Received Mar 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | Y010656 | OT / LA |
he HCP stated that no patients reported any adverse issues or side effects from any of the administered doses.; Temperature of fridge went up to 48 F excursion; This spontaneous report has been received from a medical assistant regarding a 17-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included meningococcal vaccine B rfHbp/NadA/NHBA OMV (BEXSERO). On 03-JAN-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), administered intramuscularly in the left arm as the second dose (lot number reported as Y010656, which has been verified as valid, expiration date reported and validated as 29-NOV-2026) (dose was not reported). The administered dose was exposed to a temperature that went up to 48 Fahrenheit degrees (F) (Product storage error). The vaccine was determined good for further use. The reporter stated that no patients reported any adverse issues or side effects from any of the administered doses.
Meningococcal B