Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, Incorrect dose administered
Clinical narrative: 5th dose not given; First dose 10-17-2020 / Second dose: 10-19-2020 / Third dose: 10-26-2020 / Fourth dose: 11-02-2020; This case was reported by a physician via licensee and described the occurrence of drug dose administration interval too short in a 77-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis, rabies vaccine needle device (Rabavert Needle Device) injection needle for an unknown indication, Rabies NVS (RabAvert) for prophylaxis, rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis, rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis, Rabies NVS (RabAvert) for prophylaxis, rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis, rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis, Rabies NVS (RabAvert) for prophylaxis and immunoglobulin human anti-rabies (Hrig) for prophylaxis.   Concurrent medical conditions included cat bite. Concomitant products included Rabies NVS (RabAvert) and immunoglobulin human anti-rabies (Hrig).   On 19th October 2020, the patient received the 2nd dose of RabAvert, Rabavert Pre-Filled Syringe Device and Rabavert Needle Device. On 26th October 2020, the patient received the 3rd dose of RabAvert, Rabavert Pre-Filled Syringe Device and Rabavert Needle Device. On 2nd November 2020, the patient received the 4th dose of RabAvert, Rabavert Pre-Filled Syringe Device and Rabavert Needle Device. On an unknown date, the patient received the 5th dose of RabAvert. On 19th October 2020, the patient started Hrig at an unknown dose and frequency. On 19th October 2020, unknown after receiving RabAvert, Rabavert Pre-Filled Syringe Device and Rabavert Needle Device, not applicable after receiving RabAvert, Rabavert Pre-Filled Syringe Device, Rabavert Needle Device, RabAvert, Rabavert Pre-Filled Syringe Device, Rabavert Needle Device and RabAvert and an unknown time after receiving RabAvert, the patient experienced drug dose administration interval too short and drug dose administration interval too long. On 26th October 2020, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too short, drug dose administration interval too long, drug dose administration interval too long and incomplete course of vaccination were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable. On 17th October 2020, the patient was bitten cat. A complete course of post exposure treatment for previously unvaccinated adults and children consists of a total of 5 doses of vaccine, each 1.0 mL: one IM injection (deltoid) on each of Days 0, 3, 7, 14, and 28. For previously immunized adults and children, a total of 2 doses of vaccine, each 1.0 mL: one IM injection (deltoid) on each of Days 0 and 3. No HRIG should be administered to previously vaccinated persons as it may blunt their rapid memory response to rabies antigen HRIG was administered only once (for specific instructions for HRIG use, see the product package insert). The HRIG injection is followed by a series of 5 individual injections of RabAvert (1.0 mL each) given intramuscularly on Days 0, 3, 7, 14, and 28. Postexposure rabies prophylaxis should begin the same day exposure occurred or as soon after exposure as possible. On 17th October 2020, the patient received the 1st dose of RabAvert. On 19th October 2020, the patient received the 2nd dose of RabAvert and 1ml of the immunoglobulin HRIG, which led to shortening of the vaccination schedule. They co-administered the second dose of post-exposure schedule along with 1ml of the immunoglobulin for rabies by mistake, which led to extra dose. On the second visit, day 3, the patient was given an extra dose of the HRIG. They did not give as much HRIG as the first time (day0). It was not a 5ml dose like the first one. The really believe it  was a fifth of the dose. Just one vial on the second time they given the HRIG. The patient read that it says to not do this because it can interfere with the efficacy of the vaccine. The patient have completed the protocol like it said. The only thing that was not per the protocol was the extra HRIG. On 26th October 2020. the patient received the 3rd dose of RabAvert, which led to lengthening of the vaccination schedule. On 2nd November 2020, the patient received the 4th dose of RabAvert, which led to lengthening of the vaccination schedule.