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You are here: Home / NEWS . . . . . . . . / Vaccine Victims / Gardasil / Silgard Injuries / Post-licensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine

Post-licensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine

January 15, 2011 By Norma

Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, Izurieta HS, Ball R, Miller N, Braun MM, Markowitz LE, Iskander J.

Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Mailstop D-26, Atlanta, GA 30333, USA. bfs9@cdc.gov

Comment in:

  • JAMA. 2009 Dec 23;302(24):2657; author reply 2657-8.
  • JAMA. 2009 Aug 19;302(7):795-6.

Abstract

CONTEXT: In June 2006, the Food and Drug Administration licensed the quadrivalent human papillomavirus (types 6, 11, 16, and 18) recombinant vaccine (qHPV) in the United States for use in females aged 9 to 26 years; the Advisory Committee on Immunization Practices then recommended qHPV for routine vaccination of girls aged 11 to 12 years.

OBJECTIVE: To summarize reports to the Vaccine Adverse Event Reporting System (VAERS) following receipt of qHPV.

DESIGN, SETTING, AND PARTICIPANTS: Review and describe adverse events following immunization (AEFIs) reported to VAERS, a national, voluntary, passive surveillance system, from June 1, 2006, through December 31, 2008. Additional analyses were performed for some AEFIs in prelicensure trials, those of unusual severity, or those that had received public attention. Statistical data mining, including proportional reporting ratios (PRRs) and empirical Bayesian geometric mean methods, were used to detect disproportionality in reporting.

View entire abstract here.

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Filed Under: Gardasil / Silgard Injuries, Gardasil/Silgard Reactions, Gardasil/Silgard Vaccine Tagged With: adverse events, cervical cancer vaccine, HPV vaccine, post-marketing surveillance, VAERS reports

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HPV Vaccine VAERS Reports

Description 12/14/2019  TOTAL
Disabled 3,092
Deaths 523
Did Not Recover 13,072
Abnormal Smear 695
Cervical Cancer 186
Infertility 52
Life-threatening 1,001
Emergency Room 15,419
Hospitalized 6,448
Extended Hosp. Stay 304
Serious 9,497
Total Adverse Events 64,270

Access expanded report here.

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