Sex: U
Vaccine: SMALLMNK
Symptoms: No adverse event, 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-2022-004521, is a spontaneous case report initially received from a healthcare professional via agency (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 via Bavarian Nordic 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-2022-004514, 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 Bavarian Nordic on 11-Nov-2022 included local BN case ID.; Reporter's Comments: A patient of unspecified age and gender was vaccinated with Jynneos (at unknown dose or anatomical location), administered intradermally (considered as intradermal injection) for monkeypox prophylaxis. Reportedly, 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 which is considered as product storage error and product administration error. Injection, product storage error and product administration error are all considered listed per company conventions. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos vaccination. The patient's relevant medical history and concomitant medications were not reported. Injection, product storage error and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age and gender was vaccinated with Jynneos (at unknown dose or anatomical location), administered intradermally (considered as intradermal injection) for monkeypox prophylaxis. Reportedly, 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 which is considered as product storage error and product administration error. Injection, product storage error and product administration error are all considered listed per company conventions. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos vaccination. The patient's relevant medical history and concomitant medications were not reported. Injection, product storage error and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.