Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y019318 | — |
No symptoms or side effects were reported by HCP. No additional AE; patient received a dose of improperly stored VARIVAX; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 21-JUL-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), 0.5 mL, administered for prophylaxis (lot number Y019318 has been verified to be valid for Varicella Virus Vaccine Live (Oka-Merck) [VARIVAX], expiration date 21-NOV-2026; formulation, route of administration, anatomical site of injection and vaccination scheme frequency were not provided), which was reconstituted with with sterile diluent (MERCK STERILE DILUENT) (expiration date, and lot number were not reported). The vaccine was administered after a temperature excursion at 52.2 degree Fahrenheit (F) that occurred on an unknown date and for an unknown time frame (Product storage error). No symptoms, side effects or additional adverse events were reported for the patient. No other information was provided. This is one of several reports from the same reporter.
Sterile diluent