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This is VAERS ID 531010

Case Details

VAERS ID: 531010 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-20
Onset:2013-06-21
   Days after vaccination:1
Submitted: 2014-05-15
   Days after onset:328
Entered: 2014-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000396 / 0 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Depression, Lymphoedema, Manual lymphatic drainage, Oedema peripheral, Ultrasound scan abnormal, Venogram abnormal
SMQs:, Cardiac failure (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 16 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: 17-OCT-2013: Sonogram: lymphoedema grade II; 18-OCT-2013, Phlebography: lymphoedema
CDC Split Type: WAES1405DEU006905

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # DE-1577272925-E2014-04013) on 13-MAY-2014. Case was received from a physician on 08-May-2014. Case is medically confirmed. A 14-year-old female patient (weight: 45.2 kg; height: 152 cm) received a first dose of GARDASIL (lot-no. J000396, Exp. Date: 31-JUL-2015 - this batch was not released by HA for SPMSD) IM into the deltoid muscle on 20-Jun-2013. One day later, on 21-Jun-2013, she developed lymphoedema of the right upper ankle joint. During the further course the oedema was spreading to the right lower leg. On 20-Aug-2013 the patient received the second dose of GARDASIL (lot-no. J001201, Exp. Date: 04-JUL-2015) IM into the deltoid muscle. The patient was hospitalised from 12-to 27-Sep-2013, the report was not provided. On 17-Oct-2013 duplex sonography showed lymphoedema grade II. On 18-Oct-2013 diagnosis of lymphoedema of the upper ankle joint was confirmed by phlebography. Since 17-Feb-2014 she additionally developed lymphoedema of the right wrist. On 24-Feb-2014 she received the third dose of GARDASIL (lot-no. J004473, Exp. Date: 12-OCT-2015) IM into the deltoid muscle. The patient was treated with support stockings and lymph drainage twice a week. Since Feb-2014 the patient additionally developed depressive episodes due to lymphoedema. She was treated with psychotherapy. At the time of reporting the patient had not recovered and the reporter assessed a "persisting damage". According to the reporter, the reaction was possibly related to vaccination.


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