Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | OT |
Consumer was diagnosed in February with "anal Intraepithelial neoplasia (ain iii)" after having colonoscopy in November 2024. Consumer said he has had vaccines from Merck before, but did not remember which types or when.; This spontaneous report has been received from a consumer and refers to himself, a 68-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an unspecified vaccine (indication, expiration date, lot #, strength, dose number, route and anatomical site of administration were not reported). The patient did not remember which types of vaccines received or when. On an unknown date on February 2025, the patient experienced anal Intraepithelial neoplasia (ain iii) after having colonoscopy in November 2024. At the reporting time, the outcome of the event was unknown. The causal relationship between the event and an unspecified vaccine was not provided. Upon internal review, the event of anal Intraepithelial neoplasia was determined to be medically significant. Follow up information has been received on 19-MAR-2025 from a registered nurse (RN) from the physician's office. The RN shared the only information concerning vaccines was Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) listed in patient chart (date of administration, dose, route, lot# and expiration date were not provided) for prophylaxis. I was the patient's primary physician who ordered the vaccination. This office has no information concerning it completion. Also, the patient was not taken any company oncology medications. Additional information is not expected. The causality assessment between the event and Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) was not reported. This was a previous Invalid report due to lack of therapy identification, however, upon follow up it was confirmed that the patient received Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9).
Test Date: 202411; Test Name: Colonoscopy; Result Unstructured Data: Anal Intraepithelial neoplasia (ain iii)