Received Sep 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y015760 | — |
No additional AE; HCP reported 2 issues regarding irregular pressure of GARDASIL 9 syringes when administering to patients. Both products were administered; PQC for GARDASIL 9. Caller stated HCP reported 2 issues regarding irregular pressure of GARDASIL 9 syringes when administering to patients.; This spontaneous report was received from an Other health professional (certified medical assistant [CMA]) and refers to a 12-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-AUG-2025, the patient was vaccinated with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) suspension for injection, valid lot #Y015760, expiration date: 10-FEB-2027, administered for prophylaxis (exact dose, route of administration and anatomical location were not reported). When administering the suspect vaccine, there was an irregular pressure in the human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) syringe (Poor quality device used, Syringe issue). There was no leaking from either the syringe or the vial as a result of the pressure irregularity, and the patient was eventually able to get full dose. It was difficult but possible to push the plunger rod/stopper towards the tip of the syringe. The carton that contained the syringe was not damaged on receipt. No additional adverse event was reported (no adverse event). The suspect vaccine was disposed after vaccines was administered therefore product was not available for retrieval. This is one of two reports received from the same reporter.