Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | Unknown | RL |
The patient received the first and second RabAvert vaccine in thighs; The patient received the first dose of RabAvert two days after animal exposure and second dose five days after animal exposure; Case reference number US-BN-2024-002252 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-1761) on 24-Jul-2024 and concerns a 68-years-old male patient. The patient's medical history and concomitant medication details were not provided. On 16-Jul-2024, the patient was bitten by bat. On 18-Jul-2024, two days after animal exposure, the patient was vaccinated with the three doses of co-suspect immunoglobulins (brand name: unknown, batch number unknown), at an unknown dose, administered in the wound and then in shoulders, for post-exposure prophylaxis and then with the first dose of RabAvert (batch number: unknown), at an unknown dose and route of administration, in right thigh, for post-exposure prophylaxis. As reported, the RabAvert vaccine was administered in thigh because it was not supposed to receive in the same place as immunoglobulin (explicitly coded as 'vaccine administered at inappropriate site' and 'inappropriate schedule of vaccine administered'). On 21-Jul-2024, five days after animal exposure, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose and route of administration, in left thigh (explicitly coded as 'vaccine administered at inappropriate site' and 'inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. Additional information received from consumer via Med Communications (reference number: USBAV24-1765) on 24-Jul-2024 included co-suspect information, additional reporter, and reference number.; Reporter's Comments: A 68-year-old male patient was vaccinated with the first two doses of RabAvert for post-exposure prophylaxis of a bat bite, on days 2 and 5 after the exposure (which is considered inappropriate schedule of vaccine administered). The patient received the RabAvert doses in the thigh to avoid application on the same site as the immunoglobulin, which is considered vaccine administration at inappropriate site for RabAvert. No associated adverse events were reported. The events are listed as per company convention. No medical history information was available. Inappropriate schedule of vaccine administration and vaccine administration at inappropriate site are not related to RabAvert, but to human factors. The case is non-serious.; Sender's Comments: A 68-year-old male patient was vaccinated with the first two doses of RabAvert for post-exposure prophylaxis of a bat bite, on days 2 and 5 after the exposure (which is considered inappropriate schedule of vaccine administered). The patient received the RabAvert doses in the thigh to avoid application on the same site as the immunoglobulin, which is considered vaccine administration at inappropriate site for RabAvert. No associated adverse events were reported. The events are listed as per company convention. No medical history information was available. Inappropriate schedule of vaccine administration and vaccine administration at inappropriate site are not related to RabAvert, but to human factors. The case is non-serious.
Comments: None.
Immunoglobulins