Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | Y015560 | OT |
Customer called to report TE. GARDASIL9 and VAXELIS were administered to multiple patients.; No additional AE/no PQC; Information has been received from Business Partner/CRO on 08-Sep-2025. This spontaneous report was received from a/an Nurse and refers to a(n) 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 an unknown date, the patient started therapy with . On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (lot #Y015560, expiration date: 16-Feb-2027) 0.5 mL. On an unknown date, the patient started therapy with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, ... (VAXELIS), (lot #U8267AA, expiration date: 31-Aug-2027) 0.5 mL for an unknown indication. The patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), for the treatment of Prophylaxis. On an unknown date, the patient experienced No additional AE/no PQC. On an unknown date, the patient experienced Customer called to report TE. GARDASIL9 and VAXELIS were administered to multiple patients.. At the reporting time, the outcome of No additional AE/no PQC and Customer called to report TE. GARDASIL9 and VAXELIS were administered to multiple patients. was unknown. The action taken with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, ... and Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable. Follow up information was received from other healthcare professional and refers to a 15-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 19-Aug-2025, the patient was vaccinated in private doctor's office/hospital with public funds by a healthcare professional with an improperly stored second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) lot #Y015560, expiration date: 16-Feb-2027, intramuscular. It was mentioned that there was a refrigerator temperature excursion (out of range during 16 minutes) since the point of process the medication error occurred was the refrigerator. The average of temperature excursion was 39.9 (units not provided) out of range with maximum temperature of 52.0°F. This case was previously submitted as invalid, however per FU information patient's identifiers were provided.