The Centers for Disease Control and Prevention recommends diphtheria, tetanus and whooping cough (pertussis) vaccinations for everyone. The U.S. Food and Drug Administration (FDA) has approved 11 combination vaccines to protect against diphtheria and tetanus. Eight of these vaccines also include protection against whooping cough.
If you or your loved one suffered from complications after a diphtheria, tetanus or whooping cough vaccine, you may be eligible for compensation.
Diphtheria, tetanus and whooping cough vaccines are part of the routine childhood immunization schedule and can be given as combination vaccines. A combination vaccine is when a patient receives two or more vaccines in a single shot to reduce the quantity of shots given.
Combination vaccines DT and Td are designed to protect against diphtheria and tetanus. Combination vaccines DTaP and Tdap include protection against tetanus, diphtheria and whooping cough. The capital letters in these abbreviations signify full-strength doses of the whooping cough (P) vaccine and diphtheria (D) and tetanus (T) toxoids. Toxoids are chemically modified toxins that are no longer toxic but still trigger the production of antibodies to protect to the body. The lower-case “d” and “p” represent reduced doses of diphtheria and whooping cough used in formulations of vaccines for teens and adults. The “a” in Tdap and DTaP denotes “acellular.” Acellular means that the whooping cough element contains part of the bacteria, not the whole cell.
The FDA approved DTaP and DT vaccines for children younger than 7 years old, and Tdap and Td for older children and adults.
The CDC says babies and young children need three doses of DTaP vaccine to build up high levels of protection against diphtheria, tetanus and whooping cough. Some children who received a dose of DTaP and had a bad reaction to the vaccine should not get another dose of whooping cough vaccine but may get DT, which is a vaccine without whooping cough protection. The CDC also advises two booster shots to maintain protection against the illnesses throughout early childhood. The agency recommends giving babies and children doses at 2 months, 4 months, 6 months, 15 through 18 months and 4 through 6 years. Children older than 6 years should not get DT or DTaP; they should be given the reduced-dose Td or Tdap.
To boost their immunity, older children should get one dose of Tdap between ages 11 and 12 years, according to the CDC. Teens who didn’t get Tdap when they were 11 or 12 should get one dose when they visit their doctor’s office next, the CDC says. To date, 46 states and the District of Columbia have adopted Tdap booster requirements for secondary schools. Delaware, Hawaii, Maine and South Dakota are the only U.S. states that do not require children get the Tdap vaccine to attend secondary school.
The CDC recommends that pregnant women get the Tdap vaccine during the third trimester of each pregnancy, preferably in the earlier part of the 27th through 36th week of pregnancy. This is a new CDC recommendation, and the American College of Obstetricians and Gynecologists and the American College of Nurse-Midwives support it. It replaces the CDC’s previous advice that pregnant women get the vaccine only if they had not gotten it before. Getting Tdap during the third trimester of pregnancy can help protect the baby from whooping cough in the first few months after birth, according to the CDC.
Protection from tetanus and diphtheria decreases over time, so the CDC recommends adults get one dose of the Td vaccine every 10 years. The agency also advises that adults who did not get Tdap as preteens or teens get one dose of Tdap instead of a Td dose to protect against whooping cough. If an adult needs whooping cough protection, he or she can get Tdap at any time, no matter when he or she last got the Td vaccine.
Combination vaccines containing diphtheria and tetanus toxoids and the whooping cough vaccine work differently against each disease. For 95 percent of people who receive the first three or four doses, the diphtheria toxoid element of these vaccines protect against diphtheria for 10 years. Nearly everyone who completes this primary series is also protected against tetanus for about 10 years.
About 98 percent of people who get all five doses of DTaP on time are fully protected against whooping cough within the year succeeding the last dose of the vaccine. About 70 percent of children who get all five doses of DTaP on time are fully protected against whooping cough five years following the last dose of DTaP.
In the first year after getting Tdap, about seven out of every 10 people are fully protected against whooping cough, and about three or four out of every 10 people are fully protected against whooping cough four years after getting Tdap.
Diphtheria is a serious nose and throat infection that causes a thick covering in the back of the throat and can lead to breathing problems, paralysis, heart failure and death. The infection was at one time a chief cause of illness and death among children. In 1921, the U.S. recorded more than 200,000 cases of diphtheria; 15,520 of those cases resulted in death. By 1923, diphtheria toxoid gained approval in the U.S. and diphtheria rates dropped quickly in the U.S. Between 2006 and 2016, people in the U.S. reported fewer than five cases of diphtheria to the CDC. The World Health Organization documented 7,321 cases of diphtheria reported across the world in 2014. According to the CDC, it’s likely many more cases went unreported.
Tetanus is different from diphtheria and other diseases prevented by vaccines because it does not spread from person to person. People contract tetanus when they’re cut or punctured by objects contaminated by bacteria found in soil, dust and manure. Often called “lockjaw,” tetanus causes tightening of the jaw muscles. The infection can lead to serious health problems, including being unable to open the mouth and having trouble swallowing and breathing. In the late 1940s, people reported between 500 and 600 cases of tetanus a year. An absorbed form of tetanus toxoid gained approval in the U.S. in 1937, and a combination diphtheria and tetanus vaccine for children gained approval in 1947. Tetanus infections steadily dropped and are uncommon in the U.S. today, with about 30 cases reported per year from 1996 through 2014. According to the CDC, the majority of tetanus cases reported today are in people who were never vaccinated or adults who don’t get their 10-year booster shots.
FDA-approved in 1997, DT Generic, also known as Diphtheria and Tetanus Toxoids Adsorbed, is used in children 6 weeks through 6 years of age.
Sanofi Pasteur Limited manufactures the vaccine, which is indicated for a five-dose series and is used in babies and young children who should not get vaccines that contain whopping cough protection. Mild problems reported following DT vaccination include redness, swelling and soreness where the shot was given; fever; loss of appetite; and vomiting.
No child with a severe allergy to diphtheria toxoid, tetanus toxoid, aluminum phosphate or free formaldehyde should get DT, according to the CDC. If a child has a life-threatening allergic reaction after getting DT, he or she should not get another dose of the vaccine. Parents should talk with a health care professional before their child gets DT if he or she has seizures or another nervous system problem; had severe swelling or pain after any vaccine containing diphtheria or tetanus; or has or had Guillain-Barré syndrome. If a child has a mild illness, such as a cold, at the time of the scheduled vaccination, he or she may be able to get the vaccine. However, if the illness is moderate or severe, the vaccination should be postponed until the child has fully recovered, the CDC says.
MassBiologics manufactures Td, also known as Tetanus and Diphtheria Toxoids Adsorbed. The FDA approved Sanofi Pasteur Limited’s version of the vaccine called Tenivac in 2003.
Both vaccines are used for the prevention of tetanus and diphtheria in people age 7 years and older. Primary immunization with Td includes three doses: two doses given four to eight weeks apart and a third dose given six to 12 months after the second dose. Instructions for Tenivac differ slightly: receive two doses two months apart and a third dose six to eight months after the second dose. Tenivac may be used for booster shots at 11 or 12 years of age and every 10 years thereafter. Tenivac is also approved for wound management in patients age 7 years or older.
Mild side effects of this type of vaccination can include pain, redness and swelling at the injection site; fever; headache; and feeling tired. The person giving the vaccine should be told if there is a history of life-threatening allergic reaction or severe allergy to a dose of this vaccine, any elements of this vaccine or any vaccine containing tetanus or diphtheria. A healthcare professional should also be consulted if the patient has is a history of severe swelling or pain after any vaccine containing diphtheria or tetanus or had Guillain-Barré syndrome. The CDC recommends patients wait to get vaccinated if they are moderately or severely ill at the time of the scheduled vaccination. It may be OK to get the vaccination if the illness is mild. The patient’s doctor will be able to advise them.
Whooping cough (pertussis) is a highly contagious respiratory tract infection that usually starts with cold-like symptoms. The infection can cause violent, rapid coughing that persists until the air is gone in the lungs and a person is forced to breathe in with a loud “whooping” sound. The first pertussis vaccine gained approval in the U.S. in 1915. In 1949, diphtheria and tetanus toxoids and pertussis vaccine gained U.S. approval. About 200,000 children suffered from whooping cough and 9,000 died from infection each year before the vaccine became widely available. Whooping cough rates reached a record low in the 1980s, but there has been an increase in reports of whooping cough cases since then.
“There are several reasons that help explain why we are seeing this increase,” according to the CDC website. “These include increased awareness, improved diagnostic tests, better reporting, more circulation of the bacteria and waning immunity (when a vaccine does not provide long-lasting protection). Changes in the genetic makeup of the bacteria that cause whooping cough may also be part of the reason why more cases are being reported.”
“Changes in the genetic makeup of the bacteria that cause whooping cough may also be part of the reason why more cases are being reported.”
For decades, the U.S. used whole cell whooping cough vaccines for babies and children. Public concern in the U. S. and other countries over whether whole cell whooping cough vaccines could cause neurological problems led to the development of acellular whooping cough vaccines for children, teens and adults. In the 1990s, the country switched to acellular whooping cough vaccines, which are associated with less minor and short-term side effects, such as fever, pain or swelling at the injection site. However, the CDC says it appears the acellular whooping cough vaccine used in children today may not protect them for as long as the whole cell whooping cough vaccine used in the past.
The FDA has approved six DTaP vaccines for protection against diphtheria, tetanus and whooping cough in children ages 6 years and younger. Some DTaP vaccines are indicated for a five-dose series; others are given in three doses, four doses, or as the fifth dose in the DTaP series or the fourth or fifth dose of the inactivated poliovirus vaccine (IPV). These vaccines can cause redness, swelling and soreness or tenderness at the injection site. They can also cause fever, irritability, tiredness, loss of appetite and vomiting. Reactions at the injection site and fever happen more often after the fourth and fifth doses of the DTaP series compared with earlier doses, according to the CDC. In some cases, the entire arm in which a patient received the shot swells after the fourth or fifth dose. Swelling can last up to a week.
A child should not get a subsequent dose of DTaP if he or she had a life-threatening allergic reaction after a previous dose of the vaccine or suffered a brain or nervous system disease (not attributable to another cause) within seven days after a dose of DTaP. The person who is giving the child the vaccine should be told if the child had severe pain or swelling after any vaccine containing tetanus or diphtheria.
In 2005, the FDA approved two Tdap vaccines — Adacel and Boostrix —to boost protection against diphtheria, tetanus and whooping cough in people 10 through 64 years old. According to the CDC, these vaccines should not be given to anyone younger than 7 years old. Sanofi Pasteur Limited manufactures Adacel, and GlaxoSmithKline Biologics manufactures Boostrix. Both are given as a one-dose booster shot.
Patients may experience fever, headache, chills, tiredness, nausea, vomiting, diarrhea, stomach ache, body aches, sore joints, rash and/or swollen glands following Tdap vaccination. Reactions at the injection site such as pain, redness or swelling are also possible.
The tip caps of the Adacel and Boostrix Boostrix prefilled syringes may contain natural rubber latex, which may cause allergic reactions in people sensitive to latex. People with severe allergies to any component of Tdap should not get this vaccine. Neither should anyone who has had a life-threatening allergic reaction to a dose of Tdap or to any vaccine containing diphtheria, tetanus or whooping cough protection.
Anyone who had coma or long repeated seizures within one week after a childhood dose of DTaP or a previous dose of Tdap should not get Tdap — unless something other than the vaccine caused the coma or seizures. Td is still an option for these patients. The CDC advises patients to tell their health care providers if they or their children have seizures or another nervous system problem or if they have had severe pain or swelling after any vaccine containing tetanus, diphtheria or whooping cough. Also, whoever is administering the vaccine should be told if the patient ever had Guillain-Barré syndrome.
Safety and effectiveness of Adacel and Boostrix vaccines have not been established in pregnant women. Also, it may be best for people who are moderately or severely ill to wait until they recover to get vaccinated. A doctor may OK vaccination if a person is only mildly ill.
People sometimes faint after getting diphtheria, tetanus and whooping cough vaccines. Sitting or reclining for about 15 minutes after getting a vaccine can help prevent fainting and injuries caused by a fall. It’s important to alert the health care provider if the patient experiences dizziness, vision changes or ringing in the ears following a vaccination.
Though rare, some people get a shoulder injury related to vaccine administration (SIRVA) and have trouble moving the arm in which the shot was given. People may also suffer from a severe allergic reaction that could result in death. In fact, about one in a million doses of vaccine result in severe allergic reaction. If a severe allergic reaction occurs, it would happen within a few minutes to a few hours after the vaccination.
As with any medicine, there is also a very slight chance of a vaccine causing a serious injury or death. More than 5,200 claims have been filed with the National Vaccine Injury Compensation Program (VICP) for injuries and deaths following vaccination with tetanus or tetanus-containing vaccines combined with diphtheria vaccine. Of these claims, more than 840 involve deaths and over 4,300 involve serious injuries. The VICP is a federal program established to compensate people who file injury and death claims related to certain vaccines. About half of the nearly 3,000 awards given as of August 2012 involved vaccines containing pertussis. To date, the program has paid out more than $3 billion.
Between 1990 and 2015, people reported more than 22,600 serious adverse events to the Vaccine Adverse Events Reporting System (VAERS) related to tetanus and tetanus-containing vaccines combined with diphtheria vaccine and more than 19,357 serious adverse events in connection with pertussis-containing vaccines. VAERS allows doctors to report when a patient experiences unusual symptoms after getting a vaccine. The FDA and the CDC co-manage the system.
More than 75 percent of the serious adverse events related to pertussis vaccination occurred in children younger than 4 years of age. More than 2,500 were deaths, with over 90 percent of the deaths occurring in children under 3 years of age.
More than 70 percent of the serious adverse events related to tetanus and tetanus-containing vaccines occurred in children younger than 7 years of age. Nearly 2,700 were deaths, with over 90 percent of the deaths occurring in children under 6 years of age.
Serious adverse events other than death reported after vaccinations include shock, neuropathy, convulsions, encephalopathy and paralysis. In addition, research has associated tetanus toxoid with brachial neuritis and Guillain-Barré syndrome.
Case reports have documented an association between Guillain-Barré syndrome and tetanus vaccination. Guillain-Barré syndrome is a potentially life-threatening, rare disorder in which the body’s immune system attacks the peripheral nerves.
The first symptoms usually include weakness or tingling sensations in the legs, arms and face. These symptoms can lead to paralysis, and in as many as 30 percent of cases, the condition affects the chest muscles, making it hard to breathe. Guillain-Barré syndrome is considered life-threatening and should be treated in the intensive care unit when it impairs a person’s ability to speak and swallow. About 3 to 5 percent of Guillain-Barré syndrome patients die from complications, including paralysis of the muscles that control breathing, blood infection, lung clots or cardiac arrest, according to the World Health Organization. If Guillain-Barré syndrome occurred within six weeks after getting a prior vaccine containing tetanus toxoid, the risk for developing the syndrome may be increased following a subsequent dose of a tetanus-containing vaccine, according to the CDC.
Leading health agencies list brachial neuritis as a reported reaction to vaccines containing tetanus toxoid. Up to 10 of every million patients who receive tetanus vaccines are affected by it.
It is also referred to as brachial neuropathy or a brachial plexus injury and usually only affects one side of the body. Some cases of brachial neuritis resolve on their own; others may require corticosteroids for the pain and even surgery to repair the nerves. Symptoms of brachial neuritis include severe pain in the upper arm or shoulder and can evolve into weakness, limpness or paralysis. Other symptoms include lack of muscle control in the shoulder or arm and lack of sensation or feeling in the shoulder or arm.
Researchers have concluded that about 15 percent of all cases of brachial neuritis occurred following administration of vaccine or antiserum. Tetanus toxoid was cited most frequently. They reviewed 99 patients with brachial neuritis seen at the Mayo Clinic in Rochester, Minnesota. Of the 99 patients, 14 received vaccinations in the month leading up to the development of brachial plexus neuropathy: four patients had received tetanus toxoid alone, one had received tetanus toxoid and influenza vaccine, and a 3-month-old had received DPT.
Please seek the advice of a medical professional before making health care decisions.
Calling this number connects you with Wilson and Peterson, LLP or one of its trusted legal partners. A law firm representative will review your case for free.
Wilson and Peterson, LLP funds Drugwatch because it supports the organization’s mission to keep people safe from dangerous drugs and medical devices.(877) 915-9306