Gardasil 9 Adverse Reactions

A. Summary of the safety profile: In 7 clinical trials, individuals were administered GARDASIL 9 on the day of enrollment and approximately 2 and 6 months thereafter. Safety was evaluated using vaccination report card (VRC)-aided surveillance for 14 days after each injection of GARDASIL 9. A total of 15,776 individuals (10,495 subjects 16 through 26 years of age and 5,281 adolescents 9 through 15 years of age at enrollment) received GARDASIL 9. Few individuals (0.1%) discontinued due to adverse experiences.
The most common adverse reactions observed with GARDASIL 9 were injection-site adverse reactions (84.8% of vaccinees within 5 days following any vaccination visit) and headache (13.2% of the vaccinees within 15 days following any vaccination visit). These adverse reactions usually were mild or moderate in intensity.
Safety was also evaluated in a clinical trial that included 640 women 27 through 45 years of age and 570 girls and women 16 through 26 years of age who received GARDASIL 9. The safety profile of GARDASIL 9 was comparable between the two age groups.
B. Tabulated summary of adverse reactions: Clinical Trials: Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency.
Frequencies are reported as: Very common (≥1/10); Common (≥1/100 to <1/10). (See Table 8.)


Click on icon to see table/diagram/image


In a clinical trial of 1,053 healthy adolescents 11-15 years of age, administration of the first dose of GARDASIL 9 concomitantly with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine showed that more injection-site reactions (swelling, erythema), headache and pyrexia were reported. The differences observed were < 10% and in the majority of subjects, the adverse events were reported as mild to moderate in intensity (see Interactions).
Post-Marketing Experience: The post-marketing adverse experiences were reported voluntarily from a population of uncertain size, therefore, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure. The post-marketing adverse experience with qHPV vaccine is relevant to Gardasil 9 since the vaccines contain L1 HPV proteins of 4 of the same HPV types.
GARDASIL 9: In addition to the adverse reactions reported in the clinical studies, the following adverse experiences have been spontaneously reported during post-approval use of GARDASIL 9: Nervous system disorders: syncope sometimes accompanied by tonic-clonic movements.
Gastrointestinal disorders: vomiting.
GARDASIL: Additionally, the following post-marketing adverse experiences have been spontaneously reported for GARDASIL: Infections and infestations: Injection-site cellulitis.
Blood and lymphatic system disorders: Idiopathic thrombocytopenic purpura, lymphadenopathy.
Immune system disorders: Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm and urticaria.
Nervous system disorders: Acute disseminated encephalomyelitis, Guillain-Barré syndrome.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
General disorders and administration site conditions: Asthenia, chills, malaise.