Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Product administration error, Product storage error, Underdose
Clinical narrative: Jynneos vaccine administered intradermally; Jynneos vaccine administered at dose 0.1 ml; Jynneos had a temperature excursion; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-002045 is a spontaneous case report initially received on 23-Aug-2022 from a nurse via Communication (reference number: USBAV22-1123) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On 18-Aug-2022, Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00003) had a temperature excursion (explicitly coded as 'product storage error').  On the same date, the patient was vaccinated with the affected Jynneos vaccine (batch number: FDP00003), at dose reported as 0.1 mL, administered intradermally (explicitly coded as 'underdose', 'inappropriate route of vaccination' and 'product administration error'), for monkeypox prophylaxis.   At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received from Bavarian Nordic on 24-Aug-2022 included the local BN case ID.  The case is linked to cases US-BN-2022-002030, US-BN-2022-002028, US-BN-2022-002046, US-BN-2022-002047, US-BN-2022-002048 and US-BN-2022-002049 concerning the same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated with the Jynneos vaccine, at dose reported as 0.1 mL, administered intradermally for monkeypox prophylaxis, and Jynneos vaccine had a temperature excursion prior the vaccination, which is considered as underdose, inappropriate route of vaccination, product storage error and product administration error. No associated adverse events have been reported with the reported medication error. The events of underdose, inappropriate route of vaccination, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose, inappropriate route of vaccination, product storage error and product administration error 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 vaccinated with the Jynneos vaccine, at dose reported as 0.1 mL, administered intradermally for monkeypox prophylaxis, and Jynneos vaccine had a temperature excursion prior the vaccination, which is considered as underdose, inappropriate route of vaccination, product storage error and product administration error. No associated adverse events have been reported with the reported medication error. The events of underdose, inappropriate route of vaccination, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose, inappropriate route of vaccination, product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.