Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration, Ovarian cyst, Ultrasound scan, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse for the pregnancy registry GARADASIL concerning a 14 year old white female with asthma and no allergies, no previous pregnancies and a history of appendicectomy who on 23-MAY-2007 was vaccinated with the first dose of GARDASIL, IM 0.5 mL (lot # 654535/0960F). On 02-JAN-2008 the patient was vaccinated with the second dose of GARDASIL, IM 0.5 mL (lot # 659055/1522U). On 09-APR-2008, the patient was noted to have a right ovarian cyst. On 07-MAY-2008 the patient vaccinated with the third dose of GARDASIL, IM 0.5 mL (lot # 659964/1978U). Concomitant therapy included FLOVENT and albuterol. The patient's last menstrual period was 17-MAY-2008. The estimated due date is 21-FEB-2009. The patient had a positive urine pregnancy test on 14-AUG-2008. The ultrasound was performed on 26-AUG-2008 for dates with the results of 11 week 2 day fetus. No problems reported. The patient sought medical attention in the office visit. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/14/2008; 7/8/2009.  Follow-up information was received from the LPN via a pregnancy questionnaire.  Other medication used during pregnancy included TYLENOL for headache as needed.  On 17-MAR-2009 the patient delivered a normal male baby weighing 7 pounds 14 ounces with apgar score 8/9 at 40 weeks and 2 days.  The length of the baby was 20.25 inches and head circumference was 33.5 cm.  There were no congenital anomalies or other complications or abnormalities.  There was no complication during pregnancy and labor/delivery.  There was no diagnostic test during pregnancy.  Follow-up information was received from a physician via pediatric medical records.  The baby with no known drug allergies was treated with erythromycin (05-APR-2009) (reason not reported).  On 23-MAR-2009, the baby was seen by the physician with the assessment of a well physical examination.  On 30-MAR-2009 the baby was seen with results of weight normal and bilateral dacryostenosis.  On the 05-APR-2009 visit, the mother stated the baby experienced breathing problem, wheezing and coughing for one week.  The baby developed increasing fever at night, runny nose and eyes and the baby threw up mucus.  The mother also reported a rash in the baby's diaper area.  The blood oxygen saturation was 99%.  There was no wheeze present at the time of the examination.  The mother was instructed if the baby's fever was equal to or greater than 100.4 she must go to the emergency room.  The baby was prescribed NYSTATIN 100,000 units, topical for the rash and TYLENOL.  On 13-APR-2009 visit, the mother stated "feels lumps on chest" and questioning if her son's navel was infected.  Upon the examination, it was noted that the baby had mild erythema and mild umbilical dermatitis.  The patient's mother was advised to wash, dry and apply BACITXACIN.  On 20-APR-2009 visit the mother stated "blood in bowel movement".  On examination, it was noted that the baby had nausea, vomiting and diarrhea with streaks of blood.  The baby's stool was also noted to be green in color.  It was reported that the baby had diarrhea for 4 to 5 days and now had bright red blood in the stool.  On 21-APR-2009 the mother went to the emergency room as follow up.  The baby still had diarrhea but no further bleeding was noted.  The baby was eating 4 ounces every 4 hours.  The baby was diagnosed with gastroenteritis that was slow to resolve.  The baby was vomiting after feeds, small to moderate amounts.  No fever was noted.  The infant's formula was changed to NUTRASIGEN.  Laboratory studies revealed follow abnormal creatinins-blood 0.3mg/dl, potassium-blood 5.8 mmol/L, calcium blood 10.8 mg/dl, RBC 3.69 X 10(6)/ul, HGR 12.4 g/dl, BCT 35.5 %, PLT  570 X 10(31/ul and monos 16%.  The baby was eating 8 ounces every 4 hours with cereal.  In approximately early April 2009, the patient developed an upper respiratory infection (URI).  On 28-APR-2009, the upper respiratory infection was reassessed and vaccines were held.  On 15-MAY-2009, the baby was in the office to check his URI and to receive vaccines.  It was reported that the infant's URI was resolved.  Subsequently, the patient experienced thrush after vaccination with hepatitis B rHBaAg (yeast) (manufacturer unknown) (MSD WAES # 0908USA00957).  Upon internal review, bilateral dacrystenosis was considered to be a congenital anomaly.  Additional information is not expected.  All medical records are available upon request.