Report #2827398

Overview

Sex

Female

Age

Age unknown

State

—

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

cervical cancer; cervical dysplasia; This spontaneous report was received from a consumer (patient's mother) and refers to a currently 35-year-old female patient. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On an unknown date, as a child, the patient was vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) suspension for injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient ended up with cervical cancer or cervical dysplasia. At the reporting time, the outcome of the events was unknown. Causality assessment was not provided. Upon internal review, the event of cervical cancer was determined to be medically significant. Lot # is being requested and will be submitted if received.