Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity, Weight bearing difficulty
Clinical narrative: Lower extremity weakness, frequent falls, lower extremity paraesthesia 5/1/07 Received medical records from 1st hospital where pt seen in ER & then transferred to higher level of care.  Pt experienced bilateral LE weaness & numbness of both legs while at school.  She tried to brace herself up against a wall but was unable to remain upright.  Exam revealed she was unable to bear weight secondary to weakness FINAL DX: paresthesia & motor weakness of bilateral legs, etiology unknown.  5/22/07 Received hospital Neuro clinic medical records which reveal patient evaluated 4/20/07 by MD who had seen her in ER week before for legs shaking w/weakness & numbness since 4/12/07.  Seen at outlying hospital ER & d/c.  On approx 4/10 had an episode of urinary incontinence.  Neuro exam was WNL except for slightly antalgic gait.  06/11/2009: This is in follow-up to report(s) previously submitted on 7/6/2007. Initial and follow-up information has been received from a immunization coordinator and a physician concerning a 12 year old female student with a sulfa allergy with a rash many years ago and no other medical history who on 27-MAR-2007 at 11:30 was vaccinated intramuscularly in the left arm with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot #655618/0186U). There was no concomitant medication. ON 12-APR-2007, the patient presented with progressive weakness of her lower extremities, one episode of incontinence and paraesthesias of both legs. On 12-APR-2007, at school, the patient noted that her legs started to shake and that she could not feel her legs well. She went to the nurse and was transferred to the hospital emergency room because of numbness in her legs and associated weakness. These events were also reported as "about two months post vaccination, sometime in May 2007, the patient could not walk and was complaining of leg pain." Over the course of that day, the patient was aware of numbness along both of her shins and persistence of that numbness over the following week though it spread to the anterior distal aspect of both thighs. It was largely symmetric. She still had some problem with the shaking of her legs when she went up or down the stairs and had been using crutches to help her walk. It was also noted that a couple of nights before this event occurred, the patient had a urinary accident at night which was very unusual for her. On 12-APR-2007, a CT of the brain was performed and was normal. On 20-APR-2007, the patient presented to the reporting physician for a visit. Nerve conduction studies and neurologic exam were performed and were all normal. ON 20-APR-2007, an MRI of the lumbar and thoracic spine was performed and was negative. About 2 to 3 weeks after the onset of progressive weakness of her lower extremities, incontinence and paraesthesias of both legs, the patient recovered. At the time of this report, the outcome of the leg pain, inability to walk, numbness along both shins/could not feel legs and shaking of legs was unknown. No product quality complaint was involved. According to the reporting physician, there was a concern about possible myelopathy and neuropathy such as Guillan-Barre syndrome. However, the reporting physician stated that "this has clearly not developed in the interval." Upon internal review, the patient's experience of "could not walk" was considered disabling. Additional information is not expected.