Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | FDP00595 | IM |
The RabAvert reconstituted, was not able to get the whole vaccine out of the vial (got more than 90%).The vaccine was pushed and back in the vial, pulled the whole syringe out, pulled it back to insert some air and then was able to withdraw the full; The RabAvert reconstituted, was not able to get the whole vaccine out of the vial (got more than 90%).The vaccine was pushed and back in the vial, pulled the whole syringe out, pulled it back to insert some air and then was able to withdraw the full; Case reference number US-BN-2025-00300 is a spontaneous case initially received from nurse via Med Communication (reference number: USBAV25-0470) on 28-Feb-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 28-Feb-2025, the RabAvert dose was reconstituted, and nurse was unable to get the whole vaccine out of the vial (got more than 90%). The vaccine was pushed back in the vial, pulled the whole syringe out, pulled it back to insert some air and then was able to withdraw the full amount, as reported the patient received the whole dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00595; expiration date: Dec-2027) intramuscularly, at unknown dose, route or site of administration, for pre indication exposure vaccination (explicitly coded as 'product preparation error' and 'product administration error'). As reported, nurse used one inch needle for administration for the patient that had above 200 pounds. At the time of the initial report, it was unknown if the patient experienced any of adverse events due RabAvert. No further information was provided.; Reporter's Comments: This case report concerns a female patient of unspecified age. Reportedly, the RabAvert dose was reconstituted, and nurse was unable to get the whole vaccine out of the vial (got more than 90%). The vaccine was pushed back in the vial, pulled the whole syringe out, pulled it back to insert some air and then was able to withdraw the full amount, as reported the patient received the whole dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, intramuscularly, at unknown dose, route or site of administration, for pre indication exposure vaccination which is considered as product preparation error and product administration error. Product preparation error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any of adverse events due RabAvert. The patient's medical history and concomitant medication details were not provided. Product preparation error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case report concerns a female patient of unspecified age. Reportedly, the RabAvert dose was reconstituted, and nurse was unable to get the whole vaccine out of the vial (got more than 90%). The vaccine was pushed back in the vial, pulled the whole syringe out, pulled it back to insert some air and then was able to withdraw the full amount, as reported the patient received the whole dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, intramuscularly, at unknown dose, route or site of administration, for pre indication exposure vaccination which is considered as product preparation error and product administration error. Product preparation error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any of adverse events due RabAvert. The patient's medical history and concomitant medication details were not provided. Product preparation error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: NONE