Sex: U
Vaccine: SMALLMNK
Symptoms: Product administration error, Product closure issue
Clinical narrative: The metal rings of the yellow plastic cap of the Jynneos vials are sticking up and pocking at people, the same came off before being drawn up; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-001902 is a spontaneous case report initially received on 16-Aug-2022 from a nurse via Company (reference number: USBAV22-1013) and concerns an unknown number of patients.  The patient's medical history and concomitant medication details were not provided.  On an unknown date, during preparation and administration of Jynneos vaccines (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) (batch number: FDP00005; Expiry date: 13-Aug-2023 ), the metal rings of the yellow plastic cap were sticking up and pocking at people. The same came off before being drawn up. Affected Jynneos vaccine was administrated to patients at unknown dose, route or site of administration, for monkepox prophylaxis (explicitly coded as 'product closure issue' and 'product administration error'). Four or five vials out of ten were affected, as reported.  At the time of this report, it was unknown how many patients were involved *but it was known that no one experienced adverse event due to Jynneos. This was an issue with the vial cap and metal ring that the nurses were having difficulty with.*  Additional information received on 16-Aug-2022 from Bavarian Nordic included local BN case ID.  Additional information received on 17-Aug-2022 from Bavarian Nordic included the PQC reference number (QE-001956) and Jynneos expiry date.  Follow up information received from nurse on 30-Sep-2022 included confirmation that no adverse event occurred due to Jynneos vaccine.; Reporter's Comments: On an unknown date, during preparation and administration of Jynneos vaccines the metal rings of the yellow plastic cap were sticking up and pocking at people, which is considered product closure issue. Affected Jynneos vaccine (four or five out of 10 bottles were affected) was administrated to patients for monkepox prophylaxis, which is considered as product administration error. The patient experienced no associated adverse events. Both product closure issue and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Both product closure issue and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: On an unknown date, during preparation and administration of Jynneos vaccines the metal rings of the yellow plastic cap were sticking up and pocking at people, which is considered product closure issue. Affected Jynneos vaccine (four or five out of 10 bottles were affected) was administrated to patients for monkepox prophylaxis, which is considered as product administration error. The patient experienced no associated adverse events. Both product closure issue and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Both product closure issue and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.