Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z008197 | — |
No additional information provided. No additional AE; Medical Assistant calling to report administering VARIVAX after experiencing a temperature excursion.; This spontaneous report was received from a health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly storage dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Z008197 [which has been verified to be valid lot number for Varicella Virus Vaccine Live (Oka-Merck)], expiration date reported and upon internal validation establish as 30-APR-2027, administered for prophylaxis (strength, dosage, vaccination schedule, route and anatomical site of administration were not provided). The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), (lot # and expiration date were not reported). The vaccine was administered after a temperature excursion (TE) at -13.4 degree Celsius (C) for 9 hours and 32 minutes, with a previous TE at -12.9 degree C for 2 hours and 22 minutes (Product storage error). No additional information provided (No adverse event). This is one of several reports received from the same reporter.
Sterile diluent