Sex: F
Vaccine: HPV9
Symptoms: Foetal exposure during pregnancy, Gastrooesophageal reflux disease, Upper respiratory tract infection, Weight decrease neonatal
Clinical narrative: Information has been received from a physician via medical records involving a maternal case enrolled in the Merck Pregnancy Registry for GARDASIL 9 (MARRS # 1609USA006493) referring to a 6 day old female infant patient. On 12-SEP-2016 at 11:50 am, the patient's mother was vaccinated with the first dose of GARDASIL 9 lot # L036301 (previously reported as M007764), intramuscularly (IM) in the left deltoid. The patient's exposure to GARDASIL 9 was at 28 weeks of pregnancy and the patient had a transplacental exposure (fetal exposure during pregnancy). During the pregnancy, the patient 's mother also received the following vaccines: (DTaP, reported as TdaP) (on 24-OCT-2016, 0.5 ml once) and influenza virus vaccine (unspecified) (on 07-NOV-2016, 0.5 ml once). In the course of the parent's pregnancy, there were no complications, infections or illnesses. On 22-NOV-2016, the parent gave birth to a live born female infant (weight 3220 grams, length 20.25 (unit was not provided) by cesarean section. Gestational age at pregnancy outcome, based on LMP, was 39 weeks. Birth weight: 7 lbs. 2 oz. Discharge weight: 6 lbs. 9 oz. T here were no newborn nursery problems or congenital anomalies. The patient was vaccinated with hepatitis B virus vaccine (unspecified) (dose, route, lot number and expiration date were not provided) for prophylaxis during newborn hospital admission. On 28-NOV-2016, office visit (OV): The 6 day old patient was seen for a newborn evaluation, accompanied by her mother. The patient's nutritional intake included breast milk and no formula. The patient's urine output/wet diapers were normal,and stool output normal, every diaper. The patient's weight at this visit was 6 lbs 6 oz, noted as a 10 % weight loss. Assessment:/Diagnosis: Well child examination and excessive weight loss. During parental counseling, the patient's feedings were discussed with the mom. On 23-DEC-2016, OV: The 4 weeks, 3 day old patient was seen for a well baby examination, accompanied by her mother. The patient's nutritional intake included breast milk, every 2-3 hours with 2 feedings at night and no formula. The patient's urine output/wet diapers were normal and stool output normal, with eliminations every day or every other day. The patient's weight was 8 lbs 6 oz. At the visit the patient was vaccinated with hepatitis B virus vaccine (unspecified) (dose, route, lot number and expiration date were not provided) for prophylaxis. Assessment:/Diagnosis: Well child exam and gastroesophageal reflux (GER). During parental counseling, GER precautions were discussed with the mom. On 24-JAN-2017, OV: The 9 week old patient presented for a well child examination, accompanied by her mother. The patient's weight at this visit was 10 lbs 12 oz. The patient's nutritional intake included breast milk, every 2-3 hours with 2 cluster feedings at night and no formula. The patient's stool output was normal, with eliminations every day.  At the visit the patient was vaccinated with (DTaP), HIB and ROTAVIRUS (dose, lot number and expiration date were not provided) orally for prophylaxis. Assessment/ Diagnosis: Well child examination. During parental counseling, breast feeding or formula up to 32 oz per day was discussed with the mom. The patient was prescribed unspecified vitamins (TRI-VI-SOL) daily with 400IUs of vitamin D a day. On 30-JAN-2017, the patient's mother reported that the patient went to the hospital on 27-JAN-2017 (reported as Friday night), and was diagnosed with a upper respiratory infection, no respiratory syncytial virus (RSV). The patient's mother requested the patient's doctor be aware. On 28-FEB-2017, OV: The 3 months, 6 day old patient presented for well child examination, accompanied by her mother. The patient's weight at this visit was 11 lbs 3 oz. At the visit the patient was vaccinated with IPV and PNEUMOCOCCAL CONJ (dose, route, lot number and expiration date were not provided) for prophylaxis. On 23-MAR-2017, OV: The 4 months, 1 day old patient presented for well child examination, accompanied by her mother. The patient's weight at this visit was 12 lbs 12oz.  The patient's nutritional intake included breast milk, every 2-3 hours and no formula or pureed solid food. No vitamins. The patient's stool output was normal, with eliminations once a week. At the visit the patient was vaccinated with DTaP, HIB and ROTAVIRUS, (dose, lot number and expiration date were not provided) orally for prophylaxis. Assessment:/Diagnosis: Well child examination. During parental counseling, breast feeding or formula up to 32 oz per day with introduction of solid foods (cereals, vegetables and fruits) was discussed with the mom. Pediatric medical records were received and reviewed; no adverse experiences related to the prenatal exposure or to other Merck Products were identified. All available medical records will be provided upon request. Additional information has been requested. Sender's Comments: US-009507513-1609USA006493.