Reporte zur Charge BNFDP00004

Symptomtext

Nurse got the Jynneos vaccine in her eye; The entire metal and cap came off from Jynneos vaccine; Case reference number US-BN-2022-001646 is a spontaneous case report initially received on 22-Jul-2022 from other health care professional via Agency (reference number: USBAV22-0640) and concerns a 26-year-old female patient. *The patient had no relevant medical history and was not taking any concomitant medication.* On 20-Jul-2022, one of the nurses got the Jynneos vaccine ((Smallpox and Monkeypox Vaccine, Live, Nonreplicating); batch number: BNFDP00004; expiration date 31-Aug-2023) in her eye (explicitly coded as 'accidental occupational exposure to product'). She pulled the cap off and the entire metal and cap came off and it splashed in her eyes (explicitly coded as 'product container issue'). *It was confirmed that the patient did not experience any adverse event due to Jynneos vaccine.* Additional information received on 25-Jul-2022 from Bavarian Nordic included local BN case ID and attached PQC information (PQC number: QE-001752). All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from a nurse via Bavarian Nordic on 17-Aug-2022: New information included information that the patient did not have any medical history, was not taking any concomitant medication and did not experience any adverse event due to Jynneos.; Reporter's Comments: A 26-year-old female nurse got the Jynneos vaccine in her eye which is considered as accidental occupational exposure to product. When she pulled the cap, the entire metal and cape came off and splashed in her eyes which is considered as product container issue. Accidental exposure to product and product container issue are both considered listed per company conventions. It was confirmed that the patient did not experience any adverse event due to Jynneos vaccine. The patient had no relevant medical history and was not taking any concomitant medication. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 26-year-old female nurse got the Jynneos vaccine in her eye which is considered as accidental occupational exposure to product. When she pulled the cap, the entire metal and cape came off and splashed in her eyes which is considered as product container issue. Accidental exposure to product and product container issue are both considered listed per company conventions. It was confirmed that the patient did not experience any adverse event due to Jynneos vaccine. The patient had no relevant medical history and was not taking any concomitant medication. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.