Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 3 | Z008262 | — |
No additional AE; as I was giving the injection in the arm of the patient the syringe started leaking , the vaccine was not totally administered/Product Leaked or Sprayed out of the SYRINGE/While giving the injection; Identify item with an issue: Plunger Rod and/or Stopper; as I was giving the injection in the arm of the patient the syringe started leaking , the vaccine was not totally administered; as I was giving the injection in the arm of the patient the syringe started leaking , the vaccine was not totally administered/Was the dose administered? Yes, but it was an incomplete dose; This spontaneous report was received from a Nurse and refers to a 22-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-Oct-2025, the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Z008262, expiration date: 22-Feb-2027) (route of administration not reported) in the arm (unspecified) as prophylaxis; it was reported a gushing out and leaking from the patient's arm. Regarding the syringe: functionality; parts it was reported: Not related to appearance of product, secondary packaging, printing issues or primary container but related to product preparation/administration. Regarding the issue or event it was reported that the product leaked or sprayed out of the syringe, the item with an issue was plunger road and/or stopper. The issue occurred while giving the injection; the nurse was giving the injection in the arm of the patient and the syringe started leaking, the vaccine was not totally administered (incomplete dose); the leaking occurred in the "glass syringe" (between plunger's stopper and the sides of the syringe?). Regarding syringe location of leaking, it was started that nothing fell out, it was just a leakage between the rod and the needle (Accidental underdose, Syringe issue, Device issue, Poor quality device used). In addition, the syringe was not dropped at any time. There was no damage to the carton or package or to shipping container. Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) had been stored in the refrigerator. Recombinant (GARDASIL 9) was discarded. Noone was injured using the product. None was injured using the product. No adverse event.