Information has been received from a nurse via medical records concerning a 36 day old male baby with congenital cleft lip and cleft palate (cleft lip repaired on 04-SEP-2009) who failed the newborn hearing screen on the left at birth (WAES #0807USA03163B1) who on 14-FEB-2009, 16-APR-2009 and 17-AUG-2009 was vaccinated with three doses of hepatitis B vaccine, respectively.  On 21-MAR-2009 the baby was seen by a pediatrician with complaint of spitting up.  It was reported that the baby had emesis with bottles for 1 day and had been spitting up on regular formula.  He was voiding well, stooling normally.  He was diagnosed with gastroesophageal reflux disease (GERD) and was treated with AXID 15 mg/ml, 7.5 mg twice a day.  The baby's mother was instructed to try NUTRAMIGIN and reflux precautions were explained.  On 16-APR-2009 the baby was seen again with complaint was GERD and the mother was instructed to increase the AXID to three times a day and to begin PREVACID.  The baby was vaccinated with a first dose of PREVNAR, PENTACEL and ROTATEQ.  On 11-MAY-2009 the baby was seen again.  It was reported that the baby did not get better with increased dose of AXID.  He was fussy all the time and spitting up after each feeding.  Disposition included PREVACID 15 mg Solu-Tabs, 1/2 tablet disintegrating into 1 ml solutions, P.O. daily, continued with AXID and NUTRAMIGIN.  On 14-MAY-2009, the baby was seen again and it was reported that he lost 5 oz in a week.  He was still spitting up and taking NUTRAMIGEN powder and thick rice.  The baby's tympanic membrane's were difficult to see.  The baby had the palate prosthesis in place and he sleeps from about 7 PM to 5 AM.  The physician's assessment was the weight loss was from the cleft palate and for the GERD to increase the formula to 22 calorie formula.  The plan was to check the baby in a week.  On 20-MAY-2009, it was reported that the baby vomited about 50% of medications and NUTRAMIGIN and developed poor weight gain.  The plan was to increase the formula to 24 calorie NUTRAMIGEN, see a GI physician in June and to check his weight again in one week.  On 17-JUN-2009 and 17-AUG-2009 the baby was vaccinated with second and third doses of PREVNAR, PENTACEL and ROTATEQ, respectively.  These visits were well child visits and no complaints were reported.  The baby was doing well.  On 17-JUN-2009, the baby was switched to ZANTAC 15mg/ml 0.8cc by mouth daily and still taking the PREVACID.  On 17-AUG-2009, the patient was prescribed LURIDE 0.5 mg/ml, 1/2 ml daily.  The baby was reported to be stable.  On an unspecified date the baby developed thrush.  On 02-SEP-2009 the baby was seen to recheck the thrush since the baby was scheduled for surgery on 04-SEP-2009 to repair the cleft lip and palate.  At that time the patient was on DIFLUCAN for thrush.  Physical exam showed right tympanic membrane (TM) dull slight fluid, but not red, cleft lip and nose left side with no evidence of thrush visible.  Exam was done without prosthesis in mouth and no thrush.  The doctor's assessments were thrush, newborn (resolved on clinical exam) and serous Otitis chronic.  On 04-SEP-2009 the patient had a myringotomy.  On 26-OCT-2009 the baby presented for earache for 2 days.  The onset was sudden.  It was affecting both ears.  The baby also had runny nose, but denied associated cough and fever.  Loss of appetite was also reported.  Physical examination showed purulent otorrhea in the left auditory canal and mild cerumen in the right auditory canal; left tympanic membrane (TM): tympanostomy tube was not visualized; right TM: patent tympanostomy tube secondary to all the drainage; nasal mucosa showed congestion and discharge, tape in place following cleft repair.  The baby was diagnosed with Otitis media, unspecified and was treated with CIPRODEX OTIC drops 3 drops, left ear twice a day for 5 days and AUGMENTIN ES-600 600-42.9 mg/5 1/2 tsp twice a day P.O. for 10 days.  On 17-NOV-2009 the patient presented for a scheduled 9 month well child visit and had ears rechecked.  It was reported that the symptoms seemed to have resolved.  Physical exam showed tympanic membranes normal landmarks, no fluid or Erythema bilaterally.  Additional information is not expected.