Received Dec 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
FBE called to report an AE for GARDASIL 9 on behalf of an HCP. FBE was informed by HCP that a female who was vaccinated at the age of 11 and is now in her 30s or early 40s has cervical cancer. No additional AE/no PQC.; This Spontaneous report was received from Pharmacist and referred to an Female patient who is now in her 30s or early 40s. The patient's medical history was not reported. The patient's past medications were not reported. The patient's concomitant medications were not reported. On an unknown date, at the age of 11, patient started therapy with GARDASIL 9 (dose, anatomical location, route of administration, Batch/Lot Number were not provided). On an unknown date, the patient experienced cervical cancer. The Outcome of s cervical cancer not provided. The causality for the event Cervical cancer to Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection was not reported, Upon internal review the event of cervical cancer was considered to be medically significant.