Sex: F
Vaccine: HPV9
Symptoms: Anogenital warts, Anxiety, Ill-defined disorder, Neoplasm malignant, Papilloma viral infection
Clinical narrative: which type of cancer; non invasive surgery; I went to the Emergency room for my issues / I am still not ok yet; anxiety; testing does not decipher which  HPV type I have; genital worts; This spontaneous report was received from a consumer referring to herself a 45-year-old female patient. The patient's medical history, historical drugs, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not reported).        In approximately 2000 (reported as: for over 20 years), the patient experienced anogenital warts and human papilloma viral (HPV) infection, which came out all over her body. It was reported that only two types of HPV she could possibly have, which were HPV 9 and HPV 11 for the genital worts. It was reported that she was figuring out which category for HPV she was, but the test did not decipher which HPV type she had. According to her doctors, is not important to know which type of cancer (Neoplasm malignant) she had as she received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  On 22-SEP-2020 (reported as three months ago) (conflicting information also reported as in November 2020), the patient underwent into a non-invasive surgery. It was reported that her body did not respond to anything she did. Also, she went to the emergency room for her issue (ill-defined disorder) and doctors were not helping her and not giving her answers, and they just told her it was just her anxiety; however, she knew it was not the case. It was reported that she only wanted to figure out what had happened to her, as other people who have had the same procedure had posted the same issues she had (captured in # 2012USA013058). It was reported that the patient did not want to experience that again and she felt like they ruined her and were not careful. She stated that it was negligence from the doctor and she still not ok.   At the reporting time, the outcome of surgery was unknown and for anxiety, papilloma viral infection, ill-defined disorder and anogenital warts was reported as not resolved.    The reporter considered the events to be not related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).     Upon internal review Neoplasm malignant was considered medically significant event. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the GARDASIL 9 vaccine and the reported event of neoplasm malignant cannot be established. Missing information such as subject´s medical history, dates of GARDASIL 9 vaccine administration, detailed clinical course, diagnostic workup results, treatment and outcome is essential for a proper assessment.   Company Comment- No changes to the GARDASIL 9 vaccine product safety information are warranted at this time.  Merck and Co., Inc., known as MSD, continues to monitor the safety profile of the GARDASIL 9 vaccine product.; Sender's Comments:  US-009507513-2012USA013058: