Sex: U
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administration error, Product storage error
Clinical narrative: Jynneos was administered up to a week after the 60 day limit after thawing; Jynneos was administered up to a week after the 60 day limit after thawing; Jynneos was administered intradermally in the forearm; Three out of five patients had inappropriate schedule of vaccination where Jynneos was administered more then 28 days after the first dose; Case reference number US-BN-2022-004205 is a spontaneous case report initially received on 13-Oct-2022 from a nurse via Communications (reference number: USBAV22-1701) and concerns *five patients of unknown demographics.*  *The patients had no relevant medical history and were not taking any concomitant medication.*  On an unspecified date, Jynneos vaccine (smallpox and monkeypox vaccine, live nonreplicating; batch number: not provided) was thawed for more than 60 days (explicitly coded as 'product storage error').  *On 29-Aug-2022, two patients were vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number not provided), at a dose of 0.1mL, intradermally (explicitly coded as 'injection'), in the left forearm, for monkeypox and smallpox prophylaxis.*  *On 09-Sep-2022, another two patients were vaccinated with the first dose of Jynneos (batch number not provided), at a dose of 0.1mL, intradermally (explicitly coded as 'injection'), in the left forearm.*  *On 05-Oct-2022, 37 days after the first dose, one out of five patients vaccinated with the previous dose on 29-Aug-2022, was vaccinated with the second dose, three days past thaw date expiration, of Jynneos (batch number not provided), at a dose of 0.1mL, (explicitly coded as 'inappropriate schedule of vaccine administered', 'product administration error'), intradermally (explicitly coded as 'injection') in the right forearm.*  *On 06-Oct-2022, another one patient was vaccinated with the first dose, three days past thaw date expiration, of Jynneos (batch number not provided), at a dose of 0.1mL, intradermally (explicitly coded as 'injection'), in the left forearm.*  *On 07-Oct-2022, 28 days after the first dose, two out of five patients vaccinated with the previous dose on 09-Sep-2022 were vaccinated with the second dose, four days past thaw date expiration, of Jynneos (batch number not provided), at a dose of 0.1mL, intradermally (explicitly coded as 'injection'), in the right forearm (explicitly coded as 'product administration error').*  *On 11-Oct-2022, 43 days after the first dose, one out of five patients vaccinated with the previous dose on 29-Aug-2022 was vaccinated with the second dose, eight days past thaw date expiration, of Jynneos (batch number not provided), at a dose of 0.1mL (explicitly coded as 'inappropriate schedule of vaccine administered', 'product administration error'), intradermally (explicitly coded as 'injection'), in the left forearm.*  *On 28-Oct-2022, 60 days after the first dose, one out of five patients vaccinated with the previous dose on 29-Aug-2022 was vaccinated with the third dose of Jynneos (batch number not provided), at a dose of 0.1mL, intradermally (explicitly coded as 'injection') in the left forearm.*  *On 05-Nov-2022, 30 days after the first dose, one out of five patients vaccinated with the previous dose on 06-Oct-2022 was vaccinated with the second dose of Jynneos (batch number not provided), at a dose of 0.1mL, (explicitly coded as 'inappropriate schedule of vaccine administered'), intradermally (explicitly coded as 'injection') in the right forearm.*  *It was confirmed that no patient experienced any adverse event due to Jynneos.*  Additional information received from Bavarian Nordic on 14-Oct-2022 included local BN case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from other health care professional on 20-Dec-2022: New information included a number of patients vaccinated, confirmation that no patient had a relevant medical history and was not taking any concomitant medication, confirmation that no patient experienced any adverse event due to Jynneos, vaccination details for all patients and information that patients' personal details can't be disclosed.; Reporter's Comments: On an unspecified date, Jynneos vaccine was thawed for more than 60 days, which is considered as product storage error. Five patients of unknown demographics in total received the affected vaccine at a dose of 0.1 mL, intradermally for monkeypox and smallpox prophylaxis. Reportedly, three out of five patients also received second dose more than 28 days after the first dose, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Product administration error, product storage error, intradermal injection and inappropriate schedule of vaccine administered are listed per company convention. The patients had no relevant medical history and were not taking any concomitant medication. Product administration error, product storage error, intradermal injection and inappropriate schedule of vaccine administered are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: On an unspecified date, Jynneos vaccine was thawed for more than 60 days, which is considered as product storage error. Five patients of unknown demographics in total received the affected vaccine at a dose of 0.1 mL, intradermally for monkeypox and smallpox prophylaxis. Reportedly, three out of five patients also received second dose more than 28 days after the first dose, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Product administration error, product storage error, intradermal injection and inappropriate schedule of vaccine administered are listed per company convention. The patients had no relevant medical history and were not taking any concomitant medication. Product administration error, product storage error, intradermal injection and inappropriate schedule of vaccine administered are not related to Jynneos, but to a human factor. The case is non-serious.