Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, MNQ, VARCEL
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase normal, Blood albumin normal, Blood bicarbonate decreased, Blood calcium decreased
Clinical narrative: Initial report received on 28 January 2008 from an investigator participating in a trial under the reference number MTA44.  An 18-month-old male subject developed hyperglycemia 186 days after he received a right thigh intramuscular dose of Menactra, lot number U2139AA.  During a follow-up office visit on 15 October 2007, the subject also received an intramuscular injection of DTAP, lot number C2606AA, an intramuscular injection of Hib, lot number 200AA, an intramuscular injection of MMR, lot number 0284U, an intramuscular injection of Varicella, lot number 1249F and an intramuscular injection of Hepatitis A, lot number 0800U.  The subject had no reported medical history.  On 15 January 2008, 183 days after receiving the vaccine, the subject experienced decreased activity.  The subject subsequently began to experience vomiting on 17 January 2008 leading to hospitalization the following day on 18 January 2008.  According to hospital records received, the subject began to experience some weight loss, vomiting, and decreased p.o. intake and had been a little bit sleepier, beginning two to three days prior to admission.  He had been drinking significant amounts and had significant urination with many diaper changes every day.  On the day prior to admission, the subject had been seen by their primary care physician.  They had been diagnosed with conjunctivitis, and had been sent home with some eye drops and a "slip for blood draw if the parents felt that they wanted to follow up on his labs per the parents.  They (the parents) note that the doctor said that they could check for labs but did not have to".  The subject reportedly had a low grade fever outside the emergency department but had been negative for cough, congestion, runny nose and diarrhea.  ER physical assessment findings; temperature 96.7 degrees Fahrenheit, pulse 120, respiratory rate 26, blood pressure 120/92 with crying; saturation 98% room air, slightly dry mucous membranes, slightly pale skin, alert and arousable but appeared tired, fussy and irritable.  Laboratory results revealed blood glucose levels at 703, with a bicarbonate of 17 and moderate ketones in the blood and urine, WBC (9.9), Hematocrit (47.5%), platelets (589,000), sed rate (elevated; 77), sodium (138), potassium (4.7), chloride (96), CO2 (19), BUN (22), creatinine (0.9), calcium (9.3), albumin (4.5), AST (46), ALT slightly elevated (43), acetone (moderate), CRP (<0.5) and TSH (1.14).  The subject was administered IV fluids normal saline 10 ml per kilo x1 and started on IV fluids with normal saline and KCL 20 mEq per liter at approximately 2 times maintenance.  The ER physician's final impression indicated the subject had dehydration, likely due to diabetic ketoacidosis as the patient had ketoacidosis and new onset diabetes type I.  The subject was then transferred to a pediatric intensive care unit (PICU).  While in the PICU, an insulin drip was started and glucose was monitored hourly.  On 19 January 2008, the subject's chemistries normalized and the subject was found to be ketone negative.  Sugars were well under control and the insulin drip was transitioned to subcutaneous insulin and prior IV fluids were heparin locked.  Lantus was started that evening, with insulin to carb ratios, based on the subject's size and age.  The parents were educated about diabetes management and the subject was discharged on 23 January 2008 with instructions to continue with 4 units of Lantus subcutaneously nightly, and to follow the prescribed insulin to carb ratio diet.  The subject was scheduled for follow-up evaluations at one week and four weeks post discharge.  According to the hospital summary, the discharge diagnosis was "Diabetic ketoacidosis and new onset diabetes mellitus".  According to the investigator, the event was related to the study product and the subject's recovery status remained ongoing.  Documents held by sender: hospital records.