Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Second dose of RabAvert administered on day 69; Case reference number US-BN-2023-000390 is a spontaneous case report initially received from a health care professional (reference number: USBAV23-0384) on 07-Mar-2023 and concerns a 23-year-old female patient.  *The patient had no relevant medical history.*  The patient's concomitant medications included sertraline (brand unknown) and Depo-Provera injections (medroxyprogesterone acetate).  On 12-Jan-2023, the patient was vaccinated with the first dose of RabAvert (batch number: ARBA961A; expiration date: Feb-2024), at an unknown dose, intramuscularly in the left deltoid for rabies pre-exposure prophylaxis.  On 22-Mar-2023, 69 days after the first dose of RabAvert, the patient was vaccinated with the second dose of RabAvert (batch number: ARBA949A; expiration date: Jul-2024), at an unknown dose, administered intramuscularly in the left deltoid (explicitly coded as 'inappropriate schedule of vaccine administered').  *As reported, it was not applicable if the patient was vaccinated with the third dose of RabAvert.*  At the time of *the follow-up report*, the patient did not experience any adverse events due to RabAvert vaccination. *As reported, the late receiving of the vaccine was due to logistics, not a reaction to the vaccine. *  Additional information received from Bavarian Nordic on 08-Mar-2023 included local case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information was received from a nurse on 22-Mar-2023: New information included additional reporters, patient's details, concomitant medications, vaccination details for administered doses of RabAvert, and confirmation that the patient did not experience any adverse event.  Follow-up information received from a nurse on 29-Mar-2023: New information included confirmation that the patient had no medical history, information about the third dose of RabAvert, and it was once again confirmed that the patient did not experience any adverse events.  Non-significant case correction performed for information received from a consumer on 18-Apr-2023 included the change of a reporter used for correspondence.; Reporter's Comments: A 23-year-old female patient was vaccinated with the second dose of RabAvert, 69 days after the first dose which is considered as inappropriate schedule of vaccine administration. The patient did not experience associated adverse events. Inappropriate schedule of product administration is considered listed per company convention. The patient had no relevant medical history and concomitant medications included sertraline and Depo-Provera injections. Inappropriate schedule of vaccine administered is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 23-year-old female patient was vaccinated with the second dose of RabAvert, 69 days after the first dose which is considered as inappropriate schedule of vaccine administration. The patient did not experience associated adverse events. Inappropriate schedule of product administration is considered listed per company convention. The patient had no relevant medical history and concomitant medications included sertraline and Depo-Provera injections. Inappropriate schedule of vaccine administered is assessed as not related to suspect product but to human factor. The case is non-serious.