Koutsky L. Epidemiology of genital human papillomavirus infection. Am J Med. 1997;102(5a):3–8.
Garland S, Brotherton J, Condon J, McIntyre P, Stevens MP, Smith D, et al. Human papillomavirus prevalence among indigenous and non indigenous Australian women prior to a national HPV vaccination program. BMC Med. 2011;9:104.
Chaturvedi AK. Beyond cervical cancer: burden of other HPV-related cancers among men and women. J Adolesc Health. 2010;46(4):S20–6.
Schiffman M, Castle PE, Jeronimo J, Rodriguez AC, Wacholder S. Human papillomavirus and cervical cancer. Lancet. 2007;370(9590):890–907.
European Medicines Agency. Assessment report: review under Article 20 of Regulation (EC) no 726/2004, human papillomavirus (HPV) vaccines. London: European Medicines Agency; 2015. http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/HPV_vaccines_20/Opinion_provided_by_Committee_for_Medicinal_Products_for_Human_Use/WC500197129.pdf. Accessed Nov 2017.
Brotherton J, Zuber P, Bloem P. Primary prevention of HPV through vaccination: update on the current global status. Curr Obstet Gynecol Rep. 2016;5(3):210–24.
World Health Organization. Causality assessment of an adverse event following immunisation (AEFI): user manual for the revised WHO classification. Geneva: WHO; 2013. http://www.who.int/vaccine_safety/publications/gvs_aefi/en/. Accessed Nov 2017.
World Health Organization. Human papillomavirus vaccines: WHO position paper, May 2017. Wkly Epidemiol Rec. 2017;19(92):241–68.
World Health Organization. Report from the Global Advisory Committee on Vaccine Safety (GACVS). Wkly Epidemiol Rec. 2016;91(48):564–5.
Kabakama S, Gallagher KE, Howard N, Mounier-Jack S, Burchett HE, Griffiths UK, et al. Social mobilisation, consent and acceptability: a review of human papillomavirus vaccination procedures in low and middle-income countries. BMC Public Health. 2016;16(1):834.
Macartney K, Chiu C, Georgousakis M, Brotherton J. Safety of human papillomavirus vaccines: a review. Drug Saf. 2013;36:393–412.
Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schunemann HJ. What is “quality of evidence” and why is it important to clinicians? BMJ. 2008;336(7651):995–8.
Jacobson RM, Adegbenro A, Pankratz VS, Poland GA. Adverse events and vaccination-the lack of power and predictability of infrequent events in pre-licensure study. Vaccine. 2001;19(17–19):2428–33.
Huang WT, Huang WI, Huang YW, Hsu CW, Chuang JH. The reporting completeness of a passive safety surveillance system for pandemic (H1N1) 2009 vaccines: a capture-recapture analysis. Vaccine. 2012;30(12):2168–72.
Weinbaum CM, Cano M. HPV vaccination and complex regional pain syndrome: lack of evidence. EBioMedicine. 2015;2(9):1014–5.
Tomianovic D, Bauwens J, Heininger U, Bonhoeffer J. Global vaccine safety assessment: challenges and opportunities. Paediatr Infect Dis. 2016;35:446–7.
Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the vaccine adverse event reporting system (VAERS). Vaccine. 2015;33(36):4398–405.
IOM (Institute of Medicine). Adverse effects of vaccines: evidence and causality. Washington, DC: The National Academies Press; 2012. https://doi.org/10.17226/13164.
Hildesheim A, Wacholder S, Catteau G, Struyf F, Dubin G, Herrero R, et al. Efficacy of the HPV-16/18 vaccine: final according to protocol results from the blinded phase of the randomized Costa Rica HPV-16/18 vaccine trial. Vaccine. 2014;32(39):5087–97.
Skinner SR, Szarewski A, Romanowski B, Garland S. Efficacy, safety and immunogenicity of the human papillomavirus 16/18 ASo4 adjuvanted vaccine in women older than 25 years: a 4 year interim follow up of the phase 3, double blind, randomised controlled VIVIANE study. Lancet. 2014;384(9961):2213–27.
Sow PS, Watson-Jones D, Kiviat N, Changalucha J, Mbaye KD, Brown J, et al. Safety and Immunogenicity of human papillomavirus-16/18 AS04-adjuvanted vaccine: a randomized trial in 10-25-year-old HIV-seronegative African girls and young women. J Infect Dis. 2013;207(11):1753–63.
Zhu F, Li J, Hu Y, Zhang X, Yang X, Zhao H, et al. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese girls and women aged 9 to 45 years: results from 2 randomized controlled trials. Hum Vaccin Immunother. 2014;10(7):1795–806.
Zhu FC, Chen W, Hu YM, Hong Y, Li J, Zhang X, et al. Efficacy, immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese women aged 18-25 years: results from a randomized controlled trial. Int J Cancer. 2014;135(11):2612–22.
Lim BK, Ng KY, Omar J, Omar SZ, Gunapalaiah B, Teoh YL, et al. Immunogenicity and safety of the AS04-adjuvanted human papillomavirus-16/18 cervical cancer vaccine in Malaysian women aged 18-35 years: a randomized controlled trial. Med J Malays. 2014;69(1):2–8.
Mugo N, Ansah NA, Marino D, Saah A, Garner EI. Evaluation of safety and immunogenicity of a quadrivalent human papillomavirus vaccine in healthy females between 9 and 26 years of age in Sub-Saharan Africa. Hum Vaccin Immunother. 2015;11(6):1323–30.
Li R, Li Y, Radley D, Liu Y, Huang T, Sings HL, et al. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, double-blind, placebo-controlled trial in Chinese males and females. Vaccine. 2012;30(28):4284–91.
Clark LR, Myers ER, Huh W, Joura EA, Paavonen J, Perez G, et al. Clinical trial experience with prophylactic human papillomavirus 6/11/16/18 vaccine in young black women. J Adolesc Health. 2013;52(3):322–9.
NCIRS. Evaluation of the National Human Papillomavirus Vaccination Program. Canberra: Department of Health; 2014. http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/evaluation-of-NHPVP. Accessed Nov 2017.
Harris T, Williams DM, Fediurek J, Scott T, Deeks SL. Adverse events following immunization in Ontario’s female school-based HPV program. Vaccine. 2014;32(9):1061–6.
Angelo MG, Zima J, Tavares Da Silva F, Baril L, Arellano F. Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience. Pharmacoepidemiol Drug Saf. 2014;23(5):456–65.
Subelj M, Ucakar V, Kraigher A, Klavs I. Adverse events following school-based vaccination of girls with quadrivalent human papillomavirus vaccine in Slovenia, 2009 to 2013. Euro Surveill. 2016; 21(14). https://doi.org/10.2807/1560-7917.ES.2016.21.14.30187.
Gilca V, Sauvageau C, Boulianne N, De Serres G, Crajden M, Ouakki M, et al. The effect of a booster dose of quadrivalent or bivalent HPV vaccine when administered to girls previously vaccinated with two doses of quadrivalent HPV vaccine. Hum Vaccin Immunother. 2015;11(3):732–8.
Leung TF, Liu AP, Lim FS, Thollot F, Oh HM, Lee BW, et al. Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9-14 years: results to month 12 from a randomized trial. Hum Vaccin Immunother. 2015;11(7):1689–702.
Nelson EA, Lam HS, Choi KC, Ho WC, Fung LW, Cheng FW, et al. A pilot randomized study to assess immunogenicity, reactogenicity, safety and tolerability of two human papillomavirus vaccines administered intramuscularly and intradermally to females aged 18-26 years. Vaccine. 2013;31(34):3452–60.
Sangar VC, Ghongane BB, Gupte R, Kesarkar R, Kalyan K, Chowdhary A. Comparison of post-licensure safety surveillance of bivalent and quadrivalent human papillomavirus vaccines in healthy mumbai women. Int J Pharm Pharm Sci. 2015;7(3):437–42.
Angelo MG, David MP, Zima J, Baril L, Dubin G, Arellano F, et al. Pooled analysis of large and long-term safety data from the human papillomavirus-16/18-AS04-adjuvanted vaccine clinical trial programme. Pharmacoepidemiol Drug Saf. 2014;23(5):466–79.
Stokley S, Jeyarajah J, Yankey D, Cano M, Gee J, Roark J, et al. Human papillomavirus vaccination coverage among adolescents, 2007–2013, and postlicensure vaccine safety monitoring, 2006–2014—United States. MMWR Morb Mortal Wkly Rep. 2014;63(29):620–4.
MHRA. Cervarix HPV vaccine: update on UK safety experience at end of 4 years use in the HPV routine immunisation programme. London: Medicines and Healthcare Regulatory Products Agency; 2012. http://www.mhra.gov.uk/safety-public-assessment-reports/CON221607.Accessed Nov 2017.
Einstein MH, Takacs P, Chatterjee A, Sperling RS, Chakhtoura N, Blatter MM, et al. Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: end-of-study analysis of a phase III randomized trial. Hum Vaccin Immunother. 2014;10(12):3435–45.
Einstein MH, Levin MJ, Chatterjee A, Chakhtoura N, Takacs P, Catteau G, et al. Comparative humoral and cellular immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18–45 years: follow-up through Month 48 in a phase III randomized study. Hum Vaccin Immunother. 2014;10(12):3455–65.
Therapeutic Goods Administration. Enhanced school-based surveillance of acute adverse events following immunisation with human papillomavirus vaccine in males and females, 2013: Therapeutic Goods Administration, Department of Health; 2015. https://www.tga.gov.au/enhanced-school-based-surveillance-acute-adverse-events-following-immunisation-human-papillomavirus-vaccine-males-and-females-2013. Accessed Nov 2017.
McCarthy NL, Gee J, Sukumaran L, Weintraub E, Duffy J, Kharbanda EO, et al. Vaccination and 30-day mortality risk in children, adolescents, and young adults. Pediatrics. 2016;137(3):e20152970.
Klein NP, Hansen J, Chao C, Velicer C, Emery M, Slezak J, et al. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med. 2012;166(12):1140–8.
Joura EA, Giuliano AR, Iversen OE, Bouchard C, Mao C, Mehlsen J, et al. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med. 2015;372(8):711–23.
Moreira ED, Block SL, Ferris D, Giuliano AR, Iversen O-E, Joura EA, et al. Safety profile of the 9-valent HPV vaccine: a combined analysis of 7 phase III clinical trials. Pediatrics. 2016;128(2). (pii: e20154387).
Vesikari T, Brodszki N, van Damme P, Diez-Domingo J, Icardi G, Petersen LK, et al. A randomized, double-blind, phase III study of the immunogenicity and safety of a 9-valent human papillomavirus L1 virus-like particle vaccine (V503) versus Gardasil® in 9–15-year-old girls. Pediatr Infect Dis J. 2015;34(9):992–8.
Garland SM, Cheung TH, McNeill S, Petersen LK, Romaguera J, Vazquez-Narvaez J, et al. Safety and immunogenicity of a 9-valent HPV vaccine in females 12–26 years of age who previously received the quadrivalent HPV vaccine. Vaccine. 2015;33(48):6855–64.
Kosalaraksa P, Mehlsen J, Vesikari T, Forsten A, Helm K, Van Damme P, et al. An open-label, randomized study of a 9-valent human papillomavirus vaccine given concomitantly with diphtheria, tetanus, pertussis and poliomyelitis vaccines to healthy adolescents 11–15 years of age. Pediatr Infect Dis J. 2015;34(6):627–34.
Schilling A, Parra MM, Gutierrez M, Restrepo J, Ucros S, Herrera T, et al. Coadministration of a 9-valent human papillomavirus vaccine with meningococcal and Tdap vaccines. Pediatrics. 2015;136(3):e563–72.
Gee J, Naleway A, Shui I, Baggs J, Yin R, Li R, et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink. Vaccine. 2011;29(46):8279–84.
Rodriguez-Galan MA, Perez-Vilar S, Diez-Domingo J, Tuells J, Gomar-Fayos J, Morales-Olivas F, et al. Adverse reactions to human papillomavirus vaccine in the Valencian Community (2007–2011). An Pediatr (Barc). 2014;81(5):303–9.
Alguacil-Ramos AM, Muelas-Tirado J, Garrigues-Pelufo TM, Portero-Alonso A, Diez-Domingo J, Pastor-Villalba E, et al. Surveillance for adverse events following immunization (AEFI) for 7 years using a computerised vaccination system. Public Health. 2016;135:66–74.
Oberle D, Pavel J, Rieck T, Weichert S, Schroten H, Keller-Stanislawski B, et al. Anaphylaxis after immunization of children and adolescents in Germany. Pediatr Infect Dis J. 2016;35(5):535–41.
Centers for Disease Control. Contraindications and precautions: general best practice guidelines for immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). 2017.https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.html. Accessed 4 Nov 2017.
Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA. 2009;302(7):750–7.
Naleway AL, Crane B, Smith N, Daley MF, Donahue J, Gee J, et al. Absence of venous thromboembolism risk following quadrivalent human papillomavirus vaccination, Vaccine Safety Datalink, 2008–2011. Vaccine. 2016;34(1):167–71.
Yih WK, Greene SK, Zichittella L, Kulldorff M, Baker MA, de Jong JLO, et al. Evaluation of the risk of venous thromboembolism after quadrivalent human papillomavirus vaccination among US females. Vaccine. 2016;34(1):172–8.
Liu XC, Bell CA, Simmonds KA, Svenson LW, Russell ML. Adverse events following HPV vaccination, Alberta 2006–2014. Vaccine. 2016;34(15):1800–5.
Arnheim-Dahlstrom L, Pasternak B, Svanstrom H, Sparen P, Hviid A. Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study. BMJ. 2013;347:f5906.
Scheller NM, Pasternak B, Svanstrom H, Hviid A. Quadrivalent human papillomavirus vaccine and the risk of venous thromboembolism. JAMA. 2014;312(2):187–8.
Schwarz TF, Huang LM, Medina DM, Valencia A, Lin TY, Behre U, et al. Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 10–14 years. J Adolesc Health. 2012;50(2):187–94.
Lehtinen M, Paavonen J, Wheeler CM, Jaisamrarn U, Garland SM, Castellsagué X, et al. Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial [erratum appears in Lancet Oncol. 2012 Jan; 13(1):e1]. Lancet Oncol. 2012;13(1):89–99.
Harper DM, Franco EL, Wheeler CM, Moscicki AB, Romanowski B, Roteli-Martins CM, et al. HPV Vaccine Study group. Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial. Lancet. 2006;367(9518):1247–55.
Paavonen J, Naud P, Salmeron J, Wheeler C, Chow S, Apter D, et al. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet. 2009;374(9686):301–14.
Block SL, Brown DR, Chatterjee A, Gold MA, Sings HL, Meibohm A, et al. Clinical trial and post-licensure safety profile of a prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine. Pediatr Infect Dis J. 2010;29(2):95–101.
Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, et al. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008;26(51):6630–8.
Tricotel A. Human papillomavirus vaccine and autoimmune disorders: a cohort study of 5.8 millions of adolescents and young women. Two years follow-up results. Fundam Clin Pharmacol. 2011;25(s1):1.
Chao C, Klein NP, Velicer CM, Sy LS, Slezak JM, Takhar H, et al. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012;271(2):193–203.
Konno R, Yoshikawa H, Okutani M, Quint W, Suryakiran PV, Lin L, et al. Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical intraepithelial neoplasia and cervical infection in young Japanese women. Hum Vaccin Immunother. 2014;10(7):1781–94.
Naud PS, Roteli-Martins CM, De Carvalho NS, Teixeira JC, de Borba PC, Sanchez N, et al. Sustained efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine: final analysis of a long-term follow-up study up to 9.4 years post-vaccination. Hum Vaccin Immunother. 2014;10(8):2147–62.
Watson-Jones D, Baisley K, Ponsiano R, Lemme F, Remes P, Ross D, et al. Human papillomavirus vaccination in Tanzanian schoolgirls: cluster-randomized trial comparing 2 vaccine-delivery strategies. J Infect Dis. 2012;206(5):678–86.
Ferris D, Samakoses R, Block SL, Lazcano-Ponce E, Restrepo JA, Reisinger KS, et al. Long-term study of a quadrivalent human papillomavirus vaccine. Pediatrics. 2014;134(3):e657–65.
Luna J, Plata M, Gonzalez M, Correa A, Maldonado I, Nossa C, et al. Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil in adult women. PLoS One. 2013;8(12):e83431.
Souayah N, Michas-Martin P, Nasar A, Krivitskaya N, Yacoub HA, Khan H, et al. Guillain-Barré syndrome after Gardasil vaccination: data from Vaccine Adverse Event Reporting System 2006–2009. Vaccine. 2011;29(5):886–9.
Slade BA, Gee J, Broder KR, Vellozzi C. Comment on the contribution by Souayah et al., “Guillain-Barre syndrome after Gardasil vaccination: data from Vaccine Adverse Event Reporting System 2006–2009”. Vaccine. 2011;29(5):865–6.
Scheller NM, Svanstrom H, Pasternak B, Arnheim-Dahlstrom L, Sundstrom K, Fink K, et al. Quadrivalent HPV vaccination and risk of multiple sclerosis and other demyelinating diseases of the central nervous system. JAMA. 2015;313(1):54–61.
Agence Nationale de Securite du Medicament (ANSM). Human papillomavirus vaccination and risk of auto-immune diseases: pharmaco-epidemiological study in France. France: ANSM; 2015. http://ansm.sante.fr/. Accessed Nov 2017.
Miranda S, Chaignot C, Collin C, Dray-Spira R, Weill A, Zureik M. Human papillomavirus vaccination and risk of autoimmune diseases: a large cohort study of over 2 million young girls in France. Vaccine. 2017;35(36):4761–8.
World Health Organization. Global Advisory Committee on Vaccine Safety statement on safety of HPV vaccines: 17 December 2015. Geneva: World Health Organization; 2015. http://www.who.int/vaccine_safety/committee/GACVS_HPV_statement_17Dec2015.pdf?ua=1http://www.who.int/vaccine_safety/committee/topics/hpv/en/. Accessed Nov 2017.
Grimaldi-Bensouda L, Guillemot D, Godeau B, Benichou J, Lebrun-Frenay C, Papeix C, et al. Autoimmune disorders and quadrivalent human papillomavirus vaccination of young female subjects. J Intern Med. 2014;275(4):398–408.
Langer-Gould A, Qian L, Tartof SY, Brara SM, Jacobsen SJ, Beaber BE, et al. Vaccines and the risk of multiple sclerosis and other central nervous system demyelinating diseases. JAMA Neurol. 2014;71(12):1506–13.
Cameron RL, Ahmed S, Pollock KGJ. Adverse event monitoring of the human papillomavirus vaccines in Scotland. Intern Med. 2016;46(4):452–7.
Pellegrino P, Carnovale C, Perrone V, Antoniazzi S, Pozzi M, Clementi E, et al. No evidence of a link between multiple sclerosis and the vaccine against the human papillomavirus. Eur J Epidemiol. 2013;28:705–7.
Pellegrino P, Carnovale C, Perrone V, Pozzi M, Antoniazzi S, Clementi E, et al. Acute Disseminated Encephalomyelitis onset: evaluation vased on vaccine adverse events reporting systems. PLoS One. 2013;8(10):e77766.
Ojha RP, Jackson BE, Tota JE, Offutt-Powell TN, Singh KP, Bae S. Guillain-Barre syndrome following quadrivalent human papillomavirus vaccination among vaccine-eligible individuals in the United States. Hum Vaccin Immunother. 2014;10(1):2908–13.
Brotherton J. Safety of the quadrivalent human papillomavirus vaccine. BMJ. 2013;347:f5631. https://doi.org/10.1136/bmj.f5631.
Pellegrino P, Carnovale C, Perrone V, Salvati D, Gentili M, Antoniazzi S, et al. Human papillomavirus vaccine in patients with systemic lupus erythematosus. Epidemiology. 2014;25(1):155–6.
Geier DA, Geier MR. A case-control study of quadrivalent human papillomavirus vaccine-associated autoimmune adverse events. Clin Rheumatol. 2015;34(7):1225–31.
Medicines Adverse Reactions Committee. Gardasil and autoimmune diseases. Wellington: New Zealand Medicines and Medical Devices Safety Authority; 10 Sep 2015. http://www.medsafe.govt.nz/committees/marc/Reports.asp. Accessed Nov 2017.
Yamamoto Y, Kazebayashi Y, Hirai N, Sasaki T, Ohsaki Y. Interstitial lung disease associated with human papillomavirus vaccination. Respir Med Case Rep. 2015;16:15–7.
Cerami C, Corbo M, Piccolo G, Iannaccone S. Autoimmune neuromyotonia following human papilloma virus vaccination. Muscle Nerve. 2013;47(3):466–7.
Sawai T, Shimizu M, Sakai T, Yachie A. Tubulointerstitial nephritis and uveitis syndrome associated with human papillomavirus vaccine. J Pediatr Ophthalmol Strabismus. 2016;53(3):190–1.
Holt HD, Hinkle DM, Falk NS, Fraunfelder FT, Fraunfelder FW. Human papilloma virus vaccine associated uveitis. Curr Drug Saf. 2014;9(1):65–8.
Colafrancesco S, Perricone C, Tomljenovic L, Shoenfeld Y. Human papilloma virus vaccine and primary ovarian failure: another facet of the autoimmune/inflammatory syndrome induced by adjuvants. Am J Reprod Immunol. 2013;70(4):309–16.
Little DT, Ward HR. Premature ovarian failure 3 years after menarche in a 16-year-old girl following human papillomavirus vaccination. BMJ Case Rep. 2012;2012. https://doi.org/10.1136/bcr-2012-006879. (pii: bcr2012006879).
Hawkes D, Buttery JP. Human papillomavirus vaccination and primary ovarian insufficiency: an association based on ideology rather than evidence. Curr Opin Obstet Gynecol. 2016;28(1):70–2.
Pellegrino P, Carnovale C, Perrone V, Salvati D, Gentiti M, Busadelli T, et al. On the association between human papillomavirus vaccine and primary ovarian failure [letter]. Am J Reprod Immunol. 2013;71(4):293–4.
Gee J, Weinbaum C, Sukumaran L, Markowitz LE. Quadrivalent HPV vaccine safety review and safety monitoring plans for nine-valent HPV vaccine in the United States. Hum Vaccin Immunother. 2016;12(6):1406–17.
Pellegrino P, Perrone V, Pozzi M, Carnovale C, Perrotta C, Clementi E, et al. The epidemiological profile of ASIA syndrome after HPV vaccination: an evaluation based on the vaccine adverse event reporting systems. Immunol Res. 2015;61(1–2):90–6.
Hawkes D, Benhamu J, Sidwell T, Miles R, Dunlop RA. Revisiting adverse reactions to vaccines: a critical appraisal of Autoimmune Syndrome Induced by Adjuvants (ASIA). J Autoimmun. 2015;59:77–84.
Palmieri B, Poddighe D, Vadala M, Laurino C, Carnovale C, Clementi E. Severe somatoform and dysautonomic syndromes after HPV vaccination: case series and review of literature [erratum in Immunol Res. 2017 Feb;65(1):117–119]. Immunol Res. 2017;65(1):106–16. https://doi.org/10.1007/s12026-016-8820-z.
Poddighe D, Castelli L, Marseglia GL, Bruni P. A sudden onset of a pseudo-neurological syndrome after HPV-16/18 AS04-adjuvated vaccine: might it be an autoimmune/inflammatory syndrome induced by adjuvants (ASIA) presenting as a somatoform disorder? Immunol Res. 2014;60(2–3):236–46.
Anaya JM, Reyes B, Perdomo-Arciniegas AM, Camacho-Rodriguez B, Rojas-Villarraga A. Autoimmune/autoinflammatory syndrome induced by adjuvants (ASIA) after quadrivalent human papillomavirus vaccination in Colombians: a call for personalised medicine. Clin Exp Rheumatol. 2015;33(4):545–8.
Ameratunga R, Gillis D, Gold M, Linnenberg A, Elwood M. Evidence refuting the existence of autoimmune/autoinflammatory syndrome induced by adjuvants (ASIA). J Allergy Clin Immunol. 2017;5(6):1551–5. https://doi.org/10.1016/j.jaip.2017.06.033.
Tomljenovic L, Shaw C. Death after quadrivalent human papilllomavirus (HPV) vaccination: causal or coincidental? Pharmaceut Reg Affairs. 2012;S12:001. https://doi.org/10.4172/2167-7689.S12-001.
Lee SH. Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil. J Inorg Biochem. 2012;117:85–92.
Clinical Immunization Safety Assessment (CISA) Network. Review of a published report of cerebral vasculitis after vaccination with the human papillomavirus (HPV) vaccine. Atlanta: CDC; 2012. https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/technicalreports.html. Accessed Nov 2017.
World Health Organization. Global Advisory Committee on Vaccine Safety: statement on the continued safety of HPV vaccination. Geneva; 2014. http://www.who.int/vaccine_safety/committee/topics/hpv/en/. Accessed Nov 2017.
Reisinger KS, Block SL, Lazcano-Ponce E, Samakoses R, Esser MT, Erick J, et al. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J. 2007;26(3):201–9.
Woo EJ, Winiecki SK, Ou AC. Motor palsies of cranial nerves (excluding VII) after vaccination reports to the US Vaccine Adverse Event Reporting System. Hum Vaccin Immunother. 2014;10(2):301–5.
European Centre for Disease Prevention and Control (ECDC). Technical guidance on the introduction of HPV vaccines in European Union countries - an update. Stockholm; 2012. https://ecdc.europa.eu/en/publications-data/technical-guidance-introduction-hpv-vaccines-european-union-countries-update. Accessed Nov 2017.
Donegan K, Beau-Lejdstrom R, King B, Seabroke S, Thomson A, Bryan P. Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK. Vaccine. 2013;31(43):4961–7.
Kinoshita T, Abe R, Hineno A, Tsunekawa K, Nakane S, Ikeda S. Perpheral sympathetic nerve dysfunction in adolescent japanese girls following immunisation with the human papillomavirus vaccine. Intern Med. 2014;53(19):2185–200.
Martinez-Lavin M, Martinez-Martinez LA, Reyes-Loyola P. HPV vaccination syndrome. A questionnaire-based study. Clin Rheumatol. 2015;34(11):1981–3.
Petousis-Harris H. Proposed HPV vaccination syndrome is unsubstantiated. Clin Rheumatol. 2016;35(3):833–4.
Brinth LS, Pors K, Theibel AC, Mehlsen J. Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papilloma virus. Vaccine. 2015;33(22):2602–5.
Brinth L, Theibel AC, Pors K, Mehlsen J. Suspected side effects to the quadrivalent human papilloma vaccine. Dan Med J. 2015;62(4):1–5.
Garland SM, Molesworth EG, Machalek DA, Cornall AM, Tabrizi SN. How to best measure the effectiveness of male human papillomavirus vaccine programmes? Clin Microbiol Infect. 2015;21(9):834–41.
Huygen F, Verschueren K, McCabe C, Stegmann JU, Zima J, Mahaux O, et al. Investigating reports of complex regional pain syndrome: an analysis of HPV-16/18-adjuvanted vaccine post-licensure data. EBioMedicine. 2015;2(9):1114–21.
Baxter R, Lewis N, Bohrer P, Harrington T, Aukes L, Klein NP. Sudden-onset sensorineural hearing loss after immunization: a case-centered analysis. Otolaryngol Head Neck Surg. 2016;155(1):81–6.
Schurink-Van’t Klooster TM, de Ridder MAJ, Kemmeren JM, van der Lei J, Dekker F, Sturkenboom M, et al. Examining a possible association between human papilloma virus (HPV) vaccination and migraine: results of a cohort study in the Netherlands. Eur J Pediatr. 2015;174(5):641–9.
Giuliano AR, Isaacs-Soriano K, Torres BN, Abrahamsen M, Ingles DJ, Sirak BA, et al. Immunogenicity and safety of Gardasil among mid-adult aged men (27–45 years)—the MAM study. Vaccine. 2015;33(42):5640–6.
Castellsagué X, Giuliano AR, Goldstone S, Guevara A, Mogensen O, Palefsky JM, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015;33(48):6892–901.
Van Damme P, Olsson SE, Block S, Castellsague X, Gray GE, Herrera T, et al. Immunogenicity and safety of a 9-valent HPV vaccine. Pediatrics. 2015;136(1):e28–39.
Moro PL, Zheteyeva Y, Lewis P, Shi J, Yue X, Museru OI, et al. Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006–2013. Vaccine. 2015;33(4):519–22.
Goss MA, Lievano F, Buchanan KM, Seminack MM, Cunningham ML, Dana A. Final report on exposure during pregnancy from a pregnancy registry for quadrivalent human papillomavirus vaccine. Vaccine. 2015;33(29):3422–8.
Baril L, Rosillon D, Willame C, Angelo MG, Zima J, van den Bosch JH, et al. Risk of spontaneous abortion and other pregnancy outcomes in 15–25 year old women exposed to human papillomavirus-16/18 AS04-adjuvanted vaccine in the United Kingdom. Vaccine. 2015;33(48):6884–91.
Mok CC, Ho LY, Fong LS, To CH. Immunogenicity and safety of a quadrivalent human papillomavirus vaccine in patients with systemic lupus erythematosus: a case-control study. Ann Rheum Dis. 2013;72(5):659–64.
Soybilgic A, Onel KB, Utset T, Alexander K, Wagner-Weiner L. Safety and immunogenicity of the quadrivalent HPV vaccine in female systemic lupus erythematosus patients aged 12 to 26 years. Pediatr Rheumatol Online J. 2013;11:29.
Esposito S, Corona F, Barzon L, Cuoco F, Squarzon L, Marcati G, et al. Immunogenicity, safety and tolerability of a bivalent human papillomavirus vaccine in adolescents with juvenile idiopathic arthritis. Expert Rev Vaccines. 2014;13(11):1387–93.
Jacobson DL, Bousvaros A, Ashworth L, Carey R, Shrier LA, Burchett SK, et al. Immunogenicity and tolerability to human papillomavirus-like particle vaccine in girls and young women with inflammatory bowel disease. Inflamm Bowel Dis. 2013;19(7):1441–9.
Denny L, Hendricks B, Gordon C, Thomas F, Hezareh M, Dobbelaere K, et al. Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine in HIV-positive women in South Africa: a partially-blind randomised placebo-controlled study. Vaccine. 2013;31(48):5745–53.
Giacomet V, Penagini F, Trabattoni D, Vigano A, Rainone V, Bernazzani G, et al. Safety and immunogenicity of a quadrivalent human papillomavirus vaccine in HIV-infected and HIV-negative adolescents and young adults. Vaccine. 2014;32(43):5657–61.
Toft L, Storgaard M, Muller M, Sehr P, Bonde J, Tolstrup M, et al. Comparison of the immunogenicity and reactogenicity of Cervarix and Gardasil human papillomavirus vaccines in HIV-infected adults: a randomized, double-blind clinical trial. J Infect Dis. 2014;209(8):1165–73.
Kahn JA, Xu J, Kapogiannis BG, Rudy B, Gonin R, Liu N, et al. Immunogenicity and safety of the human papillomavirus 6, 11, 16, 18 vaccine in HIV-infected young women. Clin Infect Dis. 2013;57(5):735–44.
Kojic EM, Kang M, Cespedes MS, Umbleja T, Godfrey C, Allen RT, et al. Immunogenicity and safety of the quadrivalent human papillomavirus vaccine in HIV-1-infected women. Clin Infect Dis. 2014;59(1):127–35.
World Health Organization. Meeting of the Global Advisory Committee on Vaccine Safety, 7–8 June 2017. Wkly Epidemiol Rec. 2017;92(28):393–404.
World Health Organization. Statements by WHO Global Advisory Committee on Vaccine Safety on the safety of human papillomavirus (HPV) vaccines 2013–2016. Geneva: World Health Organization; 2016. http://www.who.int/immunization/sage/meetings/2016/october/GACVS_Statement_on_the_safety_of_HPV.pdf. Accessed Nov 2017.
Ozawa K, Hineno A, Kinoshita T, Ishihara S, Ikeda SI. Suspected adverse effects after human papillomavirus vaccination: a temporal relationship between vaccine administration and the appearance of symptoms in Japan. Drug Saf. 2017;40(12):1219–29.
Chandler RE, Juhlin K, Fransson J, Caster O, Edwards IR, Noren GN. Current safety concerns with human papillomavirus vccine: a cluster analysis of reports in VigiBase®. Drug Saf. 2017;40(1):81–90.
Grimaldi-Bensouda L, Rossignol M, Kone-Paut I, Krivitzky A, Lebrun-Frenay C, Clet J, et al. Risk of autoimmune diseases and human papilloma virus (HPV) vaccines: six years of case-referent surveillance. J Autoimmun. 2017;79:84–90.
Andrews N, Stowe J, Miller E. No increased risk of Guillain-Barre syndrome after human papilloma virus vaccine: a self-controlled case-series study in England. Vaccine. 2017;35(13):1729–32.
Gronlund O, Herweijer E, Sundstrom K, Arnheim-Dahlstrom L. Incidence of new-onset autoimmune disease in girls and women with pre-existing autoimmune disease after quadrivalent human papillomavirus vaccination: a cohort study. J Int Med. 2016;280:618–26.
Willame C, Rosillon D, Zima J, Angelo MG, Stuurman AL, Vroling H, et al. Risk of new onset autoimmune disease in 9- to 25-year-old women exposed to human papillomavirus-16/18 AS04-adjuvanted vaccine in the United Kingdom. Hum Vaccin Immunother. 2016;12(11):2862–71.
Scheller NM, Pasternak B, Mølgaard-Nielsen D, Svanström H, Hviid A. Quadrivalent HPV vaccination and the risk of adverse pregnancy outcomes. N Engl J Med. 2017;376(13):1223–33.
Yih K, Maro J, Nguyen M, Baker M, Balsbaugh C, Cole D, et al. Pilot of self-controlled tree temporal scan analysis for Gardasil vaccine. The Sentinel System; 2016. https://www.sentinelinitiative.org/sites/default/files/Methods/Mini-Sentinel_PRISM_Pilot-Self-Controlled-Tree-Temporal-Scan-Analysis-Gardasil-Vaccine-Report.pdf. Accessed 8 Nov 2017.
Centers for Disease Control and Prevention (CDC), the food and drug administration (FDA), agencies of the U.S. Department of Health and Human Services. Vaccine Adverse Events Reporting System. 2012. http://vaers.hhs.gov/index. Accessed 1 May 2017.
Coelho PL, da Silva Calestini GL, Alvo FS, de Moura Freitas JM, Castro PM, Konstantyner T. Safety of human papillomavirus 6, 11, 16 and 18 (recombinant): systematic review and meta-analysis. Rev Paul Pediatr. 2015;33(4):474–82.
Vichnin M, Bonanni P, Klein NP, Garland SM, Block SL, Kjaer SK, et al. An overview of quadrivalent human papillomavirus vaccine safety: 2006 to 2015. Pediatr Infect Dis J. 2015;34(9):983–91.
Balshem H, Helfand M, Schunemann HJ, Oxman AD, Kunz R, Brozek J, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011;64(4):401–6.
Hung BT, Long NP, le Hung P, Luan NT, Anh NH, Nghi TD, et al. Research trends in evidence-based medicine: a joinpoint regression analysis of more than 50 years of publication data. PLoS One. 2015;10(4):e0121054.
Larson H. The world must accept that the HPV vaccine is safe. Nature. 2015;528(7580):9.
Hanley SJB, Yoshioka E, Ito Y, Kishi R. HPV vaccination crisis in Japan [letter]. Lancet. 2015;385(9987):2571.
Siegrist CA. Autoimmune diseases after adolescent or adult immunization: what should we expect? CMAJ. 2007;177(11):1352–4.
Darden PM, Thompson DM, Roberts JR, Hale JJ, Pope C, Naifeh M, et al. Reasons for not vaccinating adolescents: national Immunization Survey of Teens, 2008–2010. Pediatrics. 2013;131(4):645–51.
Garland SM, Kjaer S, Munoz N, Block S, Brown D, DiNubile MJ, et al. Impact and effectiveness of the quadrivalent human papillomavirus vaccine: a systematic review of 10 Years of real-world experience. Clin Infect Dis. 2016;63(4):519–27.
National Health and Medical Research Council. NHMRC additional levels of evidence and grades for recommendations for developers of guidelines. Canberra: Australian Government; 2009. https://www.nhmrc.gov.au/guidelines-publications/information-guideline-developers/resources-guideline-developers. Accessed Nov 2017.