Sex: U
Vaccine: RAB
Symptoms: Product delivery mechanism issue, Product dose omission issue
Clinical narrative: Pharmacist couldn't withdraw a full dose from the reconstituted vial of Rabavert; Patient did not receive the second dose of RabAvert; Case reference number US-BN-2022-001395 is a spontaneous case report initially received on 24-Jun-2022 from a pharmacist (reference number: USBAV22-0417) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified day, the patient received first dose of Rabavert (Rabies Virus (Inactivated, Strain Flury LEP); batch number: YRBA831B) at dose of 1 mL for rabies pre-exposure prophylaxis.  On 24-Jun-2022, the patient was about to receive the second dose of RabAvert (batch number: YRBA831B; expiration date: 20-Apr-2024) for pre-exposure prophylaxis, but there was an issue with obtaining a full dose from reconstituted vial. As reported, the pharmacist was only able to get about 0.5 ml from the vial (explicitly coded as Product delivery mechanism issue'). It was confirmed that the dose was not administered (explicitly coded as Missed dose').  At the time of this report it was unknown if the patient experienced any adverse event.  Additional information received on 25-Jun-2022 via Bavarian Nordic, included PQC number (QE- 001552).  Additional information received on 27-Jun-2022, included the local case ID.; Reporter's Comments: A patient of unknown demographics was about to receive the second dose of RabAvert for rabies pre-exposure prophylaxis, but there was an issue with obtaining a full dose from reconstituted vial. As reported, the pharmacist was only able to get about 0.5 ml from the vial, which is considered as product delivery mechanism issue. It was confirmed that the dose was not administered, which is considered as product dose omission issue. No associated adverse events have been reported with the reported medication error. Product delivery mechanism issue and product dose omission issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product delivery mechanism issue and product dose omission issue 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 patient of unknown demographics was about to receive the second dose of RabAvert for rabies pre-exposure prophylaxis, but there was an issue with obtaining a full dose from reconstituted vial. As reported, the pharmacist was only able to get about 0.5 ml from the vial, which is considered as product delivery mechanism issue. It was confirmed that the dose was not administered, which is considered as product dose omission issue. No associated adverse events have been reported with the reported medication error. Product delivery mechanism issue and product dose omission issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product delivery mechanism issue and product dose omission issue have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.