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You are here: Home / RESEARCH . . . . / Gardasil/Silgard Vaccine / Gardasil/Silgard Reactions / Quadrivalent human papillomavirus vaccine and autoimmune adverse events: a case–control assessment of the vaccine adverse event reporting system (VAERS) database

Quadrivalent human papillomavirus vaccine and autoimmune adverse events: a case–control assessment of the vaccine adverse event reporting system (VAERS) database

July 22, 2016 By Norma

Quadrivalent human papillomavirus vaccine and autoimmune adverse events: a case–control assessment of the vaccine adverse event reporting system (VAERS) database

Authors: David A. Geier, Mark R. Geier

Abstract:

Gardasil is a quadrivalent human papillomavirus (HPV4) vaccine that was approved for use by the US Food and Drug Administration in June 2006. HPV4 vaccine is routinely recommended for administration to women in the USA who are 11–12 years old by the Advisory Committee on Immunization Practices. Previous studies suggest HPV4 vaccine administration was associated with autoimmune diseases. As a consequence, an epidemiological assessment of the vaccine adverse event reporting system database was undertaken for adverse event reports associated with vaccines administered from 2006 to 2014 to 6–39 year-old recipients with a listed US residence and a specified female gender. Cases with the serious autoimmune adverse event (SAAE) outcomes of gastroenteritis (odds ratio (OR) 4.627, 95 % confidence interval (CI) 1.892–12.389), rheumatoid arthritis (OR 5.629, 95 % CI 2.809–12.039), thrombocytopenia (OR 2.178, 95 % CI 1.222–3.885), systemic lupus erythematosus (OR 7.626, 95 % CI 3.385–19.366), vasculitis (OR 3.420, 95 % CI 1.211–10.408), alopecia (OR 8.894, 95 % CI 6.255–12.914), CNS demyelinating conditions (OR 1.585, 95 % CI 1.129–2.213), ovarian damage (OR 14.961, 95 % CI 6.728–39.199), or irritable bowel syndrome (OR 10.021, 95 % CI 3.725–33.749) were significantly more likely than controls to have received HPV4 vaccine (median onset of initial symptoms ranged from 3 to 37 days post-HPV4 vaccination). Cases with the outcome of Guillain–Barre syndrome (OR 0.839, 95 % CI 0.601–1.145) were no more likely than controls to have received HPV4 vaccine. In addition, cases with the known HPV4-related outcome of syncope were significantly more likely than controls to have received HPV4 vaccine (OR 5.342, 95 % CI 4.942–5.777). Cases with the general health outcomes of infection (OR 0.765, 95 % CI 0.428–1.312), conjunctivitis (OR 1.010, 95 % CI 0.480–2.016), diarrhea (OR 0.927, 95 % CI 0.809–1.059), or pneumonia (OR 0.785, 95 % CI 0.481–1.246) were no more likely than controls to have received HPV4 vaccine. Confirmatory epidemiological studies in other databases should be undertaken and long-term clinical consequences of HPV-linked SAAEs should be examined.

Access entire paper via this link.

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Filed Under: Autoimmune Disorders, Gardasil/Silgard Reactions, HPV vaccine research Tagged With: adverse reactions, Gardasil, rheumatoid arthritis, systemic lupus erythematosus

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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

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