Age: 36.0
Sex: M
Vaccine: HPV9, HPV4, HPV9, HPV9
Symptoms: Skin lesion, Squamous cell carcinoma
Clinical narrative: he had to go to the dermatologist to have them both removed. Consumer stated that one of those skin tags seemed to be malignant; he had a skin tag that appeared on his face, and then another skin tag appear on the inside of his thigh. Consumer stated he removed both skin tags himself. Then later stated he had to go to the dermatologist to have them both removed.; Consumer stated he chose to take GARDASIL 9 & GARDASIL to reduce the risk of contracting HPV; Product Lot number issue; within the past year he found a lesion on himself/ he had to have a growth removed by a dermatologist/ it was biopsied and found to be condyloma squamous cell carcinoma in situ; within the past year he found a lesion on himself/ he had to have a growth removed by a dermatologist/ it was biopsied and found to be condyloma squamous cell carcinoma in situ; first dose of GARDASIL on 11-JAN-2021; second dose of GARDASIL 20-JAN-2021; first dose of GARDASIL 9 on 30-JUN-2020; second dose of GARDASIL 9 06-JUL-2020; vaccinated at 36 years; This spontaneous report has been received from the patient, referring to himself, a 40-years-old male patient.  The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 30-JUN-2020 (when he was approximately 36 years), 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) injection and on 06-JUL-2020, he was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection; both administrations were given as prophylaxis (strength, dose administered, route and anatomical location of administration, and expiration date were not provided; lot # reported as R017604, which is an invalid lot # for this vaccine) (product administered to patient of inappropriate age, inappropriate schedule of product administration).   Then, on 11-JAN-2021, he was vaccinated the first dose of with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered as prophylaxis (strength, dose administered, route and anatomical location of administration, and expiration date were not provided; lot # reported as S020255; which has been determined to be an invalid lot # for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL); however, lot #  S020255 is valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product lot number issue). On 20-JAN-2021, he was vaccinated the second dose of with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, also administered as prophylaxis (strength, dose administered, route and anatomical location of administration, lot # and expiration date were not provided) (interchange of vaccine products, inappropriate schedule of product administration).  On an unknown date in 2023 (also reported as within the past year), he found a lesion on himself, he did not provide location of lesion. The patient stated he had to have a growth removed by a dermatologist and it was biopsied and found to be condyloma squamous cell carcinoma in situ (squamous cell carcinoma, anogenital warts). The patient stated that before this lesion appeared, after receiving the vaccines, he had a skin tag that appeared on his face, and then another skin tag appear on the inside of his thigh on an unknown date; he removed both skin tags himself (acrochordon). Then, later, on an unknown date, he had to go to the dermatologist to have them both removed. The patient stated that one of those skin tags seemed to be malignant (skin cancer). He thinks he needs to have a through full body skin examination. He asked what his next step should be. He referred to notify his physician of concerns, and that if he would like a full body skin examination, that his physician would be the best person to provide further guidance and help him coordinate next steps. The patient stated he decided to take hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) to reduce the risk of contracting human papilloma virus (HPV), but he did not want to feel that he is being studied by the Food and Drug Administration (FDA); he stated he did not want the FDA using information he provided, and he did not want the FDA contacting him. At the time of this report, the outcome of squamous cell carcinoma, skin cancer, anogenital warts, and acrochordon was not provided.  The causal relationship between all the events and the suspect vaccines was not  provided.    Upon internal review, the events of squamous cell carcinoma and skin cancer were determined to be medically significant. Also, skin cancer has been determined to be cancer event.