TENIVAC (Tetanus and diphtheria toxoid vaccine manufactured by Sanofi Pasteur.)
- Frequently Reported Adverse Events: In pre-licensure clinical trials, pain, redness, and swelling at the injection site; fever; muscle weakness; joint pain; malaise; headache.
- Serious Reported Adverse Events: In pre-licensing clinical trials, serious adverse events included asthma, localized infection, stroke, chest pain, colonic polyp, cellulitis, angina pectoris, hip and wrist fracture, and cholecystitis. Three deaths occurred following administration of TENIVAC. Deaths were reported as cardiopulmonary arrest; myocardial infarction and septic shock; and unknown cause. After licensure (post marketing) adverse events have included Guillain-Barre Syndrome (GBS), injection site pain, swelling, warmth, itching, cellulitis and hypersensitivity; fever; lymphadenopathy; vomiting; dizziness; paresthesia; syncope; fatigue; peripheral edema; rash; joint and muscle pain; allergic and anaphylactic reactions.
