Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, Injection, Product administration error, Product storage error
Clinical narrative: Jynneos vaccine administered intradermally; vial was punctured and stored in the fridge for a week; they gave a dose technically after it had been expired due to being previously punctured; Case reference number US-BN-2022-004514, is a spontaneous case report initially received from a healthcare professional via Communication (reference number: USBAV22-1778) on a 25-OCT-2022 and concerns a patient of unspecified age and gender.  The patient's medical history and concomitant medications details were not provided.  On an unspecified date, the patient was vaccinated with an unknown dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown), at an unknown dose, intradermally (explicitly coded as 'Intradermal injection'), at an unknown anatomical site, for monkeypox prophylaxis.  As reported, the clinic had a vial that was punctured and stored in the fridge for a week and then they gave a dose technically after it had been expired due to being previously punctured (explicitly coded as 'Product storage error' and 'Product administration error').  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received from a pharmacist on 04-Nov-2022 included the information that there were 18 patients vaccinated intradermally a total of 24 times.  This case is linked with US-BN-2022-004515, US-BN-2022-004521, US-BN-2022-004516, US-BN-2022-004517, US-BN-2022-004518, US-BN-2022-004519, US-BN-2022-004520, US-BN-2022-004529, US-BN-2022-004522, US-BN-2022-004523, US-BN-2022-004524, US-BN-2022-004525, US-BN-2022-004526, US-BN-2022-004527, US-BN-2022-004528, US-BN-2022-004530 and US-BN-2022-004513 (same reporter).  Non-significant case correction received from on 11-Nov-2022 included local case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with Jynneos, applied intradermally (which is considered intradermal injection). It was reported that the vial had been previously punctured and stored in a fridge for a week (which is considered product storage error and product administration error). It was unknown if the patient experienced any adverse events. Intradermal injection, product storage error and product administration error are considered listed per company conventions. Medical history and concomitant medications were not reported. The events are assessed as not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with Jynneos, applied intradermally (which is considered intradermal injection). It was reported that the vial had been previously punctured and stored in a fridge for a week (which is considered product storage error and product administration error). It was unknown if the patient experienced any adverse events. Intradermal injection, product storage error and product administration error are considered listed per company conventions. Medical history and concomitant medications were not reported. The events are assessed as not related to Jynneos, but to human error. The case is non-serious.