No evidence found for an increased risk of long-term fatigue following human papillomavirus vaccination of adolescent girls

Klooster, Tessa M. Schurink-van't; Kemmeren, Jeanet M.; Maas, Nicoline A.T. van der; Putte, Elise M. van de; Wolbeek, Maike ter; Nijhof, Sanne L.; Vanrolleghem, Ann M.; Vliet, J. Adam van der; Sturkenboom, Miriam; Melker, Hester E. de

doi:10.1016/j.vaccine.2018.09.019

Cited by 14 publications

(9 citation statements)

References 22 publications

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“…In a small Dutch self-controlled case series of 16 vaccinated girls with longlasting fatigue from primary care, no association was found with the bivalent human papillomavirus vaccine (rate ratio 0.62, 95% confidence interval 0.07 to 5.49) in the year after any dose 16…”

Section: Discussionmentioning

confidence: 92%

Association between quadrivalent human papillomavirus vaccination and selected syndromes with autonomic dysfunction in Danish females: population based, self-controlled, case series analysis

Hviid

Thorsen

Valentiner‐Branth

et al. 2020

BMJ

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Objective To evaluate the association between quadrivalent human papillomavirus vaccination and syndromes with autonomic dysfunction, such as chronic fatigue syndrome, complex regional pain syndrome, and postural orthostatic tachycardia syndrome. Design Population-based self-controlled case series. Setting Information on human papillomavirus vaccinations and selected syndromes with autonomic dysfunction (chronic fatigue syndrome, complex regional pain syndrome, and postural orthostatic tachycardia syndrome) identified using ICD-10 (international classification of diseases, revision 10) diagnostic codes from Danish nationwide registers. Participants 869 patients with autonomic dysfunction syndromes from a cohort of 1 375 737 Danish born female participants aged 10 to 44 years during 2007-16. Main outcome measures Self-controlled case series rate ratios (95% confidence intervals) of the composite outcome of chronic fatigue syndrome, complex regional pain syndrome, and postural orthostatic tachycardia syndrome, adjusted for age and season, comparing female participants vaccinated and unvaccinated with the quadrivalent human papillomavirus vaccine. Chronic fatigue syndrome, complex regional pain syndrome, and postural orthostatic tachycardia syndrome were also considered separately in secondary analyses. Results During 10 581 902 person years of follow-up, 869 female participants with syndromes of autonomic dysfunction (136 with chronic fatigue syndrome, 535 with complex regional pain syndrome, and 198 with postural orthostatic tachycardia syndrome) were identified. Quadrivalent human papillomavirus vaccination did not statistically significantly increase the rate of a composite outcome of all syndromes with autonomic dysfunction in a 365 day risk period following vaccination (rate ratio 0.99, 95% confidence interval 0.74 to 1.32) or the rate of any individual syndrome in the risk period (chronic fatigue syndrome (0.38, 0.13 to 1.09), complex regional pain syndrome (1.31, 0.91 to 1.90), or postural orthostatic tachycardia syndrome (0.86, 0.48 to 1.54)). Conclusions When vaccination is introduced, adverse events could occur in close temporal relation to the vaccine purely by chance. These results do not support a causal association between quadrivalent human papillomavirus vaccination and chronic fatigue syndrome, complex regional pain syndrome, or postural orthostatic tachycardia syndrome, either individually or as a composite outcome. An increased risk of up to 32% cannot be formally excluded, but the statistical power of the study suggests that a larger increase in the rate of any syndrome associated with vaccination is unlikely.

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Section: Discussionmentioning

confidence: 92%

Association between quadrivalent human papillomavirus vaccination and selected syndromes with autonomic dysfunction in Danish females: population based, self-controlled, case series analysis

Hviid

Thorsen

Valentiner‐Branth

et al. 2020

BMJ

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“…Most studies included females only with ages ranging from 9 to 44 years, 1 study included males only, and 2 studies included males and females of any age. Various types of study designs were implemented to assess the risk of autoimmune diseases after HPV vaccination; 3 case-control studies including 1 matched, 18 1 unmatched 19 and 1 nested case-control 20 ; 7 case-only designs including 5 self-controlled case series [21][22][23][24][25] and 2 case-centered method 26,27 ; and 12 cohort studies 8,9,28-37 including a surveillance study. 8 More than 60 different autoimmune and rare adverse events were studied.…”

Section: Resultsmentioning

confidence: 99%

“…8 More than 60 different autoimmune and rare adverse events were studied. Some studies focused on any autoimmune diseases (n = 4), 28,31,32,35 others (n = 18) 8,9, [18][19][20][21][22][23][24][25][26][27]29,30,33,34,36,37 targeted specific outcomes. Type 1 diabetes mellitus was the most frequently studied (in 11 studies).…”

Section: Resultsmentioning

confidence: 99%

“…Four studies 9,19,21,29 among 7 including data on Guillain-Barre syndrome (GBS) provided risk estimates. Fourteen studies 8,18,20,23,24,[26][27][28][29][30][31][32]34,36 concerned 4vHPV vaccine exposure, while 4 studies 22,25,35,37 assessed 2vHPV vaccine exposure. Two studies 9,21 provided risk estimates separately for 4vHPV and 2vHPV vaccine exposures.…”

Section: Resultsmentioning

confidence: 99%

“…Five studies 8,9,20,27,37 developed complex algorithms combining diagnosis codes and additional clinical information such as medications, laboratory test results and referral to specialists to identify cases. Fifteen studies 19,[21][22][23][24][25][26][28][29][30][31][32][33][34][35][36] identifying cases by diagnosis codes only implemented a review of all medical charts or contacted health-care providers (6 studies). 21,24,26,27,33,36 Three studies, 8,20,37 in addition to elaborated algorithms, put in place a case ascertainment process with a panel of specialist physicians.…”

Section: Definition Of Outcomementioning

confidence: 99%

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Systematic Review and Meta-analysis of Postlicensure Observational Studies on Human Papillomavirus Vaccination and Autoimmune and Other Rare Adverse Events

Willame

Gadroen

Bramer

et al. 2020

Pediatric Infectious Disease Journal

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Background: Because of the limited number of subjects in prelicensure studies, autoimmune diseases and other rare adverse effects of vaccines may go undetected. Since 2006, millions of human papillomavirus (HPV) vaccine doses have been distributed and a considerable amount of postlicensure safety data has been generated. The objective of this study was to review available HPV postlicensure safety studies and to summarize risk estimates of autoimmune and other rare diseases. Methods: For this systematic review and meta-analysis, we searched literature databases to identify any postlicensure safety studies related to HPV vaccination and autoimmune adverse events from inception to April 16, 2019. Pooled risk estimates were computed using fixed-or randomeffects models if at least 2 estimates per disease and per HPV vaccine were available. Results: Twenty-two studies met our inclusion criteria. The studies applied various methodologies and used different types of data sources and outcome definitions. Quadrivalent HPV vaccine (4vHPV) was most commonly assessed. Type 1 diabetes mellitus, immune thrombocytopenia purpura and thyroiditis diseases were most frequently reported. The meta-analysis was conducted on 35 diseases corresponding to 48 pooled risk estimates. Majority of the pooled estimates showed no significant effect (n = 43). Three negative (paralysis, immune thrombocytopenia purpura and chronic fatigue syndrome) and 2 positive (Hashimoto and Raynaud diseases) associations were detected. Conclusion: Our study demonstrated an absence of clear association between HPV vaccines and autoimmune and other rare diseases. The review also highlights the need for more systematic collaborations to monitor rare safety adverse events.

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Human Papillomavirus Vaccination and Physical and Mental Health Complaints Among Female Students in Secondary Education Institutions in Denmark

et al. 2020

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Background: Previous studies have not explored the effect of HPV vaccination on health status at longer time interval. Similarly, self-reported physical and mental health in recipients of HPV vaccine has not been studied.Objective: To evaluate whether HPV vaccination was associated with physical and mental health complaints among girls in secondary education institutions. Design: Prospective cohort study.Participants: This study used data from girls aged 15-20 years who participated in the Danish National Youth Study (DNYS) 2014. Data on HPV vaccination was retrieved from the Danish Vaccination Register. Main Measures:Participants were asked whether they had experienced headaches, stomachache, neck pain, menstrual cramps, sore throat, sadness, irritation, nervousness and sleep problems in the past six months. Key results:Of 41,333 girls, 39,145 (94.7%) received at least one dose of HPV vaccine. The most prevalent health complaint among vaccinated and not vaccinated females was "been irritable" (88.2% and 88.4%, respectively). The lowest proportion of health complaints was stomachache (49.6% in vaccinated and in 50.4% in unvaccinated girls). Regression model, adjusted for sociodemographic characteristics and health behavior, showed that HPV vaccination was associated with lower likelihood of reporting sore throat (odd ratio [OR] 0.86, 95% confidence interval [CI] 0.78-0.95) and being sad (OR 0.86, 95%CI 0.76-0.97). Similar results were observed when HPV vaccination status was analyzed according to number of doses received. Conclusion:We conclude that HPV vaccination was not associated with physical and mental health complaints among girls in secondary education institutions in Denmark after a median of 5.3 years since HPV vaccination.

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No evidence found for an increased risk of long-term fatigue following human papillomavirus vaccination of adolescent girls

Cited by 14 publications

References 22 publications

Association between quadrivalent human papillomavirus vaccination and selected syndromes with autonomic dysfunction in Danish females: population based, self-controlled, case series analysis

Association between quadrivalent human papillomavirus vaccination and selected syndromes with autonomic dysfunction in Danish females: population based, self-controlled, case series analysis

Systematic Review and Meta-analysis of Postlicensure Observational Studies on Human Papillomavirus Vaccination and Autoimmune and Other Rare Adverse Events

Human Papillomavirus Vaccination and Physical and Mental Health Complaints Among Female Students in Secondary Education Institutions in Denmark

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