Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: White blood cell count normal, X-ray abnormal
Clinical narrative: A serious clinical trial report of acidosis, hypoglycemia, dehydration and acute gastroenteritis has been received from an investigator concerning a 46 month old female subject number 42453753, who is enrolled in study. Age in a Managed Care Setting. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The subject had a medical history that consisted of premature birth at 33 weeks: birth weight 3 lbs 15oz; in the ICN for three weeks with minimal respiratory difficulty on 02 per NC briefly and was tube fed: 3rd to 5th growth percentile: history of chronic diarrhea following acute illnesses; possible IBS, family history significant for possible IBS in paternal grandfather. The patient was taking psylilium 9 gram daily by mouth. The subject received FluMist on 25-Nov-2007. On 18 Dec 2007, the subject presented to the emergency department and it was noted that she was in her usual state of health until two days ago when she vomited four times. The day before her presentation, the subject had vomited three times and had taken on 10 oz of liquid and no solids. She had begun to experience intermittent crampy non-localized abdominal pain. She also had vomited two times the morning of 18-Dec-2007 and stools daily. The emesis had been non-bloody, but looked bile tinged. The subject was in daycare, but had no unusual foods, travel, foreign visitors or illness exposure. Temperature was 97.0, heart rate 15/min, respiratory rate 24/min, blood pressure 84/55, and oxygen saturation 100% on room air. Tympanic membranes were normal, lungs were clear to auscultation, and mucus membranes were moist. On 18 Dec 2007, laboratory results in the ER were as followed: K 5.4; NA 137; CL 103: C02 12: BUN 16: CREAT 0.41: GLUC 40: Anion gap 22: WBC 9.2; HGB 13.3; HCT 38.9: and PLT 350. On 18-Dec-2007, she was admitted to the hospital due to acidosis, hypoglycemia, dehydration, and acute gastroenteritis. A KUB showed midly dilated loops and the acidosis was noted to be secondary to dehydration. While hospitalized, the subject had no vomiting but did develop diarrhea. The hypoglycemia slowly improved after IV fluids although the glucose was still 50 and C02 was 13 after receiving IV fluid for six to eight hours. After 12 hours, the glucose was 87 and C02 was 22; the blood sugar remained stable while weaning off the IV and she was taking small amounts of a fluid/brat diet. Her stool was negative for WBC. The subject was discharged from the hospital on 19 Dec 2007. The events were resolved on 19-Dec-2007. The investigator assessed the acidosis, hypoglycemia dehydration, and acute gastroenteritis as not related to FluMist. The sponsor assessed the relationship to FluMist as not related. Follow-up information received 21-Oct-2008 and incorporated into the narrative: D/C summary with laboratory results. A serious clinical trial report of acidosis, hypoglycemia, dehydration, and acute gastroenteritis has been received from an investigator concerning a 46-month-old female who is enrolled in study. This case is submitted in accordance with Medimmune's post marketing conmomitent anaccelerated reporting for the newley indicated population of 2 years to 59 months of age for FLUMIST. The subject had a medical history that consisted of premature birth at 33 weeks: birth weight 3 lbs 13 oz: in the ICN for three weeks with minimal respiratory difficulty on 00 per NC briefly and was tube fed; 3rd to 5th growth percentile; history of chronic diarrhea following acute illnesses; possible IMS; family history significant for possible IBS in paternal grandfather. The patient was taking PSYLLIUM 9 grams by mouth. The subject received FLUMIST on 28-NOV-2007. On 18-Dec-2007, the subject presented to the emergency department and it was noted that she was in her usual state of health until two days ago when she vomited four times. The day before her presentation, the subject had vomited three times and had taken on 10 oz of liquid and no solids. She had begun to experience intermittent crampy non-localized abdominal pain. She also had vomited two times the morning of 12/16/2007 and while in the ED, No stools had been noted for the past four days whereas, prior to 14-Dec-2007 she had formed stools daily. The emasis had been non-bloody, but looked bile-tinged. The subject was in daycare, but had no unusual foods, travel, foreign visitors or illness exposure. Temperature was 97.0, heart rate 115/min, respiratory rate  24/min, blood pressure 84/85, and oxygen saturation 100% on room air. Tympasic membranes were normal, lungs were clear to ousculation, and mucus membranes were moist. On 18-Dec-2007, laboratory results in the ER were as followed: R. 5.40 NA 137: OL 103: CO2 12: BUN 16: CREAT 0.41: GLUC 40: Anion sup 22: WBC 9.2: RUD12.3: GCT 38.7 and FLY 359. On 19-Dec-2007, she was admitted to the hosital due to acidosis, hypoglycemia dehydration, and acute gastroenteritis. A KUS showed mildly dilated loops and the acidosis was noted to be secondary to dehydration. While hospitalized, the subject had no vomiting but did develop diarrhea. The hypoglycemia slowly improved after IV fluids althouth the glucos was still 50 and CO2 was 13 after receiving IV fluid for six to eight hours. After 12 hours, the glucose was 83 and CO2 was 22: the blood sugar remained stable while weaning off the IV and she was taking small amounts of fluid/tuat diet. Her stool was negative for WBC. The subject was discharged from the hospital on 19-Dec-2007. The events were resolved on 19-Dec-2007. The investigator assessed the acidosis, hyperglycemia dehydration, and acute gastroenteritis as not related to FLUMIST. The sponsor assessed the drelationship to FLUMIST as not related. Follow-up information received 21-Oct-2008 and incorporated into the narrative: D/C summary with laboratory results. Follow-up information received on 27-Aug-2009 clarified the events set serious criteria on 18-Dec-2007.