Received Jun 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4LM54 | OT |
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | XC891H | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | X022411 | OT |
No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner and refers to a 8-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. Historical vaccines included Havrix (Hepatitis a vaccine inact), Fluzone (Fluconazole), and Tdap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid) (vaccinated at 02-FEB-2025). On 12-Mar-2025, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X022411, expiration date: 05-Jun-2025), administered by Intramuscular route, reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported); the first dose of Flulaval (Influenza vaccine inact split 3v) (lot #4LM54, expiration date: 30-Jun-2025) (1 dose), administered by Intramuscular route; Ipol (Polio vaccine inact 3v (Vero)) (lot #XC891H, expiration date: 31-Oct-2024) (1IPOL- B POV), administered by Intramuscular route. All for prophylaxis. On 09-Apr-2025, at compliance visit, upon review by state, temperature excursion was noted from 03-Mar-2025 to 10-Mar-2025 (product storage error). Upon further investigation and review by the DDL manufacturer, it was noted as a "glitch" "most likely caused by an electronical interference". The VFC program advised revaccination and that process was currently in progress with the patients involved. No adverse event was reported. This is one of several cases from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : (redacted)@merck.com , Index date : 2025-05-14 , MNSC number : 02785949 , CLIC number : , ESTAR number : , IRMS number : Patient, Central date : 2025-05-13 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
sterile diluent