CONTRAINDICATIONS
Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL.
WARNINGS AND PRECAUTIONS
Syncope
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.
Postmarketing Experience
The following adverse events have been spontaneously reported during post-approval use of GARDASIL. Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.
Blood and lymphatic system disorders:
Autoimmune hemolytic anemia,
Idiopathic thrombocytopenic purpura,
Lymphadenopathy.
Respiratory, thoracic and mediastinal disorders:
Pulmonary embolus.
Gastrointestinal disorders:
Nausea,
Pancreatitis,
Vomiting.
General disorders and administration site conditions:
Asthenia,
Chills,
Death,
Fatigue,
Malaise.
Immune system disorders:
Autoimmune diseases,
Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, Bronchospasm and urticaria
Musculoskeletal and connective tissue disorders:
Arthralgia,
Myalgia
Nervous system disorders:
Acute disseminated encephalomyelitis, dizziness,
Guillain-Barré syndrome,
Headache,
Motor neuron disease,
Paralysis,
Seizures,
Syncope (including syncope associated with tonic-clonic movements and other seizure-like activity) sometimes resulting in falling with injury
Transverse myelitis.
Vascular disorders:
Deep venous thrombosis.
PATIENT COUNSELING INFORMATION
Inform the patient, parent, or guardian:
Vaccination does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.
GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.
Since syncope has been reported following vaccination sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended.
Vaccine information is required to be given with each vaccination to the patient, parent, or guardian.
Information regarding benefits and risks associated with vaccination.
GARDASIL is not recommended for use in pregnant women
Importance of completing the immunization series unless contraindicated
Report any adverse reactions to their health care provider.
