Sex: F
Vaccine: HPV4
Symptoms: Neonatal disorder, Normal newborn, Pregnancy test urine positive, Ultrasound antenatal screen
Clinical narrative: Information has been received for GARDASIL, a Pregnancy Registry product, concerning 17 year old female with no previous pregnancies or births and no known drug allergies who on 14-NOV-2008, 12-AUG-2009 and 11-DEC-2009 was vaccinated intramuscularly with the first 0.5 mL, second 0.5 mL and third 0.5 mL dose of GARDASIL (LOT# first dose 659180/1758U, second dose 659964/1975U and third dose 663453/0249Y), respectively. This female during entire pregnancy time period was taken prenatal vitamins, daily for prenatal care and SLOW FE, daily for anemia. The patient was found to be pregnant since the pregnancy urine test was positive. The date of the last menstrual period was in October 2009, the estimated date of delivery is in July 2010. During pregnancy delivering, the patient had complication of low amniotic fluid (had captured in WAES # 1001USA03408) and fetal distress. Obstetric labs, ultrasound and fetal stress test were performed and outcomes were unknown. On 20-JUL-2010, at LMP of 38 weeks the patient through C-section delivered a normal male infant, weight "5 pounds 1.6 ounce" and length 19.5 inches. Follow-up information was received from a certified medical assistant who reported that the baby was normal and doing well. The baby's last weight was 6 pounds and 2 oz. The mother had recovered from the C-section. The baby's next well visit was scheduled for next month (September 2010). Follow up information has been received the licensed practical nurse indicated that the baby was delivered via C-Section and was currently a healthy happy baby boy who was meeting his age appropriate milestones. The baby did not received GARDASIL. The mother received GARDASIL very early in pregnancy. Follow-up information has been received from the responsible physician and a pediatric otolaryngologist via medical records. On 06-OCT-2010, the now 2 month and 16 day old baby, who was about two and a half weeks early, but had no problems with abnormal Apgar or any other feeding difficulties, was sent with his parents for evaluation of a lump under the tongue. The parents reported a history of a small pea-sized area which they noted at birth, on the floor of the mouth, underneath the tongue. They had watched that increased in size to the point where they now felt it was interfering with his feeding. According to the mother, the baby was gaining weight and overall thriving, but over the last two to three weeks, she had noted some episodic gagging and vomiting. She believed it was related to the increase in the size of the mass underneath the tongue. Mom noted no airway or breathing issues at this juncture. The physical examine was within normal limits. The physician's impression was, 1. floor of mouth mass; 2. Cyst like appearance suggestive of a ranula/mucocele. A surgical consultation with a pediatric otolaryngologist was recommended. On 02-DEC-2010, the now 4 month old baby was seen by a pediatric otolaryngologist. He had a CT scan done. The otolaryngologist believed this was consistent with a ranula. Mom said that recently the ranula disappeared. This happened overnight. There had been no further problems. The baby was feeding well and growing well. He had no trouble breathing. On examination on 02-DEC-2010, the rightt eardrum was normal. On the left side, he had a dull, opaque eardrum, which was consistent with a persistent effusion. Tonsils were 1+. The floor of mouth looked completely normal. Other examine was within normal limits. The otolaryngologist impression was that his ranula had resolved. The doctor told the mom that sometimes a ranula would recur and sometimes it would not. The doctor also told the mom that they would recheck the baby's left otitis media with effusion in 3 months. The mother's experience had captured in WAES # 1001USA03408. Additional information is not expected.