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Human papillomavirus vaccine Side Effects

For the Consumer

Applies to human papillomavirus vaccine: intramuscular suspension

In addition to its needed effects, some unwanted effects may be caused by human papillomavirus vaccine. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking human papillomavirus vaccine, check with your doctor or nurse immediately:

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 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

Minor Side Effects

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

More common:
  • Headache
Less common:
  • Diarrhea
  • difficulty with moving
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • sore throat
  • swollen joints
  • upper abdominal or stomach pain
Rare
  • Body aches or pain
  • ear congestion
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
Incidence not known:
  • 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

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

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]

References

1. "Product Information. Cervarix (human papillomavirus vaccine)." GlaxoSmithKline, Research Triangle Park, NC.

2. "Product Information. Gardasil (human papillomavirus vaccine)." Merck & Company Inc, West Point, PA.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. Cerner Multum, Inc. "Australian Product Information." O 0

5. "Product Information. Gardasil 9 (human papillomavirus vaccine)." Merck & Company Inc, Whitehouse Station, NJ.

Not all side effects for human papillomavirus vaccine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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