Received Sep 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | UNK | Y018512 | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Y013565 | — |
no adverse reactions were experienced after the administered dose; TE occurring on 8/16/2025 and 8/17/2025 for GARDASIL-9 and VAQTA that were administered after TE on 8/18/2025. one patient was administered VAQTA & GARDASIL-9;; This spontaneous report was received from an office manager (also reported as "health business professional" [HBP]) concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 16 and 17-Aug-2025, doses of Hepatitis A Vaccine, Inactivated (VAQTA) and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) underwent temperature excursion (TE) of 1.5C degrees Celsius (C) for 2 hours, 24 minutes, 0 seconds, 0.9 C for 5 hours, 14 minutes, 0 seconds with prior excursion of 8.3C for 0 hours, 44 minutes, o seconds (7/8.) On 18-Aug-2025, the patient was vaccinated with improperly stored doses of Hepatitis A Vaccine, Inactivated (VAQTA) injection 25/0.25, batch/lot #Y018512 has been verified to be a valid batch lot number for Hepatitis A Vaccine, Inactivated, expiration date reported and upon internal validation confirmed as 03-Jul-2026, 0.5 mL (dosage regimen, anatomical location and route of administration were not reported); and with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection, batch/lot #Y013565 has been verified to be a valid batch lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration date reported and upon internal validation confirmed as 01-Feb-2027, 0.5 mL (dosage regimen, anatomical location and route of administration were not reported) (product storage error). Both vaccines were administered as prophylaxis. TE evaluation was communicated as 'supported' during the call. Reporter stated that no adverse reactions were experienced after the administered dose (no adverse event.) This was one of four reports received from the same reporter.