Age: 38.0
Sex: M
Vaccine: HPV4, HPV4, VARZOS
Symptoms: Burning sensation, Painful ejaculation, Pelvic pain, Prostatitis, Sexually transmitted disease test
Clinical narrative: near the end of December 2020 he began to experience urethra burning and testicular pain during ejaculation; near the end of December 2020 he began to experience urethra burning and testicular pain during ejaculation; chronic pelvic pain; prostatitis; near the end of December 2020 he began to experience urethra burning and testicular pain during ejaculation; He stated that he received 3 doses of Gardasil/Caller confirmed multiple times, and was adamant, that he received GARDASIL and not GARDASIL 9; This spontaneous report was received from 38 years old male patient, who was referring to himself. The patient's medical history included heart attack 10 years ago. His concomitant therapies included levofloxacin, cipro and other unspecified medications. His drug reactions/allergies included corticosteroids.    On 20-OCT-2020, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # T004598, expiration date was reported as June 2020, but upon internal validation was established as 30-JUN-2022 for prophylaxis (product administered to patient of inappropriate age). The patient confirmed multiple times, and was adamant, that he received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and not HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). On 25-NOV-2020, he received zoster vaccine live (ZOSTAVAX) lot # S039272 was confirmed to be valid, expiration date was reported as 20-JUN-2021, but upon internal validation was established as 30-JUN-2021 for indication of vaccination. Exact dose, anatomical location and route of administration were not reported for both vaccines.  Near the end of December 2020, the patient experienced urethra burning and testicular pain during ejaculation. His physician initially thought he had prostatitis but currently believes that he has had chronic pelvic pain.  On 29-DEC-2020, he was vaccinated with a second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # T004598, expiration date was reported as June 2020, but upon internal validation was established as 30-JUN-2022 for prophylaxis. On 29-APR-2021, the patient was vaccinated with a third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # T030356, expiration date was reported as September 2022 and upon internal validation was established 30-SEP-2022 for prophylaxis. Exact dose, anatomical location and route of administration were not reported for both vaccines.  On an unknown date, the patient sought medical attention and received treatment: antibiotics and anti-inflammatory medication but continued to have symptoms. Also on an unknown date, Magnetic Resonance Imaging (MRI) of prostate and pelvis area, tests of urine and semen and tests for sexual disease were performed - all test were negative. The outcome of the events was reported as not recovered/not resolved.   The causality assessment between the events and the suspect therapy was not provided.