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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: This spontaneous report was received from a consumer and lawyer via a company representative, referring to a case in litigation regarding a female patient of unknown age. The patient''s medical history and concurrent conditions were not reported. On 27-FEB-2015, the patient was vaccinated with GARDASIL 0.5 ml, intramuscular (lot# and expiration date were not reported). Concomitant therapy was not reported. On an unspecified date in February 2015, the patient experienced body pain. Subsequently on 18-MAR-2015, the patient visited her physician and a leucocyte count was performed and the result was low leukocyte count, reported as severe neutropenia (2.180 unit reported as mm/3). On 19-MAR-2015 the patient experienced fever and general clinical chart worsening and was hospitalized. During the hospitalization the patient''s hematologist reported granulocyte maturation blockade and prescribe an unknown medication to increased the leukocyte count. Also during the hospitalization the patient''s physician reported patient''s blocking the production of leukocyte setting patient''s life a risk (life threatening) once that the patient was presenting low immune response. The reporter related the blocking the production of leukocyte to the therapy with GARDASIL. On 23-MAR-2015 the patient was discharged from hospital. The outcome of body pain, severe neutropenia, fever, general clinical chart worsening, granulocyte maturation blockade, blocking the production of leucocyte and low immune response was unknown. The relatedness of body pain, severe neutropenia, fever, general clinical chart worsening, granulocyte maturation blockade, and low immune was not reported for GARDASIL. Additional information is not expected once that the case is a litigation case.
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