Received Aug 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | X017486 | OT / LL |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | OT |
No additional AE/No PQC; HCP called to report a VARIVAX TE update for Case 02824314 because the 'time out of range' was reported incorrectly on 6/18/2025. Caller stated that VARIVAX had been administered on 6/18/2025 after the original TE was reported. For updated TE S; This spontaneous report was received from nurse 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 18-JUN-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lot #X017486, expiration date reported 25-JUN-2025 0.5 mL (route of administration and anatomical location of vaccine were not reported), diluted with sterile diluent (lot #, expiration date and dose were not administered) administered for prophylaxis. The dose experienced a temperature excursion. No additional adverse event was reported. Follow-up information was received from the reporter on 11-JUL-2025. This report referes to a 1-year-old male patient. The concomitant therapies administered included Measles vaccine (+) Mumps vaccine (+) Rubella vaccine (MMR), Hepatitis a vaccine (HepA), Pneumococcal vaccine (PVC). The patient was vaccine with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) 0.5 mL, administered subcutaneously in his left leg. This report was previously considered as non-valid since no patient's identifiers were reported. Upon follow up information, patient information was reported.
MMR; HepA; PCV