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This is VAERS ID 356196

Case Details

VAERS ID: 356196 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2006-10-24
Onset:2008-12-15
   Days after vaccination:783
Submitted: 2009-08-31
   Days after onset:258
Entered: 2009-09-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0241X / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antinuclear antibody negative, Balance disorder, Blood copper normal, Ceruloplasmin normal, Dysarthria, Fatigue, Gait disturbance, Headache, Insomnia, Laboratory test normal, Nuclear magnetic resonance imaging abnormal, Serology normal, Tremor, Vitamin E
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: magnetic resonance imaging, 02Feb09, apparent increased T2 signal in mid-medullary region anterolaterally on the right; magnetic resonance imaging, 02Feb09, radiologist concluded almost certainly artefact. Otherwise normal intracranial appearance; diagnostic laboratory test, 02Feb09, Vitamin E normal; coeliac serology normal; serum ANA, 22Jan09, ANA not detected; serum copper test, 02Feb09, normal; urine ceruloplasmin test, 02Feb09, normal
CDC Split Type: WAES0908USA04316

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail concerning a 16 year old female who on 24-OCT-2006 was vaccinated with GARDASIL (lot# 660614/0241X, batch # K2852). On 15-DEC-2008 the patient experienced tremor, balance disorder, dysarthria, fatigue, gait disturbance, headache and insomnia. It was reported that the patient experienced hand tremor, loss of balance, slurred speech, tiredness, headache, difficulty sleeping, not walking (short distances with a stick) and not attending school. The events required a specialist consultation - the patient saw a neurologist and was treated with ENDEP, INDERAL and EPILIM. Investigations were ongoing and inconclusive (demyelinating disease, migraine associated dysfunction). The patient has ceased medication as they made her too tired and unsteady. Laboratory evaluations revealed that: on 22-JAN-2009, antinuclear factors did not detect ANA (antinuclear antibodies). On 02-FEB-2009, magnetic resonance imaging showed apparent increased T2 signal in mid-medullary region anterolaterally on the right; radiologist concluded almost certainly artifact; otherwise normal intracranial appearance. On 02-FEB-2009, the patient had normal copper levels, ceruloplasmin, Vitamin E and celiac serology. The patient''s symptoms persisted. The agency considered that tremor, balance disorder, dysarthria, fatigue, gait disturbance, headache and insomnia were disabling and possibly related to therapy with GARDASIL. The original reporting source was not provided. No further information is available.


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