Received May 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y013347 | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | — |
no additional AE; HCP calling to report T/E. HCP stated VARIVAX was administered.ved (including lot/exp): VARIVAX Y013347 8/08/2026; This spontaneous report was received from a nurse and refers to a 42-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On unspecified dates, varicella virus vaccine live (oka-merck) (VARIVAX) lot #Y013347 underwent temperature excursions (13 minutes in -14.0 degrees Celsius and 36 minutes in -7.8 degrees Celsius). On 07-APR-2025, the patient was vaccinated with varicella virus vaccine live (oka-merck) (VARIVAX), injection, lot #Y013347, expiration date was reported as 08-AUG-2026, however upon internal validation determined as 02-AUG-2026, for prophylaxis (dose, route of administration and anatomical location were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiry date were not reported). The vaccine underwent temperature excursion described above (Product storage error). No additional adverse event was reported.