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 booster doses of a tetanus toxoid-containing vaccine.⁵

Cases of allergic or anaphylactic reaction (ie, hives, swelling of the mouth, difficulty breathing, hypotension, or shock) have been reported after receiving some preparations containing tetanus toxoid. Death following vaccine-caused anaphylaxis has been reported.¹⁰

Certain neurological conditions have been reported in temporal association with some tetanus toxoid-containing vaccines. A review by the Institute of Medicine (IOM) concluded that the evidence favors acceptance of a causal relation between tetanus toxoid and both brachial neuritis and Guillian-Barré Syndrome.¹⁰ Other neurological conditions that have been reported include: demyelinating diseases of the central nervous system, peripheral mononeuropathies, cranial mononeuropathies, and EEG disturbances with encephalopathy (with or without permanent intellectual and/or motor function impairment). The IOM has concluded that the evidence is inadequate to accept or reject a causal relation between these conditions and vaccine containing tetanus toxoid.¹⁰ In the differential diagnosis of polyradiculoneuropathies following administration of a vaccine containing tetanus toxoid, tetanus toxoid should be considered as a possible etiology.¹⁰

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 of the manufacturer and lot number of the vaccine administered in the vaccine recipient´s permanent medical record, along with the date of administration of the vaccine, and the name, address, and title of the person administering the vaccine. The Act further requires the health-care professional to report to the US Department of Health and Human Services (DHHS) the occurrence following immunization of any event set forth in the Vaccine Injury Table that occurs within the time period specified or within 7 days, if that is longer, and any contraindicating event listed in the manufacturer´s package insert. For tetanus toxoid, these include anaphylaxis or anaphylactic shock within 7 days; brachial neuritis within 28 days; an acute complication or sequelae (including death) of an illness, disability, injury, or condition referred to above; or any events that would contraindicate further doses of vaccine, according to this package insert for Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc.^8,9

Reporting by parents, guardians, or adult patients of all adverse events after vaccine administration should be encouraged. Adverse events following immunization should be reported by health-care providers to the 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.^7,8,9

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

For information on concomitant administration of Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. with TIG (Human) see DOSAGE AND ADMINISTRATION, TETANUS PROPHYLAXIS IN WOUND MANAGEMENT.

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

No information is available regarding concomitant administration of Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. with other US licensed vaccines.

REFERENCES

5. CDC. Update on adult immunization recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 1991;40(RR-12):1-52.

8. CDC. National Childhood Vaccine Injury Act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR Morb Mortal Wkly Rep. 1988;37(13):197-200.

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

10. Institute of Medicine (IOM). Stratton KR, Howe CJ, Johnston RB Jr, eds. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: National Academy Press; 1994:67-117.

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