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 Cervarix.
Applies to human papillomavirus vaccine: intramuscular suspension.
Serious side effects of Cervarix
Along with its needed effects, human papillomavirus vaccine (the active ingredient contained in Cervarix) 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 of Cervarix
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]
