Received Mar 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | IM / RA |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | 1957407 | — |
No adverse event; Inbound call received from a customer who said doses of GARDASIL 9 were administered to two patients after experiencing a temperature excursion in December 2024. The caller said one of the doses was administered on 07JAN2025 and the other dose was ad; This spontaneous report was received from other health professional and a nurse regarding to a 10-year-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided. On an unspecified date in January 2025 (also reported as "one of the doses was administered on 07-JAN-2025 and the other dose was administered on 21-JAN-2025. The caller did not specify or clarify the date each specific patient received their dose, so this information is unknown"), the patient was vaccinated human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) injection, lot number 1957407 (lot number 1957407 had been verified to be valid lot number for human papillomavirus 9-valent vaccine, recombinant suspension for injection), expiration date 23-JAN-2026 (strength, dose, frequency, route of administration and anatomical injection site were not provided) for prophylaxis; after experiencing a temperature excursion in December 2024 (temperature: 31.6F, time frame: 240 hours, no previous temperature excursion). The caller confirmed no additional adverse effects or events were noted after administration. No additional information was provided to further clarify the details. No additional adverse event (AE) reported. No product quality complaint (PQC). This is one case from 2 cases of the same reporter.