Received May 29, 2026
Reports are unverified and do not show that a vaccine caused an event. Full disclaimer
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Z011334 | OT |
the Luer Lock connecting the prefilled syringe to the needle had broken off with the needle; the Luer Lock connecting the prefilled syringe to the needle had broken off with the needle; This spontaneous report was received from a certified medical assistant and refers to a(n) female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 28-Apr-2026, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection (lot #Z011334, expiration date: 25-Aug-2027) 0.5 mL (0.5ml), administered by Intramuscular route for HPV prophylaxis. After administrating the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) to a patient, the Luer Lock connecting the prefilled syringe to the needle had broken off with the needle when the safety cap was placed back onto the needle (device breakage; poor quality device used). Medical assistant reported that the "glass stayed on the needle at the site of connection." Caller confirmed that this was only for 1 single pre-filled syringe and that the other syringes in the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) box were intact and there were no issues. Medical assistant confirmed that this had occurred after the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was administered and taken out of the patient.