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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Information has been received from a gynecologist that a 14 year old female patient who was vaccinated IM with a first dose of GARDASIL (lot number and injection site not reported) on 06-FEB-2008. On unspecified date ("in a temporal relationship to GARDASIL vaccination"), the patient developed diabetes mellitus type I. The patient had not recovered at the time of reporting. Upon internal review on 04-JUN-2009, the case was considered medically significant. Type I diabetes mellitus was considered to be disabling by the gynecologist. Other business partner numbers included (E2009-04463). No further information is available. Follow up has been received on 16-JUN-2009. The hospital report was provided. The patient was hospitalized from 26-AUG-2008 until 12-SEP-2008. Hospital diagnosis: "Manifestation of diabetes mellitus type I with ketoacidosis and precoma diabeticum". Since a "few weeks before hospitalization" the patient experienced polydipsia and polyuria and lost 7 kg of weight. Since about 2 weeks before hospitalization her general condition began to reduce. Since one week she suffered from angina tonsillaris which was treated with antibiotics. Symptoms worsened remarkably and she was hospitalized on 26-AUG-2008. At the time the patient was slightly drowsy (Glasgow coma scale 14) showed Kussmaul respiration and signs of exsiccosis Hyperglycemia (27 mmol/L) had been determined by the physician on emergency. Therapy was started with rehydratation and insulin intravenous. Intensive insulin therapy (LANTUS and NOVORAPID) was started from the third day of hospitalization. In the course of the quantity of insulin could be measurably reduced. In the meantime the patient developed a pruritic, partly urticarial rash which was successfully treated with FENYSTIL. Lab findings see lab comments: Gliadin-IgA and Gliadin-IgG, tTG(endomysium) Ig A were normal. The patient had a family Medical history of Diabetes mellitus type 2 (maternal grand father). The patient was discharged in a good general condition. Duration and outcome was not reported for each symptom. This is an amended report. Information received date was updated in the narrative from 16-JAN-2009 to 16-JUN-2009. Gliadin-IgM was changed to Gliadin-IgG and lab data field was updated. File is closed. No further information is available. This is a corrected report, as amended.
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