Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from the authors in literature articles. This was a a retrospective, observational cohort study using administrative and healthcare data from the Vaccine Safety Datalink (VSD), a collaborative effort between the Centers for Disease Control and Prevention's Immunization Safety Office and several large health systems. The objective was to evaluate whether HPV vaccination during pregnancy or peri-conception was associated with increased risks for adverse obstetric events, adverse birth outcomes or birth defects. The cohort consisted of insured women 11-27 years old with singleton pregnancies ending in a live birth from 01-JAN-2007 through 30-SEP-2013. Women receiving the quadrivalent HPV vaccine (4vHPV) vaccine (manufacturer unknown) during pregnancy or in the peri-conception period were classified as exposed. Controls were women with singleton pregnancies and a live birth during the same period who received 4vHPV 4-18 months prior to pregnancy start or last menstrual period (LMP). Risks of gestational diabetes, hypertensive disorders of pregnancy, chorioamnionitis, preterm birth (<37 weeks' gestation), small for gestational age (SGA) birth and major structural birth defects in offspring were evaluated. Using a generalized estimating equation method the authors evaluated adjusted relative risks associated with receipt of 4vHPV vaccine (manufacturer unknown) during pregnancy, the peri-conception period, and risks for both periods combined. 720 women who received the 4vHPV vaccine peri-conception (MARRS# 1701USA001368) and 638 who received the vaccine during pregnancy (exposure during pregnancy) were compared to 8196 with distal 4vHPV exposures. Vaccination with 4vHPV was not associated with an increased risk of adverse obstetric events, birth outcomes, or major structural birth defects during any of the exposure periods as compared to controls. In this cohort of insured adolescent and young adult women, inadvertent administration of the 4vHPV vaccine (manufacturer unknown) during pregnancy or peri-conception was not associated with adverse maternal or infant outcomes. This study provided needed data for providers and expectant mothers on the safety of 4vHPV vaccine, when inadvertently administered in pregnancy. Out of 638 patients exposed to 4vHPV vaccine (manufacturer unknown) during pregnancy, total number of doses (including the dose during pregnancy) was 1 in 273 patient, 2 in 191 patients and 3 or more in 174 patients. 542 patients exposed to 4vHPV vaccine (manufacturer unknown) during pregnancy were included in analysis for major birth defects. Out of 542 patients, 10 gave birth to children with major birth defects: gastroschisis or omphalocele (1 child), cleft lip or cleft palate (2 children), congenital hydronephrosis (3 children), ear defect (1 child), microcephalus and hypospadias (1 child), cardiac defects (2 children) (this report). The fetal outcome in remaining 628 pregnancies (captured in MARRS# 1701USA010441) was not provided. This report is cross-referenced with MARRS# 1701USA001368 and MARRS# 1701USA010441.; Sender's Comments: US-009507513-1701USA001368: US-009507513-1701USA010441.