Sex: F
Vaccine: HPV4
Symptoms: Neonatal disorder, Premature labour
Clinical narrative: Information has been received from a certified nurse midwife concerning a male patient who was exposed through his mother who on 22-APR-2008, was vaccinated with her first dose of GARDASIL vaccine (Lot#659441/1446U) a pregnancy registry product. On 22-JUL-2009 his mother was vaccinated with her second dose of GARDASIL vaccine (Lot#662404/0312Y), along with a hepatitis A vaccine (inactive) (manufacturer unknown). Concomitant therapy included vitamins (unspecified) and iron (unspecified). On 30-DEC-2009, at 35 weeks of gestation, the patient's mother experienced a preterm delivery. The baby was 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 presented congenital anomalies. It was reported that the baby also experienced cysts on kidneys and respiratory distress after delivery. The baby's outcome for cyst on kidneys and respiratory distress were unspecified. Additional information has been received from a physician via medical records concerning a male baby who on 30-DEC-2009 received the first dose of hepatitis B vaccine, recom (manufacturer unknown). The patient lives with his mother, who is 16 years old and her mother in a house with a small dog and kitten. His family history was remarkable for maternal cousin who died of SIDS at 10 weeks of age. No deafness before the age of five. No hip disorders. No kidney disorders. No bleeding disorders. No heart disease. On 31-DEC-2009, the patient's chest X-ray showed improving of the radiographic appearance of the chest. The persistent parenchymal density could indicate a degree of respiratory distress syndrome. On 01-JAN-2010, the patient's chest X-ray showed a continued improvement of the radiographic appearance of the chest with some persistent hazy opacity in both lungs, which may indicate a mild degree of respiratory distress syndrome. On 07-JAN-2010, the patient was taken to a physician for a newborn visit, the patient was seven days old and was born at 37weeks via spontaneous vaginal delivery. The pregnancy was uncomplicated; however his newborn stay was complicated by a spontaneous small pneumothorax. The patient was on oxygen for two to three days and received antibiotics for 48 hours. The baby had an extra digit on his right hand which was tied off for removal. At the time of examination the patient was on breastfeeding for 15 minutes every two hours. For the last 24 hours, he had had 8 voids and 8 stools, his weight was 5 lbs. 9 oz., which is below his daily census weight of 5lbs. 13 oz. and his birth weight of 5lbs. 15 oz. On his physical examination the patient was afebrile. In general, he was alert, vigorous and in no apparent distress. He was clean in appearance. Anterior fontanelle is soft and flat. The tympanic membranes were clear bilaterally. Nose was clear. Oropharynx was pink. Mucous membranes were moist. Teeth/gums were in good condition. Conjunctivae were clear. Red reflexes were present bilaterally. No lymphadenopathy. Neck was supple. Chest was clear to auscultation bilaterally. Heart rate and rhythm were regular without murmur. Normal S1 and S2. Abdomen was benign without organomegaly. Tanner stage 1 male genitalia with testes descended. Neurological exam is non-focal. Full range of motion of the hips; no clicks. Skin is normal. Immediately below the little finger, right hand, there was a necrotic piece of tissue with a suture still tied to it. Negative for Ortolani and Barlow. The impression made on this visit was a seven day old, below his weight. P: This was likely a function of being on IV fluids with little weight loss in the hospital. His grandmother stated that he was on IV fluids up until the day of discharge. It sounds like his feeds were going well. The plan was to recheck his weight in one week and follow up sooner with any questions or concerns. On 13-JAN-2010, the patient had gained 4 oz. in the past 6 days. He was currently at his discharge weight now of 5 lbs, 13 oz. He was feeding about 3oz, every two hours now of formula and is breastfeeding as well. He had no spit ups. He was voiding 8-10 times per day and was stooling 3-4 times every day. On his physical examination, the patient was afebrile, his vital signs were stable: The patient was comfortable and cooperative. Normal cephalic. Normal facies, anterior fontanelle was open, soft and flat. No conjunctival injection. No scleral injection. No eye discharge, the tympanic membranes were clear bilaterally. Mucus membranes were moist. Nose was clear. No oropharyngeal lesions. Neck was supple. No lymphadenopathy. Normal thyroid. Heart rate and rhythm were regular without murmur. Normal S1 and S2, his lungs were clear to auscultation bilaterally. Abdomen was soft, non tender and nondistended. no rashes noted. The medical impression was a good weigh gain, although the patient was still not back to birth weight. The plan was to saw the patient back in one week. The patient status of respiratory distress and renal cyst was not reported. Upon internal review spontaneous small pneumothorax was considered as other important medical event. Extra digit on his right hand and renal cyst were considered as congenital anomaly. The mother's experience has been captured in WAES 0910USA00755. Additional information has been requested.