Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | UNK | — | — |
pituitary tumor; PAP smear showed abnormal cell growth.; car accident; This spontaneous report was received from a pharmacist and refers to a 35-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. On an unknown date (reported as in unspecified year ago), the patient received a series of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), (strength, dose, frequency, lot #, and expiration date were not reported) for prophylaxis. On an unspecified date in 2025 (reported as recently), the patient got into a car accident, and it was found out that she had pituitary tumor. On 07-NOV-2025, Papanicolaou (PAP) smear showed abnormal cell growth. Biopsy was done, but results were unknown yet. At the reporting time, the outcome of the events was not provided. The causal relationship between the events and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was not provided. Upon internal review, the event of pituitary tumor was determined to be medically significant.
Test Date: 20251107; Test Name: PAP smear; Result Unstructured Data: abnormal cell growth