Gardasil 9 Special Precautions

As for any vaccine, vaccination with HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) may not result in protection in all vaccine recipients.
This vaccine is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; CIN, VIN, VaIN, or AIN.
This vaccine will not protect against diseases that are not caused by HPV.
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Syncope (fainting) may follow any vaccination, especially in adolescents and young adults. Syncope, sometimes associated with falling, has occurred after HPV vaccination. Therefore, vaccinees should be carefully observed for approximately 15 minutes after administration of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9).
The decision to administer or delay vaccination because of a current or recent febrile illness depends largely on the severity of the symptoms and their etiology. Low-grade fever itself and mild upper respiratory infection are not generally contraindications to vaccination.
Individuals with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, Human Immunodeficiency Virus (HIV) infection, or other causes, may have reduced antibody response to active immunization. [See Use with Steroids under INTERACTIONS and Immunocompromised Individuals as follows.]
This vaccine should be given with caution to individuals with thrombocytopenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.
Immunocompromised Individuals: The immunologic response to HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) may be diminished in immunocompromised individuals [see Use with Steroids under INTERACTIONS].
Use in Children: The safety and efficacy of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) have not been evaluated in children younger than 9 years.
Use in the Elderly: The safety and efficacy of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) have not been evaluated in individuals aged 65 years and over.