Human papillomavirus (HPV) vaccine, 9-valent

HPV 9-valent vaccine is given as an injection (shot) into a muscle in your upper arm or thigh. You will receive this injection in a doctor's office or other clinic setting.

HPV 9-valent vaccine is given in a series of 3 shots. You may have the first shot at any time as long as you are between the ages of 9 and 26 years old. Then you will need to receive a second dose 2 months after your first shot, and a third dose 6 months after your first shot.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

HPV 9-valent vaccine should not be used in place of having a routine pelvic exam, Pap smear, or anal exam to screen for cervical or anal cancer.

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

An overdose of this vaccine is unlikely to occur.

Usual Adult Dose for Human Papillomavirus Prophylaxis:

Cervarix(R):
Females, up to 25 years old: 0.5 mL, IM, at 0, 1, and 6 months

Gardasil(R) and Gardasil 9(R):
Females and males, up to 26 years old: 0.5 mL, IM, at 0, 2, and 6 months

Uses: For the prevention of cervical, vulvar, and anal cancer caused by Human Papillomavirus (HPV) in females, and prevention of anal cancer, genital warts, and anal intraepithelial neoplasia cause by HPV in males.

Usual Pediatric Dose for Human Papillomavirus Prophylaxis:

Cervarix(R):
Females, aged 9 to 25 years: 0.5 mL, IM, at 0, 1, and 6 months

Gardasil(R) and Gardasil 9(R):
Females and males, aged 9 to 26 years: 0.5 mL, IM, at 0, 2, and 6 months

Uses: For the prevention of cervical, vulvar, and anal cancer caused by Human Papillomavirus (HPV) in females, and prevention of anal cancer, genital warts, and anal intraepithelial neoplasia cause by HPV in males.

Applies to human papillomavirus vaccine: intramuscular suspension

Along with its needed effects, human papillomavirus vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking human papillomavirus vaccine:

• Fever

• Anxiety
• back, leg, or stomach pains
• bleeding gums
• chest pain
• chills
• cough
• dark urine
• difficulty with breathing
• difficulty with swallowing
• dizziness or lightheadedness
• fainting
• fast heartbeat
• general body swelling
• headache
• hives or welts, itching, or skin rash
• loss of appetite
• nausea or vomiting
• nosebleeds
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• seizures
• sore throat
• sudden shortness of breath or troubled breathing
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
• tightness in the chest
• unusual tiredness or weakness
• yellowing of the eyes or skin

Some side effects of human papillomavirus vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache

• Diarrhea
• difficulty with moving
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• sore throat
• swollen joints
• upper abdominal or stomach pain

• Body aches or pain
• ear congestion
• loss of voice
• nasal congestion
• runny nose
• sneezing

• Bloating
• constipation
• darkened urine
• difficulty with moving
• fast heartbeat
• indigestion
• loss of appetite
• muscle pain or stiffness
• pain in the joints pain, swelling, or redness at the injection site
• pains in the stomach, side, or abdomen, possibly radiating to the back

Applies to human papillomavirus vaccine: intramuscular suspension

General

The most common adverse events were injection site reactions, fatigue, headache, and myalgia.[Ref]

Local

Very common (10% or more): Injection site pain (91.9%), injection site swelling (49%), injection site erythema (48.4%)
Common (1% to 10%): Injection site pruritus, injection site hematoma, injection site induration, injection site hemorrhage, injection site warmth, injection site mass, injection site reaction
Postmarketing reports: Injection site cellulitis[Ref]

Other

Very common (10% or more): Fatigue (54.6%), headache (53.4%), pyrexia (13%), fever of 99.5F or higher (12.9%)
Common (1% to 10%): Chlamydia infection, malaise
Uncommon (0.1% to 1%): Death
Postmarketing reports: Asthenia, chills[Ref]

Deaths occurred during clinical trials which were generally assessed as not vaccine related: car accidents, suicides, acute lymphocytic leukemia, hypovolemic septic shock, airplane crash, cerebral hemorrhage, gunshot wound, stomach adenocarcinoma, pulmonary embolus/deep vein thrombosis, sepsis, pancreatic cancer, arrhythmia, pulmonary tuberculosis, hyperthyroidism, post-operative pulmonary embolism and acute renal failure, traumatic brain injury/cardiac arrest, systemic lupus erythematosus, cerebrovascular accident, breast cancer, nasopharyngeal cancer, autoimmune disease, infectious disease, homicide, and 1 unexplained sudden death 678 days following the last vaccine dose.[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (48.8%), arthralgia (20.7%)
Common (1% to 10%): Back pain
Postmarketing reports: Pain in extremity[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, vomiting, abdominal pain upper, toothache
Rare (less than 0.1%): Appendicitis, gastroenteritis
Postmarketing reports: Pancreatitis[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, oropharyngeal pain, influenza, cough, nasal congestion, upper respiratory tract infection, pharyngitis
Rare (0.01% to 0.1%): Pneumonia, pulmonary embolism, asthma
Very rare (less than 0.01%): Bronchospasm
Frequency not reported: Asthmatic crisis
Postmarketing reports: Pulmonary embolus[Ref]

Nervous system

Common (1% to 10%): Dizziness, migraine
Postmarketing reports: Acute disseminated encephalomyelitis, Guillain-Barre syndrome, 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[Ref]

Immunologic

New medical conditions potentially indicative of systemic autoimmune disorders included: arthralgia/arthritis/arthropathy, autoimmune thyroiditis, celiac disease, diabetes mellitus insulin dependent, erythema nodosum, hyperthyroidism, hypothyroidism, inflammatory bowel disease, multiple sclerosis, nephritis, optic neuritis, pigmentation disorder, psoriasis, Raynaud's phenomenon, rheumatoid arthritis, scleroderma/morphea, Stevens-Johnson syndrome, systemic lupus erythematosus, uveitis, alopecia areata, ankylosing spondylitis, autoimmune thrombocytopenia, myocarditis, proteinuria, skin depigmentation, dermatomyositis, vasculitis, and vitiligo.[Ref]

Common (1% to 10%): New medical conditions potentially indicative of systemic autoimmune disorders
Postmarketing reports: Autoimmune diseases[Ref]

Hypersensitivity

Common (1% to 10%): Injection site hypersensitivity
Frequency not reported: Allergy to vaccine
Postmarketing reports: Hypersensitivity reactions (including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria)[Ref]

Hematologic

Uncommon (0.1% to 1%): Lymphadenopathy
Postmarketing reports: Autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura[Ref]

Psychiatric

Common (1% to 10%): Insomnia[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea, vaginal infection, urinary tract infection
Rare (less than 0.1%): Pelvic inflammatory disease, pyelonephritis[Ref]

Dermatologic

Common (1% to 10%): Rash, urticaria, itching/pruritus
Postmarketing reports: Cellulitis, angioedema, erythema multiforme[Ref]

Cardiovascular

Postmarketing reports: Deep vein thrombosis[Ref]

Some side effects of human papillomavirus vaccine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.