Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | X019862 | — |
No additional EAE/PQC; 3 doses of GARDASIL-9 were administered to a patient after a temperature excursion; This spontaneous report was received from a nurse regarding to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided. On an unspecified date, the patient was vaccinated with 3 doses series of human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot number X019862 (lot number X019862 had been verified to be valid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine [yeast], expiration date was not provided, but upon an internal validation, established as 14-FEB-2025) (strength, dose, frequency, route of administration and anatomical injection site were not provided) for prophylaxis. The nurse stated that the 3 doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) were administered to a patient after a temperature excursion (temperature: unknown, only knows it was above 46 F with time frame for longer than 1600 hours. There was previous temperature excursion, details unknown). No further information was available from the HCP. Consent to contact the physician was provided. No additional adverse event (AE)/product quality complaint (PQC).