Sex: M
Vaccine: HEP, HPV4
Symptoms: Drug exposure during pregnancy, Haematocrit decreased, Hyperbilirubinaemia neonatal, Hypermagnesaemia, Hypospadias
Clinical narrative: Information has been received from a physician concerning a newborn male who's mother was vaccinated on 27-MAR-2009 (lot # 659655/0940X) and 27-MAY-2009 (Lot # 662229/1497X) with a first and a second dose of GARDASIL, respectively. It was reported that this was the patient's mother first pregnancy (blood type O, rH+), it was also reported that the patient's mother had a limited prenatal care (<5 visits) and went to the hospital with a complicated delivery due to late care, pre-eclampsia and GBS carrier. She has received magnesium and a full course of bethamethasone (manufacturer unknown). She delivered at 34 weeks of gestation by cesarean with epidural and a bulb was used for suctioning; the respiratory effort at birth was spontaneous. The patient was born with genetic hypospadias at 34 weeks and weight at birth of 2280 grams. The physician added that discussions with the patient's parents have been made and this condition may be corrected when the patient is 1 year of age. After birth the patient was immediately admitted to neonatal intensive care unit (NIICU). Nucal cord x1 at delivery, the patient was taken to resuscitation room crying. His heart rate was >100/min, pink with acrocynoale and good tone. Oxygen was given briefly. The patient remained vigorous with sats 96-100%. The patient's weight birth was 2280 g, 44.2 cm, with a temperature of 36.4, in general he was alert, pink and within the normal parameter of physical examination. He was feed by parenteral nutrition during 7 days which increased his weight to 2345 g. On 16-SEP-2009, his initial hematocrit was 30.1%, the highest bilirubin level was 11 mg/dL and the last bilirubin level was 11 mg/dL. The patient received phototherapy for 7 days (from 08-SEP-2009 to 14-SEP-2009). The patient was initially made Nothing by Mouth and started on total Parenteral Nutrition. He was briefly started on feeds but these were held and he was made Nothing by Mouth when he was found to have an elevated magnesium level. His feeds were held until his magnesium levels normalized, and started with breast milk orally. He was easily advanced to full feeds of breast milk and then transitioned to completely feeds prior to discharged. The patient was noted to have an unconjugated hyperbiliribinemia, for which he was placed on bulb lights, there was little concern about ABO setup considering that his mother was O+ and antibody negative and the baby was A+ and antibody negative. He continued with bulb lights until he was normalized. Despite the patient's elevated magnesium levels, the patient never developed signs of magnesium toxicity. The patient was noted to had hypospadias at birth so circumcision was not performed. On 16-SEP-2009 the labs were within normal ranges, and at discharge it was instructed that the patient had a follow up appointment in two days, feed with breast milk every three hours, and repeat bilirubin test. He was prescribed with POLY-VI-SOL and ferrous sulfate orally. The patient recovered from unconjugated hyperbilirubinaemia and hypermagnesaemia on 16-SEP-2009. At the time of this report the patient had not recovered from genetic hypospadias. The mother's experience has been captured in WAES# 0909USA03531. Upon internal review genetic hypospadias was considered as a genetic anomaly. The patient subsequently experienced adverse experiences post vaccination with hepatitis B vaccine (manufacturer unknown) (WAES 0910USA01113). This information was previously reported in 0909USA03531. Additional information has been requested. All available medical records will be provided upon request.