Received Jul 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y018398 | RA |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y015760 | LA |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | X022737 | LA |
no symptoms reported; repeat dose 6/10/25; GARDASIL 9 was administered to a patient after product experienced a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 06-MAY-2025 (discrepancy, reported as 06-MAY-2026), the patient was vaccinated with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) suspension for injection at a dose of 0.5 mL, lot #Y018398, expiration date: 04-NOV-2026, for prophylaxis (route of administration and anatomical location were not reported). The administered vaccine underwent temperature excursion prior to administration (30.0 F for 15 hours; no previous temperature excursions) (Product storage error). No symptoms reported (No adverse event). The report is invalid due to lack of the patient's identifiers. Follow-up information was received on 20-Jun-2025. The patient was a 37-year-old female. On 06-May-2025, the patient was vaccinated with the second dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) administered in the right deltoid. On an unspecified date, the patient was vaccinated with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) lot #Y015760, expiration date: 10-Feb-2027, administered in the left deltoid. On an unspecified date, the patient was vaccinated with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) lot #X022737, expiration date: 12-Apr-2026, administered in the left deltoid (all details regarding vaccination could not be captured due to illegible source document). The following narrative was reported: The refrigerator where the immunizations were stored was out of range the morning of [missing information due to illegible source document]; vaccine given temperature was in range however unsure of how many [missing information due to illegible source document]; there was a temperature excursion. Called manufacturer recommended for [missing information due to illegible source document] to repeat dose. The provider was informed and the patient was contacted. On 10-Jun-2025, the patient was vaccinated with the repeat dose (inappropriate schedule of product administration). The case was no longer considered to be invalid.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02801226-02801218 , CLIC number : , ESTAR number : , IRMS number : 500UW00000aF2stYAC|20062025230039|5889 , Central date : 2025-06-21 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2283569 , MNSC case number : 02801226 , MNSC interaction number : 02801218 , Integration log UniqueID : 500UW00000aF2stYAC|20062025230039|5889 , Service cloud CaseID : 500UW00000aF2stYAC