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This is VAERS ID 629756

Case Details

VAERS ID: 629756 (history)  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-11-30
Onset:2012-02-11
   Days after vaccination:73
Submitted: 2016-03-02
   Days after onset:1481
Entered: 2016-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. G005669 / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Headache, Hypoaesthesia, Paraesthesia, Seizure, Skin disorder, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
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: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1603IRL000353

Write-up: Information has been received from Sanofi Pasteur MSD (reference # IE-1577272925-2016001773) on 01-MAR-2016. This is the initial spontaneous case report received from a member of the public (patient''s mother) via RA Ref no. (025988) on 26/Feb/2016 which concerns an 11 year old female patient who experienced Fatigue, Syncope, Seizure, Paraesthesia, Hypoaesthesia, Skin disorder and Headache following vaccination with GARDASIL. Concomitant medications: None. Medical history/concurrent conditions: None reported. The patient was vaccinated with 3 doses of GARDASIL - dose 1 on 30/Nov/2011 (batch/lot no. G005669, expiry date 31-JUL-2013), dose 2 on an unspecified date (batch/lot no. G005669, expiry date 31-JUL-2013) and dose 3 on 28/Mar/2012 (batch/lot no. NM31130, expiry date not reported). Post vaccination, reported as 11/Feb/2012, the patient experienced extreme fatigue, fainting, seizures, headaches, fingers tingling and going numb and a skin condition. The reporter added that the patient''s symptoms became very prominent after dose 3 and is having ongoing hospital treatment. The reporter considers the patient''s reactions as debilitating and effecting her life and future. At the time of reporting the patient''s symptoms were persisting. The reporter assessed the causal relationship between the adverse reactions and GARDASIL as Unknown. Upon internal review the batch numbers of GARDASIL were changed from (GOO5669 to G005669).


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