Sex: F
Vaccine: RAB
Symptoms: Needle issue, Product administration error, Underdose
Clinical narrative: While the patient was receiving the final dose of RabAvert post-exposure series the needle was bent, and the patient probably received less than half of the dose of RabAvert; While the patient was receiving the final dose of RabAvert post-exposure series the needle was bent, and the patient probably received less than half of the dose of RabAvert; While the patient was receiving the final dose of RabAvert post-exposure series the needle was bent, and the patient probably received less than half of the dose of RabAvert; Case reference number US-BN-2023-001278 is a spontaneous case report initially received from a pharmacist via agency (reference number: USBAV23-0996) on 19-Jul-2023 and concerns a 10-year-old female patient.  The patient's relevant medical history and concomitant medication details were not provided. As reported, the patient was otherwise healthy.  On an unspecified date, the patient had an exposure (to be confirmed).  On an unspecified date, an unspecified amount of time after the exposure, the patient was vaccinated with the first dose of Rabavert (batch number: unknown), at an unknown dosage, site or route of administration for post-exposure.  On an unspecified date, an unspecified amount of time after the exposure, the patient was vaccinated with the second dose of Rabavert (batch number: unknown), at an unknown dosage, site, or route of administration.  On an unspecified date, an unspecified amount of time after the exposure, the patient was vaccinated with the third dose of Rabavert (batch number: unknown), at an unknown dosage, site, or route of administration.  On 19-Jul-2023, an unspecified amount of time after the exposure, the patient was vaccinated with the fourth dose of Rabavert (batch number: ARBA971A, expiration date: 01-Feb-2025), at an unknown dosage, site, or route of administration. As reported, the needle was bent (caller clarified it was bent already before administering and it was administered in this manner). It looked like the patient did not receive the full amount of the dose but it was thrown away into the sharps disposal and couldn't be retrieved. The reporter later clarified patient probably received less than half of the dose (explicitly coded as: 'underdose', 'needle bent', and 'product administration error').  The reporter was inquiring if they should proceed with a repeat dose on the same day or when to evaluate the titers.  At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert   Additional information received from Bavarian Nordic on 20-Jul-2023 included local BN case ID.  Additional information received from Bavarian Nordic on 20-Jul-2023 included BN PQC reference (QE-005923).; Reporter's Comments: A 10-year-old female patient was vaccinated with the fourth dose of Rabavert and as reported, during the vaccination the needle was bent and it looked like the patient did not receive the full amount of the dose. The reporter later clarified patient probably received less than half of the dose, which is considered as underdose, needle issue and product administration error. No associated adverse events were reported. Underdose, needle issue and product administration error are listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. underdose, needle issue and product administration error is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 10-year-old female patient was vaccinated with the fourth dose of Rabavert and as reported, during the vaccination the needle was bent and it looked like the patient did not receive the full amount of the dose. The reporter later clarified patient probably received less than half of the dose, which is considered as underdose, needle issue and product administration error. No associated adverse events were reported. Underdose, needle issue and product administration error are listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. underdose, needle issue and product administration error is not related to RabAvert, but to a human factor. The case is non-serious.