Sex: F
Vaccine: HPVX
Symptoms: Unevaluable event
Clinical narrative: This literature marketed retrospective pregnancy report has been received from the authors of the published literature article describing a study. The aim of the study was to evaluate the risk of spontaneous abortion after quadrivalent human papillomavirus (4vHPV) vaccination before and during pregnancy. The authors compared risks for spontaneous abortion after 4vHPV in three exposure windows: distal (1622 weeks before the last menstrual period (LMP)), peripregnancy (within 6 weeks before the LMP), and during pregnancy (LMP through 19 weeks of gestation). Women 1227 years of age with a pregnancy between 2008 and 2014, with continuous insurance enrollment 8 months before and through pregnancy end, and with a live birth, stillbirth, or spontaneous abortion were included. The authors excluded multiple gestations, spontaneous abortions before 6 weeks of gestation, and women using medications increasing risk of spontaneous abortion. The following pregnancy outcomes were also excluded: therapeutic abortions, ectopic pregnancies, gestational trophoblastic disease, and multiple gestations. The final cohort consisted of women with spontaneous abortions occurring between 6 and less than 20 weeks of gestation, stillbirths occurring between 20 and 43 weeks of gestation, and live births. The authors identified 208965 pregnancies in women aged 1227 years, with continuous insurance enrollment from 8 months before pregnancy through pregnancy end. This report concerns 5376 female patients of unknown age vaccinated on an unspecified dates with a doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for prophylaxis (dose, unit, route of administration, lot # and expiration dates were not reported). 53 patients had dispensed medications (prostaglandin analogs, vitamin A analogs, selected immunosuppressants (mycophenolate mofetil, methotrexate, azathioprine, thalidomide), selected anticonvulsants (carbamazepine, phenytoin, phenobarbital, primidone, topiramate, valproic acid), amiodarone, warfarin, and lithium) increasing risk for spontaneous abortion. Amongst those patients 268 received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) at outside health system, 5108 received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) in wide risk windows. 919 female patients were vaccinated in distal exposure windows, 986 were vaccinated in peripregnancy exposure windows and 895 were vaccinated during pregnancy. The patients became pregnant on an unknown dates. The LMP and Estimated Date of Delivery was unknown. The outcomes of pregnancies were reported as: 1544 females had a noneligible pregnancy outcomes, 133 had a pregnancy loss <6 week of gestation or blighted ovum, 1339 had an therapeutic abortion, 48 had a ectopic pregnancy, 18 had gestational trophoblastic disease, 6 had multiple gestation, 3564 had had singleton pregnancies ending in live birth, spontaneous abortion or stillbirth and 268 had unknown outcome. Among 919 women with distal 4vHPV exposure, 10.4% experienced a spontaneous abortion; unadjusted rates were 8.6% for vaccination during pregnancy and 11.2% for peripregnancy exposures.