Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Gene mutation identification test positive, Homocystinaemia, Hyperlipidaemia, Pain in extremity
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 21 year old female on 09-JAN-2007, was vaccinated with the second dose of Gardasil (lot # 654389/0961F). She had started taking hormonal contraceptives (unspecified) birth control pills (BCP) for the first time in February 2007. On 06-MAR-2007, the patient experienced back pain, chest pain, dyspnoea, flank pain, musculoskeletal pain, pain in extremity, pulmonary embolism and pulmonary infarction. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. It was reported that the patient traveled from 03-MAR-2007 to 10-MAR-2007. It was reported that the patient had calf pain that traveled to the thigh on 06-MAR-2007. On 19-MAR-2007, the patient went to the Medical Center Emergency Room (ER) for severe pain in the lower back. Two large clots were found in the lung (Pulmonary embulus). The patient was admitted to the hospital for heparin treatment for a few days. The patient was discharged on COUMADIN for 6 months. The patient had lingering pain in the lower back and damage to the lung. She had genetic testing done after the pulmonary embolus which showed that she had a prothrombin genetic mutation, elevated lipoprotein and hemocystine line. Initially presented to the Emergency Department (ED) on 19-MAR-2007 with complaints of c/o right back pain which was worse upon lying down, as well as pain in the chest which was worse with deep breathing. The pain radiated to the right shoulder. She had been having some right leg discomfort while traveling prior to the ED visit. On 19-MAR-2007 a computed axial tomography (CT) scan revealed bilateral pulmonary emboli and consolidation in the right lower lobe of the lung with possible necrosis in the middle of the right lower lobe. A chest x-ray on 20-MAR-2007 revealed some improvement. A complete blood count (CBC) revealed white blood cell count (WBC) of 14.7 with International Normalized Ratio of 1.01. Past Medical History (PMH) revealed recent travel with 2 flights x 3 hours. On BCP, she was admitted to the hospital with the diagnosis of "LBP", right flank pain, pulmonary embolism and pulmonary infarct. Pulmonary critical care consult revealed the diagnosis of pulmonary embolism and infarct. The patient returned to the ER on 25-MAR_2007 with c/o calf pain since that morning, with shortness of breath (SOB) times (x) one week. The diagnosis was calf pain. On 21-MAY-2007, medical records (MR) were received from the treating hospital. 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 the 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. This was originally reported by an "other". Additional information has been requested.