Received Jun 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | X004819 | LA |
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | — | — |
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | X024656 | RA |
Improperly stored vaccine administered before it expired.; No additional AE; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. It was reported that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) experienced a temperature excursion on 19-MAR-2025. Because they did not know that temp TRED 30-16R was temperature. Excursion by power outage in the morning, and they did not know, On 08-APR-2025, the patient was vaccinated with an improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #X024656, expiration date: 09-APR-2025) (doses and routes of administration, were not reported) with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported) (dose, route of administration, lot number and expiration date were not reported) for prophylaxis (Product storage error). The administered dose of the vaccine experienced a temperature excursion 66 degrees Fahrenheit for 3 hours. There was no adverse effect reported. No product quality complaint was involved. Follow up information was received from the pharmacist, on 28-MAY-2025. The patient was an 8-years-old boy, who on 24-MAR-2025 (previously reported as 08-APR-2025), received a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot # X024656, expiring on 04-SEP-2025 (previously captured as 09-APR-2025), in the right deltoid (dose and route not reported) in a public health clinic/hospital, as required by school. Other vaccines administered on the same day included Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), (lot #X004819, expiration date: 22-May-2025) in Left Deltoid and Diphtheria vaccine toxoid;Pertussis vaccine acellular 5-component;Polio vaccine inact 3v (MRC 5);Tetanus vaccine toxoid (QUADRACEL) (lot #U7908AB, expiring on 03-OCT-2025) in the right deltoid. On 19-MAR-2025, the vaccines experienced a temperature excursion of 47 to 77 degrees Fahrenheit for 3 hours, due to digital data logger issue. On 02-MAY-2025, the vaccine's potency was checked and was supported. This is one of several reports form the same source
QUADRACEL