Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient received the first dose of RabAvert on 12-Dec-2023 and did not received the second dose of RabAvert on day 7 as scheduled but received it 21 days after the first dose.; Case reference number US-BN-2024-000003 is a spontaneous case report initially received from a physician via Agency (reference number: USBAV24-0001) on 02-Jan-2024 and concerns a 29-year-old female patient.  The patient's medical history and concomitant medications were not provided.  On 12-Dec-2023, the patient was vaccinated with the first dose of RabAvert *(batch number: ARBB101B, expiration date: 31-Jan-2026), at a dose of 1 mL, intramuscularly, in left deltoid * for pre-exposure immunization.   *On 02-Jan-2024, 21 days after receiving the first dose of RabAvert, the patient was vaccinated with the second dose of RabAvert (batch number: ARBB101B, expiration date: 31-Jan-2026), at a dose of 1mL, intramuscularly, in left deltoid. As reported, the patient did not receive the second dose of RabAvert on day 7 as scheduled but received it 21 days after the first dose* (explicitly coded as 'inappropriate schedule of vaccine administered').   *At the time of this follow up report, the patient did not experience any adverse event due to RabAvert vaccine.*  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a physician on 10-Jan-2024: New information included additional patient demographic details (date of birth), dosage details for the first and the second dose, confirmation about deviations or issues during the administration and that the patient did not experience any adverse event due to RabAvert vaccine.; Reporter's Comments: A 29-year-old female patient was vaccinated with the second dose of RabAvert, at a dose of 1mL, intramuscularly, in left deltoid. As reported, the patient did not receive the second dose of RabAvert on day 7 as scheduled, but received it 21 days after the first dose, which is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medications were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 29-year-old female patient was vaccinated with the second dose of RabAvert, at a dose of 1mL, intramuscularly, in left deltoid. As reported, the patient did not receive the second dose of RabAvert on day 7 as scheduled, but received it 21 days after the first dose, which is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medications were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.