Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: Initial and follow up  information has been received through the Pregnancy Registry for GARDASIL from a  physician concerning a 19 year old female who on 11-MAY-2007 was vaccinated in the left deltoid with the first dose of GARDASIL (Lot#655126/0087U). On 22-MAY-2007 the patient found out that she was pregnant. It is not known how many weeks pregnant she is. Patient plans to discontinue the series of injections. On 20-JUN-2007, the patient has an ultrasound for dating purposes which was within normal limits. On-08-AUG-2007, the patient had a normal serum alpha fetoprotein test which was negative. On 13-AUG-2007, the patient had an ultrasound for evaluation of growth which was within normal limits. On 02-JAN-2008, the patient gave birth to a 7 pond, five ounce normal male infant who was 20 1/2 inches long. The baby was born 39 weeks from LMP and stored a 9/9 on the apgar test. There were no congenital anomalies or abnormalities. There were no complications during pregnancy or labor/delivery. Follow-up information has been received in the form of medical records. On 10-JAN-2008 the baby's mother called the pediatrician's office reporting the baby had discharge from his eye. There was no redness and sclera was white. Mother advised to gently massage with warm compress. On 15-JAN-2008 the baby was seen for a routine visit with the pediatrician. Physician noted sacnt discharge from the right eye. Physician felt the baby had a right lacrimal duct stenosis and advised continuing with massage with warm washcloth. Physician examination otherwise normal. On 30-JAN-2008 the physician noted the baby's eye was improving and to continue duct massage. On 11-FEB-2008 mother to pediatrician after noticing a left inguinal lump. Physician noted a firm, non-tender lump approximately 2-3 cm in the left inguinal canal. Patient given referral to Urologist. On 13-FEB-2008, urologist saw the baby and his mom in consultation. The baby was 6 weeks of age. He was born at 7-lb 12 oz. On resent examination he was noted to have a mass in the left inguinal area. The mother noted that it was noted to be present about a week ago on a routine exam. It has been unchanged and there have been no symptoms referable to it. The child was quite happy and healthy. The mass had not varied in size. Baby's past medical history was unremarkable. He took no medications, had no known allergies. Family history was  positive of cancer, diabetes. His social history revealed he lives with his mom; who is not married. He has no siblings. On exam he was a well-nourished, well developed child. His physical exam was totally within normal limits with the exception of the left inguinal exam. Both testes were in the scrotum. The testes and epididymidis were normal in size and configuration bilaterally. The right inguinal canal was normal. The left inguinal canal had a cystic, mobile mass which appears to be located in the inguinal canal. This was not a lymph node and the reporter believed it was most likely a communicating hydrocele of the cord. It was not fixed as a hernia. The urologist's recommendation based on what he saw was for the family to keep an eye on this looking for any changes that might of significance. If no change was seen, the urologist suggested see the baby back in about six weeks for re-examination. On examination on 26-MAR-2008, it was noted that baby's communicating hydrocele of the cord had gradually disappeared. The urologist did not feel any thickening of the cord in either side. The family was cautioned that it is possible that this lesion may return at any time from a few weeks from now to a few years from now and if he does have evidence of recurrent hernia or a communicating hydrocele the family could contact the physician. It was also reported that a routine pediatric visit and physical exams revealed eye normal. It was noted on 03-MAR-2008 that the baby entered a NOVARTIS Study and was vaccinated according to protocol with ActHIB, PEDIAVAX, PNEUMAR and ROTATEQ. Examination on 02-JUL-2008 revealed that the baby was well 6 months old. No additional information is expected.  All medical records will be provided upon request.