Sex: F
Vaccine: HEP
Symptoms: Dermatitis diaper, Diarrhoea, Feeding disorder neonatal, Gastrooesophageal reflux disease, Hyperbilirubinaemia
Clinical narrative: Information has been received from a physician concerning a 4 day old female who on 09-SEP-2008 was vaccinated with the first dose of RECOMBIVAX HB (manufacturer unspecified). On 11-SEP-2008, the patient had a screening test and the results were within normal limits. On 13-SEP-2008, the patient came to the clinic for a newborn followup of hospitalization. The patient had a mild elevation of her bilirubin. Her skin showed some jaundice particularly of the face and upper torso. There was no scleral icterus noted. Transcutaneous bilirubin was 14.6 mg/dl, and a heal stick was obtained which was 12.94 mg/dl. The diagnosis was stable hyperbilirubinemia. The family also reported that the patient was now exclusively being bottle fed, and she was having some difficulties with spitting yet after she was discharged. The patient was recommended continuing with the soy formula. On 23-SEP-2008, the patient came into the clinic for her 2-week newborn check. The patient's mother reported that the patient was doing well. The patient was on ISOMIL taking 2 to 3 ounces ever 2 to 3 hours. The patient was recommended not having medications until she was 30 days of age. On 10-NOV-2008, the patient came into the clinic for her 2-month newborn check. The patient's mother reported that the patient was doing well. The patient occasionally spit up. The patient was recommended that she only had formula until after 4 months of age. And the evening feeding was fine as long as she was not doing a lot of spitting. On 28-NOV-2008, the patient was vaccinated with the first 2.0 ml (also reported as 1.0cc) PO dose of ROTATEQ (reported as lot # 661035/0895X which was valid lot number for VARIVAX). On 5 DEC-2008, the patient's mother called that the patient spit up a lot and she believed the patient needed workup reflux. The patient was given Enfamil AR, BRN was also received. The patient had wet diapers. On 17-DEC-2008, the patient came into the clinic with concern of increasing in spitting up. The patient was initially on Similac advanced and then moved to soy formula. Most recently the patient's parents switched her to Enfamil AR, and th patient had been on that formula for approximately a week. The patient was still spitting up but maybe not quite as often, but it was a little chunkier. The patient spit up most feedings, and the spitting was not projectile. The spitting did not cause any irritability. Her stools were soft. The diagnosis was gastroesophageal reflux which was pretty typical to most new born babies. The patient was recommended to start Prevacid 15mg taking 1/2 tablet until her 4 month checkup. And the physician discussed with the patient's mother that Similac formula similar to Enfamil AR was premade and the mother did voice understanding of this.  On 06-JAN-2009, the patient came into the clinic with increased fussiness. The patient also  has been running a a fever with her axillary temperature 99. Her mom adds a degree and felt that she had been running a 100 degree temperature. The patient also had some sinus congestion of clear mucous, and she had the yellow sinus drainage for the past 2 days. The patient also had a couple of diarrhea stools on 05-JAN-2009 (4x/day). The patient had been eating and drinking normally, and was on Similac sensitive RS. She was on Prevacid 7.5mg daily but she tended to spit it out. Temperature was measured with the result of 97.4 axillary. The diagnosis was upper respiratory infection, likely viral in nature. The patient was recommended to use bulb suction to suction out nasal secretions and saline nasal sprays, and use a cool mist vaporizer in the room. On 21-JAN-2009, the patient came into the clinic for her 4 month well child check. The patient had been coughing for 4 days. The patient had no fever, and had a lot of nasal drainage that was worse at night. They used Prevacid for her reflux which seemed to help her reflux. The diagnosis was persistent upper respiratory infection symptoms since early January. The patient was started Amoxil 250 per 5 to take 4 ml twice a day for 10 days. The patient was recommended to mix Prevacid within the cereal, having the head of her bed elevated using a humidifier and nasal saline. On 28-JAN-2009, the patient received the second 2.0 ml (also reported as 1.0cc) PO dose of ROTATEQ (lot # 661053/1264X). On 30-JAN-2009, the patient's mother called that the patient was not better with therapy of BRN and ATB. The patient started Albuterol TID. On 02-FEB-2009, the patient presented to the clinic and her mother reported that the patient continued to have a persistent cough for the past two weeks. It resolved but reoccurred. The cough occurred more at night but can occur during the day as well, and the patient was having difficulty sleeping. Her appetite was somewhat decreased. The patient had a history of Prevacid. The patient's mother gave her 2 1/2 day of Albuterol through the nebulizer. The diagnosis was upper respiratory tract infection with bronchiolitis. The patient was recommended to restart Albuterol by the nebulizer and to use that 3 to 4 times each day and to decrease it as the patient's cough began to improve. The patient's mother was currently using a cool mist vaporizer and was attempting to do nasal irrigations as often as possible. The influenza A and B as well as RSV were negative. On 19 FEB-2009, the patient presented to the clinic and her mother reported that she had a rash in her diaper area fir approximately two weeks. Mother had been applying desitin barrier cream on a daily basis, but it had not seemed to help improve the rash. The patient was restarted Albuterol nebulizers and cough did improve, although it recently had returned. She had not yet restarted Albuterol. The diagnosis was diaper dermatitis and bronchiolitis. It was suspected possible yeast in etiology. The patient's mother was recommended to apply Lotrimin cream to the diaper area twice each day for the next two weeks. She might continue to sue the barrier cream of Destin. The patient's mother had planned to restart Albuterol and understood how to use the medication. On 11-MAR-2009, the patient was currently on Prevacid. The patient's vaccination history included 0.5 ml IM dose of PREDIARIX (Lot # AC21B160BA), 0.5 ml IM dose of ACTHIB (lot # UF488AA) and 0.5 ml IM dose of PREVENAR (lot # D01075) on 28-NOV-2008, and 0.5ml IM dose of PENTACEL (lot # C3230AA), 0.5 ml IM dose of PREVENAR (lot # D07543) on 28-JAN-2009. At the time of reporting, hyperbilirubinemia, gastroesophageal reflux and diarrhea had recovered. The outcome of the other adverse events were unknown. The patient's mother also had an adverse experience after a dose of GARDASIL (WAES # 0802USA03032). Follow up information was received which reported that the reporter had no records of problems with vaccines. No further information is available. All medical records will be provided upon request.