Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y010656 | — |
No additional AE; infant patient was inadvertently administered an adolescent dose of GARDASIL 9 today, 3/3/2025, that was meant for their older sibling; Medical Assistant calling with a report of an adverse event regarding GARDASIL 9. Medical assistant stated that an infant patient was inadvertently administered an adolescent dose of GARDASIL 9 today, 3/3/2025, that was meant for their older sibling; This spontaneous report was received from a Physician Assistant (reported as medical assistant) and refers to an infant patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported, past drug reactions and allergies were not reported. On 03-MAR-2025, the infant patient was inadvertently vaccinated with an adolescent dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 0.5 mL, Two or Three dose series, indicated as prophylaxis (lot number Y010656 has been verified to be a valid number for Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9], expiration date: 29-Nov-2026; formulation route of administration and anatomical site of injection were not provided) that was meant for their older sibling who was of age to received their first dose (Product administered to patient of inappropriate age, Wrong patient received product). The reporter confirmed the patient involved has not experienced any medical concerns or symptoms after the administration (No adverse event).