Received Apr 27, 2026
| 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 |
Patient did not experience any symptoms or side effects.; "off-label use to treat his Recurrent Respiratory Papillomatosis; the Nurse did not "shake the GARDASIL 9 mixture prior to the administration"; This spontaneous report was received from a male patient of unknown age concerning to himself. The patient's medical history was not reported. The patient's concurrent conditions included Recurrent respiratory papillomatosis. Concomitant therapies, drug reactions or allergies were not reported. On 09-Feb-2026, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) 0.5 mL; and on 09-Apr-2026, the patient received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) 0.5 mL (lot #, expiration date, route of administration, anatomical location not provided for any dose) as treatment for his Recurrent respiratory papillomatosis (product use for unapproved indication). The patient stated that in both vaccinations, the nurse did not shake the vaccine mixture prior to administration (wrong technique in product usage process), which was confirmed as the patient asked to the nurse about this step and it was confirmed that It was not shaken. The patient did not experience any symptoms or side effects.
Respiratory papillomatosis