Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs reported/No issues. No adverse event on patient; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from the office manager on 10-MAY-2023:  Patient demographics such date of birth, address and gender were updated. This spontaneous report referred to a 13-year-old male patient.  On 11-MAR-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and/or 1780876, 09-NOV-2023 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis.  There were no issues, nor adverse event on patient.  Temperature excursion total time was 25 minutes. There were three temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions occurred as a result of a reading from a Digital Data Logger and were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines were purchased with public and private funds and were administered at private doctor's office/hospital. The medication error occurred in the point of storage in clinical practice.  This was one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2305USA003581: US-009507513-2305USA003586: US-009507513-2305USA003585: US-009507513-2305USA003584: US-009507513-2305USA003582: US-009507513-2305USA003583: US-009507513-2305USA003587: US-009507513-2305USA003595: US-009507513-2305USA003588: US-009507513-2305USA003589: US-009507513-2305USA003591: US-009507513-2305USA003596: US-009507513-2305USA003592: US-009507513-2305USA003593: US-009507513-2305USA003597: US-009507513-2305USA003594: US-009507513-2305USA003590: US-009507513-2305USA003605: US-009507513-2305USA003602: US-009507513-2305USA003601: US-009507513-2305USA003604: US-009507513-2305USA003603: US-009507513-2305USA003607: US-009507513-2305USA003598: US-009507513-2305USA003599: US-009507513-2305USA003600: US-009507513-2305USA003606: US-009507513-2305USA003610: US-009507513-2305USA003608: US-009507513-2305USA003609: US-009507513-2305USA003716: US-009507513-2305USA003729: US-009507513-2305USA003611: US-009507513-2305USA003614: US-009507513-2305USA003613: US-009507513-2305USA003612: US-009507513-2305USA003578: US-009507513-2305USA003579: US-009507513-2305USA003568: US-009507513-2305USA003576: US-009507513-2305USA003573: US-009507513-2305USA003570: US-009507513-2305USA003569: US-009507513-2305USA003572: 2304USA002221:Original Case US-009507513-2305USA003577: US-009507513-2305USA003571: US-009507513-2305USA003575: US-009507513-2305USA003574: US-009507513-2305USA003567: US-009507513-2305USA003615: US-009507513-2305USA003580: US-009507513-2305USA004081: US-009507513-2305USA004080: US-009507513-2305USA004079: US-009507513-2305USA004078: US-009507513-2305USA004077: US-009507513-2305USA004076: US-009507513-2305USA004075: US-009507513-2305USA004074: US-009507513-2305USA004073: US-009507513-2305USA004072: US-009507513-2305USA004071: US-009507513-2305USA004070: US-009507513-2305USA004069: US-009507513-2305USA004082: US-009507513-2305USA004083: US-009507513-2305USA004249: