Received Aug 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | — |
HCP called regarding alternate dosing schedule for GARDASIL 9. See Request case 0284855. Caller reported a missed dose AE for GARDASIL 9. Caller stated a female patient received 2 doses of GARDASIL "18 years ago" and then became pregnant and misse; Caller stated a female patient received 2 doses of GARDASIL "18 years ago" and then became pregnant and missed the 3rd dose.; No additional AE; This spontaneous prospective pregnancy report was received from a pharmacist regarding a currently 34-year-old female patient. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, concomitant therapies were not reported, and obstetric history was not reported. On unspecified dates in 2006 (reported as 18 years ago), the patient was vaccinated with the first and second doses of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (conflicting information also reported as Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9]), suspension for injection, as prophylaxis (volume of injection, lot numbers, and expiration dates were not reported). On another unspecified date (reported as then), the patient became pregnant (last date of menstrual period, date of conception, among other information regarding this pregnancy was not provided) (Vaccine exposure before pregnancy). Therefore, she missed the third dose (Inappropriate schedule of vaccine administered). For this reason, she was advised to restart the series and received a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), suspension for injection 0.5mL, as prophylaxis in unspecified dates in December 2024 and February 2025 (lot numbers and expiry dates were not reported). At the time of this report the pregnancy and fetal outcome had not been reported. Lot # is being requested and will be submitted if received.