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This is VAERS ID 531017

Case Details

VAERS ID: 531017 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-02-10
Onset:2012-02-28
   Days after vaccination:18
Submitted: 2014-05-15
   Days after onset:806
Entered: 2014-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: CSF pressure, CSF test, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Electroencephalogram, Fatigue, Headache, Nuclear magnetic resonance imaging brain, Ophthalmological examination, Photophobia, Syncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (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: Immunisation
Preexisting Conditions: 10/07/2011, GARDASIL
Allergies:
Diagnostic Lab Data: CSF pressure, not provided; CSF test, not provided; Echocardiogram, not provided; Electrocardiogram, not provided; Electrocardiogram ambulatory, not provided; Electroencephalogram, not provided; Nuclear magnetic resonance imaging brain, not provided; Ophthalmological examination, not provided
CDC Split Type: WAES1405DNK006921

Write-up: Information has been received from SP MSD (manufacturer control number E2014-04063) on 14-MAY-2014. Case was received from a health care professional via the Health Authorities on 09-May-2014 under the references DK-DKMA-ADR 22521429 and DK-DKMA-EFO8853. Case is medically confirmed. Primary source was a physician. A 12-year-old female patient (weight 54 kg, height 173 cm) with no medical history reported received a dose of GARDASIL (batch no. reported as 004954) via intramuscular route into not reported site of administration on 10-Feb-2012. On 28-Feb-2012, the patient developed tiredness, visual disturbance, photophobia, fainting and severe headache. MRI of cerebellum, eye examination, CSF test, pressure measurement, EEG, ECG, Holter monitoring, echocardiography was performed. No results were provided. No other medication was given. At the time of reporting, the patient was recovering. A previous dose of GARDASIL was given on 07-Oct-2011 (batch no. reported as 004954) via intramuscular route on 07-Oct-2011. Toleration was not reported.


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