Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
No additional AE; HCP called to report that a patient in their office received only half of the dose of GARDASIL-9 due to mishandling. The caller stated that the patient tensed the arm muscle which caused the nurse to pulled out the needle.; Patient received only half of the dose of Gardasil 9 due to mishandling. Patient tightened arm muscle and which caused the nurse to pulled out the needle, therefore, the vaccine was not completely administered; This spontaneous report was received from a Physician Assistant (reported as certified medical assistant [C.M.A.]) and refers to an unknown patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 25-JUL-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection, administered for prophylaxis in the arm muscle (exact dose, route of administration, lot number and expiration date were not provided). It was reported that the patient only received half the dose due to mishandling, since the patient tensed the arm muscle, which caused the nurse to pull out the needle (Accidental underdose, Wrong technique in product usage process). No additional adverse event was reported for the patient. This report was considered as non-valid due to the lack of patient´s identifiers. Follow up information has been received from the physician assistant (medical assistant) on 05-SEP-2025. It was reported that this report concerns a 13-year-old male patient (therefore, case is no longer considered as non-valid). His medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. The previously reported dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was the first dose of this vaccine ever received by the patient. The causal relationship between the events and the suspect vaccine was reported as related, but upon internal guidelines it was established as not assessed.