Sex: M
Vaccine: RAB
Symptoms: Accident at work, Accidental exposure to product, Device safety feature issue, Injury associated with device, Needle issue
Clinical narrative: The healthcare (HCP) gave the injection and there was no safety mechanism on the needle provided in the box. The HCP tried recapping the needle with two hands and the needle went out of the plastic cover and punctured HCP; The healthcare (HCP) gave the injection and there was no safety mechanism on the needle provided in the box. The HCP tried recapping the needle with two hands and the needle went out of the plastic cover and punctured HCP; Injury occurred due to accidental exposure; Case reference number US-BN-2023-001451 is a spontaneous case report initially received on 25-Aug-2023 from a nurse via Med Communications (reference number: USBAV23-1324) and concerns 36-year-old male patient.  The patient's relevant medical history and concomitant medications were not provided.  On 24-Aug-2023, the healthcare professional (HCP) administered RabAvert injection (batch number: ARBA98ZA; expiration date: Feb-2025), using the needle provided in the box after reconstitution and there was no safety mechanism on the needle. The HCP tried recapping the needle with two hands and the needle went out of the plastic cover and punctured the HCP (explicitly coded as 'accidental occupational exposure to product' and 'needle issue'). As reported, the patient had an injury that occurred due to accidental exposure (puncture) with RabAvert.  It was reported that there was waiting for follow-up with occupational health provider and that everything was good.  *On 01-Sep-2023, the patient recovered from the event of 'occupational injury'.*  The reporter assessed the event of 'occupational injury' as serious due to the criteria of medical significance, moderate in intensity, and related to RabAvert vaccine.   Additional information received from Bavarian Nordic on 28-Aug-2023 included local BN case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from nurse via Bavarian Nordic on 18-Sep-2023: New information included the patient's details and confirmation that there was one patient, one event, and the patient did not experience any additional adverse events.  Non-significant case correction received on 02-Oct-2023 from Bavarian Nordic included local BN case ID.  Follow-up information received from nurse on 04-Oct-2023: New information included additional contact details, further description of the exposure and update of verbatim, and seriousness, causality, severity, outcome and onset for the event of 'occupational injury' and additional event of 'needle issue'.  Non-significant case correction received on 16-Oct-2023 from Manufacturer included additional reference number.  Follow-up information received from nurse on 13-Oct-2023: New information included confirmed date of exposure and injury to RabAvert vaccine and provided seriousness criteria for the event of injury.  Follow-up information received from the nurse on 23-Oct-2023: New information included end date and updated outcome for the event of injury.; Reporter's Comments: The healthcare professional (HCP) administered the RabAvert, and there was no safety mechanism on the needle when using the needle provided in the box after reconstitution which is considered as needle issue. The HCP tried recapping the needle with two hands and the needle went out of the plastic cover and punctured him and the nurse which is considered as accidental occupational exposure to product. As reported, an injury occurred due to accidental exposure (puncture) with RabAvert. Accidental exposure to product and needle issue are considered listed per company conventions while accident at work is considered listed as a non-specific event. The outcome of event accident at work was resolved. The patient's relevant medical history and concomitant medications were not reported. Accidental exposure to product, accident at work and needle issue are all assessed as not related to suspect product but to human factor. The case is serious due to medical significance of accident at work.; Sender's Comments: The healthcare professional (HCP) administered the RabAvert, and there was no safety mechanism on the needle when using the needle provided in the box after reconstitution which is considered as needle issue. The HCP tried recapping the needle with two hands and the needle went out of the plastic cover and punctured him and the nurse which is considered as accidental occupational exposure to product. As reported, an injury occurred due to accidental exposure (puncture) with RabAvert. Accidental exposure to product and needle issue are considered listed per company conventions while accident at work is considered listed as a non-specific event. The outcome of event accident at work was resolved. The patient's relevant medical history and concomitant medications were not reported. Accidental exposure to product, accident at work and needle issue are all assessed as not related to suspect product but to human factor. The case is serious due to medical significance of accident at work.