Sex: U
Vaccine: SMALLMNK
Symptoms: Product closure issue, Product dose omission issue
Clinical narrative: While administering Jynneos the air was injected in and nurse flipped it upside down to withdraw the vaccine, it made a popping noise and the stopper popped out, came out of the bottle, contents fell down to the surface; The contents of Jynneos fell down to the surface; Case reference number US-BN-2022-001784 is a spontaneous case report initially received on 04-Aug-2022 from a nurse via Communication (reference number: USBAV22-0805) and concerns a patient of unknown demographics.   The patient's medical history and concomitant medication details were not reported.  On an unspecified date, while administering Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown) the nurse injected the air in and flipped it upside down to withdraw the vaccine, then it made a popping noise and the stopper popped out, came out of the bottle, the contents fell down to the surface (explicitly coded as 'product stopper coring' and 'missed dose') and it splashed up into nurse's eyes (reported in US-BN-2022-001785). It was stated that the vaccine was not frozen at the time of administration.  It was not reported if the patient experienced any adverse event.  This case is linked with case US-BN-2022-001785 due to the same reporter.  Additional information received on 05-Aug-2022 included the local case ID.  Additional information received on 08-Aug-2022 included PQC reference number (QE-001831).; Reporter's Comments: A patient of unknown demographics was about to be vaccinated with Jynneos vaccine for unknown indication, and on an unspecified date, while administering Jynneos vaccine, the nurse injected the air in and flipped it upside down to withdraw the vaccine, then it made a popping noise and the stopper popped out, came out of the bottle, the contents fell down to the surface, which is considered as product closure issue and product dose omission issue. No associated adverse events have been reported with the reported medication error. Product closure issue and product dose omission issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Product closure 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 be vaccinated with Jynneos vaccine for unknown indication, and on an unspecified date, while administering Jynneos vaccine, the nurse injected the air in and flipped it upside down to withdraw the vaccine, then it made a popping noise and the stopper popped out, came out of the bottle, the contents fell down to the surface, which is considered as product closure issue and product dose omission issue. No associated adverse events have been reported with the reported medication error. Product closure issue and product dose omission issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Product closure 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.