Information has been received from a physician concerning a 3 month old male with gastrooesophageal reflux disease and stridor inspiratory and a history of pyloric stenosis status post pylorectomy, facial rash, diarrhoea, irritability, vocal cord thickening and laryngomalcia (WAES #0801USA00092) who on 15-AUG-2008, at 13:23, was vaccinated P.O. with a first dose of ROTATEQ (Lot #660550/0616X). On 04-NOV-2008, at 17:04, and on 29-DEC-2008, at 15:24, the patient was vaccinated with a second and third doses of ROTATEQ (Lot # of the third dose 662398/1270X), respectively. Concomitant therapy included three doses of included PREVENAR (Lot #C86144, C71571 and C87310, respectively), two doses of PEDIARIX (Lot #AC21B192AA for two doses), two doses of ACTHIB (Lot #UF448AA for two doses), FLUZONE (Lot #UT2788HA) and a dose of PENTACEL (Lot# C3242AA). On 26-SEP-2008 while the patient was seen by a doctor, a sizable hernia 2-3 cm of tissue was noted in belly button. The hernia opened 0.5 cm and was easily reducible. It was reported that he had no hernia before. The hernia appeared after gaining weight. On 04-NOV-2008 the baby was seen by the doctor again. His hernia was noted to be 0.5 cm with large hernia sack. It could be fully reduced that day. The doctor recommend him back to the surgeon since there was concern about the risk of incareceration because of large hernia sack and small opening. On 20-NOV-2008 the baby was sent for a pediatric surgery evaluation. Physical examination showed he had well-healed laparoscopy incisions in the right and left upper quadrants. He had a protruding umbilical hernia which had a 7 mm ring which was reducible. He had no inguinal hernias. The doctor would not likely repair the hernia at that point and whether this was a hernia related to the trocar that was placed through his umbilicus or a natural hernia in this youngster was hard to determine. At this point, they would treat this as if it was a de novo umbilical hernia and follow it over time. They would see him back in six months time. Hopefully as his abdominal wall fascia develops more musculature and becomes more solid they could perform a repair at a later date although now there would be a high risk for recurrence if we tried to repair it while his fascia is weak, At this point mom was agreeable to this. The doctor told her the signs and symptoms of what to watch out for including a bulge or redness that is not reducible and she is aware of this. On 22-DEC-2008 the baby presented to the emergency room with fever and diarrhea. Illness began in the morning of that day, and the patient had had 7-8 watery, nonbloody stools so far that day. His temperature was to 103 at home. He was fussier than usual. He had no vomiting, no rash and was still eating, but less than usual as per mother, had only taken 2-3 bottles that day. He had no sick contacts or daycare exposure. Physical examination showed rectal temperature 36.8 Deg C. respiratory rate 40 br/min. He was diagnosed with gastroenteritis. The baby's feeding was observed. He fed quite vigorously and took and appropriate amount of formula. The doctor gave samples of pedialyte to the family. The baby improved with therapy and discharged with close follow-up recommended. On 29-DEC-2008 the patient presented for a well-child examination. He had normal stools and urine layout. He had no prolonged period of crying or fussiness. Physical examination was normal. On 15-MAY-2009, the patient presented to the hospital complaining of cough which started some time "this past week". It was reported he had a cold from mother who had this. The mother was treated for strep throat. The baby's head was hot for a few days. No temperature was taken, they did not have a thermometer. The patient was acting normal so the mother was not concerned. Per father the baby cried more at night. He also had rashes on his face and abdomen noted on 15-MAY-2009. He was eating well, playful as baseline. The doctor felt that the baby had a likely upper respiratory infection. The culture results for strep was negative. It was recommend to continue to watch closely call with any fever, fussiness, or any changes with playfulness/activity and follow-up in 2 months. On 17-MAY-2008, at 18:50, the grandmother called to report the baby coughing a little with some congestion. He had no fever. Mother recently was diagnosed with strep. The doctor explained that strep was not likely in a 10 month old and to treat this as any other respiratory illness with supportive care. If he looked worse than before, go to the emgerency room. On 18-MAY-2008 the baby was taken to the emergency room. Patient continued with rhinorrhea, had a fever, temperature was not taken, had not had a temp over the last several days. He tool Tylenol at home, formerly took a "liquid medication" for breathing, the mother did not recall what it was. The baby was not breathing faster than usual, not having difficulty catching his breath. The mother sometimes heard "some mucus in his chest". The patient saw primary care physician approximately 3 days ago, said that he "might have a virus." Mother noted that one day prior to presentation developed some 'bumps under his right eye' and some puffiness around right eye. He had never had to do breathing treatments at home, has had previous resp illnesses. Mother currently had a "sore throat." He also had diarrhea, approximately 3 soft stools daily. Physical examination showed rectal temperature was 37.8 DegC. Throat culture performed on 19-MAY-2009 was positive. The patient was diagnosed with upper respiratory infection. His facial erythema faded during observation, it was not likely cellulitis at this time. No antibiotics were given. On 23-MAY-2009 the grandmother called the doctor stating that the patient was generally happy, had slight pulling at ear without fever. The doctor recommended to continue Tylenol or Ibuprofen PRN if pain/distress. On 08-JUN-2009 the mother mentioned red, peeling diaper rash in the candidal diaper derm. Clotrimazole 1% cream three times a day PRN was prescribed. On 17-JUN-2009 the patient was seen by a doctor complained of rash which started about 1 month ago noted on back and trunk. His father had eczema. Shae butter, baby lotions were tried and the baby was bathed daily using baby johnsons or baby wash. The baby was diagnosed with eczema and was treated with hycort 2.5% twice a day on trunk, pet jelly after 15 min twice a day, was QOD/q3days. On 29-JUN-2009 the patient presented to the doctor for well-child examination. Lab results showed blood lead 6 kirby ug/ml (normal range 0-9.9), hemoglobin 9.6 & 12.4 (normal range 11-14). Acetaminophen 160/5 5ml every 6 hours as needed were prescribed to the baby. The doctor thought the patient's lead level was in the normal range, but it is not zero. Even a trace of lead can affect the child and should be treated by making changes in the child's living areas. They should repeat a lead level in 3-6 months to make sure it is not rising. To limit the child's lead exposure, the doctor asked the parents to do the following: 1. Wipe the child's face and hands before each meal. 2. Run the cold water one minute before getting water for cooking/drinking. 3. Wet wipe the window sills, baseboards and floors in the child's bedroom and play areas once each week (and if floor is carpeted, vacuum weekly). 4. Make sure the child was eating a good diet. Avoid meals high in fat. 5. Give a multivitamin with iron, vitamin C, and calcium everyday. 6. Stop the child if they are eating things are not food. During the visit, when blood was drawn for PB and hemoglobin test, the patient bled quite a bit. He had a family history of Von Willebrand disease. The baby was also sent to pediatric hematology/oncology for evaluation for possible coagulopathy in light of a large amount of bleeding following a finger stick for hemoglobin (12.4 g/dl) and lead (pending). At the time of reporting, the final diagnosis and outcome were not reported. This is one of several reports regarding the same patient. Additional information is not expected.