Initial report was received 03 December 2008 from a health care professional. A 22-month-old female patient with no past medical history, has received FLUZONE no Preservative 2008-2009 (route and site not reported), lot number U12794GA on 02 December 2008 and 30 minutes later, she began vomiting which worsened to where the patient was vomiting bile and a thin coffee ground substance. The child was taken to the emergency room and admitted overnight. Laboratory test results included elevated WBC and BUN levels. The patient was discharged on 03 December 2008. The patient had no concurrent illness at the time of vaccination. The patient had not been taking any concomitant medications and had not received any other vaccines during the four weeks prior to receipt of FLUZONE. At the time of the report, the patient was not recovered from the event. This report was received as a cluster report. The reporter for this case is the same as in case 2008-03865 which involved the patient's twin sibling. Documents held by sender: None. Follow-up information received 19 January 2009 from a health care professional in the United States. The patient had no illness at the time of the vaccination and the reporter stated that both parents came down with a similar illness after they brought the patient home. According to the reporter, the patient recovered from the event. No additional information was provided. Follow up information received on 17 February 2009 from a health care professional in the United States. The patient received Fluzone at 4:30 pm on 02 December 2008. At 6pm the patient began vomiting. Initially the vomit was clear and later became blood tinged. The patient did not have diarrhea, rash, fever, decreased urine output, apparent abdominal pain or decreased alertness. However the patient did have decreased activity. The physical examination and review of system were unremarkable. Vital signs were pulse 161, respirations 32, temperature 37.1, and blood pressure 133/80. The patient was placed on physician's observation at 22:45 for vomiting and coffee ground emesis. The patient was treated with 20 cc/kg normal saline bolus. The patient was re-evaluated every 1-2 hours. During the first re-assessment, the patient received a second 20 cc/kg normal saline bolus and the patient improved. No further emesis was noted. During the second re-assessment the patient continued to improve. Laboratory data was reviewed at the time which included an elevated BUN 23, decreased creatinine 0.3, increased WBC 32.6. The patient was seen at 03:30 and had 2 episodes of emesis during that hour. The patient's abdomen remained soft and nontender. The patient was admitted to the pediatric unit. The patient did not have an egg allergy, gastrointestinal problems or any preceding illness. Mild pharyngeal erythema was noted upon assessment. The patient's diagnosis was Mallory Weiss tear, gastritis, and "Digestion". No further information was provided. Follow-up information received 09 March 2009 from a health care professional in the United States who confirmed the patient had recovered from the event. The reporter had no additional information to provide at the time of the report. Follow-up information was received 12 June 2009 from a health care professional in the United States. FLUZONE No Preservative 2008-2009 had been administered as a subcutaneous left deltoid injection and the patient was reported to have been fully recovered on 07 December 2008. Both parents had recovered from their similar illnesses in two days and neither parent had received Fluzone. No further information was provided. This report was received as a cluster report. The reporter for this case is the same as in case 2008-03865 which involved the patient's twin sibling. Documents held by sender: medical records.