Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Congenital anomaly, Exposure during pregnancy, Limb reduction defect, Ultrasound antenatal screen abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A female patient on an unspecified date was vaccinated with a third dose of GARDASIL (lot #, site and route of administration not reported). At the time that the patient was vaccinated, she did not know that she was 2 weeks pregnant. On an unspecified date ultrasound before birth revealed no legs. Laboratory tests performed found no genetic defect. The mother was instructed to register on this web site. On an unspecified date she had a male baby (weight 6 pounds and 10 ounces) who was born without legs. Onset date reported as age 0.3 (28-JUN-2008). During the pregnancy, the mother did not receive any other medication or vaccines. The listing indicated that the event was considered to be disabling and a congenital anomaly. The original reporting source was not provided. The VAERS ID # is 348547. Follow up information has been received from a physician concerning a 16 year old female patient, who on 29-JUN-2007 was vaccinated with the first dose of GARDASIL (Lot # 657736/0389U) (route not reported), on 03-MAR-2008 was vaccinated with the second dose of GARDASIL (Lot # 659441/1446U) (route not reported) and on 20-JUN-2008 was vaccinated with the third dose of GARDASIL (Lot # 659962/1740U) (route not reported). Concomitant therapy given on 20-JUN-2008 included a dose of HAVRIX (Lot # AHAVB264CA) (route not reported). At the time that the mother received the third dose of GARDASIL, she did not know she was 2 weeks pregnant. The patient was aware at the fourth or fifth month of pregnancy that the baby had not lower extremities. At that time, the patient received genetic counseling. There were no complications during the mother's pregnancy. She delivered a male baby (weight 6 pounds 10 ounces) by C-section due to a breech birth. The baby was born with no lower extremities. The patient had tubes placed in his ears (date not reported). The patient's baby was seen by an orthopedic specialist for prosthesis of lower extremities. Upon internal review, C-section was considered to be an other important medical event. Follow up information has been received from an other health professional reported that the 16 year old female patient with penicillin allergy and no illness at time of vaccination who on 20-JUN-2008 was vaccinated with the third dose of GARDASIL (Lot # 659962/1740U) intramuscularly in the left arm. Concomitant therapy given on 20-JUN-2008 included the second dose of HAVRIX (Lot # AHAVB264CA) given intramuscularly in the right arm. Patient was pregnant at time dose was given, son was born without legs. The baby born with no lower extremities was disabling and a congenital anomaly. The baby's experience has been captured in WAES 0907USA05158B1. No further information is available. Information has been received from a published literature article. On an unknown date, the patient was vaccinated with VAQTA (dose, route, anatomical location, lot number and expiration date were not reported) while being pregnant. Additional information has been requested. It has been determined that case # 1412USA011730 is a duplicate of case # 0907USA05185. Therefore, case # 1412USA011730 is being deleted from our files and the case to be consolidated into case # 0907USA05185.