Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy, Ultrasound scan, Vacuum extractor delivery
Clinical narrative: Information has been received from a physician concerning a 17 year old female with hearing loss with a history of 0 pregnancies and 0 live births and a history of meningitis at 2 years old and haematuria in May 2007 who on 15-JUN-2007 was vaccinated with the first dose of Gardasil (lot# 655849/0263U).  On 23-AUG-2007, the patient received the second dose of Gardasil (lot# 658100/0525U).  In August 2007, an ultrasound confirmed that the patient was pregnant (LMP 01-JUN-2007; EDD 07-MAR-2008).  Follow up information received from the physician, indicated that on 22-FEB-2008, the patient had a vacuum assisted delivery of a normal male infant, head circumference 36 inches, weight 7 lb. 14 oz, length 17 inches, with initial Apgar score of 1 (no details provided).  There were no congenital anomalies or other abnormalities.  Additional information is not expected. This is in follow-up to report(s) previously submitted on 3/14/2008. Information has been received from a physician, in the form of medical records, for GARDASIL, a Pregnancy Registry product, concerning a male infant with a family history of asthma. The newborn screening tests collected on 24-FEB-2008 were all normal. At the first neonatal visit a 2/6 systolic murmur was noted. The treatment plan indicated a well child born at 36-4 after ARDM via vaginal delivery with an episiotomy and vacuum assist. The nuchal cord was present, no signs of infection. APGARS reported as 8 and 9, no complications, doing well. A hearing test was passed. Discussed was safety, anticipatory guidance, only MBM/formula feeds, sleeping on back reassurance about a normal cord and normal growth and development. An episodic illness visit was done on 06-MAR-2008 in which the mother's primary complaint was that the baby was constipated. The treatment plan indicated soft, pasty green stool that was "normal baby poop". There was good weight gain since the last visit and the mother was reassured. An episodic illness visit was done on 11-MAR-2008 in which the baby was seen for noisy, fast breathing, 2/6 systolic murmur was audible in the bilateral axilla. Assessment included that the mother was reassured that these were normal findings in a neonate and she was given information about the signs and symptoms of respiratory distress. A well baby visit (birth - 4 weeks) was done on 28-MAR-2008, in which white spots were noted on tongue and lower gums. The assessment was oral candida which was treated with nystatin syrup. Treatment plan also includes a discussion of safety, anticipatory guidance, only formula feeds, tummy time and normal growth and development. An episodic illness visit was done on 07-APR-2008 for re-evaluation after an emergency room visit for a possible chocking spell. It was reported the baby had no color change, but had a shaking spell which was transient and did not reoccur. There was mild nasal congestion, no cough or dyspnea. Assessment included ED follow-up, "PPAS" murmur and thrush. The treatment plan included supportive care and emergency instruction and nystatin. An episodic illness visit was done on 10-APR-2008 in which the baby presented with a 1-2 week history of wheezing and a cough that had resolved. Occasional rhonchi were heard. It was reported the baby had some spitting up and flaking of the scalp. Assessment was an upper respiratory infection. The treatment plan was instruction not to give water for constipation as the stool pattern appeared normal, supportive care, no wheezing that day, at risk for asthma and the baby was monitored. A well baby visit (2-3 months) was done on 17-APR-2008. Occasional spitting up noted, but baby gained weight well. Assessment was oral candidiasis and heart murmur "PPAS". The treatment plan included continuation of nystatin, continued to monitor "PPAS" and discussed were safety, discouraged co-sleeping, risks of suffocation and reassured the mother regarding spitting up versus reflux. An episodic illness visit was done on 10-JUN-2008 in which the baby was seen with congestion and a productive cough for 1 week. Respiratory rate 48, SpO2 91% RA with tight expiratory wheezes bilaterally and minimal subcostal retractions. Assessment was asthma and bronchiolitis. After a mini-nebulizer treatment the respiratory rate was 40's, SpO2 increased to 96-97% with wheezing much improved. The baby was smiling and in no apparent distress. The plan was to continue albuterol nebulizers at home with a home health visit for re-evaluation. An episodic illness visit was done on 12-JUN-2008 for follow-up of asthma and bronchiolitis. Upper airway congestion was noted. Assessment was asthma and bronchiolitis. The treatment plan was the baby was doing better and albuterol nebulizer therapy was continued as needed. A well baby visit (4-5 months) was done on 24-JUN-2008). A small umbilical hernia was noted. The murmur could not be appreciated due to upper airway noise. Assessment was well child exam. Treatment plan included anticipatory guidance, safety plan, shots, feeding solids and current infant care was continued. An episodic illness visit was done on 01-JUL-2008 in which it was reported the baby had been tugging at his ear for two days with no sign of pain. Assessment was well child, worried mom. The treatment plan included reassurance of the mother. The vaccination records received for the infant were: ENGERIX-B (GSK) on 22-FEB-2008, 17-APR-2008 (lot # AC218141AA) and 24-JUN-2008 (lot # AC21856EA); INFANRIX (GSK) on 17-APR-2008 (lot # AC2181AA) and 24-JUN-2008 (lot # AC128156EA); ACTHIB (Sanofi) on 17-APR-2008 (lot # CP241AC) and 24-JUN-2008 (lot # UF348AA); PREVNAR (Wyeth) 17-APR-2008 (lot # C49923) and 24-JUN-2008 (lot # C63114); ROTATEQ on 17-APR-2008 (lot # 0014X) and 24-JUN-2008 (lot # 0276X). Additional information is not expected.