Received Mar 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | — | — |
a pregnant female patient that received first 2 doses of a 3 dose series of Gardasil 9 while pregnant. The patient did not know she was pregnant a; This spontaneous report was received from a nurse Practitioner referring to an early 30s female patient. The patient's medical history included History of abnormal paps. The patient's concurrent conditions, Concomitant therapies, and drug reactions/allergies were not reported. On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 1, (indication, expiration date, and lot # were not reported). On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 2, (indication, expiration date, and lot # were not reported). The patient was pregnant while receiving the first 2 doses of a 3-dose series of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (Vaccine exposure during pregnancy). The patient did not know she was pregnant at the time. The outcome of the event was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was reported as drug withdrawn.
Medical History/Concurrent Conditions: Papanicolaou smear abnormal; Comments: unknown