Received Sep 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y015760 | — |
No additional AE; irregular pressure of GARDASIL 9 syringes; regarding irregular pressure of GARDASIL 9 syringes when administering to patients; This spontaneous report was received from a medical assistant and refers to an 11-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 11-AUG-2025, the patient was vaccinated with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) suspension for injection at a total dose of 1 dosage form, lot #Y015760, expiration date: 10-FEB-2027, administered for prophylaxis (route of administration and anatomical location were not reported). When administering, 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. No additional adverse event was reported. This is one of two reports received from the same reporter.