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Decavac

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Decavac

Decavac

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates.

In a clinical study involving 58 individuals 6-58 years of age, 19% of the individuals noted local reactions consisting of erythema, tenderness and induration at the injection site and 2% systemic reactions consisting of headache, malaise and temperature elevations.5

Data from Post-Marketing Experience

The following adverse events have been spontaneously reported during the post-marketing use of Td manufactured by Sanofi Pasteur Inc. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination. The following adverse events were included based on severity, frequency of reporting or the strength of causal association to DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine.

Blood and lymphatic system disorders

Lymphadenopathy.

Immune system disorders

Allergic reactions (such as rash, urticaria, pruritus, and face edema), including anaphylactoid reactions.

Nervous system disorders

Headache, paresthesia, dizziness, syncope, and convulsions.

Gastrointestinal disorders

Nausea, vomiting.

Musculoskeletal, connective tissue and bone disorders

Myalgia, arthralgia, pain in extremities, musculoskeletal stiffness.

General disorders and administration site conditions

Injection site reactions (including swelling, redness, warmth, induration, cellulitis, and nodules).

Pyrexia, chills, pain, malaise, asthenia, fatigue, edema peripheral.

Reporting of Adverse Events

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.8 The Act further requires the health-care professional to report to the US Department of Health and Human Services the occurrence of certain adverse events following vaccination.8 For Td, events required to be reported are anaphylaxis or anaphylactic shock within 7 days; brachial neuritis within 28 days; any acute complication or sequelae (including death) of the above events; or any events that would contraindicate further doses of vaccine according to the manufacturer's package insert.9 These events and other suspected adverse reactions should be reported to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov. Health-care providers should also report adverse events following DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine to Sanofi Pasteur Inc. at 1-800-822-2463.

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

DRUG INTERACTIONS

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine.

No safety and immunogenicity data are available regarding concomitant administration of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine with other US licensed vaccines.

REFERENCES

5. Myers MG, et al. Primary immunization with tetanus and diphtheria toxoids. JAMA 248:1982;2478-2480.

8. CDC. Current trends - national vaccine injury act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 1988;37(13):197-200.

9. CDC. Vaccine Adverse Event Reporting System (VAERS) Table of Reportable Events Following Vaccination. 2005;1-2. http://vaers.hhs.gov/pdf/ReportableEventsTable.pdf

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

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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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