Received May 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | Y015179 | OT |
Nurse practitioner calling to report that a dose of GARDASIL 9 was inadvertently administered to a pregnant woman who is "30 or 31 weeks gestation." She states that the woman was in the office for her second dose of an unspecified hepatitis b vaccine; Nurse practitioner calling to report that a dose of GARDASIL 9 was inadvertently administered to a pregnant woman who is "30 or 31 weeks gestation.; She states that the woman was in the office for her second dose of an unspecified hepatitis b vaccine when the medication error occurred; She states that the patient has been alerted and has has not experienced any clinical side effects; This spontaneous prospective pregnancy report was received from a nurse practitioner and refers to a female patient of unknown age. The patient's medical history, historical drugs, obstetric history, concurrent conditions, and concomitant therapies were not reported. There were no known allergies. On an unspecified date (reported as about 30-31 weeks ago), the patient became pregnant. All the information regarding this pregnancy such as last menstrual period date and date of conception were not reported. On 11-Apr-2025, when she presented to the office for her second dose of an unspecified hepatitis B vaccine, she was inadvertently vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection (lot #Y015179, expiration date: 28-Jan-2027), administered by intramuscular route in a medication error while she was at 30 or 31 weeks of gestation (Maternal exposure during pregnancy) (Product use in unapproved population) (Wrong vaccine administered). She stated that the patient had been alerted and had not experienced any clinical side effects. The patient had been advised to follow up with her OBGYN but the caller was unsure if the patient had called at that point. Nurse practitioner stated that the patient did sign a form that stated the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was going to be administered even though it was a medication error. She also stated she had alerted compliance and her medical director about the incident as well. At the time of this report, both fetal and pregnancy outcome were unknown.
Pregnancy
Comments: NKA