Received Mar 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | Y011500 | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 3 | Y011500 | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
No additional AE; shorter than recommended interval between 2nd and 3rd dose; delayed 2nd dose; This spontaneous report was received from a nurse practitioner and referred to a 25-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 02-OCT-2014, the patient was vaccinated with the first dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) (dose, strength, route, anatomical site, lot # and expiration date were not reported) for prophylaxis. On 16-SEP-2024, the patient was vaccinated with the second dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9), and on 18-OCT-2024, the patient was vaccinated with the third dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) (for both doses: 0.5 mL, lot # Y011500, expiration date was reported as 18-OCT-2024, but upon internal validation was established as 29-MAY-2026; strength, route and anatomical site were unknown) for prophylaxis. The second dose was delayed and the interval between the second and the third dose was shorter than recommended (inappropriate schedule of product administration, inappropriate schedule of product administration). No additional adverse event (no adverse event). The outcome of the events was unknown.