Received May 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | Y013818 | IM / LA |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | Y013818 | OT / LA |
No symptomatic events were reported. No additional AE; improper storage of product in use/ Medication error occurred during storage in medical practice; This spontaneous report was received from an Other health professional (medical assistant) and refers to a 13-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Historical drugs included Gardasil 9 (HPV vaccine VLP rL1 9v (yeast)). Concomitant therapies were not reported. On 19-Feb-2026, the patient was vaccinated with an improperly stored Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection (valid lot #Y013818, expiration date: 12-Feb-2027), dose number 2, administered by Intramuscular route in left arm for prophylaxis by trained health care professional at clinic. Medication error occurred during storage in medical practice (product storage error). No symptomatic events were reported; no additional AE (no adverse event). Vaccine/device was available to return. The temperature excursion occurred as a result of a reading from a Digital Data Logger. This is one of several reports received from the same reporter.