Sex: F
Vaccine: HPVX
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from the authors in a published literature article titled as above. OBJECTIVE: Limited data exist on human papillomavirus (HPV) vaccine (manufacturer unknown) safety during pregnancy. Although pregnancy is a contraindication, inadvertent vaccination does occur. Our 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. STUDY DESIGN: We performed 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 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 we evaluated adjusted relative risks associated with receipt of 4vHPV vaccine (manufacturer unknown) during pregnancy, the peri-conception period, and risks for both periods combined. RESULTS: We identified 720 women who received the 4vHPV vaccine peri-conception (linked to MARRS# 1701USA001368) and 638 who received the vaccine during pregnancy (Drug exposure during pregnancy), 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 (see table). CONCLUSION: 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. This retrospective pregnancy report referred to 638 female patients (detail information as above). On unknown dates the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) (lot#, strength, dosage, frequency and route unspecified) for prophylaxis during pregnancy.  The last menstrual period (LMP) and estimated due date (EDD) were not known. The outcome of Drug exposure during pregnancy was reported as recovered/resolved (details as above). Additional information has been requested.; Sender's Comments: US-009507513-1701USA001368: