Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse experiences; GARDASIL 9 administered after a temperature excursion; This non-valid spontaneous report was received from a licensed practical nurse and refers to an unspecified patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707593 was verified to be a valid lot number, expiration date was reported and established as 24-MAR-2022; dose was not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) ) (lot # T018669 was verified to be a valid lot number, expiration date was reported and established as 29-MAY-2022; dose and route of administration were not provided), both for prophylaxis, were improperly stored (product storage error). The vaccines were stored at a temperature of 56.7 Fahrenheit (F) for a time frame of 1 hour and 14 minutes with no previous temperature excursion. The reporter was unable to confirm if the vaccines were administered to a patient. No additional adverse event (AE) was reported.   This case was considered non-valid due the lack of patient identifiers.  Follow up information has been received from a licensed practical nurse on 15-FEB-2022. No doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) were administered to patients after previously reported temperature excursion.  This report refers to an 18-year-old female patient. No pre-existing conditions, allergies and concomitant medications were reported. She had no adverse events following prior vaccinations. The patient was considered to be generally healthy and had no illness at the time of vaccination. On 23-NOV-2021, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # T030749 with expiration date on 16-MAR-2023, intramuscularly (IM) in the left deltoid (LD) for prophylaxis. On 17-DEC-2021, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T030749 with expiration date on 16-MAR-2023/) was improperly stored (temperature out of range). Refrigerator doors were opened frequently due to a monthly inventory, resulting in refrigerator temperature reaching 56.7 F. Once the inventory was completed and doors were closed, the temperature resumed range of 46.4 F in 1 hour 14 minutes. On 29-DEC-2021, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), dose 2, lot # T030749 with expiration date on 16-MAR-2023, intramuscularly (IM) in the right deltoid (RD). The vaccine was not available for return and evaluation as it was in a sharps container. No adverse experiences were reported. The temperature incident was discovered on 04-JAN-2022 via digital data logger. The improperly stored vaccine was labeled "do not use" and quarantined until viability was confirmed.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid (patient identifiers were provided).