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This is VAERS ID 299242

Case Details

VAERS ID: 299242 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2007-03-29
Onset:2007-04-01
   Days after vaccination:3
Submitted: 2007-12-10
   Days after onset:253
Entered: 2007-12-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0014U / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Aura, Computerised tomogram normal, Electroencephalogram normal
SMQs:, Convulsions (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Remeron, Zoloft, Topamax
Current Illness: Anxiety; Depression
Preexisting Conditions: HPV #2, Lot # 0181U, given RA 6/4/07; HPV #3, Lot # 1265U, given RA 10/5/07. PMH: migraines, depression. Chickenpox & RSV in infancy, recurrent OM w/ ear tube placement in childhood. Anorexia nervosa. Hospitalized for croup. Precocious puberty, amenorrhea, bradycardia, bone age of 16 yrs on 3/29/07. Family hx: HTN, leukemia
Allergies:
Diagnostic Lab Data: electroencephalography no epileptic activity detected, head computed axial no mass or tumors LABS: EEG WNL.
CDC Split Type: WAES0712USA01112

Write-up: Information has been received from a physician, concerning a 14 year old female patient, with anxiety and depression and no known drug allergies, who was vaccinated IM with the first, second and third doses of Gardasil, 0.5 ml, as follows: dose one on 29-MAR-2007, (lot #653736/0014U), dose 2 on 04-JUN-2007 (lot #656371/0181U), and dose 3 on 05-OCT-2007 (lot #659435/1265U). Concomitant therapy included sertraline HCl (ZOLOFT), mirtazapine (REMERON) and topiramate (TOPAMAX). In mid-April, following the first dose, the patient experienced a seizure. The seizures have occurred weekly. The patient was seen in the emergency room 4 or 5 times, and was examined by a neurologist (details not provided). A 24 hour electroencephalogram showed no epileptic activity, and imaging of the head showed no mass or tumors. The seizures were further described as tonic clonic, with aura. It was not known if the patient was actually hospitalized. At the present time, the patient was not being treated with anti-seizure medications, and the source of the seizures had not been identified. At the time of this report, the seizures were ongoing. The physician considered the events to be serious, as an other important medical event, and as disabling/incapacitating. Additional information has been requested. 3/23/09 Received hospital medical records of 3/29/07-12/11/2007. FINAL DX: no d/c summary dictated & neuro consult dx non-epileptic events, possible panic attacks. Records reveal patient experienced possible seizures since 4/2007. Right anterior ilias spne tenderness & difficulty walking 8/3/07, hip x-rays neg. Admitted on 11/14-15/07 for video EEG. Symptoms included falls, shaking lasting 1-10 min, fatigue, dizziness, metal tast, unable to speak, heart fluttering, nausea/vomiting, anorexia. Neuro examination WNL. Returned to hospital 12/11-12/12/2007 for continued possible partial seizure/syncope episodes. Neuro examination WNL. When 48hr video EEG neg, referred to psych. 4/29/08 Received Neuro consult of 11/8/2007. FINAL DX: Seizure, possible complex partial seizure. Psychogenic nonepileptic events cannot be entirely ruled out. Syncope. Records reveal patient experienced increasingly frequent episodes of fatigue, dizziness, metallic taste & disorientation. Was currently on antiseizure meds & had normal EEGs & CT scan. Antiseizure meds were d/c & pt scheduled for video EEG.


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