Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, Neonatal disorder, Pre-eclampsia, Premature delivery, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a registered nurse for the pregnancy registry for GARDASIL, via an initial pregnancy questionnaire concerning a 21 year old female patient with type 1 diabetes mellitus (poorly controlled), hypothyroidism and a history of 1 abortion spontaneous in a previous pregnancy (date unspecified) who on 23-MAY-2011, was vaccinated with the first dose of GARDASIL (route and dose not reported) (lot number 666595/0992Z). Concomitant therapy included DEPO-PROVERA, HUMALOG and LANTUS. Subsequently the patient was pregnant. The estimated conception date was 01-MAY-2011, LMP: 10-MAY-2011, EDD: 05-FEB-2012. On 15-AUG-2011, was performed an ultrasound as prenatal testing (no results were provided). At the time of the report the outcome of the patient was unknown. Follow up information has been received via an initial pregnancy questionnaire from the obstetrician who indicated that on 15-AUG-2011 the patient had an ultrasound as prenatal testing (results: normal though spine not seen). The obstetrician also stated that the patient had 1 previous pregnancy with no birth defects and no infant complications. Follow up information has been received from a nurse who reported that although the thoracic spine was not clearly seen, that did not mean an abnormally existed, in fact, nothing was said about abnormalities. It was also reported that the pregnancy proceeded. A repeat ultrasound would be done at a later date to rule out any abnormalities. Follow up information was received from the registered nurse (RN) via complete pregnancy questionnaire concerning the female previous smoker patient with type 1 diabetes mellitus since age 13 and an obstetric history of pre-term delivery (at 34 weeks) (date unspecified), 1 elective termination (because health reasons: kidney were falling) (date unspecified). It was reported that concomitant therapy also included PHENERGAN. The RN also indicated that on 28-DEC-2011 the patient delivered a premature male baby, weighting 5 pounds 5 ounces, baby's length was 18.5 inches, Apgar score 5 (1 minute) and 8 (5 minutes) and head circumference 31 cm. The RN reported that complications during pregnancy included pre-eclampsia (date unspecified). The infant had ventricular septal defect. There were no other congenital anomalies or complications during labor/delivery and no illness or infarctions during pregnancy. The baby's experiences were captured in WAES #1109USA01051B1. Follow-up information has been received from a registered nurse (R.N.) who stated that the patient was seen at the clinic one time for initial obstetrical visit then the patient was transferred to an other clinic. The patient was given a dose of GARDASIL on 23-MAY-2011 before she was aware of pregnancy and was not given at this clinic. Follow-up information has been received from healthcare professional via B-form. The HCP reported that the patient was vaccinated with the first dose of GARDASIL (lot number 666595/0992Z) on 23-MAY-2011 at 4 pm, intramuscularly in her right deltoid. It has been reported that the patient was pregnant at time vaccine was given and the patient's baby was born premature and with ventricular septal defect. The reporter also stated that the patient had diabetes and was not using insulin for the whole pregnancy. Additional information is not expected.