Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Anaemia, Drug exposure during pregnancy, Foetal disorder, Premature labour, Ultrasound antenatal screen
Clinical narrative: Information has been received from Merck Pregnancy Registry for GARDASIL from a healthcare professional concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not reported). The patient was pregnant. Follow up information has been received from a certified nurse midwife regarding a 16 year old female patient with no pertinent medical history who on 22-APR-2008 was vaccinated with her first dose of GARDASIL (Lot Unknown) a pregnancy registry product. On 22-JUL-2009 the patient was vaccinated with her second dose of GARDASIL (Lot#662404/0312Y) along with hepatitis A virus vaccine (unspecified) (manufacturer unknown). Concomitant therapy included prenatal vitamins and iron supplement. It was reported that the patient LMP was 11-APR-2009 and the estimated date of delivery (EDD) is 01-FEB-2010. There was no adverse event reported. Follow up information has been received from a certified nurse midwife regarding the 16 year old female patient with no previous pregnancies and no pertinent medical history who on 22-APR-2008 was vaccinated with her first dose of GARDASIL (Lot#659441/1446U) a pregnancy registry product. On 22-JUL-2009 the patient was vaccinated with her second dose of GARDASIL (Lot#662404/0312Y). On 02-OCT-2009, a routine ultrasound was performed and the result showed that the patient was 22.6 weeks. There was no adverse event reported. Follow up information has been received from a certified nurse midwife concerning the 16 year old female with asthma. There were no complications, infections or illnesses during pregnancy. It was reported that ultrasounds were performed on 02-OCT-2009 and 23-OCT-2009 (at 22.6 weeks and 25.6 weeks, respectively). During pregnancy, the patient was on therapy with prenatal vitamins and iron for anemia. It was reported that on 30-DEC-2009, at 35 weeks of gestation, the patient experienced preterm delivery, the patient delivered a normal male baby (weight 5 pounds 15 ounces, the head circumference was 33.5 cm. the length was 19 inches, the apgar score was 4/8). The baby did not present congenital anomalies. It was reported that the patient's baby also experienced cysts on kidneys and respiratory distress after delivery. Follow up information has been received from a physician via medical records who reported that the patient was breast feeding her baby. It was also noted that the baby was born with an extra digit on his right hand. Follow up information has been received from a nurse from the pediatrician's office, who stated that she also called the patient to see if she could verify any information regarding the baby's renal cysts, and according to the nurse, the patient said she had not been told anything about renal cysts; she was not aware of this. Follow up information has been received from a certified nurse midwife who indicated that she had no knowledge about the baby's current status. The certified nurse midwife stated that she had reviewed the patient's prenatal ultrasounds, and there was nothing in them about renal cysts. She also reported that she did not know where the information regarding the cysts on the kidneys came from, and that this information was inaccurate. The certified nurse midwife added that there was no information anywhere for this mother that her baby had any renal cysts. The baby's experience has been captured in WAES 0910USA00755B1. Additional information is not expected. All available medical records will be provided upon request.