Received Sep 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | 2014634 | OT |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | OT |
during the administration, the patient moved their arm and did not received the full dose; the patient bleeding a little at the injection site; This spontaneous report was received from a Pharmacist and refers to a(n) 12-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 14-Aug-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, lot #; expiration date, route of administration, anatomical location not provided) with no medical concerns after administration; and on 15-Aug-2025 (also reported as last Friday), she received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL (lot #2014634, expiration date: 20-Sep-2025) administered Intramuscularly in the arm (unspecified side) as human papillomavirus (HPV) Vaccination, following the 2 doses schedule. When receiving the second dose, the patient moved her arm and did not receive the full dose (accidental underdose). She also had a little bleeding in the injection site. The patient was accompanied by her mother and waited full 15 minutes waiting the period for observation or reactions, but did not have medical concerns and was sent home. At the reporting time, the outcome of the injection site bleeding was unknown. The causal relationship between the event of vaccination site bleeding and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported.