Received Jun 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | Z003112 | — |
No additional AE.; one dose of GARDASIl-9 was administered to a patient on 12-JUN-2026 after the excursions; This Spontaneous report was received from Nurse and referred to a 12-years-old Female patient. The patient's medical history, current conditions, past medications and concomitant medications were not reported. On 12-JUN-2026, the patient was vaccinated with an improperly stored Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisia... Suspension for injection 64458329:4121 (GARDASIL 9) Injection once (Lot Number: Z003112, Expiration date reported as 23-FEB-2027 but upon internal validation set as 22-Feb-2027) for prophylaxis following a temperature excursions 10-JUN-2026: 56.1F or 2 hours 24 minutes 0 seconds, on 11-JUN-2026: 34.5F for 50 minutes 0 seconds and on 11-JUN-2026: 31.1F for 2 hours 54 minutes 0 seconds (Product storage issue). No additional AE. (No adverse event).