Age: 2.0
Sex: M
Vaccine: FLUN3, HEPA
Symptoms: Culture stool negative, Dehydration, Diarrhoea, Gastroenteritis, Lip dry
Clinical narrative: A serious report of dehydration and acute gastroenteritis has been received from a study investigator concerning a 33-month-old male (PID 27391993) participating in a post-marketing study from FluMist MI MA162 "A Post Marketing Evaluation of the Safety of FluMist in Children 24-59 Months of Age in a Managed Care Setting.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the study indicated population of 2 years to 59 months of age for FluMist.  Medical history included no known allergies, hospitalization in August 2006 for acute gastroenteritis and dehydration and chronic diarrhea in December 2006.  Concomitant medications included Paaracetamol.  On 05 Feb-2008, the subject received FluMist.  He also received the Hepatitis A vaccine on the same day.  On 10-Feb-2008, the patient presented to the emergency room (ER) for vomiting, diarrhea, and fever.  Vomiting started at 4:00am on 17-FEB-2008 and continued about three or four times an hour until 11:00pm.  The patient also had diarrhea several times an hour during the first eight hours of the illness.  On 18-Feb-2008, the patient developed fever to 104 at home and continued with vomiting and diarrhea several times with no blood or muccus.  Given the fevers and signs of dehydration he had three urines in 24 hours, dark colored, dried lips, less energy, and sleeping all day, his patients brought him to the ER.  There was no cough or runny nose, no headache or ear pain.  The patient drank about 20 ounces of fluids on 18-Feb-2008 but threw up most of it.  In the ER, he was given normal saline. 20ml/kg intravenous (IV) bolus and ondansetron.  He had poor oral intake, several episodes of diarrhea and emesis and was therefore admitted on 19-Feb-2008 for further IV hydration and observation.  Diagnoses were dehydration and acute gastroenteritis.  The patient had a normal white blood cell count 11.6 with some left shift consistent with viral process and mild hyponatremia (sodium 133) with metabolic acidosis consistent with dehydration. Blood Chloride was 86, carbon dioxide 19 and anion gap 18.  In the hospital, the patient was treated with IV fluids at 1.25x maintenance rate initially, weaned to 1x maintenance.  He was tolerating oral fluids well with no vomiting and the diarrhea slowed down significantly.  The patient had diaper rash for which his parents had been applying zinc oxide (DESITIN).  He was having good urine output and only one stool overnight.  The exam on the day of discharge ws unremarkable.  Stool test for cryptosporidium, Cloxtridiam difficile, and stool cultures were all negative.  The patient recovered from the events on 20-Feb-2008.  The investigator asscesed causality of the events of dehydration and acute gastroenteritis to FluMist as remote and provided the alternative etiology of "natural and the severity as mild.  Additional information received on 24-Oct-2008 and incorporated into the narrative included medical history, concomitant medications, details about the hospitalization and event outcome.