Received Jan 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | 2 | Y018512 | — |
No additional AE/No PQC; Medical Assistant reported administration of improperly stored vaccines to multiple patients beginning on 10/2/2025; This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 02-Oct-2025, the patients were vaccinated with improperly stored vaccines as following: Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y013818, expiration date: 12-Feb-2027, route unknown), Hepatitis A Vaccine, Inactivated (VAQTA) (lot #Y018582, expiration date: 03-Jul-2026, route unknown), Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (+) Inactivated Poliovirus (+) Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine (VAXELIS) (lot #U8335AA has been verified to be a valid lot number, expiration date reported as October 2027, but upon internal validation established as 31-Oct-2027, route unknown), also received Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ)(lot #2117047, expiration date: 18-May-2026, route: Oral), all for prophylaxis. The dose and strength for all suspect vaccines were not reported. No previous temperature excursions reported. No additional adverse event. No product quality complaints (PQC). Administered doses of suspect vaccines experienced the temperature excursion (TE) below 34.3 Fahrenheit degrees (F) for 3 hours 57 minutes 30 seconds on 02-OCT-2025, below 34.8 F for unknown at time of call, below34.7 F for 7 hours 45 minutes 0 seconds on 15-OCT-2025, below 35 F for unknown at time of call. The reporter called back, and TE was completed with another agent while this AE case was being worked on, TE case noted with caller stating that the two unknown dates/temps were a mistake, and that there were only two excursion dates. The case is non-valid due to multiple patients. Follow-up has been received from a medical assistant on 11-Dec-2025. The patient was updated to a 1-year-old infant. The suspect vaccine was Hepatitis A Vaccine, Inactivated (VAQTA); 0.5 ml administered on 24-Oct-2025. It was already 2nd dose. Lot# was updated to Y018512, expiry date 03-Jul-2026. The outcome of the event was updated to resolved.