Can diphtheria vaccine cause injury & death?

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 the 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 the 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 of 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. 

In October 2022, the FDA approved the Boostrix Tdap vaccine for use in pregnant women, to be administered during the third trimester, for the prevention of pertussis in infants younger than two months of age. This approval was made based on a re-evaluation of the Boostrix data from an observational case-control study of the pertussis component of the Tdap vaccine. 

The evaluation of Boostrix Tdap vaccine’s safety data in pregnant women was based on a study of 680 women, with 340 receiving a non-U.S. formulated BOOSTRIX Tdap vaccine, and 340 receiving a normal saline placebo. The FDA considered the non-U.S. formulated Boostrix Tdap vaccine to be comparable to the U.S. licensed vaccine even though the non-U.S. formulation contains less aluminum per dose. Following childbirth, the women who received a saline placebo during pregnancy were given a dose of the non-U.S. formulated BOOSTRIX Tdap vaccine. According to the FDA, the side effects of giving the vaccine to women during pregnancy were similar to women who got the vaccine after pregnancy. Additionally, the FDA reported that this study did not demonstrate any vaccine-related adverse events on the pregnancy, developing infant, or newborn infant. 

In January 2023, Adacel Tdap vaccine received FDA approval for use in pregnant women, for the prevention of pertussis in infants under two months of age, to be administered during the third trimester of pregnancy.  Safety of the use of Adacel vaccine in pregnant women was based on the use of vaccine in 225 women who received the vaccine during pregnancy when compared with 675 women who did not. According to data submitted to the FDA, there were three serious adverse events (SAEs) that resulted in death among the study participants. One death occurred in a fetus whose mother received Adacel Tdap vaccine at 2.5 weeks gestation. At 23 weeks gestation, the fetus was noted to have a complete atrioventricular canal defect and death occurred at 33 weeks. Details of the two additional fetal deaths were not provided, except that both reportedly occurred in women who were vaccinated more than 30 days prior to the onset of pregnancy and deemed unrelated to vaccination. 

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.

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 September 27, 2024, there have been 216,046 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 3,479 related deaths, 25,873 hospitalizations, and 3,808 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 October 1, 2024, there have been 6,567 claims filed so far in the federal Vaccine Injury Compensation Program (VICP) for 881 deaths and 5,686 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 2,636 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.