Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | Unknown | IM |
Patient received the Rabavert vaccine via intramuscular route in the quadricep instead of the deltoid site; Case reference number US-BN-2024-002577 is a spontaneous case initially received from health care professional via Med Communications (reference number: USBAV24-2579) on 01-Oct-2024 and concerns a 66-year-old female patient. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient had rabies exposure due to dog bite. On 16-Sep-2024, unknown amount of time after rabies exposure, at hospital, the patient was vaccinated with the first dose of RabAvert (batch number: unknown, NDC number: 50632-010-01), at a dose of one milliliter, intramuscularly in quadricep for indication post exposure prophylaxis (explicitly coded as 'vaccine administered at inappropriate site'). It was reported that patient has not received any additional doses at hospital, and patient was out of town. At the time of the follow up report, the patient did not experience any adverse events 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 health care professional on 11-Oct-2024: New information included added patient demographic details (initials and age), RabAvert dosage information and confirmation on the absence of adverse events. Follow up information received from health care professional on 24-Oct-2024: New information included confirmation on the type of rabies exposure and confirmation that patient did not receive any additional doses at hospital.; Reporter's Comments: An adult patient of unknown age and gender was vaccinated with the first dose of RabAvert (at a dose of one milliliter) intramuscularly in quadricep for post exposure prophylaxis, which is considered as vaccine administered at inappropriate site. It was unknown if the patient experienced any adverse events due to RabAvert. Product administered at inappropriate site is considered as listed per company convention. Reportedly, the patient has not received any additional doses at hospital. The patient's medical history and concomitant medication details were not provided. The patient did not experience any adverse events due to RabAvert. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult patient of unknown age and gender was vaccinated with the first dose of RabAvert (at a dose of one milliliter) intramuscularly in quadricep for post exposure prophylaxis, which is considered as vaccine administered at inappropriate site. It was unknown if the patient experienced any adverse events due to RabAvert. Product administered at inappropriate site is considered as listed per company convention. Reportedly, the patient has not received any additional doses at hospital. The patient's medical history and concomitant medication details were not provided. The patient did not experience any adverse events due to RabAvert. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.