Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal X-ray, Abdominal pain, Abdominal pain upper, Abdominal tenderness, Blood alkaline phosphatase increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female with a history of attention deficit/hyperactivity disorder (ADHD) and bipolar disorder and no preexisting illness, in perfect health who on 11-JAN-2011 was vaccinated IM into left arm with the third dose of GARDASIL (lot # 666598/0786Z). It was reported that the patient had a family history of her grandparents having diabetes. Since the day of her shot, the patient started having stomach pain, not feeling well. Her family thought she had the flu. On the 21-JAN-2011, however, she was turning gray, could barely respond so she was taken to the emergency room (ER), where they said she had a glucose of over 800 and was close to a diabetic coma. The patient now had type I diabetes, 4 finger pokes and 4 shots everyday. Per hospital records (22-JAN-2011 to 26-JAN-2011), the patient was diagnosed as new onset type I diabetes mellitus. The patient was transferred from another facility in diabetic ketoacidosis with infusion of IV fluids and insulin. The patient complained of abdominal pain for 3 days, vomiting, decreased appetite, decreased urine output, fever (2 days), dizziness, headache, intermittent chest pain, dry mouth, weight loss, increased urinary frequency, polydipsia, food had a strange taste. Physical exam: very thin, temperature 99.3 F, eyes slightly sunken, dry oral mucosa, mild kussmaul respirations. The patient was admitted to pediatric ICU for management. ER records on 22-JAN-2011 were with impression: 1) new onset Insulin-Dependent Diabetes Mellitus (IDDM); 2) diabetic ketoacidosis (DKA). The patient presented with complaint as noted above. Physical exam: dehydrated, sunken eyes, dry oral mucosa, decreased bowel sounds, right upper quadrant tenderness, decreased skin turgor, breath smells of acetone. Abdominal x-ray was suggestive of constipation. The patient started on IV fluids and insulin drip. The patient was transferred for higher level care. It was reported that "the patient was perfectly normal until these shots, then something happened the same day as her last injection that changed her life forever. The patient would always be a diabetic now." Lab data on 22-JAN-2011 included: blood glucose 803 mg/dl (high), bicarb 16 mEq/L (low), Na 132 mEq/L (low), K 5.2 mEq/L (high), creatinine 1.2 mg/dl (high), CO2 9 mEq/L (low), PH 7.21 (low), insulin antibodies 12.5 U/ml (high), red blood cell 5.66 M/mm3 (high), blood hemoglobin 16.3 g/dl (high), whole blood hematocrit 45.2% (high), alkaline phosphatase 549 U/L (high). Urine: ketone (+), glucose (+), acetone 3+ (high). Chest X ray was unremarkable. X-ray of abdomen was abnormal. The status of the patient was unknown at the time of this report. All of the events were considered to be immediately life threatening and permanent disability by the agency. The report was considered as serious. The original reporting source was the patient's family. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The VAERS ID is 433455. No further information is available.