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Decavac

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Decavac

Decavac Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Decavac (tetanus and diphtheria toxoids adsorbed) vaccine (also called Td) is used to help prevent tetanus (lockjaw) and diphtheria in adults and children who are at least 7 years old. It is an immunization. This medication is available in generic form. Common side effects include pain/redness/warmth/bruising/swelling at the injection site, tiredness, fever, or headache.

Decavac vaccine may be used in persons 7 years of age and older who have not been immunized previously against tetanus and diphtheria, as a primary immunization series of three 0.5 mL doses. The first two doses are administered 4-8 weeks apart and the third dose is administered 6-12 months after the second dose. Decavac may interact with steroids, medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, or medicines to treat or prevent organ transplant rejection. Tell your doctor all medications and supplements you use, and all other vaccines you have recently received. During pregnancy, Decavac should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Decavac (tetanus and diphtheria toxoids adsorbed) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Decavac in Detail - Patient Information: Side Effects

You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with tetanus or diphtheria is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have 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 you have any of these serious side effects:

  • extreme drowsiness, fainting;
  • severe headache or vomiting;
  • 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;
  • 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 Decavac (Tetanus and Diphtheria Toxoids Adsorbed) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Decavac FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Data from Clinical Studies

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.

Primary Immunization

In a clinical study, 42 persons 6-58 years of age underwent primary immunization against tetanus and diphtheria. Eight of these participants (19%) noted local reactions consisting of pain and tenderness, induration, and erythema at the injection site; none reported systemic symptoms.4

Booster Immunization

In a clinical study, 792 adolescents 11-17 years of age and 573 adults 18-64 years of age received a booster dose with DECAVAC vaccine. Study participants had not received tetanus or diphtheria toxoid-containing vaccines within the previous 5 years. Solicited local reactions and systemic adverse events were monitored daily for 14 days post-vaccination using subject diary cards.

Serious adverse events were monitored through 6 months post-vaccination. Ninety-seven percent of participants who received DECAVAC vaccine completed the 6-month telephone follow-up.

Solicited Adverse Events

The frequency of selected solicited injection site reactions (pain, swelling, or erythema) occurring during Days 0-14 following booster vaccination with DECAVAC vaccine in adolescents 11 through 17 years of age, and adults 18 through 64 years of age are presented in Table 2. Pain at the injection site was the most common adverse reaction occurring in 71% of adolescents and 62.9% of adults.

Table 2: Frequencies of Solicited Injection Site Reactions for Adolescents and Adults, Days 0-14 Following BoosterVaccination with DECAVAC Vaccine

Adverse Event Adolescents 11-17 years Adults 18-64 years
Na = 783-787 (%) Na = 551-561 (%)
Injection Site Any 71.0 62.9
Moderateb 15.6 10.2
Pain Severec 0.6 0.9
Any 18.3 17.3
Moderate  
Injection Site Swelling   1.0 to 3.4 cm 5.7 5.4
Severe  
   ≥ 3.5 cm 5.5 5.5
   ≥ 5 cm 3.6 2.7
Any 19.7 21.6
Moderate  
Injection Site Erythema   1.0 to 3.4 cm 4.6 8.4
Severe  
   ≥ 3.5 cm 5.3 4.8
   ≥ 5 cm 2.9 3.0
aN = number of participants who provided data (not all participants evaluated every event).
bInterfered with activities, but did not necessitate medical care or absenteeism.
cIncapacitating, prevented the performance of usual activities, may have/or did necessitate medical care or absenteeism.

The frequency of solicited systemic adverse events occurring during Days 0-14 following booster vaccination with DECAVAC vaccine are presented in Table 3. Headache was the most frequent solicited systemic adverse event, and was usually of mild or moderate intensity.

Table 3: Frequencies of Solicited Systemic Adverse Events for Adolescents and Adults, Days 0-14 Following Booster Vaccination with DECAVAC Vaccine

Adverse Event Adolescents 11-17 years Adults 18-64 years
Na = 787 (%) Na = 560-561 (%)
Headache Any 40.4 34.1
Moderateb 11.1 10.5
Severec 1.5 2.1
Body Ache or Muscle Weakness Any 29.9 18.8
Moderateb 6.9 5.7
Severec 0.9 0.9
Tiredness Any 27.3 20.7
Moderateb 7.5 6.1
Severec 1.0 0.5
Chills Any 12.6 6.6
Moderateb 2.5 1.6
Severec 0.1 0.5
Nausea Any 12.3 7.9
Moderateb 3.2 1.8
Severec 0.6 0.5
Sore and Swollen Joints Any 11.7 7.0
Moderateb 2.5 2.1
Severec 0.1 0.5
Diarrhea Any 10.2 11.3
Moderateb 2.0 2.7
Severec 0.0 0.5
Lymph Node Swelling Any 5.3 4.1
Moderateb 0.5 0.5
Severec 0.0 0.0
Vomiting Any 2.8 1.8
Moderateb 1.1 0.9
Severec 0.3 0.2
Fever Any ≥ 38.0°C ( ≥ 100.4°F) 2.7 1.1
≥ 38.8°C to ≤ 39.4°C ( ≥ 102.0°F to ≤ 103.0°F) 0.6 0.2
≤ 39.5°C ( ≤ 103.1°F) 0.1 0.2
Rash Any 2.0 2.3
aN = number of participants who provided data (not all participants evaluated every event).
bInterfered with activities, but did not necessitate medical care or absenteeism. incapacitating, prevented the performance of usual activities, may have/or did necessitate medical care or absenteeism.

Serious Adverse Events

Among 792 adolescents 11-17 years of age and 573 adults 18-64 years of age who received a booster dose with DECAVAC vaccine, 2 adolescents and 2 adults reported a serious adverse event that occurred within 30 days following vaccination. Events reported in adolescents were jaw fracture secondary to trauma and abdominal pain/appendectomy. Events reported in adults were atrial septal defect and elective surgical repair in one subject, and myocardial infarction in one subject with a history of coronary artery disease.

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 with DECAVAC vaccine.

Blood and Lymphatic System Disorders

Lymphadenopathy.

Immune System Disorders

Allergic reactions (such as rash, urticaria, pruritus, and angioedema), including anaphylactic 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.

Read the entire FDA prescribing information for Decavac (Tetanus and Diphtheria Toxoids Adsorbed) »

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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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