Received Jul 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y015108 | LL |
No additional AE; HCP called to report a temperature excursion for VARIVAX and PROQUAD. HCP reported that VARIVAX and PROQUAD were administered to multiple patients on multiple dates after being improperly stored.; This spontaneous report was received from a nurse referring to a patient, age and gender was not provided. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided. On 27-JUN-2025, the patient was vaccinated with an improperly stored dose of varicella virus vaccine Live (Oka/Merck) (VARIVAX) , for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not reported, valid lot number Y015108 with an expiration date on 06-SEP-2026) which was reconstituted with sterile diluent solution for injection (MERCK STERILE DILUENT) (lot number and expiration date not provided). The administered dose of the vaccine experienced a temperature excursion 6.3 degrees Fahrenheit for 16 minutes, it was not reported if the information was recorded by a data logger or not. There was no adverse effect reported. Follow up information was received from the nurse on 07-JUL-2025 regarding the 12-month-old male patient. The nurse had saw a note here where the parents reported the patient had a reaction to the Band-Aids but nothing else was reported. The Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was given in the left thigh. On 27-JUN-2025, the patient was also vaccinated with dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number Y013130, expiration date 30-JUL-2026) in the right thigh for prophylaxis, which was reconstituted with sterile diluent (MERCK STERILE DILUENT). On the same date, the patient also received dose of Hepatitis a vaccine (lot number J4K4X, expiration date 28-DEC-2026) in the left thigh. No vaccines were given in the 4 weeks prior. No illness at time of vaccination. No past medical history. No concomitant medications. No adverse events reported after vaccination.
Medical History/Concurrent Conditions: Adverse reaction
M-M-R II; sterile diluent; Hep A; Sterile diluent