Received Mar 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y010656 | OT |
No additional AE; HCP called to report a patient received a dose of GARDASIL 9 via subcutaneous route instead of intramuscularly. No side effects or symptoms have been reported. No Additional information provided. No Additional AE/PQC.; This spontaneous report has been received from a physician assistant, regarding to a 16-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 05-MAR-2025, the patient was vaccinated with a dose of human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) 0.5 mL (Lot No. y010656 has been verified to be a valid lot number for [human papillomavirus 9-valent vaccine, recombinant suspension for injection], expiration date reported and upon internal validation established as 29-NOV-2026) (strength, dose number, anatomical location of administration and vaccination scheme frequency were not reported) that was administered as prophylaxis by subcutaneous route instead of intramuscular route (incorrect route of product administration) No additional adverse events were reported (no adverse event).