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This is VAERS ID 618553

Case Details

VAERS ID: 618553 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-08-25
Onset:2015-01-13
   Days after vaccination:141
Submitted: 2015-11-17
   Days after onset:308
Entered: 2015-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J010618 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Fatigue, Gait disturbance, Memory impairment, Myalgia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament 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: No other medications
Current Illness: Immunisation
Preexisting Conditions: Psychological trauma; Eating disorder; 04/23/2014, GARDASIL, immunisation; 02/12/2014, GARDASIL, immunisation
Allergies:
Diagnostic Lab Data: Blood test, not reported.
CDC Split Type: WAES1511DNK007754

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # E2015-12787) as part of business agreement on 13-NOV-2015. Case received from Health Care Professional via Health Authorities on 11-Nov-2015 under the reference number DK-DKMA-ADR 23221751 and DK-DKMA-WBS-0001596. The case is medically confirmed. The primary reporter was a physician. A 12-year-old female patient (weight: 47 kg; height: 164 cm) had received the third dose of GARDASIL, batch number J010618 via intramuscular route of administration in unspecified site of administration on 25-Aug-2014 and later on 13-JAN-2015, she developed reduced gait function, muscle pain, memory impairment, fainting and tiredness. Insidious debut of abovementioned symptoms. The parents suspect adverse reactions to HPV vaccinations. The case is serious due to seriousness criterion disability. No other vaccines or medications. The patient has undergone blood tests (not further specified). The patient''s medical history included psychological impact after bullying and the parents'' divorce. Early eating difficulties. Noteworthy: The HA had not coded the abovementioned in medical history, the company chose to code psychological trauma and eating disorder, unspecified. Previous doses of GARDASIL (D1-D2, batch no. D1 and D2: J012135) were given via IM route of administration in unspecified site of administration on 12-Feb-2014 and 23-Apr-2014. At the time of reporting, the patient had not recovered.


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