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Administered by: Private Purchased by: Private
Life Threatening? Yes
Write-up: RECEIVED GARDASIL, VARICELLA VACCINE AND MENACTRA 6-21-07. DEVELOPED LOWER EXTREMITY NUMBNESS 7-2-07 AND DIAGNOSED WITH GUILLAN-BARRE SYNDROME 7-5-07. This is in follow-up to reportial previously submitted on 08/14/2007; 10/8/2007, 1/17/2008. Initial and follow up information has been received from a physician and identitied from a line listing obtained on request by the Company form the FDA under the Freedom of Information Act, an 18 year old female with mild eviornmental allergies and positive Epstein-Marr Virus titer by history, with no pre-existing illness, and no illness at the time of vaccination whose reported weight was 158 pounds and whose reported height was 56.5 inches, who on 21-Jun-2007 was vaccinated at 10:30 a.m., intramuscularly into the right deltoied with a firset dose of HPV lot #657868/0523U and concomitantly vaccinated, intramuscularly into the right arm with the second dose of secondary suspect therapy VARIVAX Merck, (lot #657412/0594U) and vaccinated IM with the first dose of MENACTRA, (lot # U2155CA), (Sanofi Aventis-Pasteur). The physician reported that the patient developed "Guillan Barre Syndrome" after receiving a dose of HPV over at the hospital and had to be hospitalized. In follow up the physician reported that on 02-Jul-2007 the patient''s parents contacted him and stated that the patient had foot and lip numbness (hypoaesthisis). The patient went to the ER on 05-Jul-2007. She was admitted to the hospital on 05-Jul-2007 where she was seen by a neurolgist and the neurologist diagnosed the patient with Gullian-Barre Syndrome. While hospitalized the patient received the following treatment, oxygen no intubation IV therapy hyperailmentotion for nutrition and IV immunoglobin. She also received physical therapy, speech and recreational therapy. She was discharged from the hospital on 27-Jul-2007. She required physical therapy after hospital discharge. In the hospital unspecifed labs and spinal tap were performed. The "spinal tap results was positive high protein and the culture was negative". The outcome was partial recovery. This listing indicated that one or more of the events required hospitalization. No further informatio is available.The reporter indicated that the patient''s adverse events were disabling, life-threatening and an other important medical event. Information was received via Medical Recored concerning an 18 year old, female, student with mild enviornmental allergies and positive Epstein-Barr Virus titier by history, with no pre-existing illness, no allergies and no illness at the time of vaccination whose reported weight was 158 pounds and whose reported height was 56.5 inches, with a past medical history of constipation, right extraocular muscle weakness with right extraocular muscle repair, who lives with her parents and two sisters, who on 21-Jun-2007 wa vaccinated at 10:30 a.m., intramuscularly into the right deltoid with a first dose of HPB lot #657868/0523U and concomitantly vaccinated, intramuscularly into the right arm with the second dose of secondary suspect therapy MENACTRA (lot # U2155CA). "Sanofi Aventis-Pasteur". It was reported that the patient went to the hospital on 05-Jul-2007 wtih numbness and weakness of bilateral lower extremities and right hand and facial paralysis. The patient initially had an acute onset of weakness starting on 30-Jun-2007. She was vacationing at the time. The patient continued to have increased weakness after returning from her vacation. The patien was evaluated at the emergency room. She had a CAT scan of the head, within normal limits. InitiallyLP was declined. The patient was evaluated in the clinic on 05-Jul-2007, and found absent deep tendom reflexes, and she was admitted ot pediatric intensive care unit. The patient''s symptoms advanced status post five courses of IVIG. The patient continued with bilateral facial paralysis. The patient had mild imporvement in the right upper extremity weakness, and bilateral lower extremity weakness. The
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