Received Mar 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y007322 | — |
No additional AE/PQC reported.; AE AND PRECAUTIONARY PQC FILED: HCP calling to report patient received less than recommended dose of GARDASIL 9 due to needle leakage while administering vaccine. Caller stated patient was receiving dose of GARDASIL 9 when leakage occurred, caller st; GARDASIL 9 due to needle leakage while administering vaccine.; This spontaneous report was received from a nurse practitioner 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 18-FEB-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9) lot # Y007322 and expiration date 18-AUG-2026 for prophylaxis (exact dose, dose number, route and site of administration were not provided). The patient received less than recommended dose of GARDASIL 9 due to needle leakage while administering vaccine (needle leakage and accidental underdose). Caller stated patient was receiving dose of GARDASIL 9 when leakage occurred, caller stated it was unknown if leakage was from a product defective or improperly attaching needle. Product was administered. No additional AE/PQC reported (no adverse event).