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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.