Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Neonatal disorder, Ultrasound scan abnormal
Clinical narrative: Information has been received from a physician for the Pregnancy Registry for GARDASIL concerning a 22 year old female who on 06-SEP-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot# not reported).  There was no concomitant medication.  On 08-NOV-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# 659435/1265U) and was pregnant.  The patient's LMP was originally reported as 08-NOV-2007 with a due date of 14-AUG-2008.  However the follow up information indicated an LMP date of 29-Oct-2007 with an estimated delivery date of 06-Aug-2008.  The patient had an ultrasound on 21-Dec-2007 and sought medical attention in the physician's office.  Follow up information has been received from a certified medical assistant on 19-FEB-2009.  It was reported that the patient delivered vaginally, a normal and healthy baby boy on 30-JUL-2008.  His birth weight was 7 lbs 5 oz;  length:  201/4";  Apgar 9/9.  She mentioned that the patient was just in their office last week and "was doing fine."  Pediatric medical records were received and reviewed and the following experience was identified:  On 05-AUG-2008 the infant was seen in the clinic.  The physician reported that the baby had plenty of wet diapers and had been eating well, but since yesterday his feeding had decreased.  The diagnosis was decreased feeding x1 day and mom was to call if no improvement.  On 07-AUG-2008, 08-AUG-2008 and 12-AUG-2008 the baby was again seen by the physician and continued to have poor feeding with stable weight but no gain.  The mother reported that she had to wake him every 4 hours to feed and she couldn't get him to take more than 1 and a 1/2 oz at a time.  On 12-AUG-2008, his weight was 6 lbs 15 ozs.  The physician's plan was to put him on soy formula and if no change in weight would do some labs.  On 15-AUG-2008 the baby was seen for weight check.  His formula intake was still down.  He was taking approximately 10 oz per day.  His bowel movements (BM's) were "hard, pebble-like" and his gums looked like "blisters."  His weight was 7lb 6 ozs.  He was on soy formula and MYLICON.  The physical findings were that the child looked good, rectal exam produced stool.  Diagnosis made was excellent weight gain, mild constipation.  Plan was for the mother to add 1 oz juice/1oz water to diet daily.  On 19-AUG-2008 the baby was seen by the physician.  The complaint was that he was spitting up with every feed, occasional projectile "forceful".  He was having a BM daily and seemed to eat without problems.  He was on soy and juice daily.  His weight was 7lbs 12 ozs.  The diagnosis was gastroesophageal reflux disease (GERD).  The physician discussed with the mother about changing formula to Enfamil AR and putting baby on ZANTAC 15/mL, 11/2 mL twice daily, and elevating head of bed.  On 12-SEP-2008 the baby was seen in clinic.  He had a rash on his chest, neck and face x 4 days.  The physical exam showed seborrhea and baby acne.  The physician discussed using SELSUN BLUE and dove soap with the mother and also informed her that if the seborrhea  worsened she could use 0.5% hydrocortisone twice daily x 1 week only.  On 18-SEP-2008 the baby was seen by physician.  The baby's right eye was closed and crusted.  The diagnosis was closed tear duct.  Mom was informed to massage the tear ducts and call if symptoms return, and to return to office if needed.  The baby's closed tear duct was considered a congenital anomaly.  Pediatric medical records were received and reviewed;  an experience related to ROTATEQ was identified, and is described in WAES report # 0906USA02160.  Additional information is not expected.  All medical records will be provided upon request.