Age: 15.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Biopsy cervix, Dysplasia, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: severe dysplasia due to HPV; severe dysplasia due to HPV; She reports her daughter received three doses of GARDASIL 9 between 2014-2015 and despite being fully vaccinated, still developed severe dysplasia due to HPV; Product Lot number issue; This spontaneous report was received from a clinical director who is a patent's mother and refers to a 22-year-old (reported also as currently 23-year-old) female patient.  The patient's pertinent medical history, drug reactions or allergies and concurrent conditions were not reported. The patient's concomitant medications included birth control pills.  On 11-SEP-2014, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly for prophylaxis (dose, strength, lot #, and expiry date were not provided) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, lot #K003520, expiration date: 20-NOV-2016, administered intramuscularly for prophylaxis (dose, strength was not provided) (product lot number issue).  On 11-NOV-2014, the patient was vaccinated with additional dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), lot #K009482, expiry date: 06-MAR-2017.  On 11-MAR-2015, the patient was vaccinated with additional dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), lot #K008931, expiry date: 04-MAR-2017.  Reporter reported hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot #K003520, #K009482 and #K008931 which were not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). However, lot #K003520, #K009482 and #K008931 are valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  On an unknown date in July 2022, the patient experienced human papillomavirus (HPV) infection despite being fully vaccinated with three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (vaccination failure). On an unknown date in July 2022, the patient experienced severe dysplasia due to the HPV, and was treated for it.  On an unknown date in July 2022, the patient was first diagnosed with dysplasia via routine pap smear which showed abnormal.  On an unknown date in 2022, the patient subsequently had a biopsy to confirm the dysplasia diagnosis and a cone procedure to surgically remove the tissue with the HPV. Biopsy showed severe dysplasia.  At the time of reporting, the patient was recovering from the events of dysplasia and HPV infection and the reporter states that she does not have any further procedures planned for treatment. The outcome of vaccination failure was not reported.  The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. The causal relationship between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.