Received Oct 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | K010215 | OT |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 3 | M014929 | OT |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | L040459 | OT |
No additional AE information provided; first dose received 1/27/16 (lot K010215) second dose 5/16/16 (lot L040459), third dose 2/6/17 (lot M014929); This spontaneous report was received from a patient referring herself as a female of unspecified age. Her medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 27-Jan-2016, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), 1 dosage form, batch/lot #K010215 has been verified to be a valid batch lot number for Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, expiration date not reported, but upon internal validation established as 05-May-2017. On 16-May-2016, she received the second dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), 1 dosage form, batch/lot # L040459 has been verified to be a valid batch lot number for Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, expiration date not reported, but upon internal validation established as 06-Apr-2017. Then, on 06-Feb-2017, the patient was vaccinated with the third dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), 1 dosage form, batch/lot # M014929 has been verified to be a valid batch lot number for Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, expiration date not reported, but upon internal validation established as 27-May-2017 (inappropriate schedule of product administration). All vaccine doses were administered as prophylaxis (anatomical location [s] and route [s] of administration were not provided.) Reporter stated that she did not know whether she received the original Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) or Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) (all vaccine doses were confirmed to be Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine [GARDASIL] upon internal verification), and requested information on whether she should receive a booster of Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9). No additional adverse event information was provided (no adverse event.)