Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram abnormal, Endotracheal intubation, Guillain-Barre syndrome, Haemothorax, Hypoaesthesia
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 26 year old female with a history of anaemia, previous-smoker and family history of GBS, on 17-AUG-2009 was vaccinated with a fourth dose of GARDASIL (lot # 662404/0312Y, route unknown) in the left arm. Concomitant therapy included YAZ. On 30-SEP-2009 the patient experienced arachnoid cyst, areflexia, asthenia, back pain, blood product transfusion, endotracheal intubation, Guillain-Barre syndrome, haemothorax, hypoaesthesia, hypoaesthesia oral, influenza like illness, intensive care, muscular weakness, plasmapheresis, reflex test abnormal, respiratory failure and tracheostomy. The patient experienced ascending paralysis, respiratory failure requiring intubation. She had IVIG (intravenous immunoglobulin) for 5 days followed by plasmapheresis for 5 days. The patient remained intubed and was in ICU (intensive care unit). On 22-OCT-2009 Hospital records were received for dates 01-OCT-2009 to 26-OCT-2009. The patient was currently diagnosed as GBS (Guillain-Barre syndrome). On 01-OCT-2009 the patient presented to ER with complaint of numbness in all extremities, pain, weakness in legs, back pain, numbness in mouth. Patient was in ER 1 day prior and sent home. Symptoms increased patient returned to ER. The patient complained of flu like symptoms 10 days prior. Assessment: WNL (Within normal limits) except, absent knee reflexes, hypoflex of lower extremities (+) intramuscular fluid around dpine at occipital cervical junction. The patient's diagnoses at time of assessment were GBS vs idiopathic polyneuropathy vs MS (Multiple Sclerosis). Patient was admitted to medical unit, symptoms deteriorated and she was transferred to ICU. Further assessments: absent deep tendon reflexes of upper and lower extremities, complaint of pain throughout entire spine. MRI of spine (+) arachnoid cyst. On 05-OCT-2009 the patient was intubated, and treatment with IVIG, no response. The patient had lab test of Plasmapheresis. The patient was diagnosed as GBS, respiratory failure and hemothorax. ON 15-OCT-2009 tracheotomy was placed. The patient required ER visit, and the outcome was not reported at the time of report. Diagnostics and labs included: EKG sinus tachycardia; DVT(-); abdominal US(-); CXR abnormal-LLL infiltrates, CT chest (-); LP abnomral-CSF protein(H); CSF glucose(H); CSF WBC(H); CSF ALB 9(L). The listing indicated that one or more of the events required hospitalization, required extended hospital stay , was considered to be immediately life-threatening. 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 and was released. The originally reporting source was not provided. The VAERS ID # is 361227.