Sex: F
Vaccine: RAB
Symptoms: Product dose omission issue
Clinical narrative: Piece of the filter/rubber stopper came off inside the vial/particulate matter in the top; The patient did not receive the dose of RabAvert; There was particulate matter in the top of RabAvert vaccine; Case reference number BN-2022-000819 is a spontaneous case report initially received from other health professional via Communication (reference number: USBAV22-0098) on 21-Mar-2022 and concerns an adult female patient.  The patient's medical history and concomitant medication details were not provided.  On 21-Mar-2022, as reported, the patient took the RabAvert vaccine (Rabies Virus (Inactivated, Strain Flury LEP) (PCEC), batch number: YRBA821A) to the doctor's office to have it administered, but a piece of the filter/rubber stopper came off inside the vial. There was also a particulate matter in the top, as reported (explicitly coded as 'product closure issue' and 'product contamination particulate matter'). The patient did not receive the dose and took it back to the pharmacy (explicitly coded as 'missed dose').   At the time of this follow-up report, it was not confirmed which dose number was postponed.  Additional information was received on 21-Mar-2022 included the PQC reference number *(QE-000760)*.  Additional information was received  on 22-Mar-2022 included the local case ID.  Additional information was received from Communication (reference number: USBAV22-0106) included corrected batch number for RabAvert vaccine from ARBA911D to YRBA821A.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information was received from a pharmacist via Communication on 20-Apr-2022: new information included additional reporter, reference number (USBAV22-0136), updated expiration date for Rabipur vaccine and updated details regarding the vaccine issue.  Additional information was received on 22-Apr-2022 and included confirmation that the patient did not receive the dose at doctor's office.  Additional information was received on 25-Apr-2022 and included additional PQC reference *(QE-001036)*.  Additional information was received on 28-Apr-2022 and included information that the patient wanted another vaccine, probably the second dose (not confirmed).  All updated information is blended into the case narrative above, with the corrected information presented between asterisks (*).  Need for significant correction identified on 06-May-2022, for the information received on 21-Mar-2022 and 20-Apr-2022 included PQC reference number added in the narrative section.; Reporter's Comments: An adult female patient took the RabAvert vaccine to the doctor's office to have it administered, but a piece of the filter/rubber stopper came off inside the vial. There was also a particulate matter in the top, as reported, which is considered as product closure issue and product contamination physical. Reportedly, the patient did not receive the dose and took it back to the pharmacy, which is considered as product dose omission issue. No associated adverse events have been reported with the reported medication error. Product closure issue, product dose omission issue and product contamination physical are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product closure issue, product dose omission issue and product contamination physical 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: An adult female patient took the RabAvert vaccine to the doctor's office to have it administered, but a piece of the filter/rubber stopper came off inside the vial. There was also a particulate matter in the top, as reported, which is considered as product closure issue and product contamination physical. Reportedly, the patient did not receive the dose and took it back to the pharmacy, which is considered as product dose omission issue. No associated adverse events have been reported with the reported medication error. Product closure issue, product dose omission issue and product contamination physical are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product closure issue, product dose omission issue and product contamination physical have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.