Sex: F
Vaccine: HEP
Symptoms: Irritability, Lethargy, Pyrexia, Rash macular, Tympanic membrane disorder
Clinical narrative: Information has been received from a medical record via a pregnancy registry concerning a 6 month old female with bilateral feet inversion most likely due to inutero positioning and no known drug allergies, who on 10-APR-2008 and 11-APR-2008 was vaccinated with doses of RECOMBIVAX.  Concomitant vaccinations administered on 10-JUN-2008 and 12-AUG-2008 included PEDIARIX (AC21B156CA) administered in the right lower thigh, PREVNAR (C63110) and (C68311) administered in the left anterior thigh, and ACTHIB (UF238AB) and (UF262AB) administered in the left lower thigh.  On 22-APR-2008 the patient was seen at the office for follow-up. The patient's tympanic membranes were dull and she failed the left hearing test.  It was reported that the patient would be seen the following Thursday for a re-check.  On 10-JUN-2008 the infant responded to noise.  On 22-AUG-2008 the patient's tympanic membranes were clear and intact.  There was no further mention of hearing loss or hearing disorders.  On 25-JUL-2008 the patient was seen at the office with complaints of increased number of vomiting episodes and a little diarrhea the day before.  The vomiting was described as projectile.  The patient had experienced some mild reflux, and over the last two weeks it had gotten worse.  The patient was fussy and irritable.  It was reported that the patient had been switched to another formula and was presently back on the traditional formula.  The patient's pulse was 140 and temperature was 97.6.  The plan was to perform an ultrasound of the abdomen and upper gastrointestinal in order to rule out pyloric stenosis and gastrointestinal reflux disease.  It was also being considered to switch the patient to a hypoallergenic formula.  On 07-AUG-2008 an abdominal ultrasound was performed and showed no evidence of hypertrophic pyloric stenosis and pedialyte passed smoothly through the pylorus.  The ultrasound was normal.  An upper GI series was also performed and normal esophageal motility was seen with no evidence of obstruction, stricture, or mucosal abnormality.  There was no evidence of gastroesophageal reflux.  The stomach demonstrated a normal mucosal pattern.  Normal gastic emptying was observed.  The duodenojejunal junction was normally positioned.  The visualized small bowel had a normal appearance.  The upper GI series was unremarkable.  On 12-AUG-2008 the patient was seen and had experienced diaper candidiasis and GERD.  On 17-AUG-2008 the patient was seen in the emergency room and treated for bronchitis.  On 22-AUG-2008 the patient was seen for follow-up to the emergency room visit.  The patient was treated with AZITHROMYCIN.  The mother reported that the patient has been doing well and did not have any trouble breathing.  The plan was to continue the AZITHROMYCIN as previously prescribed (also reported that the patient had finished the therapy), continue TYLENOL and MOTRIN as necessary for fever, continue fluid intake, and to monitor urine output and fluid status.  The patient was advised to return to the clinic or emergency room if any of her symptoms worsened such as lethargy, persistent irritability, worsening fevers, difficulty breathing, decrease urine output, decreased by mouth intake, or other concerns.  On 08-SEP-2008 the patient was seen with multiple loose watery stools, a splotchy rash on her body including her cheek, several bouts of vomiting, and a low grade fever of 99.6.  It was reported that the patient was recently started on squash which was the only new food over the last week.  The patient experienced a decrease in amount of feeding only taking on bottle per day and a decrease in urine output.  The patient was still making tears.  The patient was diagnosed with viral gastroenteritis and was prescribed TYLENOL every sis hours as needed.  The patient was instructed to use a humidifier, saline spray in the nose and a bulb syringe.  The rash was consistent with a viral exanthem and was expected to resolve over the next seven to 10 days.  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.