Data from FDA - Curated by Toby Galbraith - Last updated 17 April 2017
FDA (Food and Drug Administration, USA)
• Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine. (4.2)
individuals. (5.2, 17)
• If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré
syndrome may be increased following a subsequent dose of Adacel vaccine. (5.3)
• Progressive or unstable neurologic conditions are reasons to defer Adacel vaccination. (5.4)
• Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine should
not receive Adacel unless at least 10 years have elapsed since the last dose of a tetanus toxoid-containing vaccine. (5.5)
• Syncope (fainting) can occur in association with administration of injectable vaccines, including Adacel. Procedures should be in place to prevent falling injury and manage syncopal reactions. (5.7)
- For Adolescents 11-17 years of age: pain (77.8%), swelling (20.9%), erythema (20.8%).
- For Adults 18-64 years of age: pain (65.7%), swelling (21.0%), erythema (24.7%) (6.1).
• The most common solicited systemic reactions occurring within 0-14 days following vaccination with Adacel were:
- For Adolescents 11-17 years of age: headache (43.7%), body ache or muscle weakness (30.4%), tiredness (15.1%).
- For Adults 18-64 years of age: headache (33.9%), body ache or muscle weakness (21.9%) (6.1).
• Pregnancy Surveillance Registry: contact Sanofi Pasteur Inc. at 1-800-822-2463 (1-800-VACCINE). (8.1)
|Date First Approved||10-06-2005|
|Marketing authorisation holder||Sanofi Pasteur Limited|