Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | UNK | K010574 | OT |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | OT |
patient's Papsmear test done in July 2025 showed that she has HPV.; She received GARDASIL-9 as her second dose on 07-Sep-2016 about 13 months after the first dose.; She received GARDASIL-9 as her second dose on 07-Sep-2016 about 13 months after the first dose.; This spontaneous report was received from a nurse and refers to a 21-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported. On 14-Jul-2015, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injection (lot# K010574, expiration date not reported, but upon internal validation established as 08-Apr-2017; strength, dose and anatomical site not provided) administered by intramuscular route for prophylaxis. On 07-Sep-2016, the patient was vaccinated with the second dose of HPV vaccine, as Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) injection administered by intramuscular route (strength, dose, anatomical site, lot # and expiration date were not reported) for prophylaxis (Interchange of vaccine products and Inappropriate schedule of product administration). On an unknown date in July 2025, the patient had Papsmear test done and it showed that she has HPV. The patient sought medical attention due to the event, and no treatment was given. The patient is going to get a repeat Papsmear test in 1 year. At the reporting time, the outcome of HPV infection was unknown. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) was not applicable. The causal relationship between the event of HPV infection and the suspect vaccines was not provided. Lot# for Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) is being requested and will be submitted if received.
Test Date: 202507; Test Name: Pap smear; Result Unstructured Data: showed that she has HPV