Sex: F
Vaccine: RAB
Symptoms: Headache, Inappropriate schedule of product administration, Musculoskeletal stiffness, Product administration error, Product preparation error
Clinical narrative: RabAvert vaccine was a blue, with a little black suspension on it; Patient think that they gave them just saline solution without vaccine; Patient think that they gave them just saline solution without vaccine; The patient had received a defective dose of RabAvert ten days after previous dose; Case reference number US-BN-2023-010700 is a spontaneous case report initially received from a consumer (reference number: USBAV23-2104) on 15-Dec-2023 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as ten days prior defective RabAvert dose, the patient was vaccinated with a dose of RabAvert (batch number: unknown), at an unknown dose, or route, or site of administration, for an unknown indication.  On an unspecified date, as reported then days after the previous dose, the patient was vaccinated with a dose of RabAvert (batch number: ARBB101A; expiration date: Jan-2026), at an unknown dose, route and site of administration (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported the patient knew that when the vaccine reconstituted look like a pearl sort of color, solution in the syringe was clear and it was reconstituted in the vial and the vial look like a whitish color she was given a vaccine, and it wasn't that color, it was blue with a little black suspension in it. The patient talked to the pharmacist about it and know it was an error and the pharmacist informed it was not an error (explicitly coded as 'product color issue').  As reported, usually when the patient got the vaccine, the patient got a headache, ringing in ears or a stiff neck and now the patient had no symptoms. The patient guess that was given to them just a saline solution without the vaccine (explicitly coded as 'active ingredient not added to diluent' and 'product administration error').  As reported, the patient did not know what syringe they utilized and only brought out a vial and said that was it. As reported, the patient had received the previous dose prior defective dose, and that one did not look like the one the patient had later.  It was confirmed that the patient had no symptoms due to RabAvert vaccination.  *As reported in the investigation report the similar cases trend analysis showed no other similar complaint had been reported involving the syringe final container and formulated bulk batch used in the production of finished product batch ARBB101A. Retained samples investigation checked and no defect related to the complaint was found. Five retained samples were sent to quality control (QC) Department for testing. The test result for dissolution time and coloration was within the specification. No coloration or extended dissolution time were detected. No defect linked to the reporter issue was identified. The raw material investigation included the investigation of needles, vials, vial stoppers, syringes and stoppers, showed no deviation linked to the complaint occurred on these needles, vial, vial stoppers, syringes and stoppers batches. The bulk investigation(vials), formulation investigation(vials), filling investigation (vials and syringes), showed no deviation or event directly linked to the complaint. The batch of antigen vial was 100 percent visually inspected semi-automatically and the batch of diluent syringe 100 percent visually inspected automatically after filling. The whole process of visual inspection showed no deviation or event directly linked to the complaint. The manual statistical visual inspection of the batch was conforming. No deviation or event was recorded during warehousing or distribution. Given the outcome of investigation, Manufacturer considered the complaint that was the object of this report as unsubstantiated.*  Additional information received from the consumer on 18-Dec-2023 included confirmation for patient's gender.  Additional information received from Bavarian Nordic on 18-Dec-2023 included product quality reference number (QE-007969).  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from the consumer via regulatory authority (USBAV24-0031) on 09-Jan-2024: New information included clarification on the syringe utilized by the patient, additional inappropriate schedule of vaccine administered, and additional reference number.  Additional information received on 11-Jan-2024 from Bavarian Nordic included local BN case ID.  Follow up information received on 02-Feb-2024 from Manufacturer included final investigation report and additional reference number (400011882).; Reporter's Comments: A female patient of unknown age was vaccinated with dose of RabAvert on the day 10 after the previous dose, which is considered as inappropriate schedule of vaccine administered. As reported the patient knew that when the vaccine was reconstituted would look like a pearl sort of colour, solution in the syringe was clear and it was reconstituted in the vial and the vial looked like a whitish colour she was given a vaccine, and it wasn't that colour, it was blue with a little black suspension in it. The patient talked to the pharmacist about it and knew it was an error and the pharmacist informed it was not an error, which is considered as product colour issue. Reportedly, the patient guessed that was given just a saline solution without the vaccine, which is considered as active ingredient not added to diluent and product administration error. It was confirmed that the patient had no symptoms due to RabAvert vaccination. Product colour issue, product preparation error, inappropriate schedule of vaccine administered and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product colour issue, product preparation error, inappropriate schedule of vaccine administered and product administration error have 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 female patient of unknown age was vaccinated with dose of RabAvert on the day 10 after the previous dose, which is considered as inappropriate schedule of vaccine administered. As reported the patient knew that when the vaccine was reconstituted would look like a pearl sort of colour, solution in the syringe was clear and it was reconstituted in the vial and the vial looked like a whitish colour she was given a vaccine, and it wasn't that colour, it was blue with a little black suspension in it. The patient talked to the pharmacist about it and knew it was an error and the pharmacist informed it was not an error, which is considered as product colour issue. Reportedly, the patient guessed that was given just a saline solution without the vaccine, which is considered as active ingredient not added to diluent and product administration error. It was confirmed that the patient had no symptoms due to RabAvert vaccination. Product colour issue, product preparation error, inappropriate schedule of vaccine administered and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product colour issue, product preparation error, inappropriate schedule of vaccine administered and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.