Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Improperly Stored GARDASIL 9; This non-valid spontaneous report was received from a registered nurse and refers to an unspecified patients of an unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On an unknown date, the patients were possibly (unable to confirm at this time) vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe lot # U008897, expiration date 16-MAY-2023 (dose, dose number, strength, route of administration and anatomical location were not provided), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe lot # T036444, expiration date 09-APR-2023 (dose, dose number, strength, route of administration and anatomical location were not provided) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S0287376 (this lot number was not valid), expiration date 30-APR-2022 (dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). The temperature excursion was 11.1 Celsius degrees for 22 hours 45 minutes on 24-FEB-2022. Previous temperature excursions included the temperature of 2 Celsius degrees to 8 Celsius degrees, 8.1 Celsius degrees for 30 minutes on 31-JAN-2022, the temperature of 2 Celsius degrees to 8 Celsius degrees, 8.1 Celsius degrees for 16 minutes on 21-FEB-2022, the temperature of 2 Celsius degrees to 8 Celsius degrees, 8.4 Celsius degrees for 1 hour on 22-FEB-2022, the temperature of above 9 Celsius degrees, 9.0 Celsius degrees for 2 hours on 22-FEB-2022, the temperature of above 9 Celsius degrees, 10.0 Celsius degrees for 11 hours on 23-FEB-2022, the temperature of above 9 Celsius degrees, 9.0 Celsius degrees for 2 hours 29 minutes on 23-FEB-2022. No additional adverse event was reported (No adverse event).  Lot number S0287376 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Lot number S0287376 does not match any Company product as confirmed by Lot Verification team.  Follow up information has been received from a registered nurse on 10-MAR-2022. The nurse stated that the there was only one patient that received the vaccine after excursion, it was a 27-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included allergic to bacitracin, neomycin, neosporin, propylen glycol, and polymixin. Concomitant therapies were not reported.  On 16-FEB-2022, the patient was vaccinated with the improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot #T038529 (previously reported as invalid lot # S0287376) (has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)), expiration date: 11-MAR-2023 (also reported as 24-MAY-1994, conflicting information), administered for prophylaxis in the right deltoid (strength, and route of administration were not provided). The vaccine was administered in a private doctor's office by a registered nurse, who was trained to use the vaccine. No other vaccines were administered 4 weeks prior or on the same day. The patient had no illness at time of vaccination. No further information was available.  This case was previously considered non-valid, but upon receipt of follow-up it was determined to be valid.