Received May 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y014939 | — |
administrations of VARIVAX following a temperature excursion; No other AE/PQC; This spontaneous report was received from a consumer or other non health professional and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with unknown number of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Y014939, expiration date: 04-Sep-2026, administered for prophylaxis (strength, dose and route of administration were not provided) following a temperature excursion (5.5°F up to 14.4°F (-14.4°C up to -10.4°C) 0 hours 50 minutes; 14.5°F up to 46.4°F (-10.5°C up to 8.4°C) 11 hours 30 minutes; 46.5°F to 77.4°F (8.5°C to 25.4°C) 0 hours 40 minutes; 77.5°F/25.5°C or warmer 0 hours 0 minutes) (Improper storage of product in use). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot and expiration date were not provided). No previous temperature excursion. No symptoms reported and no additional details provided. No other adverse event (AE) (No adverse event). This is an invalid case due to lack of patient's identifiers.; Reporter's Comments:
Sterile diluent