Received Jul 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | OT |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | — | OT |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 3 | — | OT |
They had a 9 year old patient who had severe warts on his entire body, they explained it as the worst they had seen. After being vaccinated with 3 doses of GARDASIL 9 his symptoms resolved completely.; This spontaneous report was received from a nurse and refers to a 9-year-old male patient. His medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), dose number 1, administered by unknown route (indication, expiration date, and lot # were not reported). On an unknown date, the patient was administered Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), dose number 2, administered by unknown route (indication, expiration date, and lot # were not reported). On an unknown date, the patient was administered Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), dose number 3, administered by unknown route (indication, expiration date, and lot # were not reported). On an unspecified date, after being vaccinated with 3 doses of the suspect vaccine, the patient's severe warts on his entire body (described as "the worst they had seen") resolved completely (Therapeutic response unexpected). At the reporting time, the outcome of event was not known. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) was not applicable.