Gardasil Side Effects

Clinical Trials: In 7 clinical trials (6 placebo-controlled), individuals were administered QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) or placebo on the day of enrollment and approximately 2 and 6 months thereafter. QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) demonstrated a favorable safety profile when compared with placebo (aluminum or non-aluminum containing). Few individuals (0.2%) discontinued due to adverse experiences. In all except one of the clinical trials, safety was evaluated using vaccination report card (VRC)-aided surveillance for 14 days after each injection of QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) or placebo. The individuals who were monitored using VRC-aided surveillance included 10,088 individuals (6,995 girls and women 9 through 45 years of age and 3,093 boys and men 9 through 26 years of age at enrollment) who received QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) and 7,995 individuals who received placebo.
The vaccine-related adverse experiences that were observed among recipients of GARDASIL at a frequency of at least 1.0% and also at a greater frequency than that observed among placebo recipients are listed according to frequency and system organ class.
The frequency classifications are as follows: Very Common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Very Rare (<1/10,000).
Vaccine-Related Clinical Adverse Experiences in Girls and Women 9-45 Years: Nervous System Disorders: Very Common: Headache. Common: Dizziness.
Gastrointestinal Disorders: Common: Nausea.
Musculoskeletal and Connective Tissue Disorders: Common: Pain in extremity.
General Disorders and Administration Site Conditions: Very Common: Pyrexia.
The following injection site reactions occurred at a greater incidence in the group that received QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) compared with either the amorphous aluminum hydroxyphosphate sulfate adjuvant-containing or the saline placebo group: Very Common: Erythema, pain and swelling. Common: Pruritus and hematoma.
Most injection site reactions were mild to moderate.
In addition, bronchospasm was reported very rarely as a serious adverse experience.
Vaccine-Related Clinical Adverse Experiences in 9 through 26 Year-Old-Boys: Nervous System Disorders: Common: Headache.
General Disorders and Administration Site Conditions: Very Common: Pyrexia.
The following injection-site reactions occurred at a greater incidence in the group that received QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) compared with either the amorphous aluminum hydroxyphosphate sulfate adjuvant-containing or the saline placebo group: Very Common: Erythema, pain, and swelling. Common: Pruritus and hematoma.
Most injection-site reactions were mild to moderate.
In addition, bronchospasm was reported very rarely as a serious adverse experience.
Vaccine-Related Clinical Adverse Experiences in 9- Through 26-Year-Old Boys and Men: Nervous System Disorders: Common: Headache.
General Disorders and Administration Site Conditions: Common: Pyrexia.
The following injection-site reactions occurred at a greater incidence in the group that received QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) compared with either the amorphous aluminum hydroxyphosphate sulfate adjuvant-containing or the saline placebo group: Very Common: Erythema, pain, and swelling.
The following injection-site reaction occurred at a greater incidence in the group that received QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) compared with the amorphous aluminum hydroxyphosphate sulfate adjuvant-containing placebo group: Common: Hematoma.
Most injection-site reactions were mild to moderate.
Concomitant Administration with Other Vaccines: The safety of QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) when administered concomitantly with other vaccines was evaluated in clinical studies.
The frequency of adverse experiences observed with concomitant administration with hepatitis B vaccine (recombinant) was similar to the frequency when QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) was administered alone.
There was an increase in headache and injection-site swelling when QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) was given concomitantly with Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine, (adsorbed, reduced antigen(s) content).
There was an increase in injection-site swelling when QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) was given concomitantly with Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine and Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap).
The majority of these adverse experiences seen with concomitant administration with other vaccines were reported as being mild to moderate in intensity.
Post-Marketing Reports: The following adverse experiences have been spontaneously reported during post-approval use of QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL). Because these experiences were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.
Infections and Infestations: Cellulitis.
Blood and Lymphatic System Disorders: Idiopathic thrombocytopenic purpura, lymphadenopathy.
Nervous System Disorders: Acute disseminated encephalomyelitis, dizziness, Guillain-Barré syndrome, headache, syncope sometimes accompanied by tonic-clonic movements.
Gastrointestinal Disorders: Nausea, vomiting.
Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia.
General Disorders and Administration Site Conditions: Asthenia, chills, fatigue, malaise.
Immune System Disorders: Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria.