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

摘要: Abstract Introduction In 2013, the Netherlands Pharmacovigilance Center Lareb published an overview of reports long-lasting fatigue following bivalent HPV-vaccination (2vHPV). After update this in 2015, concerns regarding safety 2vHPV was picked up by media, which led to further fatigue. Therefore, Dutch National Institute for Public Health and Environment (RIVM) investigated a possible association between long-term Methods retrospective cohort study conducted Integrated Primary Care Information database, we occurrence chronic syndrome (CFS), ≥6 months 3–6 months all girls born 1991–2000 during follow-up period January 1st 2007-December 31st 2014 (2007–2008 pre-vaccination 2009–2014 post-vaccination). Patients with certain ≥6 m were asked consent link their primary care information vaccination data. Incidence rates per 10,000 person years (PY) 12–16-year-old compared pre- post-HPV-vaccine era. A self-controlled case series (SCCS) analysis performed using consenting vaccinated cases. high-risk 12 months after each dose defined. Results The consisted 69,429 accounting 2758 PY 57,214 post-vaccination. Differences post-vaccination incidences (CFS: 3.6 (95% CI 0.5–25.7)/10,000 0.9 (0.4–2.1); ≥6 m: 7.3 (1.8–29.0) 19.4 (16.1–23.4); 3–6 m: 0.0 16.6 (13.6–20.3), respectively) not statistically significant. SCCS analyses 16 cases resulted age-adjusted RR 0.62 (95%CI 0.07–5.49). Conclusions Fatigue 3–6 m frequently found among adolescent girls, but CFS rarely diagnosed. No significant increased incidence similar age groups pre-vaccination. included low number revealed no elevated risk period.