Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | y007322 | OT |
no adverse event; Accidental underdose; poor quality device used; This spontaneous report has been received from a health care professional regarding a 33-year-old female patient. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On 04-MAR-2025, the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (reported as GARDASIL 9 INJ 1DS X 10 SYRINGES), 0.5 mL for prophylaxis, lot number Y007322 which has been verified to be valid, expiration date reported and validated as 18-AUG-2026(strength, scheme, route of administration and anatomical site not provided). On the same date the health care professional reported that the vaccine leaked between the syringe hub luer lock and syringe needle while being administered. No physical defects in the syringe were noted. (accidental underdose) (poor quality device used) (no adverse event).