Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | UNK | — | OT |
She had an "abnormal pap smear"; This spontaneous report was received from other health professional and refers to a 37-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date (reported as received the first generation Gardasil vaccine series in year 2006/2007), the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), administered by Unknown route (dose, anatomical location, lot #, and expiration date were not reported) as prevention of human papilloma virus (HPV). On an unknown date, the patient experienced an abnormal pap smear requiring colonoscopy for further evaluation on 01-APR-2025. At the reporting time, the outcome of event was not provided. Additional information was not known at that time. The causal relationship between the event and the suspect vaccine was not reported. Additional information is not expected.