Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | FDP005553 | SC |
The patient received Rabavert subcutaneously instead of intramuscularly with 1 inch needle to back of the upper arm and not the deltoid; The patient received Rabavert subcutaneously instead of intramuscularly with 1 inch needle to back of the upper arm and not the deltoid; The patient received only one dose of Rabavert; Case reference number US-BN-2025-000393 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV25-0639) on 20-Mar-2025 and concerns a 60-years-old female patient. The patient's medical history and concomitant medication detail was not provided. The patient's current medical history included hyperlipidemia. On 20-Mar-2025, the patient was vaccinated with RabAvert (batch number: FDP005553; expiration date: Dec-2027), at a dose of 1 ml, subcutaneously instead of intramuscularly with 1 inch needle to back of the *upper* arm and not the deltoid, for indication pre-exposure *prophylaxis* (explicitly coded as 'inappropriate route of vaccination' and 'vaccine administered at inappropriate site'). *As reported, the patient received only one dose of RabAvert (explicitly coded as 'incomplete course of vaccination'). * At the time of the *follow-up* report, the patient *did not* experience any adverse events due to RabAvert vaccine. 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 24-Apr-2025: New information included indication term and site of administration updated, and confirmation that patient received only one dose of RabAvert and did not experience any adverse events due to RabAvert vaccine.; Reporter's Comments: A 60-year-old female patient was vaccinated with RabAvert at a dose of 1 ml, subcutaneously instead of intramuscularly with 1 inch needle to back of the arm and not the deltoid, for indication pre-exposure prophylaxis, which is considered as inappropriate route of vaccination and vaccine administered at inappropriate site. Reportedly, the patient received only one dose of RabAvert, which is considered as incomplete course of vaccination. Incorrect route of product administration, incomplete course of vaccination and product administered at inappropriate site are considered listed per company conventions. The patient did not experience any adverse events due to RabAvert vaccine. The patient's medical history and concomitant medication detail was not provided while current medical history included hyperlipidemia. Incorrect route of product administration, incomplete course of vaccination and product administered at inappropriate site are assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 60-year-old female patient was vaccinated with RabAvert at a dose of 1 ml, subcutaneously instead of intramuscularly with 1 inch needle to back of the arm and not the deltoid, for indication pre-exposure prophylaxis, which is considered as inappropriate route of vaccination and vaccine administered at inappropriate site. Reportedly, the patient received only one dose of RabAvert, which is considered as incomplete course of vaccination. Incorrect route of product administration, incomplete course of vaccination and product administered at inappropriate site are considered listed per company conventions. The patient did not experience any adverse events due to RabAvert vaccine. The patient's medical history and concomitant medication detail was not provided while current medical history included hyperlipidemia. Incorrect route of product administration, incomplete course of vaccination and product administered at inappropriate site are assessed as not related to suspect product but to human factor. The case is non-serious.
Hyperlipidemia