Received Jul 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Z005469 | — |
HCP calling to report a PQC for GARDASIL 9. Caller states "the syringe broke" following the administration of a GARDASIL 9 dose to a patient. Caller states the "glass part" near the plunger broke for one of the syringes of GARDASIL 9.; Syringe broken; No adverse event; This spontaneous report was received from Other health professional and refers to a patient of unknown age and gender. 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 syringe broke" following the administration of a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) lot #Z005469, expiration date: 27-Feb-2026 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis to the patient. The primary reporter stated that the "glass part near the plunger" near the plunger broke for one of the syringes of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). The break was noticed after the administration and the needle was removed from the patient's arm. Caller states the break occurred prior to placing the needle cover. Even with the break, the HCP administering the vaccine was able to cover the needle with the safety cover. The patient received the full dose. Other doses from the box have been administered with no issues. No adverse event reported.; Reporter's Comments