Received Jul 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
No additional AE; An Email/Case was received in the Email to case Queue via interaction 02830005 on 06/30/2025 at 0457ET containing a question from a consumer sent by a Merck group. GARDASIL 9 was administered on 06/28/2025 so this case i; The solution appeared clear, whereas the package insert states that the vaccine should be shaken well before use and that it should appear cloudy after shaking; This spontaneous report was received from a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 28-JUN-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) as prophylaxis. However, the patient, noticed that the nurse administered the vaccine without shaking the vial beforehand. It was reported that the solution appeared clear, whereas the package insert states that the vaccine should be shaken well before use and that it should appear cloudy after shaking. The patient was concerned whether the vaccine was administered correctly and whether it would still be effective under these circumstances and asked on whether the dose needed to be repeated or if any further action was necessary. No additional adverse event reported. Lot # is being requested and will be submitted if received.