Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | Y000206 | — |
No additional AE; leaking; syringe popped out; patient received partial dose of GARDASIL 9; This spontaneous report was received from a Physician via a company representative 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 10-Feb-2025, the patient was vaccinated with partial dose (about half dose) (Accidental underdose) of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL (lot #Y000206, expiration date: 23-Sep-2026, dose number 1) for prophylaxis. During the vaccination, the syringe popped out (Device connection issue) and about half of it leaked out (Device leakage). The reporter confirmed syringe was not cracked or broken and needle was locked in place at time of vaccination and only leak was at the syringe hub/luer lock. The vaccine was not available for retrieval as it was discarded. No additional adverse event (no adverse event).
Test Name: unknown; Result Unstructured Data: unknown