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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 patient was on a thin, pureed diet with a speech therapist working with the patient. The patient had been followed by a respiratory therapist. Negative inspiratory force had been around -60. The patient was transferred to acute inpatient rehabilation. On review of the patient''s history and physical the patient had some numbness, on the platar aspect of bilateral feet. The patient had no pain and had facial weakness with bilateral facial paralysis. She was able to move slightly her right perioral muscles. She was able to smile slightly on the right side. She was alert and oriented times. Her speech and language were fluend and intact. Her temperature was 16.7: pulse 98, and blood pressure 100/70 mmHg. The patient''s upper extremity strenght was 4/5. The patient DTK were absent throughout. The patient''s sensation was grossly intact to light touch, though she complained of some numbness and tingling in the bottome of her feet bilaterally. The patient had gait abnomality, dysphasia. Gullian-Barre syndrome. The plan was to admit the patient to an acute inpatient rehabilitaiotn facility with physical therapy working on pregressive transfers and mobility to imporve balance. Occupational therapy woud be used for strengthening of her right upper extremity, and work with the patient regarding activities of daily living eating grooming, toileting, toilet transfers. The patient was scheduled for speech therapy regarding the patient''s bilaterial facial paralysis. When was on a pureed diet with liquids, with plans to unprage her diet per recommendation form speech therapy. Respiratory was scheduled to monitor the patient''s negative inspiratory force. The patient was scheduled for neurolgic evaluation for increasing weakness. The estimated time for inpatient treatment was 2 weeks time with the goal of the patient being discharged to home. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addtion, an expanded lot check investigatoin was performed. The testing performed on the batch prior to release me all release specification. The lot met the requirements of the Centerfor Biologics Evaluation and Research and was released. Additional information has been requested. Follow up information has been received from a local television news station that reported "the patient was a high school athlete and the picture of health until she suddenly ended up in the hospital. She ended up staying there for 23 days. Her family suspected an adverse reaction to the GARDASIL. Her neurologist says it is a possibility". "When the patient went to get a physical before heading off to college, she received three vaccines that day: one for HPV, one for meningitis and one for chicken pox. Within a week, the former soccer player could barely move". "At first my outer fingers, my pinkies, were going numb". She said "and my outer toes were going numb. When I went into the hospital, I couldn''t walk at all. I had to have a wheelchair". Additional information is not expected. This is a consolidation of two reports concerning the same patient.
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