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Life Threatening? No
Write-up: Information has been received from a licensed practical nurse (LPN) concerning a 20 year old female patient, who on 16-FEB-2007 was vaccinated, IM with the first dose, 0.5ml, of Gardasil (Lot #655165/1425F). Concomitant therapy included ELMIRON. On 16-FEB-2007, the patient developed a local reaction of redness and swelling at the injection site. On 19-Apr-2007, the patient was vaccinated IM with the second dose, 0.5ml, of Gardasil (Lot # 210U). Following the second vaccination, the patient again developed a local reaction of redness and swelling. Sometime following the second vaccination, the patient also became incontinent and developed numbness in her legs, feet, hands, and arms. On 03-MAY-2007, the patient was diagnosed with Guillian Barre syndrome; the next day, 04-MAY-2007 she was hospitalized. The length of the hospital stay was unknown. On 17-MAY-2007, the patient was examined by her physician with some improvement of the symptoms noted, though she continued to experienced weakness. The reporter considered one or more of the events following the second vaccination, to be significantly disabling/incapacitating, to require hospitalization, and to have required intervention as an other significant medical event. Additional information has been requested. 06/19/2007 MR received for ER visit of 4/23/07 and hospitalization 5/3-10/07. ER visit of 4/23/07 for c/o weakness, paresthesias-numbness tongue, fingers and toes, impaired swallowing, balance difficulties and light-headedness. PE:WNL. Discharged from ED with DX of Anxiety and Dizziness. Returned to ER on 5/3/2007 with c/o 3 week hx of numbness to her tongue and feet. Increased paresthesias of her lower extremities including an episode of loss of bladder control. Developed anxiety/panic attack over worsening symptoms. Sent to ER for a full GBS workup. PE WNL except for DTR''s were not elicited in the lower extremities. Admitted with assessment of Paresthesias and loss of bladder control; R/O GBS. Final DX: Guillain-Barre Syndrome. Polycystic ovaries. Migraine headaches.
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