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.1 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:2
- Pain, swelling, and redness at the injection site
- Loss of appetite
- Non-stop crying for 3 hours or longer
- Fever greater than 105 F
- Swelling of the entire vaccinated limb
- Long-term seizures
- Lowered consciousness
- Permanent brain damage
- Severe allergic reaction
According to the CDC, possible side effects from Tdap vaccine include:3
- Pain, redness, and swelling at injection site that can last several days and interfere with activities
- Swelling of the entire arm
- Nausea, diarrhea, stomach ache, vomiting
- Joint pain
- Body aches
- Swollen glands
- 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
According to the CDC, possible side effects from Td vaccine include:4
- Pain, redness, and swelling at injection site
- 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
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).5 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.6
Published studies have reported on serious adverse reactions following tetanus toxoid vaccination. Adverse events include anaphylaxis,7 8 brachial neuritis,9 bullous pemphigoid10 11 12 Guillain-Barre Syndrome (GBS),13 14 acute disseminated encephalomyelitis (ADEM),15 erythema multiforme,16 17 18 myocarditis,19 20 21 22 23 arthritis,24 25 optic neuritis,26 27 and additional autoimmune disorders.28 29
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.30
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” 31 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.”32 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.33 In 2018, ACIP reported that studies on the use of Tdap vaccine in pregnancy have not shown any “new or unexpected safety concerns”34 but admitted that safety studies on Tdap vaccine administration during pregnancy at close intervals to another tetanus toxoid containing vaccine were limited.35
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.”36 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.37 The Boostrix product insert states that “safety and effectiveness of BOOSTRIX have not been established in pregnant women”38 and is FDA approved only to be administered as a single dose.39
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. 40 41 42 43 44
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.45
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.
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1 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.
2 CDC DTaP (Diphtheria, Tetanus, Pertussis) VIS Aug. 24, 2018
3 CDC Tdap (Tetanus, Diphtheria, Pertussis) VIS Feb. 24, 2015
4 CDC Td (Tetanus, Diphtheria) VIS Apr. 11, 2017
5 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
6 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
7 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.
8 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.
9 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.
10 Fournier B, Descamps V, Bouscarat F et al. Bullous pemphigoid induced by vaccination. Br J Dermatol. 1996 Jul;135(1):153-4.
11 Venning VA, Wojnarowska F. Induced bullous pemphigoid. Br J Dermatol. 1995 May;132(5):831-2.
12 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.
13 Bakshi R, Graves MC. Guillain-Barré syndrome after combined tetanus-diphtheria toxoid vaccination. J Neurol Sci. 1997 Apr 15;147(2):201-2.
14 Newton N Jr, Janati A. Guillain-Barré syndrome after vaccination with purified tetanus toxoid. South Med J. 1987 Aug;80(8):1053-4.
15 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.
16 Griffith RD, Miller OF III Erythema multiforme following diphtheria and tetanus toxoid vaccination. J Am Acad Dermatol. 1988 Oct;19(4):758-9.
17 Frederiksen MS, Brenøe E, Trier J. Erythema multiforme minor following vaccination with paediatric vaccines. Scand J Infect Dis. 2004;36(2):154-5.
18 Kaur S, Handa S. Erythema multiforme following vaccination in an infant. Indian J Dermatol Venereol Leprol. 2008 May-Jun;74(3):251-3.
19 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
20 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
21 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.
22 Dilber E, Karagöz T, Aytemir K et al. Acute myocarditis associated with tetanus vaccination. Mayo Clin Proc. 2003 Nov;78(11):1431-3.
23 Amsel SG, Hanukoglu A, Fried D, Wolyvovics M Myocarditis after triple immunisation. Arch Dis Child. 1986 Apr; 61(4): 403–405.
24 Jawad AS , Scott DG Immunisation triggering rheumatoid arthritis? Ann Rheum Dis. 1989 Feb; 48(2): 174.
25 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.
26 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
27 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.
28 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.
29 Shoenfeld Y, Aron-Maor A. Vaccination and autoimmunity-'vaccinosis': a dangerous liaison? J Autoimmun. 2000 Feb;14(1):1-10.
30 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.
31 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
34 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
36 FDA Adacel Product Insert Jan. 11, 2019
38 FDA Boostrix Product Insert Apr. 25, 2016
40 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.
41 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.
42 Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. Johns Hopkins Bloomberg School of Public Health
43 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.
44 AHRQ Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS) Dec 1, 2007-Sep. 30, 2010
45 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