Received May 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y014868 | RA |
No additional AEs were reported; Patient received improperly stored vaccine; This spontaneous report was received from a health care professional referring to a patient, age and gender not reported. Information regarding the patient's pertinent medical history, drug allergies or reactions, or concomitant medications was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (VARIVAX), for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, were not reported, valid lot number Y014868, with an expiration date on 03-SEP-2026) which was reconstituted with sterile diluent solution for injection (BAXTER STERILE DILUENT) (lot number and expiration date not provided). The administered dose of the vaccine experienced a temperature excursion 5.5°F up to 14.4°F degrees Fahrenheit for 40 minutes, 14.5°F up to 46.4°F and 15. 8 degrees Fahrenheit for 10 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 an other health care professional on 05-MAY-2025. The patient was a 2-year-old male. He received varicella virus vaccine live (VARIVAX) on 24-APR-2025 in the left upper, outer arm, lot# Y014868, expiration date 03-SEP-2026. The patient also received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine (M-M-R II) on the same day, lot# Y010372, expiration date 05-JUN-2026, given in the left upper, outer arm. No side effects were reported. Patient had no significant past medical history. No illness at time of vaccination. No daily medications. No further information was available.
M-M-R II; sterile diluent MMR