Received Jul 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | Y013469 | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
Inbound call from pharmacist who states she has a patient who initiated GARDASIL-9 at age 45 years old but received their second dose at age 46 years old on 7-MAR-2025. Caller states patient is now requesting their 3rd dose to complete the series bu; Information has been received from Business Partner/CRO on 08-Jul-2025. This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), dose number 1, (indication, expiration date, and lot # were not reported). On 07-Mar-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (lot #Y013469, expiration date: 10-Oct-2026), dose number 2, for an unknown indication (Inappropriate schedule of vaccine administered).