Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | IM / RA |
Patient was vaccinated with RabAvert and Immunoglobulin in the right shoulder; Case reference number US-BN-2024-002008 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1305) on 07-Jun-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication was not reported. On an unknown date, the patient was scratched by a bat. On 05-Jun-2024, unknown time after the animal exposure, the patient was vaccinated with a dose of RabAvert (batch number: unknown) at an unknown dose, via intramuscular use in right deltoid for post exposure prophylaxis. On an unknown date, the patient was vaccinated with the co-suspect immunoglobulin (brand name: unknown, batch number: unknown) at an unknown dose, via unknown route for unknown indication. As reported, patient was vaccinated with RabAvert shot on the right deltoid and they gave the Immunoglobulin shots around the hand where the scratch or bite took place and there was little residual, so they gave it in the right shoulder as well (explicitly coded as 'lack of vaccination site rotation'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Rabipur vaccine. Additional information received by a health care professional via Med Communication (reference number: USBAV24-1307) on 07-Jun-2024: included additional reference number (USBAV24-1307), reporter information, confirmation of animal exposure and Rabavert site of administration.; Reporter's Comments: A female patient of unknown age was vaccinated with the co-suspect immunoglobulin, at an unknown dose, via unknown route for unknown indication. Reportedly, the patient was vaccinated with RabAvert shot on the right deltoid and they gave the Immunoglobulin shots around the hand where the scratch or bite took place and there was little residual, so they gave it in the right shoulder as well which is considered as lack of vaccination site rotation. Lack of vaccination site rotation is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Rabipur vaccine. The patient's medical history and concomitant medication was not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the co-suspect immunoglobulin, at an unknown dose, via unknown route for unknown indication. Reportedly, the patient was vaccinated with RabAvert shot on the right deltoid and they gave the Immunoglobulin shots around the hand where the scratch or bite took place and there was little residual, so they gave it in the right shoulder as well which is considered as lack of vaccination site rotation. Lack of vaccination site rotation is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Rabipur vaccine. The patient's medical history and concomitant medication was not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.
Immunoglobulins