Applies to human papillomavirus vaccine: intramuscular suspension.

Serious side effects

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:

Less common

• Fever

Incidence not known

• 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
• nosebleeds
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• seizures
• sore throat
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• tightness in the chest
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Other side effects

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:

More common

• Pain, redness, itching, or swelling at the injection site

Less common

• Bleeding, bruising, or lumps at the injection site
• diarrhea
• difficulty with moving
• joint pain or swelling
• muscle ache, cramps, pain, or stiffness
• upper abdominal or stomach pain

Rare

• Blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, numbness, rash, redness, scarring, soreness, stinging, tenderness, tingling, ulceration, or warmth at the injection site
• body aches or pain
• ear congestion
• loss of voice
• sneezing
• stuffy or runny nose

Incidence not known

• Bloating
• constipation
• dark urine
• difficulty with moving
• indigestion
• pains in the stomach, side, or abdomen, possibly radiating to the back

For Healthcare Professionals

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

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]

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]

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]