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Life Threatening? No
Write-up: Information has been received from a registered nurse, concerning a 50 year old female with hearing loss (16-AUG-2007), a facial nerve disorder, Lyme disease with arthritis, pruritus, multiple allergic reactions to antibiotics including tetracycline, CECLOR and KEFLEX, and multiple drug hypersensitivities including morphine, and propoxyphene and DARVOCET, who on 21-FEB-2007 was vaccinated with the first dose, 0.5 ml, IM in the left deltoid, of GARDASIL (lot #656372/0243U). Concomitant therapy included INDERAL, MINOCIN, TRILISATE TABLETS/LIQUID), DIAMOX and MIDRIN. On 05-APR-2007 the patient was hospitalized after she developed facial palsy. The nurse reported that on 09-APR-2007, the patient called the office to report her condition. The patient remained hospitalized until 16-APR-2007, and on that day she called the office, and stated that she "had a possible diagnosis of Guillian Barre syndrome." The patient reported she believed that Gardasil caused her condition, and had requested a human papilloma virus antibody test. The reporter considered the event of facial palsy and possible Guillian Barre syndrome to be an other significant medical event. Additional information has been requested. 5/27/08 Received additional medical records from FDA which patient had provided & include consultant records from out of state clinic neurologist on 10/02/2007 diagnosing w/GBS Miller Fisher variant. Tx w/IVIG w /some improvement but residual facial deficits. Patient also submitted own VAERS report. 5/29/07 Received hospital medical records which reveal patient experienced sudden inability to speak, close eyelids or move face, and unable to swallow. Admitted 4/4-4/16/07. Neuro & Psych consults done. Treated w/IV antibiotics in hospital & continued on IV antibiotics at home FINAL DX: cerebral Lyme disease. 1/21/2010 Many permanent, significant, severe and disabling neurological and other-including whole body-symptoms from Guillian Barre Syndrome.
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