Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
GARDASIL 9 was inadvertently administered to a 38 year old female patient who is 28 weeks pregnant; no other AE; GARDASIL 9 was inadvertently administered to a 38 year old female patient who is 28 weeks pregnant; This spontaneous prospective pregnancy report was received from a physician and refers to a 38-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown pregnancy conception date, the patient became pregnant with the date of last menstrual period estimated as 13-DEC-2024. On 27-JUN-2025, the 28-week-pregnant patient was inadvertently vaccinated with an unspecified dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) suspension for injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (Exposure during pregnancy, Accidental exposure to product). No symptoms were reported. Pregnancy outcome and fetal outcome were unknown. Estimated delivery date was 19-SEP-2025. Lot# is being requested and will be submitted if received.