Received Jun 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y012864 | — |
No other AE/No PQC.; Pharmacist calling with report of a product being administered after a temperature excursion. GARDASIL 9 y012864; This spontaneous report was received from a Pharmacist and refers to a 41-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. Since 01-Apr-2026 until 16-Apr-2026, human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9), Lot Number: Y012864 (Expiration date: 29-May-2026) underwent a temperature excursion, with a temperature of 14.9 (C) degree Celsius for 384 hours. On 16-Apr-2026, after the temperature excursion, the patient was vaccinated with this improperly stored vaccine human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) suspension for injection, at a dose of 0.5 milliliters (mL) (Lot No. Y012864 has been verified to be a valid lot number for [human papillomavirus 9-valent vaccine, recombinant], expiration date reported and upon internal validation established as 29-May-2026), administered as prophylaxis (product storage issue). No previous temperature excursion. No other adverse event (No adverse event). This is one of several reports received from the same reporter.