Received May 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | X002469 | OT |
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Y013582 | OT |
No additional AE/No PQC reported; vaccine storage issue; This spontaneous report was received from a nurse practitioner (also was vaccine provider) and referred to a 7-year-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included Diphtheria vaccine toxoid (+) Pertussis vaccine acellular (+) Tetanus vaccine toxoid) (TDAP) (lot# 67983AA), Hepatitis A vaccine (lot# DN273), Influenza vaccine inact split 3v (FLULAVAL) (lot# 4LM54), Polio vaccine inact (IPV) (lot# X1C891M). No illness at time of vaccination. On 21-MAR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y013582, expiration date was reported as 02-FEB-2026, but upon internal validation established as: 03-FEB-2026; strength and dose were not reported) administered via intramuscular (IM). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). On the same day, the patient was also vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot #X002469, expiration date: 22-MAY-2025; strength and dose were not reported) via IM, all products were used for prophylaxis at a hospital clinic. The vaccines were involved in temperature excursion and storage issue (Product storage error). It was also reported it was a data logger discrepancy not a true excursion as the fridge and freezer never alarmed At compliance visit on 09-APR-2025, upon reviewed by store, temperature excursion noted on 03-MAR-2025 to 10-MAR-2025. Upon further investigation, and reviewed by the DDL manufacturer, it was noted as a "glitch", most likely caused by an electrical interference. The VFC program advised revaccination and that process was currently in progress with the patient involved. No adverse event was reported. This is one of several reports received from the same reporter.
TDAP; HAV; FLULAVAL; IPV; Sterile diluent