Can diphtheria vaccine cause injury & 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.  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: 

• 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
• Severe allergic reaction
• death

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

• Pain, redness, and swelling at injection site
• Ringing in the ears
• Headache
• Nausea, diarrhea, stomach ache, vomiting
• Joint pain
• Fatigue
• Fever
• Dizziness or fainting
• Severe allergic reaction
• Death

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

• Pain, redness, and swelling at injection site
• Fever
• Fatigue
• Headache
• Nausea and vomiting
• Stomachache
• Ringing in the ears
• Vision changes
• 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).  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.

This 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. There was, however enough evidence to convincingly support an association between anaphylaxis and tetanus, diphtheria toxoid and acellular pertussis vaccines. 

In 2017, researchers in Guinea-Bissau compared the mortality rates of diphtheria, tetanus, and whole cell pertussis (DTP) vaccinated infants between three and five 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. 

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 reactions  in pregnant women vaccinated more frequently due to multiple pregnancies spaced closely together. ACIP, however, 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. 

In 2018, ACIP reported that studies on the use of Tdap vaccine in pregnancy have not shown any “new or unexpected safety concerns”  but admitted that safety studies on Tdap vaccine administration during pregnancy at close intervals to another tetanus toxoid containing vaccine were limited. 

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.  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.  The Boostrix product insert states that safety and effectiveness of BOOSTRIX have not been established in pregnant women  and is FDA approved only to be administered as a single dose. 

Adverse reactions reported by vaccine manufacturers as listed in the vaccine package 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, angioedema, 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 fever relative 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 events 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 events 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 events 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 events 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 events 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 events 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 events 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 the March 29, 2024 data release, there have been 211,851 adverse events reported to the Vaccine Adverse Events Reporting System (VAERS) in connection with diphtheria and diphtheria-containing vaccines combined with additional vaccines since 1990, including 3,437 related deaths, 25,400 hospitalizations, and 3,768 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 diphtheria 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 problems 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.       

As of April 1, 2024, there have been 6,487 claims filed so far in the federal Vaccine Injury Compensation Program (VICP) for 880 deaths and 5,607 injuries that occurred after diphtheria and diphtheria-containing vaccines combined with additional vaccines. Of that number, the U.S. Court of Claims administering the VICP has compensated 2,572 children and adults, who have filed claims for diphtheria vaccine associated injury.

The U.S. Government recognizes the following as injuries associated with DTP, DTaP, Tdap, DT, or Td vaccines: 

• Anaphylaxis occurring within 4 hours of vaccine administration
• Brachial Neuritis occurring within 2 and 28 days of vaccine administration
• Vasovagal syncope occurring within 1 hour of vaccine administration
• Encephalopathy and encephalitis occurring within 72 hours of vaccine administration
• Shoulder Injury Related to Vaccine Administration (SIRVA) occurring within 48 hours of vaccine administration

For more information on adverse reactions from combination pertussis, diphtheria and tetanus vaccines, visit the NVIC pertussis (whooping cough) webpage.

IMPORTANT NOTE: NVIC encourages you to become fully informed about Diphtheria and the Diphtheria 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.

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