Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (KINRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 2T93 | OT |
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Y004546 | — |
HCP reported that an expired dose of PROQUAD was administered to a patient. The product did not have any temperature excursions. No symptoms reported. No additional information provided. No additional AE/no PQC.; Just a low-grade fever; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 29-AUG-2025, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot #Y004546, which has been verified to be valid, expiration date: 19-Aug-2025, reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), administered for prophylaxis (dose, anatomical site of injection and route of administration were not provided) (Expired product administered). The product did not have any temperature excursions. No symptoms were reported. No additional information was provided (No adverse event). Follow up information was received from the same reporter on 13-OCT-2025. Patient age and gender was reported and was refers to a male of 4-years-old. On 29-AUG-2025, the patient received a dose of Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component; Polio vaccine inact 3v (Vero); Tetanus vaccine toxoid (KINRIX) administered intramuscularly (dose and anatomical location were not reported, lot number 2T93, with an expiration date reported as 04-MAR-2026). On an unknown date in 2025, the patient experienced a low-grade fever (Pyrexia). At the reporting time, the outcome of the event was unknown. It was reported that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) would be administered on 17-OCT-2025, to complete vaccination (No more information provided). The causal relationship between the event of Pyrexia and the suspect vaccines was not reported.
Sterile diluent