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This is VAERS ID 523039

Case Details

VAERS ID: 523039 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-11
Onset:2013-11-21
   Days after vaccination:10
Submitted: 2014-02-19
   Days after onset:90
Entered: 2014-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005923 / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Decreased appetite, Fatigue, Gastritis, Malaise, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402GBR008500

Write-up: Information has been received from SPMSD (manufacturer control# E2014-01344) on 17-FEB-2014. This case was received from health authority on 12-Feb-2014. GB-MHRA ADR 22411680. The case is medically confirmed. The case is linked to the case E2014-01347 (same patient, same product, same reporter, several same adverse events). A 12 year old female patient, with no medical history reported, received a first dose of GARDASIL (batch number J005923, lot number J005923, expiration date: 28-FEB-2016) 0.5 mL intramuscularly, site of administration not reported, on 11-Nov-2013. On 21-Nov-2013, the patient experienced pyrexia, prolonged vomiting, malaise and fatigue. On unreported dates, the patient also had no appetite and vomiting caused gastritis. The patient had 2 weeks school absence due to these symptoms. The patient''s parents were very concerned about girl''s health and suspected reaction to GARDASIL. The patient was treated with paracetamol. On 05-Dec-2013, the patient had recovered from pyrexia. On 28-Jan-2014, she had recovered from fatigue. On 29-Jan-2014, she had recovered from malaise. At the time of reporting, the outcome for appetite lost and gastritis was unknown. The regulatory authority considered that case serious due to the patient''s disability.


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