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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This spontaneous report was received from a nurse refers to an adult female patient of unknown age. The patient''s current condition included asthma. There were no medical history, drug reactions/allergies and concomitant medications reported. On unknown dates prior to 2015, the patient was vaccinated with GARDASIL and M-M-R II (dosing details not provided). Approximately in May 2015, the patient was diagnosed with immature ovarian teratoma. Nurse reported that the patient was seen and treated by unspecified healthcare providers, and had several unspecified lab/diagnostic testing at unspecified locations on unspecified dates. The patient required medical attention and was treated with six rounds of chemotherapy with several medications including cisplatin, etoposide and bleomycin. However, the patient was not hospitalized. Nurse stated that the patient was incapacitated for an unspecified reason for an unspecified amount of time after an unspecified treatment for immature ovarian teratoma. Outcome of the event was reported as not recovered. Nurse reported that it was decided to re-vaccinate the patient with M-M-R II on unspecified date in September or October 2016, due to possible effect of chemotherapy treatment on the immunity of measles, mumps and rubella. It was unknown whether the patient was re-vaccinated or not. Reporting nurse had not assessed the causality of the event with respect to both vaccines, GARDASIL and M-M-R II. Nurse considered the event to serious due to disability. Upon internal review, the event immature ovarian teratoma was considered to be medically significant. Additional information has been requested.
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