Received Apr 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | X020725 | — |
No additional AE; TE for GARDASIL 9 that occurred on02/13/2025 and then was inadvertently administered to apati ent on 02/19/2025.; This spontaneous report was received from a medical assistant and refers to a 16-year-old male patient. The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported. On 19-FEB-2025, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9 SYRINGE (DEVICE)) (involved lot # was X020725, expiration date: 16-APR-2026 [verified to be valid]); 0.5 ml/once, administered for prophylaxis (strength, and route of administration were not provided). Temperature excursion was 1.2 C for 0 hours 30 minutes 0 seconds (On 13-FEB-2025). There was no previous temperature excursion nor report of adverse event or product quality complaint involved.