Received May 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 3 | — | — |
pap smear came back "abnormal"; Patient received one dose of GARDASIL in AUG 2007, one dose of GARDASIL in AUG 2008, and one dose of GARDASIL in AUG 2009; Patient received one dose of GARDASIL in AUG 2007, one dose of GARDASIL in AUG 2008, and one dose of GARDASIL in AUG 2009; This spontaneous report was received from a Nurse and referring to a 27-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. The patient received one dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, route, lot # and expiration date were not reported) in August 2007, one dose in August 2008 (Inappropriate schedule of product administration) and one dose in August 2009 (Inappropriate schedule of product administration). On an unknown date (reported as recently), when patient came in for routine appointment, pap smear came back "abnormal". No treatment was given. At the reporting time, the outcome of the event was unknown. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was not applicable. The causal relationship between the event of pap smear came back "abnormal" and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was unknown.