Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | — | — |
the patient was diagnosed with HPV; HCP calling regarding an inquiry for GARDASIL-9 dosing schedule and mentioned that she previously had a patient who received one dose of GARDASIL 4 valent vaccine and a dose of GARDASIL-9 as the second dose of the series; This spontaneous report was received from a Nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were unknown by the reporter. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), Injection, dose number 1. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection, administered as the second dose of the series (Interchange of vaccine products); both vaccines were administered as prophylaxis (dose, formulation, route of administration, anatomical site of injection, lot number and expiration date were not provided for any of the vaccines). On an unknown date, the patient was diagnosed with Human papilloma virus (HPV) (Papilloma viral infection), but the reporter was not sure whether the patient had the HPV even before she had the vaccine. Caller stated this happened a long time ago and she does not recall any further details. No further information was available. At the time of the report, the outcome of the event of Papilloma viral infection was not reported. The causal relationship between the suspect vaccines and the event of Papilloma viral infection was not provided.