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This is VAERS ID 630641

Case Details

VAERS ID: 630641 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
   Days after vaccination:335
Submitted: 2016-03-04
   Days after onset:304
Entered: 2016-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Colour blindness, Daydreaming, Diplegia, Disturbance in attention, Dizziness, Dyschromatopsia, Electroencephalogram, Eye swelling, Feeling abnormal, Headache, Hypoaesthesia, Memory impairment, Mini mental status examination, Myalgia, Nuclear magnetic resonance imaging, Ophthalmological examination, Seizure, Syncope, Vision blurred, Visual field defect, Wheelchair user
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1603AUS001254

Write-up: Information was obtained on a request by the Company from the agency (Agency # 373060) via a Public Case Detail concerning to a 13 year old female patient. There were not concurrent conditions and medical history reported. On 02-APR-2014, the patient was vaccinated with the first dose of GARDASIL (route, dose, anatomical place of vaccination, lot# and expiration date were not provided, then on 04-JUN-2014, the patient was vaccinated with the second dose of GARDASIL (route, dose, anatomical place of vaccination, lot# and expiration date were not provided). There were not concomitant therapies reported. On 05-MAY-2015, the patient experienced frequent seizures, frequent fainting, muscle aches, constant headache, dizziness, constant blurred vision, ongoing loss of peripheral vision, constant dizziness, episodes of apnea, temporary paralysis of legs - full and partially lasting from days to weeks, numbness of legs and or parts of legs and right side of face, swollen eyes, memory lapses, "zoning out" absentmindedness, lacks concentration - unable to read and absorb information also, was reported that temperature was recorded (on an unknown date) with some of the seizure episodes (results was not provided), colourblind and mixed up colours for almost 2 months (from an unknown date in May 2014 to 30-JUN-2014) (conflicting information). On an unknown date, the patient was hospitalized (no coded by the agency), a wheelchair was given, the patient was treated with PANADOL, NUROFEN and ENDONE. On an unknown date, was performed a Electroencephalogram (EEG), a magnetic resonance imaging (MRI), a series of pediatric appointments, a ophthalmologist evaluation and a mental health evaluation with unknown results. At the time of the report, it was stated that the medicine halted and the patient only received 2 doses as those was given before. They connected the events with the therapy with GARDASIL, therefore the 3rd dose was not administered. The outcome of vision blurred, headache, paralysis, seizure and disturbance in attention was reported as not yet recovered. The reporter considered seizure, paralysis, headache, disturbance in attention and vision blurred to be possible related to GARDASIL. The reporter also reported that the events produced incapacity/disability to the patient. Additional information is not expected, as no further information can be obtained from the agency.

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