Received May 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | UNK | — | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | — |
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | UNK | — | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | — |
Caller stated that VARIVAX was reconstituted using a VAXELIS pre-filled syringe rather than the sterile diluent and administered to a 2 month old patient on 02/18/2025; Caller stated that VARIVAX was reconstituted using a VAXELIS pre-filled syringe rather than the sterile diluent and administered to a 2 month old patient on 02/18/2025; No reported signs or symptoms of adverse effects have been reported; This non-serious spontaneous safety report, with reference number 02757161 (Interaction number 02757158), was received by partner on 20-FEB-2025 and forwarded on 21-FEB-2025 from a nurse. Due to the nature of the event, the causality between the event "Caller stated that VARIVAX was reconstituted using a VAXELIS pre-filled syringe rather than the sterile diluent and administered to a 2-month-old patient on 02/18/2025" and Vaxelis was not applicable. Further information is expected. SIGNIFICANT FOLLOW UP INFORMATION was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 23-APR-2025 with the following VAERS Primary ID 2830176. The original narrative from the sender is the following: No reported signs or symptoms of adverse effects have been reported; VARIVAX was reconstituted using a VAXELIS pre-filled syringe rather than the sterile diluent and administered; This spontaneous report was received from a nurse and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-FEB-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) as prophylaxis, the vaccine was reconstituted using a diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus (VAXELIS) prefilled syringe rather than the sterile diluent (product preparation error) (exact dose, strength, vaccination site, route of administration, lot number and expiration were not reported). No reported signs or symptoms of adverse effects have been reported. Lot number is being requested and will be submitted if received. No further information is expected.
Prophylaxis