Sex: F
Vaccine: RAB, UNK
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: Tired after all RabAvert doses; The patient received the first dose of RabAvert, which had a light-yellow color; The patient received the first dose of RabAvert six days after exposure, the second dose eight days, and the third dose 13 days after exposure; Case reference number US-BN-2023-010654 is a spontaneous case report initially received from a consumer (reference number: USBAV23-2047) on 07-Dec-2023 and concerns a female patient of unknown age.  The patient's medical history and concomitant details were not provided.  On 21-Nov-2023, the patient had potential exposure. The patient's cat was attacked by something, and the patient had a cut on the finger and some saliva from the other animal got on that.   On 27-Nov-2023, six days after the exposure, the patient was vaccinated with the first dose of RabAvert (batch number: ARBA949A, expiration date: 31-Jul-2024), at an unknown dose, route, and site of administration, for post-exposure prophylaxis (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, the vaccine was light-yellow color (explicitly coded as 'product discoloration'). At that time, the patient did not have any questions about it.  On 29-Nov-2023, eight days after the exposure, the patient was vaccinated with the second dose of RabAvert (batch number: ARBA949A, expiration date: 31-Jul-2024), at an unknown dose, route, and site of administration, as reported the second dose was administered a day too early (explicitly coded as 'inappropriate schedule of vaccine administered').  On 30-Nov-2023, nine days after the exposure, the patient was vaccinated with a dose of co-suspect immunoglobulin (brand name: unknown, batch number: unknown), at an unknown dose, route, and site of administration, for post-exposure prophylaxis.  On an unspecified date, as reported, uncertainties arose on 29-Nov-2023 when the patient received the second dose, which was transparent. The same was observed on 04-Dec-2023 for the third dose. The patient stated that the product was administered to the patient and a defect was observed during the administration of the vaccine. The patient stated that there were a series of mistakes with that treatment. The patient stated that treatment was delayed because the physician told the patient could only get rabies from a bite. The patient stated dates were not set properly once the patient was changed from pre- to post-exposure. The second dose was on 29-Nov-2023, but it should have been on 30-Nov-2023, and when patient contacted poison control, the patient was told to have Immunoglobulin with the first dose and then the patient was advised to go to the Emergency Room and get the Immunoglobulin. The patient stated that it was the first time to treat rabies at the location. As reported, the doctor messed it up at first. The patient should get the poison control and CDC involved to get the right treatment. The patient did not have the actual card from the vaccination but had the NDC number, 50632-0010-01 RabAvert for injection first vial. The patient stated that they did not know about giving the immunoglobulin. As reported, the patient was going to get the antibody test when the patient completed the series. As reported the patient had got the second dose of RabAvert a day too early because CDC had the dates wrong. The patient stated it was reconstituted improperly or something went wrong, and they did not want to tell what would have caused it to be yellow. The patient stated that the pharmacist did not recall it being yellow, but the patient stated that it was specifically remembered it being yellow.  On 04-Dec-2023, 13 days after the exposure, the patient was vaccinated with the third dose of RabAvert (batch number: unknown), at an unknown dose, route, and site of administration (explicitly coded as 'inappropriate schedule of vaccine administered').  The patient stated that the subsequent doses of RabAvert that received were all clear.  As reported, the patient stated did not have any other side effects other than being tired from all the RabAvert injections and then the immunoglobulin. The patient was concerned if it may be first dose was void and that may need to get a fifth dose because sometimes rabies symptoms would take up to a year to show up. The first time the patient called to get the lot number the pharmacy told that the expiration date was Apr-2024 and then for the next dose they gave a lot number and said it was the same lot number for the first and second doses. They said then that both doses expire in Jul-2024. As reported, the patient asked how it could be sure if they gave the right information and, if was there any way to see if that lot number had been shipped. The patient was supposed to get a fourth dose of RabAvert as scheduled on 11-Dec-2023 but they forgot to order it, the patient stated that should get it by the afternoon. The patient needed to get details since the treatment had not been done properly. The patient knew where to send the blood sample to get it tested for the titers but was not sure where to get the blood drawn. The patient would be switching doctors once that was completed.  On 11-Dec-2023, the patient was scheduled for a fourth RabAvert dose. The patient added that the first dose received in stock was not used a lot.  At the time of the initial report, it was unknown if the patient recovered from the event of tired after all doses of RabAvert. The reporter did not provide the seriousness and causality assessment for the event of tired after all doses of RabAvert.  As reported in the investigation report the similar cases trend analysis showed no other similar complaint had been reported involving the formulated bulk batch and the syringe final container batch used in the production of finished product batch ARBA949A. 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: ''clear to slightly opalescent, colorless to slightly pink suspension''. No defect linked to the reporter issue was identified.* The bulk investigation, formulation investigation and filling investigation showed no deviation or event directly linked to the complaint. The batch was 100 percent visually inspected automatically after filling. The visual inspection too showed no deviation or event directly linked to the complaint. The manual statistical visual inspection of the batch was conforming. No deviation was recorded during warehousing or distribution.* Given the outcome of quality control investigation, Manufacturer considered the complaint that was the object of this report as unsubstantiated. *  Additional information received from Bavarian Nordic on 08-Dec-2023 included the Product Quality Complaint (PQC) number (QE-007782).  Additional information received on 08-Dec-2023 new information included physician clarification on events and the vaccinations schedules, and details, and additional reference number (USBAV23-2058).  Additional information received on 11-Dec-2023 new information included the start date of the third dose of RabAvert, batch number, and expiry date for the first and second dose of RabAvert, and additional reference numbers (USBAV23-2063, and USBAV23-2065).  Additional information received from Bavarian Nordic on 12-Dec-2023 new information included an update on expiration date of the first and second dose of RabAvert and included local BN case ID.  Additional information received from the Manufacturer on 12-Dec-2023 new information included confirmation on the reported defect classified as vaccine appearance, and additional reference number.  Additional information received from the Manufacturer on 22-Dec-2023 new information included investigational conclusion that was ongoing.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information received from the Manufacturer on 16-Jan-2024: New information included investigation results and confirmation that investigational conclusion was still ongoing.  Follow up information received from the Manufacturer on 18-Jan-2024: New information included final report to reflect the outcome and conclusion of the investigation.; Reporter's Comments: A female patient of unknown age received the first dose of RabAvert six days after exposure, the second dose eight days, and the third dose 13 days after exposure, which are considered as inappropriate schedules of vaccine administered. The first dose of RabAvert was light-yellow color, which is considered as product color issue. After all doses patient reportedly experienced fatigue. Fatigue is listed/expected for RabAvert according to insert, whilst product color issue and inappropriate schedule of vaccine administered are listed per company convention. The patient's medical history and concomitant details were not provided. The outcome was unknown. Due to implied temporal relationship and product known safety profile, the causality for reported fatigue is assessed as related to RabAvert. Product color issue and inappropriate schedule of vaccine administered are not related to RabAvert, but to a human factor/technical issue. The case is non-serious.; Sender's Comments: A female patient of unknown age received the first dose of RabAvert six days after exposure, the second dose eight days, and the third dose 13 days after exposure, which are considered as inappropriate schedules of vaccine administered. The first dose of RabAvert was light-yellow color, which is considered as product color issue. After all doses patient reportedly experienced fatigue. Fatigue is listed/expected for RabAvert according to insert, whilst product color issue and inappropriate schedule of vaccine administered are listed per company convention. The patient's medical history and concomitant details were not provided. The outcome was unknown. Due to implied temporal relationship and product known safety profile, the causality for reported fatigue is assessed as related to RabAvert. Product color issue and inappropriate schedule of vaccine administered are not related to RabAvert, but to a human factor/technical issue. The case is non-serious.