Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Anal skin tags, Back pain, Biopsy site unspecified abnormal, Blood albumin decreased, Blood alkaline phosphatase normal
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 10 year old female patient with no previous illness and medical history of reflux symptoms and sternal chest pain on 17-OCT-2007, was vaccinated with a third dose of GARDASIL (Lot # 658563/1063U) (site and route unknown). There were no other concomitant medications at the time of vaccination. On 01-DEC-2007, the patient developed life threatening Crohn's Disease after this vaccine. For 2 years she was unable to function normally, incurred school, daily pain, hospitalized twice, searched for alternative medicine treatments, they found one that worked at the time off allopathic drugs, functioning normal for most part. She was not getting chelation treatment for mercury toxicity related to all of her vaccine. 2 years of pure hell for the family. The following information was obtained through follow up and/or provided by the government. On 14-DEC-2011: Hospital, outpatient records received. Service dates 22-MAY-2008 to 06-JUN-2008. Diagnosis: Inflammatory bowel disease consistent with Crohn's disease. Patient presented with severe colitis, anemia, had not grown in height at a normal rate. Occasional back pain. Prominent anal skin folds and fissure. Fever. Places on prednisolone and iron with improvement. Muscle aches. Perianal erythema. On 14-DEC-2011, consultant records received. Service dates 29-MAR-2007 to 18-JUN-2008. Additional information abstracted. Diagnosis: inflammatory bowl disease (IBD) most consistent with Crohn's disease. Frequency of bowel movements decrease. Subxiphoid pain. Decreased prednisone, began sulfasalazine and folic acid. On 14-DEC-2011, primary care provider (PCP) medical records received. Service dates 23-MAY-2007 to 21-JUN-2008. Diagnosis: Probable viral illness. Crohn's disease. Patient presented with cough, runny nose. Later diarrhea, abdominal pain, blood in stools. Sore throat and fever, abdominal pain. On 21-DEC-2011, discharge summary received. Service date 25-MAY-2008, diagnosis: Colitis, Crohn's Disease, Microcytic anemia, Hematochezia/Diarrhea. No additional information abstracted. On 09-JAN-2012, hospital records and discharge summary received. Service dates 23-OCT-2008 to 25-OCT-2008. Additional information abstracted. Diagnosis: Crohn's disease, fever most likely secondary to viral infection. Patient presented with increased stool frequency, urgency, tenesmus, and fever. Patient had been taking multiple "alternative" medications and was seen in the emergency room (ER) for concerned that she was having a flare. Short stature. Admitted for IV hydration and steroids. Iron discontinued and patient tolerated a regular diet. Feeling much better and discharged. The following information was obtained through follow-up and/or provided by the government on 14-DEC-2011, a colonoscopy was abnormal; biopsy to GI tract multiple sites was abnormal and medical observation showed reflux symptoms and mid sternal chest pain. On 09-JAN-2012, serum albumin test was 3.0; serum alkaline phosphatase test was 114; serum alanine aminotransferase test was 9; blood hemoglobin test was 10.7; blood platelet count was 605; mean corpuscular hemoglobin was 21.1; mean corpuscular hemoglobin concentration was 30.1; red cell distribution width test was 15.6; blood segmented neutrophil count was 86; blood lymphocyte count was 7; antisocyte observation was slight and poikilocyte observation was slight. The listing indicated that one or more of the events required hospitalization and was considered to be immediately life threatening. The original source was not provided. The VAERS ID # 445232. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 658563/1063U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.