Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 5 | FDP00555 | IM / RA |
The patient received second dose of RabAvert vaccine subcutaneously instead of intramuscularly; Case reference number US-BN-2024-002415 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-2177) on 29-Aug-2024 and concerns a 72-year-old female patient. The patient's medical history and concomitant medication details were not provided. *On unspecified date, the patient had rabies exposure, reported as awoken to bat flying around bedroom. As reported, the patient was not sure if bat bite occurred.* *On 16-Aug-2024, unknown amount of time after bat exposure,* the patient was vaccinated with the first dose of RabAvert *(batch number: FDP00555, expiry date: 01-Sep-2027), at a dose of one milliliter, via intramuscular use in right upper arm for bat exposure.* *On 18-Aug-2024, unknown amount of time after bat exposure,* the patient was vaccinated with the second dose of RabAvert *(batch number: FDP00555, expiry date: 01-Sep-2027), at a dose of one milliliter, via subcutaneous use in right upper arm (explicitly coded as 'inappropriate route of vaccination'). As reported, human factors (nurse misread the order) were contributed during the administration of RabAvert.* *On 22-Aug-2024, unknown amount of time after bat exposure,* the patient was vaccinated with the third dose of RabAvert *(batch number: FDP00543, expiry date: 01-Sep-2027), at a dose of one milliliter, via intramuscular use in right upper arm.* *On 29-Aug-2024, unknown amount of time after bat exposure, the patient was vaccinated with the fourth dose of RabAvert (batch number: FDP00552, expiry date: 01-Nov-2027), at a dose of one milliliter, via intramuscular use in right upper arm.* *On 03-Sep-2024, unknown amount of time after bat exposure, the patient was vaccinated with the fifth dose of RabAvert (batch number: FDP00543, expiry date: 01-Sep-2027), at a dose of one milliliter, via intramuscular use in left upper arm.* *As reported, the patient did not experience any adverse event due to RabAvert.* All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a pharmacist on 11-Sep-2024: New information included added patient initials, RabAvert dosage information and confirmation on adverse event and contributing factors.; Reporter's Comments: A 72-year-old female patient was vaccinated with the second dose of RabAvert, subcutaneously, which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. The patient did not experience any adverse event due to RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 72-year-old female patient was vaccinated with the second dose of RabAvert, subcutaneously, which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. The patient did not experience any adverse event due to RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.