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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: Information has been received from a physician concerning a 15 year old female patient with no drug reactions/allergies and a history of learning disability and cognitive impairment who on 23-JAN-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot # 660557/0072X). There was no concomitant medication. On 20-MAR-2009 the patient received the second dose of GARDASIL (lot # 660557/0072X) and on 18-SEP-2009 the patient received the third dose of GARDASIL (lot # 663452/0671Y). On 07-NOV-2009 the patient developed a seizure and was hospitalized for 2 to 3 days. The physician saw the patient on 13-NOV-2009 "today" and the patient''s mother said the patient was "fine". The patient was on an unspecified antiseizure medication. A neurology consult was pending. MRI results were pending, cat scan and blood tests were normal. Seizure was considered to be immediately life-threatening and disabling. Additional information has been requested. 11/23/2009 Out-patient progress notes and laboratory test reports received for DOS 09/18/2009-11/13/2009. Assessment: Seizure Disorder Patient had generalized seizure (2 episodes). Hospitalized 11/07/2009 through 11/09/2009. Progress note of 11/13/2009 notes patient alert and oriented X3 and neuro intact. 12//8/09 Inpatient hospital records received. Service dates 11/7/09 to 11/9/09. Assessment: Generalized Tonic/Clonic Seizure. Mother heard strange noise, found patient stiff, head turned to left. Tonic/Clonic movements of limbs followed by postictal state. Urinary incontinence. Presents unresponsive. Seizure in ER. Cold sensation. Headache. Hand grasp weak. Slow to answer questions.
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