Reporte zur Charge 1063U

Symptomtext

started dragging her left foot not lifting in properly, just you can tell something was happening to her gate, she was walking different"/She couldn't speak. she wouldn't walk/ She can barely hold a pen or pencil, leg tingling and pain is constant,; Tingling and numbness of her left leg below the knee; Tingling and numbness of her left leg below the knee/ pain is constant, it doesn't away, it hurts for her to walk very far at all/Leg paranesthesia and dysarthria; She just progressively gets worse/ she is deteriorating and her body is deteriorating.; spasticity; Seizures; I never took her back for the third dose; This spontaneous report was received from a patient's mother concerning to a 29-year-old female patient. The patient's concurrent condition included: extraocular muscle paresis and allergy to cats. Her medical history included: tonsils removed and 2 surgeries as a child. Concomitant therapies were not reported. In December 2007, the patient received the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), by intramuscular route, lot #1063U, with an expiration date of 17-APR-2010 and on 04-FEB-2008, the patient received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), by intramuscular route, lot # 1267U, with an expiration date of 18-JUL-2010, for human papilloma virus (HPV) prevention (prophylaxis) (strength, dose, and anatomical site of injection were not reported). The patient did not received the third dose of the vaccine (intentional dose omission). Since 04-FEB-2008, the reporter stated: "the patient started dragging her left foot not lifting in properly, just you can tell something was happening to her gate, she was walking different". The patient's mother took her to a neurologist. An magnetic resonance imagining (MRI) spine, brain and electromyography (EMG) were performed but the results were not provided. Additionally, the patient's mother stated the neurologist kept seeing her for years telling her things were gonna get better and they were getting worse. At the end of her 18th year, the patient started going to another neurologist and another spine, brain MRI, genetic testing and EMG were performed and showed sensory ataxia, sensory neuropathy. Additionally, the patient experienced spasticity, leg paranesthesia and dysarthria, tingling and numbness of her left leg below the knee, and demyelinating. She received different drugs and experienced bad side effects. Moreover, she was having seizures, she could not speak, not walk. The mother took her to a geneticist and a movement disorder specialist. On an unknown date, a genetic test was performed and the result was inconclusive. She can barely hold a pen or pencil, leg tingling and pain was constant and her body was deteriorated. The patient went to the gym 4 times a week but it did not help her to speech. It was reported that the patient was hospitalized due to the events on an unknown date. Therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) was discontinued. The outcome of ataxia, seizure, muscle spasticity, condition aggravated, peripheral sensory neuropathy and demyelination was reported as not recovered. The reporter considered ataxia, muscle spasticity, condition aggravated, seizure, demyelination and peripheral sensory neuropathy to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). Upon internal review, the events of ataxia, seizure, and demyelination were considered medically significant. The events of ataxia, muscle spasticity, condition aggravated, seizure, demyelination, and peripheral sensory neuropathy were considered as disabling conditions.