Age: 13.0
Sex: M
Vaccine: HEP, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event/ no known pt adverse event; Indavertently administered improperly stored GARDASIL 9/ Temps went out of range - Vaccines were given despite temperature excursions; # of previous doses 3; This spontaneous report was received from a licensed practical nurse (LPN) regarding to an unknown patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot number U007667 with an expiration date of 23-MAY-2023 (dose, anatomical location and route of administration were not reported) for prophylaxis. There were no additional adverse event details. Administered dose of vaccine experienced the temperature excursion of 27.2 degrees Fahrenheit (F) and 49.8 F for 8 hours 30 minutes and 21 hours and 15 minutes respectively. There were no previous excursions reported.   The case was considered to be non-valid due the lack of patient identifiers.  Follow up information has been received from a Director of Nursing on 18-FEB-2022. It was reported that the caller wanted to know if she needed to send information on every patient that received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) after being improperly stored. Also, it was mentioned that the caller declined to stay on the phone to provide patient information and stated she will have her nurses fax over this information. Additional information has been requested.  Follow up information has been received from the licensed practical nurse (LPN) on 23-FEB-2022 and refers to a 13-year-old male patient. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier's were received. On unknown dates, the patient was vaccinated with first, second and third doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (doses, strength, formulations, anatomical location, routes of administration, lot numbers and expiry dates were not reported for all three doses) for prophylaxis. On an unknown date, the patient was vaccinated with first dose of hepatitis B vaccine rhbsag (yeast) (ENGERIX B) (dose, strength, formulation, route of administration, lot number and expiry dates were not reported) for prophylaxis. On 26-JAN-2022, the patient was vaccinated intramuscularly in is left deltoid with improperly stored (product storage error) fourth dose (extra dose administered) of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot number: U007667 (discrepant information, also reported as J7H4D; upon internal lot validation, lot number J7H4D is not valid for GARDASIL 9), expiry date: 23-MAY-2023 (discrepant information, also reported as 23-MAR-2022) (strength, dose and formulation were not provided) for prophylaxis and second dose of hepatitis B vaccine rhbsag (yeast) (ENGERIX B), intramuscularly in his left deltoid, lot number J7H4D (discrepant information, also reported as U007667), expiry date: 23-MAR-2022 (discrepant information, also reported as 23-MAY-2023) (strength, dose and formulation were not provided) for prophylaxis.  This is one of nine reports received from the same reporter.  As of 04-MAR-2022, all telephone attempts trying to obtain additional information has been unsuccessful ; Sender's Comments:  US-009507513-2202USA007811: US-009507513-2202USA007814: US-009507513-2202USA007815: US-009507513-2202USA007816: US-009507513-2202USA007817: US-009507513-2202USA007818: US-009507513-2202USA007812: US-009507513-2202USA007813: