Diptheria and Tetanus
- Tetanus is frequently a fatal infectious disease.
- Tetanus is caused by a type of bacteria (Clostridium tetani).
- The tetanus bacteria often enter the body through a puncture wound, which ca"...
Diphtheria and Tetanus
Diptheria and Tetanus Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with diphtheria or tetanus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.
Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if the child has a serious side effect such as:
- extreme drowsiness, fainting;
- severe headache or vomiting;
- fussiness, irritability, crying for an hour or longer;
- confusion, seizure (black-out or convulsions); or
- high fever.
Less serious side effects include:
- redness, pain, tenderness, swelling, or a hard lump where the shot was given;
- mild fever;
- mild fussiness or crying;
- joint pain, body aches;
- mild drowsiness; or
- mild vomiting.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
Read the entire detailed patient monograph for Diptheria and Tetanus (Diphtheria and Tetanus Toxoids) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Diptheria and Tetanus FDA Prescribing Information: 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
Post Dose 1
Post Dose 2
Post Dose 3
* 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
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
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 entire FDA prescribing information for Diptheria and Tetanus (Diphtheria and Tetanus Toxoids) »
Additional Diphtheria and Tetanus Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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