Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink |
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Authors: | Gee Julianne Naleway Allison Shui Irene Baggs James Yin Ruihua Li Rong Kulldorff Martin Lewis Edwin Fireman Bruce Daley Matthew F Klein Nicola P Weintraub Eric S |
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Affiliation: | a Immunization Safety Office, Division of Healthcare Quality and Promotion, Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30333, USA b Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA c Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA d Vaccine Study Center, Northern California Kaiser Permanente, Oakland, CA, USA e Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, USA |
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Abstract: | BackgroundIn 7 large managed care organizations (MCOs), we performed a post-licensure safety assessment of quadrivalent human papillomavirus vaccine (HPV4) among 9-26 year-old female vaccine recipients between August 2006 and October 2009.MethodsSequential analyses were conducted weekly to detect associations between HPV4 exposure and pre-specified outcomes. The pre-specified outcomes identified by ICD-9 codes using computerized data at the participating MCOs included: Guillan-Barré Syndrome (GBS), stroke, venous thromboembolism (VTE), appendicitis, seizures, syncope, allergic reactions, and anaphylaxis. For rare outcomes, historical background rates were used as the comparison group. For more common outcomes, a concurrent unexposed comparison group was utilized. A standardized review of medical records was conducted for all cases of GBS, VTE, and anaphylaxis.ResultsA total of 600,558 HPV4 doses were administered during the study period. We found no statistically significant increased risk for the outcomes studied. However, a non-statistically significant relative risk (RR) for VTE ICD-9 codes following HPV4 vaccination of 1.98 was detected among females age 9-17 years. Medical record review of all 8 vaccinated potential VTE cases in this age group revealed that 5 met the standard case definition for VTE. All 5 confirmed cases had known risk factors for VTE (oral contraceptive use, coagulation disorders, smoking, obesity or prolonged hospitalization).ConclusionsIn a study of over 600,000 HPV4 vaccine doses administered, no statistically significant increased risk for any of the pre-specified adverse events after vaccination was detected. Further study of a possible association with VTE following HPV4 vaccination is warranted. |
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Keywords: | Quadrivalent human papillomavirus vaccine Vaccine safety Vaccine Safety Datalink project |
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