Received Oct 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 3 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | — | — |
patient came back with recent pap test abnormalities with positive for some of the unspecified HPV types; This spontaneous report was received from a Nurse and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 27-Feb-2023, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), 1 dosage form, administered for prophylaxis (route of administration, anatomical site of injection, lot # and expiration date were not reported). On 01-Jun-2023, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), 1 dosage form, administered for prophylaxis (route of administration, anatomical site of injection, lot # and expiration date were not reported). On 05-Feb-2024, the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), 1 dosage form, administered for prophylaxis (route of administration, anatomical site of injection, lot # and expiration date were not reported). On 29-Sep-2025, Pap test showed Pap test abnormalities with positive results for some of the unspecified HPV types and negative for type 16, 18, and 45 (Human papilloma virus test positive). At the reporting time, the outcome of the event was unknown. The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant was not reported.
Test Date: 20250929; Test Name: Pap test; Result Unstructured Data: Pap test abnormalities with positive for some of the unspecified HPV types and negative for type 16, 18, 45.