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Diptheria and Tetanus

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Diphtheria and Tetanus

Side Effects
Interactions

SIDE EFFECTS

BODY SYSTEM AS A WHOLE

Adverse reactions may be local and include redness, warmth, edema, induration, with or without tenderness, as well as urticaria, and rash. Malaise, transient fever, pain, hypotension, nausea and arthralgia may develop in some patients after the injection. Arthus-type hypersensitivity reactions, characterized by severe local reactions (generally starting 2 to 8 hours after an injection) may occur, particularly in persons who have received multiple prior boosters.2

Rarely, an anaphylactic reaction (i.e., hives, swelling of the mouth, difficulty breathing, hypotension, or shock) and death have been reported after receiving preparations containing diphtheria and tetanus antigens.2

The vaccine was well tolerated clinically. No local or systemic reactions were observed in approximately half of the infants and only mild or moderate reactions were observed in the remainder of the study group (Table 3).3

TABLE 33 SUMMARY OF CLINICAL REACTIONS

 
Category of Reactions
None
Mild*
Moderate**
Severe
Post Dose 1
9/20 (45%)
11 (55%)
0
0
Post Dose 2
11/20 (55%)
7 (35%)
2/20 (10%)
0
Post Dose 3
11/20 (55%)
9 (45%)
0
0

* A small local reaction and/or temperature elevation to < 39°C (< 102.2°F).
** Temperature elevation to ≥39°C (≥102.2°F) and/or a significant area of redness, swelling, and induration associated with tenderness.

Deaths due to causes other than SIDS, including deaths from serious infections, have been reported in temporal association with the administration of diphtheria and tetanus (diphtheria and tetanus (diphtheria and tetanus toxoids) toxoids) toxoids containing vaccines. On rare occasion, anaphylaxis has been reported following administration of products containing diphtheria and tetanus (diphtheria and tetanus (diphtheria and tetanus toxoids) toxoids) toxoids. Upon review, a report by the Institute of Medicine (IOM) concluded the evidence established a causal relationship between diphtheria and tetanus (diphtheria and tetanus (diphtheria and tetanus toxoids) toxoids) toxoids and anaphylaxis.9

NERVOUS SYSTEM

The following neurologic illnesses have been reported as temporally associated with vaccine containing tetanus toxoid: neurological complications14 including cochlear lesion,15 brachial plexus neuropathies,15,16 paralysis of the radial nerve,17 paralysis of the recurrent nerve,15 accommodation paresis, Guillain-Barré syndrome (GBS),and EEG disturbances with encephalopathy.18 The IOM following review of the reports of neurologic events following vaccination with tetanus toxoid, Td or DT, concluded the evidence favored acceptance of a causal relationship between tetanus toxoid and brachial neuritis and GBS.9,19

EPINEPHRINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCUR DUE TO ANY COMPONENT OF THE VACCINE.

Reporting of Adverse Events

The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other health-care providers who administer vaccines to maintain permanent vaccination records and to report occurrences of certain adverse events to the US Department of Health and Human Services. Reportable events include those listed in the Act for each vaccine and events specified in the package insert as contraindications to further doses of the vaccine.12,13

Reporting by parents or guardians of all adverse events after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by health-care providers to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS).Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967.11,12,13

Health-care providers also should report these events to the Pharmacovigilance Department, Aventis Pasteur Inc., Discovery Drive, Swiftwater, PA 18370,or call 1-800-822-2463.

Read the Diphtheria and Tetanus (diphtheria and tetanus toxoids) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

If passive immunization for tetanus is needed, TIG (Human) is the product of choice for tetanus.It provides longer protection than antitoxin of animal origin and causes few adverse reactions. The currently recommended prophylactic dose of TIG (Human) for wounds of average severity is 250 units intramuscularly. When tetanus toxoid and TIG (Human) are given concurrently, separate syringes and separate sites should be used. The ACIP recommends the use of only adsorbed toxoid in this situation.2

Diphtheria Antitoxin (equine) is available for treatment of the acute phases of diphtheria. When DT and Diphtheria Antitoxin are used together, they must be given at different sites using separate needles and syringes.

As with other intramuscular injections, use with caution in patients on anticoagulant therapy.

Immunosuppressive therapies may reduce the response to vaccines (see PRECAUTIONS GENERAL section).

REFERENCES

2. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Diphtheria, Tetanus, and Pertussis: Recommendations for vaccine use and other preventive measures. MMWR 40:No.RR-10,1991

3. Pichichero ME, et al. Pediatric diphtheria and tetanus (diphtheria and tetanus (diphtheria and tetanus toxoids) toxoids) toxoids-adsorbed vaccine: Immune response to the first booster following the diphtheria and tetanus (diphtheria and tetanus (diphtheria and tetanus toxoids) toxoids) toxoids vaccine primary series. Pediatr Infec Dis 5:428-430,1986

9. Stratton KR, et al. Adverse events associated with childhood vaccines. Evidence Bearing on Causality. National Academy Press, Washington,DC,1994

11.CDC.Vaccine Adverse Event Reporting System United States. MMWR 39:730-733,1990

12.CDC. National Childhood Vaccine Injury Act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37:197-200,1988

13.Food and Drug Administration. New reporting requirements for vaccine adverse events. FDA Drug Bull 18 (2),16-18,1988

14.Rutledge SL, et al .Neurological complications of immunizations. J Pediatr 109:917-924,1986

15.Wilson GS. The Hazards of Immunization. Allergic manifestations: Post-vaccinal neuritis. pp 153-156,1967

16.Tsairis P, et al. Natural history of brachial plexus neuropathy.Arch Neurol 27:109-117,1972

17.Blumstein GI, et al. Peripheral neuropathy following Tetanus toxoid administration. JAMA 198:1030-1031,1966

18.Cody CL, et al. Nature and rates of adverse reactions associated with DTP and DT immunizations in infants and children. Pediatr 68:650-660,1981

19.Pollard JD, et al. Relapsing neuropathy due to tetanus toxoid: report of a case. J Neurol Sci 37:112-125,1978

Last reviewed on RxList: 6/8/2006
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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