Received May 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z005455 | — |
no adverse event; Inbound call from HCP calling for a TE evaluation for VARIVAX. Vaccine was administered after the first excursion.; This Spontaneous report was received from an Other health professional (Medical Assistant) and referred to a patient of an unknown age and gender. The patient's medical history, past medications and concomitant medications were not reported. On 28-APR-2026, patient was vaccinated with an improperly stored Varicella Virus Vaccine Live (VARIVAX) powder and solvent for solution for injection (Batch/Lot Number: Z005455, expiration date: 04-Mar-2027, dose, route of administration were not provided) for prophylaxis; the suspect vaccine was reconstituted with sterile diluent solution for injection (dose, route of administration, lot # and expiry date were not provided). Administered dose of suspect vaccine was exposed to the temperature excursion on an unknown date: 13.8 Fahrenheit degrees for 7 minutes (product storage issue, onset date: 28-APR-2026). It was the first temperature excursion. There was no additional adverse event (AE) reported (no adverse event).
DILUENT MRK