Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Anogenital warts, Biopsy skin abnormal, Skin cosmetic procedure
Clinical narrative: Condyloma acuminatum/Genital warts; This spontaneous report was received from a regulatory authority (VAERS ID 831440) referring to a White female patient of approximately 20 years-old with overweight. The patient had no other illnesses at the time of vaccination and up to one month prior neither reported allergies to medications, food or other products. She was no taking any prescription, over-the-counter medication, dietary supplements or herbal remedies at the time of vaccination.   On 03-JAN-2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # M034780, expiration date on 15-APR-2019, by intramuscular route (site unknown). On 28-SEP-2016, patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #M016193, expiration date on 24-APR-2018 and the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)was administered on 09-AUG-2016, non-valid lot #M11840, expiration date reported as on 01-FEB-2018) (conflicting information between dose number series and reported dates).  On 18-JUN-2019, patient was diagnosed with condyloma accuminata (anogenital warts). No history of sexual contact at all and no intimate skin to skin contact. A biopsy was done (no result provided) and no PCR (Polymerase chain reaction) was done.  At reporting time, the patient was not recovered from anogenital warts. The causality assessment was not reported.  Follow up information was received from the pediatrician on 16-OCT-2020  via telephone call which reported that  there was no patient identifier for the patient, only an age and  the physician mentioned that she would "dig around" and see if she could provide any further information.  On 19-OCT-2020, the physician mentioned that the current condition include hypertrophic labia. It was reported that  the patient first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  was on 09-AUG-2016 , non-valid lot #M11840, expiration date reported as on 01-FEB-2018) , by intramuscular route in the right  deltoid instead as third dose as reported in the  previously version by the agency and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #M016193, expiration date on 29-APR-2018 (previously reported as 24-APR-2018 by the Agency)  was administered by intramuscular route in the left deltoid. The third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), non-valid  lot # M03470 (previously reported a by the agency as M034780), expiration date on 15-APR-2019, by intramuscular route in the left deltoid, on 30-JAN-2017 instead of 15-APR-2019 as mentioned previously by the Agency). Other suspect vaccine  included  a first dose of hepatitis a vaccine, inactivated(VAQTA) lot # M015290, expiration date: 20-SEP-2017) , by intramuscular route in the left deltoid and a  second dose of meningococcal acyw conj vaccine (dip toxoid)(MENACTRA),  lot # U5416AA, expiration date reported as on 20-OCT-2017) , by intramuscular route in the left deltoid administered on the same date on 09-AUG-2016. No temperature excursion occurred as a result of reading of digital data logger. It was reported that the patient presented to pediatrics office on 03-SEP-2019 with concerns about genital warts. She denied any sexual contact (vaginal, oral, intimate skin to skin), The patient saw her gynecologist on 04-SEP-2017 for hypertrophic labia, she was told it that it was a cosmetic issue. She underwent cosmetic surgery on the labia on 18-JUN-2019 in other country. Her surgeon in that country diagnosed with genital warts and sent a biopsy reported to be a consistent with condyloma acuminatum. No Polymerase chain reaction (PCR) done to confirm HPV . The plastic surgeon told the patient the warts could be secondary to vaccine. The reporter physician referred the patient to a gynecologist, on the same day. Per gynecologist note no active lesions were presented and scar tissue was normal. The patient declined a pap smear and a HPV testing. The outcome was reported as unknown (previously reported a not recovered by the agency). The physician considered Condyloma acuminatum/Genital warts to be a medically significant (IME).