Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 3 | Unknown | IM |
When the patient received the shot felt like no medicine was administered into arm hardly, patient thinks a lot of medicine escaped through the aeration of the needle; When the patient received the shot felt like no medicine was administered into arm hardly, patient thinks a lot of medicine escaped through the aeration of the needle; Case reference number US-BN-2024-002545 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-2496) on 24-Sep-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient had rabies exposure. On 16-Sep-2024, unknown amount of time after rabies exposure, the patient was vaccinated with the first dose of RabAvert (batch number: unknown) at an unknown dose, intramuscularly in unknown site of administration for post exposure. On the same day the patient was vaccinated with the first dose of co-suspect IgG (immunoglobulin G) (brand name: unknown; batch number: unknown) at an unknown dose, intramuscularly, as reported in buttocks instead in leg, for post exposure. On 19-Sep-2024, unknown amount of time after rabies exposure, the patient was vaccinated with the second dose of RabAvert (batch number: unknown) at an unknown dose, intramuscularly in unknown site of administration. On 23-Sep-2024, unknown amount of time after rabies exposure, the patient was vaccinated with the third dose of RabAvert (batch number: unknown) at an unknown dose, intramuscularly in unknown site of administration. As reported, when the patient received the shot felt like no medicine was administered into arm hardly, patient thinks a lot of medicine escaped through the aeration of the needle (explicitly coded as 'vaccine underdose' and 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to RabAvert. No further information was provided.; Reporter's Comments: A female patient of unknown age was vaccinated with the third dose of RabAvert for post exposure, and as reported, when the patient received the shot felt like no medicine was administered into arm hardly, patient thinks a lot of medicine escaped through the aeration of the needle, which is considered as vaccine underdose and product administration error. It was unknown if the patient experienced any adverse events due to RabAvert. Underdose and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the third dose of RabAvert for post exposure, and as reported, when the patient received the shot felt like no medicine was administered into arm hardly, patient thinks a lot of medicine escaped through the aeration of the needle, which is considered as vaccine underdose and product administration error. It was unknown if the patient experienced any adverse events due to RabAvert. Underdose and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.
Immunoglobulin G human