus toxoid vaccine licenses in 1945 included Parke Davis and Co., Sharp and Dohme, Cutter Laboratories, Lederle Laboratories and more.91

In 1966, the Public Health Service Advisory Committee on Immunization Practices (now the CDC’s Advisory Committee on Immunization Practices) published its first tetanus, diphtheria and pertussis vaccine recommendations as well as recommendations for tetanus disease prevention pertaining to wound management. In this report, the Advisory Committee on Immunization Practices (ACIP) formally recommended that all infants receive three doses of diphtheria, tetanus, and pertussis vaccine (DTP) beginning between 2 and 3 months of age at intervals of 4 to 6 weeks. Additional booster doses were recommended at 1 year of age and between the age of 3 and 6 years, preferably prior to school entry. School children and adults not previously vaccinated with DTP were recommend to receive two doses of tetanus-diphtheria (Td) vaccine at 4 to 6 weeks intervals with a booster dose one year later, and routine booster doses every 10 years. The Td vaccine was recommended for use among schoolchildren and adults instead of the DTP vaccine. This recommendation was made due to the significant increase in adverse reactions that were noted to occur following full doses of the diphtheria toxoid found in the DTP vaccine as age increased. For wound management, when a tetanus toxoid vaccine booster dose had previously been administered more than one year prior or when a person was not previously vaccinated against tetanus, Td vaccination was recommended. However, tetanus toxoid booster doses administered more frequently than every 10 years were not recommended by ACIP as they were reported to be associated with more frequent and severe reactions.92

In September of 1984, the CDC’s Advisory Committee on Immunization Practices (ACIP) published its first adult vaccination guidelines. In this publication, adults not previously vaccinated with tetanus toxoid vaccine were recommended to receive 2 doses of Td vaccine at least 4 weeks apart, followed by a booster dose one year later and routine booster doses every 10 years. In the case of wound management, Td vaccine was recommended if a person had not received a Td vaccine within five years. Persons previously vaccinated with the DTP primary series were recommended to receive the first booster dose of Td vaccine between the age of 14 and 16.93

The FDA approved the first acellular pertussis combination vaccine (DTaP) for use in the United States in 1991,94 however, between 1991 and 1996, the whole cell diphtheria, tetanus, and pertussis (DPT) vaccine continued to be recommended for the first three primary doses at 2, 4, and 6 months of age.95 The DTaP vaccine was only approved for use in children between the ages of 15 months and 6 years after completion of three primary doses of DPT.96 

In 1995, the American Academy of Pediatrics (AAP) and the CDC’s Advisory Committee on Immunization Practices (ACIP) published a harmonized childhood vaccine schedule 97 and decreased the recommended age of the adolescent booster dose of tetanus-diphtheria (Td) vaccine from 14-16 years, to age 11-12 years. In this recommendation, ACIP stated that blood antibody levels considered to be protective against tetanus declined with age, and reported that 28 percent of children and teenagers between the ages of 6 and 16 years of age, despite previous vaccination, were found to have tetanus antibodies below minimally acceptable levels considered protective against tetanus disease. Further, ACIP stated that lowering the recommended age of the Td booster dose to 11-12 years of age would encourage a routine preadolescent healthcare visit where health care practitioners could administer additional vaccines such as a second MMR dose,98 recommended in 1989 following a resurgence in measles cases related to MMR vaccine failure,99 and the hepatitis B vaccine, in children not previously vaccinated.100

In 1997, the CDC’s Advisory Committee on Immunization Practices (ACIP) updated its diphtheria, tetanus, and acellular pertussis vaccine (DTaP) recommendation, and recommended that all children receive five doses of DTaP vaccine, at 2, 4, 6, 15-18 months and 4-6 years of age, in lieu of the highly reactive whole cell DPT vaccine.101

In 2005, the FDA approved two tetanus, diphtheria and acellular pertussis vaccines (Tdap), targeting adolescents and adults. Boostrix vaccine received initial approval for use in persons between 10 and 18 years of age, and Adacel received approval for use in individuals aged 11 through 64 years. Following FDA approval, the CDC’s Advisory Committee on Immunization Practices (ACIP) promptly recommended that all 11-12 year olds receive a dose of Tdap vaccine. This recommendation was made in response to the high number of pertussis cases and outbreaks occurring among adolescents due to the waning of vaccine acquired pertussis immunity. ACIP recommended that all 11 to 18 year old adolescents receive a dose of Tdap, including those already vaccinated with the previously recommended booster dose of tetanus-diphtheria (Td) vaccine at age 11-12. While ACIP recommended a five year interval between Tdap and Td vaccine administration related to the increased risk of both local and systemic reactions, they stated that vaccination at an interval of less than five years was still acceptable. Additionally, ACIP encouraged health care practitioners to administer the newly FDA approved Tdap vaccine at the same time as the newly licensed meningococcal conjugate vaccine (MCV4). This recommendation was made even though no safety or immunogenicity data existed to support the administration of both vaccines simultaneously.102

In 2006, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended that all adults between the ages of 19 and 65 years receive a dose of Tdap vaccine. The Tdap vaccine was recommended to be administered one time in lieu of the Td vaccine and given if more than 10 years had passed since administration of Td vaccine had occurred. ACIP, however, reported that the Tdap vaccine could be administered at an earlier interval, to protect a person against pertussis. In their report, ACIP admitted that pre-licensing clinical trials of Adacel vaccine, the only Tdap vaccine FDA approved at the time for use in adults between 19 and 64 years of age, had purposely excluded all persons previously vaccinated with any vaccine containing tetanus or diphtheria toxoid and/or pertussis vaccine within the preceding five years, and that it was not known if vaccinating at an earlier interval than 10 years was, in fact, safe. ACIP also acknowledged that adult safety studies of Adacel vaccine were not sufficient enough to be able to detect rare adverse events that might occur following vaccination. Tdap vaccine was also recommended for all women of childbearing age, and vaccination was encouraged prior to pregnancy or immediately postpartum. As well, all health care providers with direct patient contact were also recommended to receive Tdap vaccine if at least 2 years had passed since a previous dose of Td vaccine had been administered.103

In October of 2012, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended that all pregnant women receive a Tdap vaccine during each pregnancy, between 27 and 36 weeks gestation.104 At the time of this recommendation, ACIP acknowledged that “a theoretical risk exists for severe local reactions105 in pregnant women vaccinated frequently due to multiple pregnancies spaced closely together, but reported that current tetanus toxoid containing vaccines contained less tetanus toxin than previously recommended tetanus toxoid vaccines and stated that “the potential benefit of preventing pertussis morbidity and mortality in infants outweighs the theoretical concerns of possible severe adverse events.106 In this recommendation, ACIP also acknowledged that no studies had ever examined the safety of administering Tdap vaccine to pregnant women during subsequent pregnancies, but reported that going forward, they planned to monitor both the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) to assess for adverse events, maternal adverse pregnancy outcomes and birth outcomes.107

The CDC currently recommends that all children receive 5 doses of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) at 2, 4, 6, 15-18 months, and 4-6 years, with an adolescent booster dose of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) at age 11-12. Adults not previous vaccinated with Tdap are recommended to receive one dose of the vaccine, and then continue to receive booster doses of tetanus-diphtheria (Td) vaccine every 10 years. All pregnant women are recommended to receive a Tdap vaccine between 27 and 36 weeks gestation, during each pregnancy, regardless of any previous Tdap vaccination.108

In 2016, the CDC reported that 58 percent of adults 65 years and older, 64.2 percent of adults 50 to 64 years, 62.8 percent of adults 19 to 49, and 62.2 percent of adults 19 and younger had received a tetanus containing vaccine within the previous 10 years. When Tdap vaccination rates could be assessed among adults, 20.4 percent of adult 65 years and older, 28 percent of adults 19 to 64 years, and 26.6 percent of adults 19 and younger had reported receiving a dose Tdap vaccine within the previous 10 years. Whites were found to have a higher tetanus vaccination rates when compared to Hispanics, blacks, and Asians.109

In 2017, the CDC reported that 94 percent of all 19 to 35 month old children had received at least three doses of the tetanus toxoid containing DTaP vaccine and 83 percent had received at least four DTaP vaccine doses.110 As well, in 2017, the CDC also reported that 88.5 percent of all adolescents had received a booster dose of Tdap vaccine.111

How effective is Tetanus vaccine?

No randomized control studies on the efficacy of the tetanus toxoid have ever been completed. Data on what can be considered the minimal level of blood anti-tetanus antibodies believed to be protective against tetanus disease is scarce however, a tetanus antibody level of 0.01 IU/mL and above is considered indicative of protection against tetanus disease.112  

The CDC reports that a single dose of tetanus toxoid will likely not protect a person from developing tetanus but that three tetanus toxoid vaccine doses should induce vaccine acquired blood antibody levels considered to be protective against tetanus disease in nearly all individuals. Vaccine acquired tetanus blood antibody levels, however, decrease with time and within 10 years, most individuals may only have blood antibody levels considered minimally protective against tetanus disease. As a result, the CDC recommends tetanus vaccination every 10 years, however, in the event that a serious wound occurs and the previous dose of tetanus toxoid vaccine is greater than 5 years earlier, a booster dose of tetanus toxoid vaccine is recommended.113

There are several published case studies reporting on the incidence of tetanus disease among vaccinated persons, including severe and fatal tetanus cases among persons found to have blood anti-tetanus antibodies considered to be well above the minimum level considered to be protective against tetanus.114 115 116 117 118 119 120

Neonatal tetanus cases have also been reported in newborns found to have significantly elevated tetanus blood antibody levels. In one study, seven newborns diagnosed with neonatal tetanus were found to have antibody levels between 4 and 13 times the minimally accepted level (0.01 IU/ml) considered to be protective against tetanus disease. The mothers of all but one infant had received a dose of tetanus toxoid vaccine (TT) during pregnancy. Two additional newborns diagnosed with neonatal tetanus, born to mothers who had received multiple doses of tetanus toxoid during pregnancy, were found to have antibody levels at 100 and 400 times the minimal protective level. Researchers hypothesized that the administration of the tetanus toxoid vaccine (TT) during pregnancy might produce tetanus disease by overwhelming the pre-existing tetanus anti-toxin levels and that multiple doses of tetanus toxoid vaccine administered during pregnancy could also result in an ineffective immune response.121

Between 2001 and 2008, there were a total of 233 reported cases of tetanus (average of 29 cases per year). Of the 197 cases where outcomes were known, 26 (13.2 percent) were fatal. Tetanus vaccination status was known in 92 out of 233 cases (39.5 percent). 55 individuals (59.3 percent) reported receiving at least one dose of a tetanus toxoid vaccine (TT), with 24 (26.1 percent) reported having received at least 4 or more tetanus toxoid vaccine doses. 122

Between 2009 and 2015, there were 197 cases and 2 deaths associated with tetanus disease. Tetanus vaccination status was reported on a total of 49 cases (25 percent). Of cases where vaccination status was reported, 10 cases of tetanus disease (20 percent) occurred in individuals reporting a history of receiving at least three doses of tetanus toxoid vaccine.123

The Adacel (Tdap) vaccine product insert reports that in clinical studies examining the concomitant administration of Adacel with the trivalent inactivated influenza vaccine, Fluzone, tetanus booster response rates were significantly lower in the group receiving the vaccines concurrently when compared to those who received the vaccines separately. In both groups, however, more than 98 percent of vaccine recipients were found to have blood immune levels considered to be protective against tetanus.124

Can Tetanus vaccine cause injury and death?

The Institute of Medicine (IOM) has acknowledged that there is individual susceptibility to vaccine reactions for genetic, biological and environmental reasons, but that vaccine providers cannot accurately predict prior to a vaccine’s administration who will suffer complications, injury or death from vaccination.125 However, a person who has previously had a serious reaction to a vaccination or is acutely or chronically ill should become informed about all potential risks associated with vaccination and discuss any concerns with a trusted health care professional before receiving a DTaP/Tdap/Td vaccine or any other vaccine.

According to the CDC, possible side effects from DTaP vaccine include:126

  • Pain, swelling, and redness at the injection site
  • Fatigue
  • Fussiness
  • Fever
  • Loss of appetite
  • Vomiting
  • Non-stop crying for 3 hours or longer
  • Fever greater than 105 F
  • Swelling of the entire vaccinated limb
  • Long-term seizures
  • Coma
  • Lowered consciousness
  • Permanent brain damage
  • Severe allergic reaction
  • death

According to the CDC, possible side effects from Tdap vaccine include:127

  • Pain, redness, and swelling at injection site that can last several days and interfere with activities
  • Swelling of the entire arm
  • Headache
  • Nausea, diarrhea, stomach ache, vomiting
  • Joint pain
  • Chills
  • Fatigue
  • Fever
  • Body aches
  • Swollen glands
  • Rash
  • Severe swelling, pain, redness, and bleeding in arm where vaccine was administered
  • Severe pain and impaired mobility to the shoulder
  • Dizziness or fainting
  • Severe allergic reaction
  • Death

According to the CDC, possible side effects from Td vaccine include:128

  • Pain, redness, and swelling at injection site
  • Fever
  • Fatigue
  • Headache
  • Severe swelling, pain, redness, and bleeding in arm where vaccine was administered
  • Severe pain and impaired mobility to the shoulder
  • Dizziness or fainting
  • Severe allergic reaction
  • Death

In 1994, the Institute of Medicine (IOM) reported that there was compelling scientific evidence to conclude that tetanus, DT and Td vaccines can cause Guillain-Barre syndrome (GBS) including death; brachial neuritis; and death from anaphylaxis (shock).129  However, in 2012, the IOM committee reported that there was a lack of evidence to support or reject a causal association between GBS and tetanus, diphtheria toxoid and acellular pertussis vaccines. The committee also reported a lack of evidence to support or reject a causal association between encephalopathy, encephalitis, infantile spasms, seizures, ataxia, autism, acute disseminated encephalomyelitis (ADEM), transverse myelitis, chronic inflammatory disseminated polyneuropathy, optic neuritis, onset of multiple sclerosis in adults, relapse of multiple sclerosis in adults, relapse of multiple sclerosis in children, opsoclonus myoclonus syndrome, or Bell ’s palsy and tetanus, diphtheria toxoid and acellular pertussis vaccines. The committee, however, reported that evidence convincingly supported an association between anaphylaxis following tetanus, diphtheria toxoid and acellular pertussis vaccines.130

Published studies have reported on serious adverse reactions following tetanus toxoid vaccination. Adverse events include anaphylaxis,131 132 brachial neuritis,133 bullous pemphigoid134 135 136 Guillain-Barre Syndrome (GBS),137 138 acute disseminated encephalomyelitis (ADEM),139 erythema multiforme,140 141 142 myocarditis,143 144 145 146 147 arthritis,148 149 optic neuritis,150 151 and additional autoimmune disorders.152 153

In 2017, researchers in Guinea-Bissau compared the mortality rates of diphtheria, tetanus, and whole cell pertussis (DTP) vaccinated infants between 3 and 5 months of age with children who were not yet vaccinated with the DTP vaccine and discovered that mortality rates from all causes were significantly higher among DTP vaccinated infants when compared to infants who were not yet vaccinated. Researchers also noted that if the oral polio vaccine (OPV) was administered simultaneously with the DTP vaccine, all-cause mortality rates decreased, however they were still significantly higher when compared to infants who had not yet been vaccinated.154

When the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended that all pregnant women receive a Tdap vaccine during each pregnancy, between 27 and 36 weeks gestation, in October of 2012, they acknowledged that “a theoretical risk exists for severe local reactions155 in pregnant women vaccinated frequently due to multiple pregnancies spaced closely together. In this recommendation, ACIP reported that the amount of tetanus toxin in the current tetanus toxoid containing vaccines contained less tetanus toxin than those historically reported to cause severe adverse reactions and stated that “the potential benefit of preventing pertussis morbidity and mortality in infants outweighs the theoretical concerns of possible severe adverse events.156 However, ACIP also acknowledged that no studies had ever examined the safety of administering Tdap vaccine to pregnant women during subsequent pregnancies, but reported that going forward, they planned to monitor both the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) to assess for adverse events, maternal adverse pregnancy outcomes and birth outcomes.157 In 2018, ACIP reported that studies on the use of Tdap vaccine in pregnancy have not shown any “new or unexpected safety concerns158 but admitted that safety studies on Tdap vaccine administration during pregnancy at close intervals to another tetanus toxoid containing vaccine were limited.159

The Adacel vaccine product insert states that “there are no adequate and well-controlled studies of Adacel administration in pregnant women in the U.S.”160 The product insert also states that for routine booster vaccination, a second dose of Adacel vaccine may be administered if eight years or more has passed since the first Tdap vaccine.161 The Boostrix product insert states that “safety and effectiveness of BOOSTRIX have not been established in pregnant women162 and is FDA approved only to be administered as a single dose.163

Adverse reactions reported by vaccine manufacturers as listed in the vaccine product inserts:

Infanrix (Diphtheria, tetanus toxoids, and acellular pertussis vaccine manufactured by GlaxoSmithKline.)

  • Frequently Reported Adverse Events: Pain, redness, and swelling at the site of the injection; drowsiness; irritability/fussiness; loss of appetite.
  • Serious Reported Adverse Events:Hypotonic-hyporesponsive (collapse) episode; persistent cry for three or more hours; high fever, and convulsions (seizures). After licensure (post-marketing), reported adverse events included bronchitis, cellulitis, respiratory tract infection, lymphadenopathy, thrombocytopenia, anaphylactic reaction, encephalopathy, headache, hypotonia, ear pain, apnea, cough, angiodema, pruritus, rash, fatigue and Sudden Infant Death Syndrome (SIDS).

DAPTACEL (Diphtheria and tetanus toxoids and acellular pertussis vaccine manufactured by Sanofi Pasteur.)

  • Frequently Reported Adverse Events: injection site soreness, tenderness, redness, and increase in arm circumference; fussiness/irritability; inconsolable crying; decreased activity/lethargy.
  • Serious Reported Adverse Events:Convulsions (seizures), including infantile spasms; bronchiolitis; pneumonia; meningitis; sepsis; irritability; unresponsiveness. After licensure (post-marketing), reported adverse events have also included cyanosis, nausea, diarrhea, cellulitis, and allergic reaction.

Pediarix (diphtheria and tetanus toxoids and acellular pertussis, hepatitis B recombinant and inactivated poliovirus vaccine manufactured by GlaxoSmithKline.)

  • Frequently Reported Adverse Events: Local injection site reactions (pain, redness, or swelling); fussiness, high fever (Pediarix is associated with higher rates of feverrelative to separately administered vaccines. The prevalence of fever was highest on the day of vaccination and the day following vaccination.)
  • Serious Reported Adverse Events: High fever that required medical attention (In a safety study that evaluated medically attended fever after Pediarix or separately administered vaccines when co-administered with 7-valent pneumococcal and Hib conjugate vaccines, infants who received Pediarix had a higher rate of medical encounters for fever within the first 4 days following the first vaccination); febrile and afebrile convulsions (seizures); gastroenteritis, bronchiolitis; asthma, diabetes mellitus, and chronic neutropenia; anaphylactic reactions (hives, swelling, difficulty breathing, hypotension or shock), demyelinating diseases.

Kinrix (diphtheria and tetanus toxoids, acellular pertussis and inactivated poliovirus vaccine manufactured by GlaxoSmithKline.)

  • Frequently Reported Adverse Events: Injection site pain, including redness, swelling and increase in arm circumference; drowsiness; fever; loss of appetite.
  • Serious Reported Adverse Events:Gastroenteritis, dehydration, and cellulitis. After licensure (post-marketing) reported adverse event reports have also included apnea, collapse or shock-like state (hypotonic-hyporesponsive episode), convulsions (with or without fever), injection site vesicles; pruritus (intense itching); allergic reactions, including anaphylaxis; urticaria; angioedema; lympadenopathy, and thrombocytopenia.

Quadracel (diphtheria and tetanus toxoid, acellular pertussis and inactivated poliovirus vaccine manufactured by Sanofi Pasteur.)

  • Frequently Reported Adverse Events: Injection site pain, including redness, swelling and increase in arm circumference; malaise; muscle pain; headache.
  • Serious Reported Adverse Events: After licensure (post-marketing) reported adverse event reports have also included cyanosis; convulsions (with or without fever); injection site abscess; injection site cellulitis; pallor; screaming; allergic reactions, including anaphylaxis; urticarial, and dyspnea

Pentacel (diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus and Haemophilus b conjugate (tetanus toxoid conjugate) vaccine manufactured by Sanofi Pasteur.)

  • Frequently Reported Adverse Events: Systemic reactions that occurred in clinical trials in more than 50 percent of participants following any dose included fussiness/irritability and inconsolable crying; fever; injection site reactions, including tenderness, abscess and increase in arm circumference.
  • Serious Reported Adverse Events: Cases of encephalopathy and death also occurred during clinical trials. After licensure (post marketing), there have been reports of febrile and afebrile convulsions (seizures); bronchiolitis, gastroenteritis, dehydration, pneumonia, lethargy/somnolence; hypotonic/hyporesponsive episode (collapse); apnea, cyanosis, asthma.

VAXELIS (diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, Haemophilus b conjugate, and hepatitis B recombinant vaccine manufactured by MCM Vaccine Company.)

  • Frequently Reported Adverse Events: Systemic reactions that occurred in clinical trials following any dose included injection site redness, swelling, and pain, fever, crying, decreased appetite, irritability, vomiting, and somnolence
  • Serious Reported Adverse Events: In the two U.S. clinical trials, 6 deaths were reported but were determined by trial investigators not to be attributed to VAXELIS. These deaths included sepsis, asphyxia, hydrocephalus, unknown cause, and two cases of sudden infant death syndrome. As VAXELIS is not currently available for use in the United States, post-marketing data on serious adverse events are limited to those events considered to have a causal link to the vaccines containing the antigens of VAXELIS. These include anaphylaxis, hypersensitivity, seizures, including febrile seizures, and excessive swelling of the injected limb.

Diphtheria and Tetanus Toxoid Adsorbed (diphtheria and tetanus toxoid vaccine manufactured by Sanofi Pasteur.)

  • Frequently Reported Adverse Events: In pre-licensure clinical trials, pain, redness, and swelling at the injection site, loss of appetite, crying, and fever. Adverse events were monitored for only 24 hours following vaccination.
  • Serious Reported Adverse Events:  After licensure (post marketing) adverse event reports have included injection site pain, swelling and hypersensitivity; syncope; convulsion; somnolence; headache; rash; pallor; itching; lymphadenopathy.

Adacel (Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine manufactured by Sanofi Pasteur.)

  • Frequently Reported Adverse Events: In clinical trials, most common reactions were pain and swelling at the injection site; fever (especially in adolescents); headache; body aches/muscle weakness; fatigue; chills, sore and swollen joints; nausea, lymph node swelling.
  • Serious Reported Adverse Events: After licensure (post-marketing), adverse event reports have included severe injection site swelling, bruising, sterile abscess; facial palsy; convulsion; syncope (fainting); parasthesia; Guillain-Barre Syndrome (GBS); myelitis; anaphylactic reaction; hypersensitivity reaction (angioedema, rash, hypotension); urticaria; muscle spasm; myocarditis.

Boostrix (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine manufactured by GlaxoSmithKline.)

  • Frequently Reported Adverse Events: In pre-licensure clinical trials, pain, redness, and swelling at the injection site, increase in arm circumference of injected arm; headache; fatigue; gastrointestinal symptoms.
  • Serious Reported Adverse Events: One case of diabetes developed after Boostrix administration in clinical trials. After licensure (post marketing) adverse event reports have included extensive inflammation, swelling of injected limb, nodule, itching; encephalitis (brain inflammation); convulsion; facial palsy; lymphadenitis; lymphadenopathy; myocarditis; arthralgia; back pain; myalgia; urticaria; Henoch-Schonlein purpura.

TDVAX (Tetanus and diphtheria toxoid vaccine manufactured by MassBiologics.)

  • Frequently Reported Adverse Events: Pre-licensing clinical trial data on adverse events following TDVAX are not listed as part of the product insert.
  • Serious Reported Adverse Events:  After licensure (post marketing) adverse event reports have included injection site pain, swelling, warmth, itching and hypersensitivity; fever; cellulitis; nausea; rash; joint and muscle pain; dizziness; convulsion; malaise; headache;

TENIVAC (Tetanus and diphtheria toxoid vaccine manufactured by Sanofi Pasteur.)

  • Frequently Reported Adverse Events: In pre-licensure clinical trials, pain, redness, and swelling at the injection site; fever; muscle weakness; joint pain; malaise; headache.
  • Serious Reported Adverse Events: In pre-licensing clinical trials, serious adverse events included asthma, localized infection, stroke, chest pain, colonic polyp, cellulitis, angina pectoris, hip and wrist fracture, and cholecystitis. Three deaths occurred following administration of TENIVAC. Deaths were reported as cardiopulmonary arrest; myocardial infarction and septic shock; and unknown cause. After licensure (post marketing) adverse event reports have included Guillain-Barre Syndrome (GBS), injection site pain, swelling, warmth, itching, cellulitis and hypersensitivity; fever; lymphadenopathy; vomiting; dizziness; paresthesia; syncope; fatigue; peripheral edema; rash; joint and muscle pain; allergic and anaphylactic reactions;

As of January 30, 2019, there have been over 182,116 adverse events reported to the Vaccine Adverse Events Reporting System (VAERS) in connection with tetanus and tetanus-containing vaccines combined with additional vaccines since 1990, including 3,139 related deaths, 21,684 hospitalizations, and 3,175 related disabilities. However, the numbers of vaccine-related injuries and deaths reported to VAERS may not reflect the true number of serious health problems that occur develop after tetanus vaccination.

Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to federal health agencies (VAERS), many doctors and other medical workers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. There is evidence that only between one and 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials, who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations. 164 165 166 167 168

As of March 1, 2019, there have been 5,861 claims filed so far in the federal Vaccine Injury Compensation Program (VICP) for 864 deaths and 4,997 injuries that occurred after tetanus and tetanus-containing vaccines combined with additional vaccines. Of that number, the U.S. Court of Claims administering the VICP has compensated 2,142 children and adults, who have filed claims for tetanus vaccine associated injury.169

Who should not get Tetanus vaccine?

The tetanus toxoid vaccine is only available in combination with other routinely administered vaccines and most frequently combined with diphtheria (DT, Td) and acellular pertussis vaccines (DTaP, Tdap). It is also found in combination with vaccines for polio, haemophilus influenzae B (HIB), and hepatitis B.

The CDC’s Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of all infants and young children with the combination diphtheria, tetanus, and acellular vaccine (DTaP) at 2, 4, 6, 15-18 months, and 4 to 6 years, however, children under the age of seven with a contraindication to pertussis vaccination are recommended to receive the diphtheria-tetanus toxoid vaccine (DT) in place of the pertussis containing DTaP vaccine.170

According to the CDC, diphtheria, tetanus, and acellular pertussis vaccines (DTaP) should not be administered to any person who has experienced a severe allergic reaction to a previous dose or to anyone with a severe allergy to any ingredient found within the vaccine.171

If a person has a previous health history of Guillain-Barré Syndrome (GBS) within 6 weeks of receiving a dose of a tetanus toxoid containing vaccine, or is considered moderately or severe ill, the CDC recommends that vaccination be given only if the potential benefits to vaccination outweigh the possible risks. As well, anyone who has experienced an Arthus-type hypersensitivity reaction following a previous dose of a diphtheria or tetanus toxoid containing vaccine should not receive another tetanus-diphtheria (Td) vaccine more frequently than every 10 years.172

Any person who developed encephalopathy within seven days of vaccination with a pertussis containing vaccine (DTP, DTaP, Tdap) should not receive another pertussis containing vaccine (DTaP, Tdap).173

The CDC also states that additional doses of DTaP vaccines should only be administered when both parents and vaccine providers believe the potential benefits to vaccination outweigh the possible risks in children who have:174

  • Experienced a seizure within 3 days of a previous dose of DTP/DTaP vaccine
  • Developed a temperature of 105 F or higher within 2 days of previous vaccination with DTP/DTaP
  • Persistently cried for at least 3 hours or more within 48 hours of receiving a previous dose of DTP/DTaP
  • Collapsed or experienced a shock-like state within 2 days of a previous DTP/DTaP vaccine

Contraindications and precautions to vaccination as listed in the vaccine manufacturer product inserts

INFANRIX vaccine contraindications and precautions (Please see GlaxoSmithKline product insert for complete list):

    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination;
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination;
    • Serious allergic reaction to a previous pertussis vaccination;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • Children with a progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy;
    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Infanrix vaccine product insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination;
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, assessment of the possible risks and potential benefits of receiving Infanrix should be carefully considered prior to vaccination;
    • The tip caps of prefilled Infanrix syringes contain latex and may cause an allergic reaction in persons sensitive to latex.

INFANRIX is FDA approved for use in infants and children between 6 weeks through 6 years of age. INFANRIX should not be administered to infants younger than 6 weeks or children older than 6 years of age.

DAPTACEL vaccine contraindications and precautions (Please see Sanofi Pasteur product insert for complete list):

    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination;
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination;
    • Serious allergic reaction to a previous pertussis vaccination;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy);
    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. DAPTACEL vaccine product insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination.
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, assessment of the possible risks and potential benefits of receiving DAPTACEL should be carefully considered prior to vaccination.

DAPTACEL is FDA approved for use in infants and children between 6 weeks through 6 years of age. DAPTACEL should not be administered to infants younger than 6 weeks or children older than 6 years of age.

Pediarix vaccine contraindications and precautions (Please see GlaxoSmithKline product insert for complete list):

    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination;
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination;
    • Serious allergic reaction to a previous pertussis vaccination;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy);
    • Sensitivity to any component of Pediarix, including yeast or neomycin and polymyxin B (antibiotics);
    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Pediarix vaccine product insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination.
    • The tip caps of prefilled Pediarix syringes contain latex and may cause an allergic reaction in persons sensitive to latex;
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, assessment of the possible risks and potential benefits of receiving Pediarix should be carefully considered prior to vaccination.

Pediarix is FDA approved for use in infants and children between 6 weeks through 6 years of age. Pediarix should not be administered to infants younger than 6 weeks or children older than 6 years of age.

Kinrix vaccine contraindications and precautions (Please see GlaxoSmithKline product insert for complete list):

    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination;
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination;
    • Serious allergic reaction to a previous pertussis vaccination;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy);
    • Severe allergic reaction to any component of Kinrix, including neomycin and polymyxin B (antibiotics);
    • The tip caps of prefilled Kinrix syringes contain latex and may cause an allergic reaction in persons sensitive to latex;
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, assessment of the possible risks and potential benefits of receiving Kinrix should be carefully considered prior to vaccination.

Kinrix is FDA approved for use in children between the ages of 4 and 6 years. Kinrix should not be administered to children younger than 4 years or older than 6 years of age.

Quadracel vaccine contraindications and precautions (Please see Sanofi Pasteur product insert for complete list):

    • Serious allergic reaction following administration of a pertussis, tetanus, diphtheria, or polio containing vaccine or any ingredient of Quadracel vaccine;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy);
    • Seizures within 3 days of a previous pertussis vaccination;
    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, assessment of the possible risks and potential benefits of receiving Quadracel should be carefully considered prior to vaccination.

Quadracel is FDA approved for use in children between the ages of 4 and 6 years. Quadracel should not be administered to children younger than 4 years or older than 6 years of age.

Pentacel vaccine contraindications and precautions (Please see Sanofi Pasteur product insert for complete list):

    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination;
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination;
    • Serious allergic reaction to a previous pertussis vaccination;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy)
    • Severe allergic reaction to any component of Pentacel, including neomycin and polymyxin B (antibiotics);
    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Pentacel vaccine product insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination;
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, assessment of the possible risks and potential benefits of receiving Pentacel should be carefully considered prior to vaccination.

Pentacel is FDA approved for use in infants and children between 6 weeks through 4 years of age. Pentacel should not be administered to infants younger than 6 weeks or children older than 4 years of age.

VAXELIS vaccine contraindications and precautions (Please see MCM Vaccine Company product insert for complete list):

    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause;
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination;
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination;
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination;
    • Serious allergic reaction to a previous dose of VAXELIS, any ingredient found in VAXELIS, or any other tetanus toxoid, diphtheria toxoid, pertussis-containing vaccine, hepatitis B vaccine, inactivated poliovirus vaccine, or H. influenzae type b vaccine;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy);
    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. VAXELIS vaccine product insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination;
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, assessment of the possible risks and potential benefits of receiving VAXELIS should be carefully considered prior to vaccination.

VAXELIS is FDA approved for use in infants and children between 6 weeks through 4 years of age. VAXELIS should not be administered to infants younger than 6 weeks or children older than 4 years of age.

Diphtheria and Tetanus Toxoid Adsorbed vaccine contraindications and precautions (Please see Sanofi Pasteur product insert for complete list):

    • Serious allergic or hypersensitivity reaction to a previous shot, or to any diphtheria or tetanus toxoid vaccine;
    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Diphtheria and Tetanus Toxoid Absorbed vaccine product insert warns that the decision to vaccinate an infant born prematurely should take into consideration both the potential risks and possible benefits of vaccination;
    • If Guillain-Barré Syndrome (GBS) occurred within 6 weeks of a previous tetanus toxoid vaccine, the risk of a recurrent case may be increased following vaccination with Diphtheria and Tetanus Toxoid Adsorbed.

Diphtheria and Tetanus Toxoid Adsorbed is FDA approved for use in infants and children between 6 weeks through 6 years of age. Diphtheria and Tetanus Toxoid Adsorbed should not be administered to infants younger than 6 weeks or children older than 6 years of age.

Adacel vaccine contraindications and precautions (Please see Sanofi Pasteur product insert for complete list):

    • Moderate or severe acute illness (with or without fever) until the illness resolves;
    • Serious allergic or hypersensitivity reaction to a previous shot;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • In adolescents, a progressive neurologic disorder, including progressive encephalopathy or uncontrolled epilepsy (convulsions);
    • In adults, an unstable neurologic condition, such as cerebrovascular events and acute encephalopathic conditions;
    • If Guillain-Barré Syndrome (GBS) occurred within 6 weeks of a previous tetanus toxoid vaccine, the decision to administer Adacel should carefully examine the possible risk and benefits of Adacel prior to vaccination;
    • Anyone who has experienced an Arthus-type hypersensitivity reaction following a previous dose of a tetanus toxoid vaccine should not receive Adacel more frequently than every 10 years;
    • The tip caps of prefilled Adacel syringes contain latex and may cause an allergic reaction in persons sensitive to latex.

Adacel is approved to be administered in persons between the ages of 10 and 64 years of age. A second dose of Adacel may be administered if there has been an interval of at least eight years between a prior Tdap vaccine dose.  Adacel should not be administered to children younger than 10 years or adults older than 64 years.

Boostrix vaccine contraindications and precautions (Please see GlaxoSmithKline product insert for complete list):

    • Serious allergic or hypersensitivity reaction to a previous shot;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • In adolescents and adults, a progressive neurologic disorder, including progressive encephalopathy or uncontrolled epilepsy (convulsions);
    • If Guillain-Barré Syndrome (GBS) occurred within 6 weeks of a previous tetanus toxoid vaccine, the decision to administer Boostrix should carefully examine the possible risk and benefits of vaccination;
    • Anyone who has experienced an Arthus-type hypersensitivity reaction following a previous dose of a tetanus toxoid vaccine should not receive Boostrix more frequently than every 10 years;
    • The tip caps of prefilled Boostrix syringes contain latex and may cause an allergic reaction in persons sensitive to latex.

Boostrix is approved to be administered as a single dose in persons older than 10 years. Boostrix should not be administered to children younger than 10 years of age.

TDVAX vaccine contraindications and precautions (Please see MassBiologics product insert for complete list):

    • Serious allergic or hypersensitivity reaction to a previous shot, or to any diphtheria or tetanus toxoid vaccine;
    • If Guillain-Barré Syndrome (GBS) occurred within 6 weeks of a previous tetanus toxoid vaccine, the decision to administer TDVAX should carefully examine the possible risk and benefits prior to vaccination;
    • Anyone who has experienced an Arthus-type hypersensitivity reaction following a previous dose of a tetanus toxoid vaccine should not receive TDVAX more frequently than every 10 years.

TDVAX is approved for use in adults and children 7 years of age and older. TDVAX should not be administered to children younger than 7 years.

TENIVAC vaccine contraindications and precautions (Please see Sanofi Pasteur product insert for complete list):

    • Serious allergic or hypersensitivity reaction to a previous shot, or to any diphtheria or tetanus toxoid vaccine;
    • If Guillain-Barré Syndrome (GBS) occurred within 6 weeks of a previous tetanus toxoid vaccine, the decision to administer TENIVAC should carefully examine the possible risk and benefits prior to vaccination;
    • Anyone who has experienced an Arthus-type hypersensitivity reaction following a previous dose of a tetanus toxoid vaccine should not receive TENIVAC more frequently than every 10 years;
    • The tip caps of prefilled TENIVAC syringes contain latex and may cause an allergic reaction in persons sensitive to latex;
    • Administering TENIVAC vaccine more frequently than prescribed may result in the increased incidence and severity of adverse reactions.

TENIVAC is approved for use in adults and children 7 years of age and older. TENIVAC should not be administered to children younger than 7 years.

Who is at highest risk for complications from Tetanus vaccine?

There is a gap in medical knowledge in terms of doctors being able to predict who will have an adverse reaction to tetanus vaccination, and who will not.

Persons with a history of Guillain-Barre Syndrome (GBS) within 6 weeks of receiving a tetanus containing vaccine may be at an increased risk of recurrent GBS illness following tetanus vaccination.175 176 177 178 179 180 181 182 183 184 185 186

Anyone who has experienced an Arthus-like reaction (severe painful swelling of the injected arm) following a previous dose of tetanus toxoid vaccine are also considered to be at a greater risk of recurrent reaction and should not be vaccinated with tetanus toxoid vaccine more frequently than every 10 years.187

Infants born prematurely have been noted to experience apnea following intramuscular vaccination, placing them at higher risk for complications following vaccination. DTaP and DT vaccine product inserts state that the decision to vaccinate an infant born prematurely should take into consideration health status and the possible risks and potential benefits of vaccination.188 189 190 191 192 193

Residual milk allergens may persist following the manufacturing of DTaP and Tdap vaccines. While the CDC’s Advisory Committee on Immunization Practices (ACIP) does not consider a milk allergy to be a contraindication to vaccination and recommends both DTaP and Tdap vaccines for persons with known milk allergies, it does, however, strongly advise the monitoring of milk allergic patients due to the potential risk of anaphylaxis.194  

Pre-licensing clinical studies of Adacel vaccine (Tdap) reported that when the vaccine was administered concomitantly with the Hepatitis B vaccine, there were an increase in reports of redness and swelling at the injection site and an increase of reports of swollen joints and body aches. Additionally, when Adacel was administered with the trivalent inactivated influenza vaccine (TIV), Fluzone, pain at the injection site was noted to be statistically higher when compared to the separate administration of Adacel vaccine. Rates of joint pain and swelling were also noted to be higher when Adacel was administered concurrently with Fluzone. As a result, persons who receive simultaneous vaccinations with one or more vaccines may be at a higher risk for adverse events.195

The TENIVAC (Td) vaccine product insert states that administering the vaccine more frequently than prescribed may result in the increased incidence and severity of adverse reactions.196

What questions should I ask my doctor about the Tetanus vaccine?       

NVIC’s If You Vaccinate, Ask 8! Webpage downloadable brochure suggests asking eight questions before you make a vaccination decision for yourself, or for your child. If you review these questions before your appointment, you will be better prepared to ask your doctor questions.  Also make sure that the nurse or doctor gives you the relevant Vaccine Information Statement (VIS) for the vaccine or vaccines you are considering well ahead of time to allow you to review it before you or your child gets vaccinated. Copies of VIS for each vaccine are also available on the CDC's website and there is a link to the VIS for vaccines on NVIC's “Quick Facts” at the top of this page.

It is also a good idea to read the vaccine manufacturer product insert that can be obtained from your doctor or public health clinic because federal law requires drug companies marketing vaccines to include certain kinds of vaccine benefit, risk and use information in product information inserts that may not be available in other published information. Tetanus vaccine product inserts are located on the Food and Drug Administration’s website.

Other questions that may be useful to discuss with your doctor before getting the tetanus vaccine are: 

  • If other vaccines in addition to tetanus vaccine are scheduled for my child at this office visit, am I allowed to modify the schedule so fewer vaccines are given at once?
  • What should I do if my child has a high fever or appears very ill after vaccination?
  • What other kinds of reaction symptoms should I call to report after tetanus vaccination?
  • If the tetanus vaccine doesn’t protect my child, do I have any other options for preventing tetanus infection?

Under the National Childhood Vaccine Injury Act of 1986, doctors and all vaccine providers are legally required to give you vaccine benefit and risk information before vaccination; record serious health problems following vaccination in the permanent medical record; keep a permanent record of all vaccines given, including the manufacturer’s name and lot number; and report serious health problems, injuries and deaths that follow vaccination to VAERS.

Remember, if you choose to vaccinate, always keep a written record of exactly which shots/vaccines you or your child have received, including the manufacturer’s name and vaccine lot number. Write down and describe in detail any serious health problems that develop after vaccination, and keep vaccination records in a file you can access easily.  

It also is important to be able to recognize a vaccine reaction and seek immediate medical attention if the reaction appears serious, as well as know how to make a vaccine reaction report to federal health officials at the Vaccine Adverse Reporting System (VAERS). NVIC’s Report Vaccine Reactions—It’s the Law webpage can help you file a vaccine reaction report yourself to VAERS if your doctor fails or refuses to make a report.

NVIC Press Releases, Statements & Commentaries Related to Tetanus 

NVIC DPT Vaccine Video Playlist

View the collection of video resources within the player below for more information on the DPT vaccine (diphtheria, pertussis, and tetanus combination vaccine).

To view the entire video collection, click the hamburger menu in the upper left corner of the video player above. This will expand a full list of videos. You may also open the video player in full screen mode for optimal display.

The Vaccine Reaction

Bibliography & Resource Links

Medical Literature 

 

1 CDC Tetanus - Clostridium tetani Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

2 CDC Tetanus - Epidemiology Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

3 MedlinePlus Tetanus – Summary May 23, 2018

4 CDC Tetanus - Epidemiology Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

5 CDC Tetanus - Clostridium tetani Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

6 CDC Tetanus – Pathogenesis Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

7 CDC Tetanus - Clinical Features Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

8 CDC Symptoms and Complications Feb. 28, 2019

9 CDC Surveillance Manual – Chapter 16 – Tetanus – Background Nov. 17, 2017

10 Ibid

11 CDC Tetanus - Clinical Features Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

12 FDA Vaccines Licensed for Use in the United States Mar. 18, 2019

13 CDC Tetanus – Adverse Reactions Following Vaccination Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

14 Mayorga C, Torres MJ, Corzo JL et al. Immediate allergy to tetanus toxoid vaccine: determination of immunoglobulin E and immunoglobulin G antibodies to allergenic proteins. Ann Allergy Asthma Immunol. 2003 Feb;90(2):238-43.

15 Martín-Muñoz MF, Pereira MJ, Posadas S et al. Anaphylactic reaction to diphtheria-tetanus vaccine in a child: specific IgE/IgG determinations and cross-reactivity studies. Vaccine. 2002 Sep 10;20(27-28):3409-12.

16 Hamati-Haddad A, Fenichel GM. Brachial neuritis following routine childhood immunization for diphtheria, tetanus, and pertussis (DTP): report of two cases and review of the literature. Pediatrics. 1997 Apr;99(4):602-3.

17 Bakshi R, Graves MC. Guillain-Barré syndrome after combined tetanus-diphtheria toxoid vaccination. J Neurol Sci. 1997 Apr 15;147(2):201-2.

18 Newton N Jr, Janati A. Guillain-Barré syndrome after vaccination with purified tetanus toxoid. South Med J. 1987 Aug;80(8):1053-4.

19 Hamidon BB, Raymond AA. Acute disseminated encephalomyelitis (ADEM) presenting with seizures secondary to anti-tetanus toxin vaccination. Med J Malaysia. 2003 Dec;58(5):780-2.

20 Jawad AS, Scott DG Immunisation triggering rheumatoid arthritis? Ann Rheum Dis. 1989 Feb; 48(2): 174.

21 Kaul A, Adler M, Alokaily F, Jawad A Recurrence of reactive arthritis after a booster dose of tetanus toxoid Ann Rheum Dis. 2002 Feb; 61(2): 185.

22 Amsel SG, Hanukoglu A, Fried D, Wolyvovics M Myocarditis after triple immunisation. Arch Dis Child. 1986 Apr; 61(4): 403–405.

23 CDC Tetanus - Clostridium tetani Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

24 Ibid

25 Ibid

26 CDC Tetanus – Pathogenesis Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

27 CDC Tetanus - Clinical Features Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

28 CDC Symptoms and Complications Feb. 28, 2019

29 Hinfey PB Tetanus – Background Medscape Jan 18, 2019

30 CDC Tetanus For Clinicians – Treatment Feb. 28, 2019

31 WHO Western Pacific Region Q & A - What are the symptoms of tetanus? 2019

32 CDC Tetanus – Laboratory Diagnosis Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

33 CDC Tetanus- Surveillance Feb. 28, 2019

34 CDC Reported incidence of notifiable diseases in the United States, 1952 MMWR Oct. 26, 1953 1 (54); 1-10

35 CDC Tetanus- Surveillance Feb. 28, 2019

36 CDC Surveillance Manual – Chapter 16 – Tetanus – Background Nov. 17, 2017

37 WHO Tetanus Jan. 21, 2019

38 CDC Tetanus – About Tetanus  Feb. 28, 2019

39 CDC Tetanus - Clostridium tetani Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

40 CDC Tetanus – Pathogenesis Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

41 CDC Tetanus – Causes and Transmission Feb. 28, 2019

42 Ibid

43 CDC Tetanus – Epidemiology Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

44 CDC Tetanus Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

45 Brightman C Tetanus: an ever-present infection risk Trends in Urology & Men’s Health May/June 2018; p 29-31

46 CDC Tetanus Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

47 Brightman C Tetanus: an ever-present infection risk Trends in Urology & Men’s Health May/June 2018; p 29-31

48 Smithsonian The Antibody Initiative-Battling Tetanus No Date

49 Ibid

50 CDC Tetanus Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

51 CDC Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Apr. 27, 2018 / 67(2);1–44

52 CDC Surveillance Manual – Chapter 16 – Tetanus – Background Nov. 17, 2017

53 CDC Reported incidence of notifiable diseases in the United States, 1952 MMWR Oct. 26, 1953 1 (54); 1-10

54 CDC Reported morbidity and mortality in the United States annual summary 1980 MMWR Sep. 1981; 29(54); 1-144

55 CDC Current Trends Tetanus -- United States, 1982-1984 MMWR Oct. 04, 1985; 34(39);602,607-11

56 CDC Current Trends Tetanus -- United States, 1987 and 1988 MMWR Jan. 26, 1990; 39(3);37-41

57 CDC Tetanus Surveillance --- United States, 2001—2008 MMWR Apr. 1, 2011; 60(12);365-369

58 CDC Surveillance Manual – Chapter 16 – Tetanus – Background Nov. 17, 2017

59 CDC National Notifiable Diseases Surveillance System, Weekly Tables of Infectious Disease Data. Table 2q - 2018 – Week 52.  Atlanta, GA. CDC Division of Health Informatics and Surveillance. 

60 WHO Tetanus – 2017 Global Figures Nov. 2, 2018

61 WHO Neonatal Tetanus – 2017 Global Figures Nov. 2, 2018

62 CDC Symptoms and Complications Feb. 28, 2019

63 Ibid

64 CDC Tetanus- Surveillance Feb. 28, 2019

65 Hinfey PB Tetanus – Prognosis Medscape Jan. 18, 2019

66 CDC Traveler’s Health – Tetanus – Who is at Risk? Mar. 9, 2013

67 CDC Tetanus – Secular Trends in the United States Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

68 CDC Tetanus For Clinicians – Risk Groups Feb. 28, 2019

69 CDC Tetanus – Epidemiology Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

70 Hinfey PB Tetanus – Prognosis Medscape Jan. 18, 2019

71 Ibid

72 Mayo Clinic Tetanus Feb. 22, 2019

73 CDC Tetanus For Clinicians –Wound Management for Tetanus Prevention Feb. 28, 2019

74 Hinfey PB What is the role of tetanus immune globulin (TIG) in the treatment of tetanus (lockjaw)? Medscape Jan. 18, 2019

75 Mayo Clinic Tetanus Feb. 22, 2019

76 WebMD Understanding Tetanus -- Diagnosis and Treatment Mar. 18, 2017

77 Hemilä H, Koivula T. Vitamin C for preventing and treating tetanus. Cochrane Database Syst Rev. 2013 Nov 13;(11):CD006665

78 CDC Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Apr. 27, 2018 / 67(2);1–44

79 Ibid

80 FDA Boostrix Product Insert Apr. 25, 2016

81 FDA Adacel Product Insert Jan. 19, 2019

82 Ibid

83 FDA Boostrix Product Insert Apr. 25, 2016

84 CDC Tetanus Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

85 CDC Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Apr. 27, 2018; 67(2);1–44

86 Smithsonian The Antibody Initiative-Battling Tetanus No Date

87 CDC Tetanus Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

88 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality.  (Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility). Washington, DC: The National Academies Press. 1994. Chapter 5 Diphtheria and Tetanus Toxoids p 67 - 117

89 CDC Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Apr. 27, 2018; 67(2);1–44

90 Institute of Medicine Committee to Review Adverse Effects of Vaccines Adverse Effects of Vaccines: Evidence and Causality.(Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility). Washington, DC: The National Academies Press. 2012 Chapter 10 Diphtheria Toxoid–, Tetanus Toxoid–, and Acellular Pertussis–

Containing Vaccines p 525-598

91 CDC Public Health Report – BIOLOGICAL PRODUCTS Establishments Licensed for the Preparation and Sale of Viruses, Serums, Toxins ,and Analogous Products Public Health Rep. Oct. 5, 1945 60(40):1172-1178

92 CDC Morbidity and mortality weekly report, Vol. 15, no. 48, December 3, 1966 MMWR 15(48); 416-418

93 CDC Adult immunization : recommendations of the Immunization Practices Advisory Committee (ACIP) MMWR Sep. 28, 1984; 33 (supp. 1); 1-68

94 CDC Pertussis Vaccination: Acellular Pertussis Vaccine for Reinforcing and Booster Use -- Supplementary ACIP Statement Recommendations of the Immunization Practices Advisory Committee MMWR Feb. 07, 1992; 41(RR-1);1-10

95 CDC. Pertussis vaccination: use of acellular pertussis vaccines among infants and young children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Mar. 28, 1997;46(RR-7):1–25

96 CDC Pertussis Vaccination: Acellular Pertussis Vaccine for Reinforcing and Booster Use -- Supplementary ACIP Statement Recommendations of the Immunization Practices Advisory Committee MMWR Feb. 07, 1992; 41(RR-1);1-10

97 CDC Recommended Childhood Immunization Schedule -- United States, 1995 MMWR June 16, 1995; 44(RR-5);1-9

98 Ibid

99 CDC Measles Prevention: Recommendations of the Immunization Practices Advisory Committee (ACIP) MMWR Dec. 29, 1989; 38(S-9);1-18

100 CDC Recommended Childhood Immunization Schedule -- United States, 1995 MMWR June 16, 1995; 44(RR-5);1-9

101 CDC. Pertussis vaccination: use of acellular pertussis vaccines among infants and young children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Mar. 28, 1997;46(RR-7):1–25

102 CDC Preventing Tetanus, Diphtheria, and Pertussis Among Adolescents: Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccines Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Mar. 24, 2006; 55(RR03);1-34

103 CDC Preventing tetanus, diphtheria, and pertussis among adults; use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine : recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Dec. 15, 2006; 55; RR-17

104 CDC Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) in Pregnant Women — Advisory Committee on Immunization Practices (ACIP), 2012 MMWR Feb 22, 2013; 62(07);131-135

105 Ibid

106 Ibid

107 Ibid

108 CDC Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Apr. 27, 2018; 67(2);1–44

109 CDC AdultVaxView Vaccination Coverage Among Adults in the United States, National Health Interview Survey, 2016 – Tetanus Vaccination. Feb. 26, 2018

110 CDC Vaccination Coverage Among Children Aged 19–35 Months — United States, 2017 MMWR Oct. 12, 2018; 67(40);1123–1128

111 CDC National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13–17 Years — United States, 2017 MMWR Aug. 24, 2018; 67(33);909–917

112 CDC Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Apr. 27, 2018; 67(2);1–44

113 CDC Tetanus – Tetanus Toxoid Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

114 Vollman KE, Acquisto NM, Bodkin RP. A case of tetanus infection in an adult with a protective tetanus antibody level. Am J Emerg Med. 2014 Apr;32(4):392.e3-4

115 Pryor T, Onarecker C, Coniglione T. Elevated antitoxin titers in a man with generalized tetanus. J Fam Pract. 1997 Mar;44(3):299-303.

116 Passen EL, Andersen BR. Clinical tetanus despite a protective level of toxin-neutralizing antibody. JAMA. 1986 Mar 7;255(9):1171-3.

117 Crone NE, Reder AT. Severe tetanus in immunized patients with high anti-tetanus titers. Neurology. 1992 Apr;42(4):761-4.

118 Abrahamian FM, Pollack CV Jr, LoVecchio F et al. Fatal tetanus in a drug abuser with "protective" antitetanus antibodies. J Emerg Med. 2000 Feb;18(2):189-93.

119 Hahn BJ, Erogul M, Sinert R. et al. Case report of tetanus in an immunized, healthy adult and no point of entry. J Emerg Med. 2004 Oct;27(3):257-60.

120 Murphy KJ. Fatal tetanus with brain-stem involvement and myocarditis in an ex-serviceman. Med J Aust. 1970 Sep 19;2(12):542-4.

121 Maselle SY, Matre R, Mbise R, Hofstad T. Neonatal tetanus despite protective serum antitoxin concentration. FEMS Microbiol Immunol. 1991 Jun;3(3):171-5.

122 CDC Tetanus Surveillance --- United States, 2001—2008 MMWR Apr. 1, 2011; 60(12);365-369

123 CDC Surveillance Manual – Chapter 16 – Tetanus – Background Nov. 17, 2017

124 FDA Adacel Product Insert Jan. 11, 2019

125 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality. Evaluating Biological Mechanisms of Adverse Events (p. 57-102), Increased Susceptibility (p. 82). Washington, DC: The National Academies Press 2012.

126 CDC DTaP (Diphtheria, Tetanus, Pertussis) VIS Aug. 24, 2018

127 CDC Tdap (Tetanus, Diphtheria, Pertussis) VIS Feb. 24, 2015

128 CDC Td (Tetanus, Diphtheria) VIS Apr. 11, 2017

129 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality.  (Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility). Washington, DC: The National Academies Press. 1994. Chapter 5 Diphtheria and Tetanus Toxoids p 67 - 117

130 Institute of Medicine Committee to Review Adverse Effects of Vaccines Adverse Effects of Vaccines: Evidence and Causality.(Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility). Washington, DC: The National Academies Press. 2012 Chapter 10 Diphtheria Toxoid–, Tetanus Toxoid–, and Acellular Pertussis–

Containing Vaccines p 525-598

131 Mayorga C, Torres MJ, Corzo JL et al. Immediate allergy to tetanus toxoid vaccine: determination of immunoglobulin E and immunoglobulin G antibodies to allergenic proteins. Ann Allergy Asthma Immunol. 2003 Feb;90(2):238-43.

132 Martín-Muñoz MF, Pereira MJ, Posadas S et al. Anaphylactic reaction to diphtheria-tetanus vaccine in a child: specific IgE/IgG determinations and cross-reactivity studies. Vaccine. 2002 Sep 10;20(27-28):3409-12.

133 Hamati-Haddad A, Fenichel GM. Brachial neuritis following routine childhood immunization for diphtheria, tetanus, and pertussis (DTP): report of two cases and review of the literature. Pediatrics. 1997 Apr;99(4):602-3.

134 Fournier B, Descamps V, Bouscarat F et al. Bullous pemphigoid induced by vaccination. Br J Dermatol. 1996 Jul;135(1):153-4.

135 Venning VA, Wojnarowska F. Induced bullous pemphigoid. Br J Dermatol. 1995 May;132(5):831-2.

136 Sezin T, Egozi E, Hillou W et al. Anti-laminin-332 mucous membrane pemphigoid developing after a diphtheria tetanus vaccination. JAMA Dermatol. 2013 Jul;149(7):858-62.

137 Bakshi R, Graves MC. Guillain-Barré syndrome after combined tetanus-diphtheria toxoid vaccination. J Neurol Sci. 1997 Apr 15;147(2):201-2.

138 Newton N Jr, Janati A. Guillain-Barré syndrome after vaccination with purified tetanus toxoid. South Med J. 1987 Aug;80(8):1053-4.

139 Hamidon BB, Raymond AA. Acute disseminated encephalomyelitis (ADEM) presenting with seizures secondary to anti-tetanus toxin vaccination. Med J Malaysia. 2003 Dec;58(5):780-2.

140 Griffith RD, Miller OF III Erythema multiforme following diphtheria and tetanus toxoid vaccination. J Am Acad Dermatol. 1988 Oct;19(4):758-9.

141 Frederiksen MS, Brenøe E, Trier J. Erythema multiforme minor following vaccination with paediatric vaccines. Scand J Infect Dis. 2004;36(2):154-5.

142 Kaur S, Handa S. Erythema multiforme following vaccination in an infant. Indian J Dermatol Venereol Leprol. 2008 May-Jun;74(3):251-3.

143 Kumar V, Sidhu N, Roy S, Gaurav K. Myocarditis following diphtheria, whole-cell pertussis, and tetanus toxoid vaccination in a young infant. Ann Pediatr Cardiol. 2018 May-Aug;11(2):224-226

144 Yamamoto H, Hashimoto T, Ohta-Ogo K et al. A case of biopsy-proven eosinophilic myocarditis related to tetanus toxoid immunization. Cardiovasc Pathol. 2018 Nov - Dec;37:54-57

145 Wu SJ, Sun S, Li JY et al. Acute fulminant myocarditis after diphtheria, polio, and tetanus vaccination. Asian Cardiovasc Thorac Ann. 2006 Dec;14(6):e111-2.

146 Dilber E, Karagöz T, Aytemir K et al. Acute myocarditis associated with tetanus vaccination. Mayo Clin Proc. 2003 Nov;78(11):1431-3.

147 Amsel SG, Hanukoglu A, Fried D, Wolyvovics M Myocarditis after triple immunisation. Arch Dis Child. 1986 Apr; 61(4): 403–405.

148 Jawad AS , Scott DG Immunisation triggering rheumatoid arthritis? Ann Rheum Dis. 1989 Feb; 48(2): 174.

149 Kaul A, Adler M, Alokaily F, Jawad A Recurrence of reactive arthritis after a booster dose of tetanus toxoid Ann Rheum Dis. 2002 Feb; 61(2): 185.

150 O'Brien P, Wong RW Optic neuritis following diphtheria, tetanus, pertussis, and inactivated poliovirus combined vaccination: a case report. J Med Case Rep. 2018 Nov 30;12(1):356

151 Cabrera-Maqueda JM, Hernández-Clares R, Baidez-Guerrero AE et al. Optic neuritis in pregnancy after Tdap vaccination: Report of two cases. Clin Neurol Neurosurg. 2017 Sep;160:116-118.

152 Ruhrman-Shahar N, Torres-Ruiz J, Rotman-Pikielny P, Levy Y Autoimmune reaction after anti-tetanus vaccination-description of four cases and review of the literature. Immunol Res. 2017 Feb;65(1):157-163.

153 Shoenfeld Y, Aron-Maor A. Vaccination and autoimmunity-'vaccinosis': a dangerous liaison? J Autoimmun. 2000 Feb;14(1):1-10.

154 Mogensen SW, Andersen A, Rodrigues A et al. The Introduction of Diphtheria-Tetanus-Pertussis and Oral Polio Vaccine Among Young Infants in an Urban African Community: A Natural Experiment. EBioMedicine. 2017 Mar;17:192-198.

155 CDC Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) in Pregnant Women — Advisory Committee on Immunization Practices (ACIP), 2012 MMWR Feb 22, 2013; 62(07);131-135

156 Ibid

157 Ibid

158 CDC Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Apr 27, 2018; 67(2);1–44

159 Ibid

160 FDA Adacel Product Insert Jan. 11, 2019

161 Ibid

162 FDA Boostrix Product Insert Apr. 25, 2016

163 Ibid

164 Kessler DA, the Working Group, Natanblut S, et al. A New Approach to Reporting Medication and Device Adverse Effects and Product Problems. JAMA. 1993;269(21):2765-2768.

165 FDA.gov. Kessler DA. Introducing MEDWatch: A New Approach to Reporting Medication and Device Adverse Effects and Product Problems. Reprint from JAMA. June 9, 1993.

166 Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. Johns Hopkins Bloomberg School of Public Health

167 Rosenthanl S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995; 85: pp. 1706-9.

168 AHRQ Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS) Dec 1, 2007-Sep. 30, 2010

169 U.S. Department of Health and Human Services. National Vaccine Injury Compensation Program Data—March 1, 2019. National Vaccine Injury Compensation Program. Mar. 1, 2019

170 CDC Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Apr. 27, 2018; 67(2);1–44

171 CDC Diphtheria, Tetanus, and Pertussis Vaccine Recommendations – Contraindications and Precautions Dec. 17, 2018

172 Ibid

173 Ibid

174 Ibid

175 FDA Boostrix Product Insert Apr. 25, 2016

176 FDA Adacel Product Insert Jan. 11, 2019

177 FDA TENIVAC Product Insert Oct. 25, 2013

178 FDA TDVAX Product Insert Nov. 15, 2018

179 FDA Infanrix Product Insert Apr. 28, 2016

180 FDA DAPTACEL Product Insert Sep. 14, 2016

181 FDA Pediarix Product Insert Apr. 25, 2016

182 FDA Kinrix Product Insert Apr. 25, 2016

183 FDA Quadracel Product Insert Mar. 24, 2015

184 FDA VAXELIS Product Insert Dec. 21, 2018

185 FDA Pentacel Product Insert Mar. 16, 2017

186 FDA Diphtheria and Tetanus Toxoids Adsorbed Product Insert Dec. 18, 2018

187 CDC Tetanus - Adverse Events Following Vaccination Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

188 FDA Infanrix Product Insert Apr. 28, 2016

189 FDA DAPTACEL Product Insert Sep. 14, 2016

190 FDA Pediarix Product Insert Apr. 25, 2016

191 FDA Pentacel Product Insert Mar. 16, 2017

192 FDA VAXELIS Product Insert Dec. 21, 2018

193 FDA Diphtheria and Tetanus Toxoids Adsorbed Product Insert Dec. 18, 2018

194 CDC Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Apr. 27, 2018; 67(2);1–44

195 FDA Adacel Product Insert Jan. 11, 2019

196 FDA TENIVAC Product Insert Oct. 25, 2013


Make a Difference Support NVIC

NVIC is 100% funded by donations.
Please give.

Help educate families about preventing vaccine injury and death by donating to NVIC today.

Discover How You Can Take Action to Support Our Efforts

Support NVIC!


Connect with us!

  • NVIC Pinterest
  • NVIC Facebook
  • NVIC Twitter
  • NVIC Youtube
  • NVIC Instagram

Ask 8 Kiosk & Educational Marketplace

Ask 8 Questions

Visit our Ask 8 Kiosk to explore a variety of FREE educational materials, from posters and brochures to embeddable web graphics and other resources.

View FREE Downloads