Received Dec 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
Nurse calling in to report a patient was administered GARDASIL 9 while in her 3rd trimester; No additional AE; This spontaneous prospective pregnancy report was received from a Nurse and refers to a(n) female patient of unknown age (date of last menstrual period (LMP) was unknown date in 2025; pregnancy outcome and fetal outcome was unknown; number of Fetus was 1). The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 22-Oct-2025, the patient was administered with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) injection, administered for prophylaxis (dose, strength, route, anatomical site, lot # and expiration date were not reported) while in her 3rd trimester (Exposure during pregnancy). Reporter chose not to provide patient information and did not wish to receive the AEFU letter. Reporter was inquiring if a GARDASIL 9 Pregnancy registry was still active. No additional information provided. No additional AE/No PQC (No adverse event). Additional information were not expected.