An unmasking phenomenon in an observational post-licensure safety study of adolescent girls and young women

Vaccine
Steven J JacobsenNicola P Klein

Abstract

Our recent experience in a post-licensure safety study of autoimmune conditions following the quadrivalent human papillomavirus vaccine in 189,629 girls and young women ages 9-26 years led us to question the adequacy of the exclusion of Day 0 events to prevent the erroneous association of prevalent conditions with vaccination. Of the 18 confirmed cases of Graves' disease diagnosed in days 1-60 following vaccination, only 6 cases appeared to be truly new onset. Among the remaining 12 cases, 2 cases had abnormal thyroid stimulating hormone or thyroxine labs drawn prior to or on Day 0 but had no documented pre-existing symptoms. The other 10 cases had mention of symptoms of hyperthyroidism referencing a period prior to first HPV-4 dose. This 'unmasking' phenomenon, due to health care visits that include vaccination and new workups of preexisting symptoms, may not be adequately controlled through the exclusion of Day 0 events.

References

Dec 23, 1999·The Pediatric Infectious Disease Journal·S BlackH Guess
Nov 3, 2004·Archives of Pediatrics & Adolescent Medicine·Eric K FranceRobert Chen
Mar 7, 2007·Archives of Pediatrics & Adolescent Medicine·Cynthia M RandPeter G Szilagyi
Jul 21, 2009·Vaccine·Irene M ShuiUNKNOWN Vaccine Safety Datalink Research Team
Jul 1, 2010·Pediatrics·Nicola P KleinUNKNOWN Vaccine Safety Datalink
Feb 9, 2011·Pediatrics·Lisa A JacksonUNKNOWN Vaccine Safety Datalink Team

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Citations

Aug 14, 2012·Vaccine·Gregory A Poland, Steven J Jacobsen
Apr 1, 2016·Human Vaccines & Immunotherapeutics·Julianne GeeLauri E Markowitz
Aug 9, 2012·Human Vaccines & Immunotherapeutics·Chun Chao, Steven J Jacobsen
Mar 13, 2014·International Immunopharmacology·Alexander Batista-DuharteIracilda Zeppone Carlos
Jan 1, 2013·Vaccines·Roger Baxter, Nicola P Klein
Oct 19, 2017·Journal of Internal Medicine·A HviidL Arnheim-Dahlström

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