3d
(Human Papillomavirus 9-valent Vaccine, Recombinant)
Suspension for intramuscular injection
Initial U.S. Approval: 2014
6.2 Postmarketing Experience
The postmarketing 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 safety profile of GARDASIL 9 and GARDASIL are similar. The postmarketing safety experience
with GARDASIL is relevant to GARDASIL 9 since the vaccines are manufactured similarly and contain the
same L1 HPV proteins of four 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:
Gastrointestinal disorders: Vomiting.
Skin and subcutaneous tissue disorders: Urticaria.
General disorders and administration site conditions: Injection-site nodule.
9
GARDASIL
The following postmarketing adverse experiences have been spontaneously reported for GARDASIL:
Blood and lymphatic system disorders: Autoimmune hemolytic anemia, idiopathic thrombocytopenic
purpura, lymphadenopathy.
Respiratory, thoracic and mediastinal disorders: Pulmonary embolus.
Gastrointestinal disorders: Nausea, pancreatitis, vomiting.
General disorders and administration site conditions: Asthenia, chills, death, fatigue, injection-site
nodule, malaise.
Immune system disorders: Autoimmune diseases, hypersensitivity reactions including
anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Acute disseminated encephalomyelitis, dizziness, Guillain-Barrรฉ syndrome,
headache, 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.
Infections and infestations: Cellulitis.
Vascular disorders: Deep venous thrombosis.
Suspension for intramuscular injection
Initial U.S. Approval: 2014
6.2 Postmarketing Experience
The postmarketing 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 safety profile of GARDASIL 9 and GARDASIL are similar. The postmarketing safety experience
with GARDASIL is relevant to GARDASIL 9 since the vaccines are manufactured similarly and contain the
same L1 HPV proteins of four 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:
Gastrointestinal disorders: Vomiting.
Skin and subcutaneous tissue disorders: Urticaria.
General disorders and administration site conditions: Injection-site nodule.
9
GARDASIL
The following postmarketing adverse experiences have been spontaneously reported for GARDASIL:
Blood and lymphatic system disorders: Autoimmune hemolytic anemia, idiopathic thrombocytopenic
purpura, lymphadenopathy.
Respiratory, thoracic and mediastinal disorders: Pulmonary embolus.
Gastrointestinal disorders: Nausea, pancreatitis, vomiting.
General disorders and administration site conditions: Asthenia, chills, death, fatigue, injection-site
nodule, malaise.
Immune system disorders: Autoimmune diseases, hypersensitivity reactions including
anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Acute disseminated encephalomyelitis, dizziness, Guillain-Barrรฉ syndrome,
headache, 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.
Infections and infestations: Cellulitis.
Vascular disorders: Deep venous thrombosis.
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