Received Apr 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y010656 | — |
no adverse event; infant patient was inadvertently administered an adolescent dose of GARDASIL 9; This spontaneous report has been received from a consumer regarding an infant patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On 03-MAR-2025, the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis, 0.5 milliliter, lot number Y010656 which has been verified to be valid, expiration date reported and validated as 29-NOV-2026 (strength, scheme, route of administration, anatomical site not reported). Medical assistant stated that an infant patient was inadvertently administered an adolescent dose that was meant for their older sibling who was of age to receive their first dose. Medical Assistant confirmed the patient involved has not experienced any medical concerns or symptoms after the dose of the vaccine was inadvertently administered to the infant patient. No additional information provided. (Product administered to patient of inappropriate age) (no adverse event).; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02763078-02763070 , CLIC number : , ESTAR number : , IRMS number : 500UW00000V7QvFYAV|04042025230052|4876 , Central date : 2025-04-05 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2260612 , MNSC case number : 02763078 , MNSC interaction number : 02763070 , Integration log UniqueID : 500UW00000V7QvFYAV|04042025230052|4876 , Service cloud CaseID : 500UW00000V7QvFYAV