Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 2 | Y014182 | OT / LL |
No additional AE; HCP called and reported inadvertent administration of VARIVAX after a temperature excursion that occurred on 31JAN2025.; This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2231763. The previous case ID: 2502USA001424. As a consequence of migration, the follow-up report may indicate in the appropriate field that it is an initial report. This spontaneous report has been received from a nurse concerning to multiple patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter. On 31-JAN-2025 and 03-FEB-2025, multiple patients were vaccinated with a improperly storage doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot # involved Y014182 (valid lot number, expiration date reported and validated as 20-AUG-2026) and Y003891 (valid lot number, expiration date reported and validated as 06-FEB-2026) reconstituted with sterile diluent (lot # and expiration date were not reported) administered as prophylaxis (strengths, doses, routes and anatomical locations of administration were not provided). The doses were administered after undergoing a temperature excursion of 21 Fahrenheit (F) for 2 hours, 12 minutes, o seconds and 14.3 F for 1 hour 5 minutes 0 seconds. It was reported a previous temperature excursion of 31 F for 4 hours 0 minutes 0 seconds (product storage error). No additional adverse event was reported. Follow up information has been received from the nurse on 06-FEB-2025. The reported stated that previously provided temperature excursion was incorrect. The vaccine was reevaluated, however no details where reported. The nurse stated that the varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered to patients after providing the previously incorrect temperature excursion. Follow-up was received on 10-APR-2025 from a registered nurse. The patient details were updated. On 03-FEB-2025, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX). On the same date, the patient was vaccinated with measles, mumps and rubella (Wistar RA 27-3) virus vaccine (MMR II) subcutaneously on right thigh with lot # Y010046 with second dose and was vaccinated with Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid (DTAP/DVP) intramuscularly on left thigh with lot # 47838AA.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :, Index date : 2025-04-14 , MNSC number : 02747559 , CLIC number : , ESTAR number : , IRMS number :, Central date : 2025-04-10 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : US-009507513-2231763
MMR; DTAP/DPV; MMR; Sterile diluent