Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 3 | — | — |
patient was recently diagnosed with HPV e6 and e7; patient had 2 doses at age 13 of GARDASIL dates of administration as follows: 8/28/2012 and second dose 12/3/2012, and third dose (GARDASIL 9) on 9/19/2016; Originally, patient had 2 doses at age 13 of GARDASIL dates of administration as follows: 8/28/2012 and second dose 12/3/2012, and third dose (GARDASIL 9) on 9/19/2016; This spontaneous report was received from a nurse via company representative and referred to a 23-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were unknown. On 03-Dec-2012, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (dose, route, anatomical site, lot # and expiration date were not reported) for the treatment of prophylaxis. On 28-Aug-2012, the patient was vaccinated with the second dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (dose, route, anatomical site, lot # and expiration date were not reported) for the treatment of prophylaxis. On 19-Sep-2016, the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, route, anatomical site, lot # and expiration date were not reported) for the treatment of prophylaxis (inappropriate schedule of product administration; interchange of vaccine products). On an unknown date in 2025 (reported as recently), the patient was recently diagnosed with HPV e6 and e7 (papilloma viral infection). At the reporting time, the outcome of papilloma viral infection was not reported. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not applicable. The causal relationship between the event of papilloma viral infection and both suspect therapies was not reported. Lot # is being requested and will be submitted if received.
Test Date: 2025; Test Name: investigation; Result Unstructured Data: diagnosed with HPV e6 and e7.