Sex: U
Vaccine: RAB
Symptoms: Wrong technique in product usage process
Clinical narrative: she pulled air into the syringe and injected the air and liquid into the vial; This case was reported by a pharmacist via licensee and described the occurrence of wrong technique in product usage process in a patient who received Rabies NVS (RabAvert) (batch number ARBA731A, expiry date September 2023) for prophylaxis.   On 12th August 2020, the patient received RabAvert 1 ml. On 12th August 2020, unknown after receiving RabAvert, the patient experienced wrong technique in product usage process. On an unknown date, the outcome of the wrong technique in product usage process was unknown.  Additional details were provided as follows: The age at vaccination was not reported. one of the old products and it went fine, but the 3 new ones were difficult with the withdrawal from the vial. The reporter had a family of 4 coming in later today to get the vaccine and we need to know how to get this out easier. The reporter have 8 more vials of this lot: ARBA731A Exp: September 2023. The 1st  vial the nurse could not get all of the vaccine out and just discarded it as she felt she contaminated it. The next one she devised her own way of doing it, the reporter not saying this was correct, and she pulled air into the syringe and injected the air and liquid into the vial and was able to get the majority of it out on the other vials this way, which led to wrong technique in product. The reporter know that is not what the PI says. I see where it says to unscrew the syringe from the needle end and that is just unheard of from a sterility standpoint. I would like more information on this. The reporter also never leave a needle in the vial when we reconstitute. The reporter had a concern about unscrewing the needle from the syringe. That is not sterile and we do not leave the needle in the vial for any reconstitution. The part about unscrewing the needle is not part of the body of the paragraph. It was like an addendum and 2 paragraphs down. Someone would miss that as it is not in the actual directions. The nurse did it like she always does and did not think she would have an issue, but she did. They (nurses) think the vial is different, but the pharmacist is not sure because she does not have any of the other lot to compare. The reporter had 8 more of that lot and expiration that have not been used, but a family of 4 is coming today. Asked RPh if nurse did like the PI and removed the syringe from the needle to help with the pressure. RPh stated: I know that she did not do that, because she just thought she was going to do it like she always has. The reporter had a concern from about unscrewing the syringe from the needle. That is not sterile and they do not leave the needle in the vial for any reconstitution. If patients come in today before I hear back from you I will do it like the PI says and remove the syringe. They (nurses) think the vial was different, but pharmacist is not sure. She doesn't have any of the old product left to compare.   Following internal review it was determined that initial reciept date was 13th August 2020 for follow up 1 and 17th August 2020 for follow 2 and 3, which is earlier than initially reported. On callback to pharmacist on 17th August 2020 pharmacist stated that they had since administered the vaccine and followed the directions and it worked just fine.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR163383: US-GLAXOSMITHKLINE-US2020AMR163382: