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This is VAERS ID 523069

Case Details

VAERS ID: 523069 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Submitted: 2014-02-19
Entered: 2014-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005923 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Headache, Malaise, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 11/11/2013, GARDASIL; Drug Reaction: Gastritis; 11/11/2013, GARDASIL, Drug Reaction: Vomiting; 11/11/2013, GARDASIL, Drug Reaction: Pyrexia; 11/11/2013, GARDASIL, Drug Reaction: Malaise; 11/11/2013, GARDASIL, Drug Reaction: Fatigue; 11/11/2013, GARDASIL, Drug Reaction: Decreased appetite
Diagnostic Lab Data:
CDC Split Type: WAES1402GBR008906

Write-up: Information was received from Sanofi Pasteur MSD (SPM) (MFR Control# E2014-01347) on 17-FEB-2014. This case was received from health authority in the foreign country on 12-Feb-2014. GB-MHRA ADR 22422253. The case is medically confirmed. The case is linked to the case E2014-01344 (same patient, same product, same reporter, several same adverse events). A 12 year old female patient, received a second dose of GARDASIL (batch number J005923, expiry-28-FEB-2016) 0.5 mL intramuscularly, site of administration not reported, on 14-Jan-2014. Nine days after the vaccine, the patient experienced headache, vomiting, fatigue and malaise. On unreported dates, the patient experienced pyrexia controlled with paracetamol, stomach pains and joints and body aching. The patient was absent from school for 7 school days. The patient''s mother stated that her daughter seemed recovered now. She consulted general practitioner who advised that symptoms were not due to human papillomavirus vaccine. The patient''s parents were very concerned about her girl''s health and suspected adverse reaction after second dose of GARDASIL, so the mother had withdrawn her consent for the third dose of human papillomavirus vaccine. The patient received a first dose of GARDASIL (batch number not reported) route and site of administration not reported, on 11-Nov-2013 and experienced appetite lost, fatigue, gastritis, malaise, pyrexia and vomiting (see case E2014-01344 for more information). At the time of reporting, the patient had recovered from all adverse events. The MHRA considered that case serious due to the patient''s disability.

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