Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dehydration, Dizziness, Enzyme abnormality, Gastrointestinal tube insertion, Injection site pain
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 13 year old female with seasonal allergies and no pre-existing illnesses who on 27-FEB-2007 was vaccinated, intramuscularly into the left arm with the first dose of Gardasil, (lot # 654741/1208F). It was reported that the patient experienced abdominal pain, upper, blood test, body temperature increased, chest pain, computerized tomogram abnormal, dizziness, dehydration, enzyme abnormality, gastrointestinal tube insertion, injection site pain, lipase increased, nausea, pain, pancreatic cyst, pancreatic pseudocyst drainage, pseudocyst, surgery, swelling, vomiting and nausea. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. (Per the mother's written statement submitted to the Health department on 18-JUL-2007) on 27-FEB-2007, at approximately 1:30 p.m. the patient received Gardasil. That evening she ran a low grade temperature and complained of pain at the injection site. The following afternoon at approximately 2:30 p.m., she began to experience pain in her chest and upper abdomen and continued to run a low grade fever. On 29-FEB-2007, she began experiencing nausea and vomiting which continued through the week. On 02-MAR-2007, she went to the family physician who felt that it was a virus and prescribed some prescription nausea medication and something for her stomach. She continued to throw up and run a low grade fever that rarely went over 101 degrees Fahrenheit. On 13-MAR-2007, the patient was taken to the Emergency Room (ER). The patient's mother requested that blood tests be done because the patient had been sick a long time. The mother thought the patient was dehydrated and she thought that something other than a virus was going on with the patient. The ER physician checked the patient's enzyme levels and her lipase was over 1000. The patient was hospitalized for 11 days and her enzymes continued to fluctuate. "Hospital was called and they did not have any beds available at that time." A computed axial tomography (CAT scan) revealed a small pseudocyst on her pancreas and it was expected to resolve on its' own. She was released on the 23-MAR-2007. On 30-MAR-2007, she was taken to the hospital and admitted. They found the pseudocyst had grown and she had developed another cyst on her pancreas as well. She was hospitalized until 02-APR-2007 and then released. On 05-APR-2007, the patient went to the physician and her enzymes were back up over 700. On 24-APR-2007, they had come down to 435. On 03-MAY-2007, her pain got worse and she was taken back to the hospital and was released, as she was to have surgery on 14-MAY-2007. On 14-MAY-2007, she had surgery and her pseudocyst was drained. She was released on 20-MAY-2007. On 09-JUN-2007, she was taken back to the ER and her enzymes were up again on 12-JUN-2007. No further information is available. A lot check of concern has been requested. A standard lot check investigation was performed. 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 and was released. Additional information has been  requested. 8/30/07-records received for DOS 3/30-4/2/07-DC DX: Chronic pancreatitis. Pancreatic pseudocyst. Four to five days prior developed an acute episode of nausea and vomiting and abdominal pain. Thirty days prior she developed abdominal pain.