This is a post-licensure safety surveillance program to detect potential safety signals in subjects, from the managed care organizations database, who have used GARDASIL™.
Study Type
OBSERVATIONAL
Enrollment
189,629
Incidence Rate of Syncope
Syncope was defined as the presence of a syncope diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.
Time frame: On day of each vaccination
Incidence Rate of Cellulitis
Cellulitis was defined as the presence of a cellulitis or abscess diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.
Time frame: Within 14 days and within 60 days immediately after each vaccination
Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy
Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.
Time frame: First dose of Gardasil in pregnancy up to 6 months after birth
Number of Miscarriages Among Females Who Received Gardasil During Pregnancy
Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.
Time frame: First dose of Gardasil in pregnancy up to pregnancy resolution
Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil
Autoimmune cases were defined as newly diagnosed cases within 6 months after any dose of Gardasil, as confirmed by medical record review by panels of physicians specializing in the 16 autoimmune conditions of interest.
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Time frame: within 6 months immediately after each vaccination