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This is VAERS ID 644516

Case Details

VAERS ID: 644516 (history)  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2016-04-07
Onset:2016-04-07
   Days after vaccination:0
Submitted: 2016-07-12
   Days after onset:96
Entered: 2016-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K021266 / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Blood test normal, Chest X-ray normal, Dizziness, Electroencephalogram normal, Headache, Muscle twitching, Nausea, Nuclear magnetic resonance imaging normal, Pain in extremity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Asthma; Drug hypersensitivity
Preexisting Conditions: Penicillin (unspecified), Drug hypersensitivity
Diagnostic Lab Data: Blood test, clear; Chest X-ray, clear; Electroencephalogram, clear, More information is available with the sender about this lab test; Nuclear magnetic resonance imaging, clear, More information is available with the sender about this lab test
CDC Split Type: WAES1607IRL002489

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control number: 2016007087), as a part of business agreement, on 06-JUL-2016. This case was received from the agency on 05-JUL-2016 under reference number IE-HPRA-2016-026529. Case received from a consumer/other non health professional on 05-JUL-2016. A 13-year-old female adolescent patient received GARDASIL (lot number: K021266) on 07-APR-2016. The patient experienced Dizziness on 07-APR-2016, Nausea on 07-APR-2016, Headache on an unknown date, Groin Pain on 09-APR-2016 2 days Post Administration, Leg, Calf and Knee Pain on 10-APR-2016 3 days Post Administration, Collapse on 10-APR-2016 3 days Post Administration, Involuntary Jerking and Twitching (constant) on 10-APR-2016 3 days Post Administration and Attention Lapse on an unknown date. The patient was admitted to hospital on an unspecified date. The patient had a medical history of: Drug hypersensitivity, Asthma. Additional investigations included: Blood Magnesium n/a on an unknown date, Chest X-Ray n/a on an unknown date, Electroencephalogram n/a on an unknown date, Nuclear Magnetic Resonance Imaging n/a on an unknown date. The patient''s outcome was reported as Recovering/Resolving. The reporter assessed the causal relationship: between Dizziness and GARDASIL as Unknown, between Nausea and GARDASIL as Unknown, between Headache and GARDASIL as Unknown, between Groin Pain and GARDASIL as Unknown, between Pain in extremity and GARDASIL as Unknown, between Faint and GARDASIL as Unknown, between Twitching and GARDASIL as Unknown, between Attention impaired and GARDASIL as Unknown.


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