Initial U.S. Approval: 2003
TENIVAC is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.
Serious adverse events within 30 days following TENIVAC included localized infection, asthma, colonic polyp, cellulitis, angina pectoris, hip and wrist fracture, cholecystitis, chest pain and cerebrovascular accident.
All of the reported deaths were in participants ≥60 years of age and occurred >30 days post-vaccination: three in the TENIVAC group (cardiopulmonary arrest; myocardial infarction and septic shock; and unknown cause)…
In the primary immunization study (N = 18) in which serious adverse events were monitored for 3 days following each vaccination and in three other booster immunization studies in which serious adverse events were monitored for either four days (N = 347) or one month (N = 426) following vaccination, no serious adverse events were reported.
Postmarketing Experience
– Lymphadenopathy
– Allergic reactions (such as erythematous rash, maculopapular rash, urticaria and pruritus); anaphylactic reaction (bronchospasm and angioedema).
– Paresthesia, dizziness, syncope
– Guillain-Barré syndrome
– Vomiting
– Myalgia, pain in extremities
– Injection site reactions (including inflammation, mass, edema, induration, warmth, pruritus, cellulitis, discomfort)
– Fatigue, edema peripheral
Each 0.5 mL dose of TENIVAC contains… 1.5 mg of aluminum phosphate (0.33 mg of aluminum) as the adjuvant…
TENIVAC has not been evaluated for carcinogenic or mutagenic potential or impairment of male fertility in animals.