Gardasil 9 Side Effects

Generic name: human papillomavirus vaccine

Medically reviewed by Drugs.com. Last updated on Jun 18, 2023.

Note: This document contains side effect information about human papillomavirus vaccine. Some dosage forms listed on this page may not apply to the brand name Gardasil 9.

Applies to human papillomavirus vaccine: intramuscular suspension.

Serious side effects of Gardasil 9

Along with its needed effects, human papillomavirus vaccine (the active ingredient contained in Gardasil 9) 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:

More common

• Fever

Less common

• Black, tarry stools
• bleeding gums
• blood in urine or stools
• blurred vision
• body aches or pain
• chills
• constipation
• cough
• depressed mood
• difficulty with breathing
• dry mouth
• dry skin and hair
• ear congestion
• feeling cold
• flushed, dry skin
• fruit-like breath odor
• headache
• hoarseness or husky voice
• increased hunger
• increased thirst
• increased urination
• loss of consciousness
• loss of voice
• muscle cramps and stiffness
• nasal congestion
• nausea
• pinpoint red spots on skin
• runny nose
• slowed heartbeat
• sneezing
• sore throat
• stomachache
• sweating
• troubled breathing
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Rare

• Difficulty with swallowing
• dizziness
• fast heartbeat
• hives
• itching
• noisy breathing
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• tightness in the chest
• wheezing

Incidence not known

• Anxiety
• back pain, sudden and severe
• back, leg, or stomach pains
• bloating
• chest pain
• convulsions (seizures)
• dark urine
• fainting
• general body swelling
• hives or welts
• hoarseness
• inability to move the arms and legs
• indigestion
• irritation
• joint pain, stiffness, or swelling
• loss of appetite
• loss of bladder control
• muscle spasm or jerking of all extremities
• muscle weakness, sudden and progressing
• nosebleeds
• pain in the stomach, side, or abdomen, possibly radiating to the back
• pain, redness, or swelling in the arm or leg
• pale skin
• paralysis
• rash
• redness of the skin
• shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination
• sudden loss of consciousness
• sudden numbness and weakness in the arms and legs
• sudden shortness of breath or troubled breathing
• swelling of the eyelids, face, lips, hands, or feet
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• yellowing of the eyes or skin

Other side effects of Gardasil 9

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

• Red streaks on the skin, swelling, tenderness, pain, or itching at the injection site

Less common

• Changes in skin coloring
• cloudy urine
• diarrhea
• difficulty with moving
• general feeling of discomfort or illness
• hair loss, thinning of hair
• muscle pain or stiffness
• pain in the joints
• sleeplessness
• toothache
• trouble with sleeping
• unable to sleep

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]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer