Received Sep 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV2 | HPV (CERVARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| HPVX | HPV (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| HPVX | HPV (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Product origin unknown; patient was diagnosed with E6/E7 positive PAP/got a positive diagnosis of a ¨bad PAP¨; This spontaneous report was received from a Nurse Practitioner and refers to a 25-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2014, while the patient was 14-years-old, she was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (manufacturer unknown), with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (manufacturer unknown) (reported as HPV Vaccine) (Product origin unknown), administered as prophylaxis; or with HPV vaccine VLP rL1 2v (baculovirus) (CERVARIX) (indication was not reported) (dose, formulation, route of administration, anatomical site of injection, lot number and expiration date were not provided for any of the mentioned vaccines). Patient could not confirm which HPV vaccine she received. On an unknown date, a human papilloma virus test was conducted, and the patient was diagnosed with E6/E7 positive PAP (Papilloma viral infection) (also reported as got a positive diagnosis of a ¨bad PAP¨). It was unknown if the patient had completed the vaccination schedule. At the time of the report, the outcome of the event Papilloma Viral Infection was unknown. The causal relationship between the event of Papilloma Viral Infection and the suspect vaccines was not reported.
Test Name: Human Papillomavirus test; Result Unstructured Data: E6/E7 positive pap