Received Feb 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | UNK | — | — |
Merck employee called to report AE. She stated that she spoke to a person (female) yesterday and the person informed her that she was diagnosed with HPV. The person shared with Merck employee that she received GARDASIL many years ago when she was in; This spontaneous report was received from a patient referring to herself, an adult female patient (reported as approximately 40 years of age). The patient's medical history included Colposcopy. The patient's concurrent conditions and concomitant therapies were not reported. On an unknown date (reported as many years ago, when she was in college), the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), administered for prophylaxis (dose, lot #, expiration date, route of administration and anatomical site of injection were not reported). On an unknown date, the patient was diagnosed with human papillomavirus (HPV) infection. At the reporting time, the outcome of the HPV infection was unknown. The causal relationship between the event and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was not provided.
Medical History/Concurrent Conditions: Colposcopy
Test Name: She stated that she spoke to a person (female) yesterday and the person informed her that she was diagnosed with HPV.; Test Result: Positive