Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Product administration error, Product storage error, Underdose
Clinical narrative: The patient was vaccinated with Jynneos vaccine intradermally; The patient was vaccinated with a 0.1 milliliter dose of Jynneos vaccine; After the vial of the Jynneos was out of the fridge and punctured for administration, it was placed back in the fridge and the next day another dose from that vial was administrated to the patient.; After the vial of the Jynneos was out of the fridge and punctured for administration, it was placed back in the fridge and the next day another dose from that vial was administrated to the patient.; Case reference number US-BN-2022-001978 is a spontaneous case report initially received on 19-Aug-2022 from a healthcare professional via agency (reference number: USBAV22-1090), and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not reported.  On 18-Aug-2022, the patient received Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00013) at a dose of 0.1 milliliters, at an unknown anatomical site of administration, intradermally for monkeypox prophylaxis. A dose administrated to the patient was from the same vial of the Jynneos that was out of the fridge the day before and was punctured for administration, and then placed back in the fridge (explicitly coded as 'inappropriate route of vaccination', 'vaccine underdose', 'product storage error', 'product administration error')  At the time of this report, it was unknown whether the patient experienced any adverse events due to Jynneos.  Additional information received on 19-Aug-2022 from Bavarian Nordic included local BN case ID.  This case is linked with US-BN-2022-001978 (same reporter).; Reporter's Comments: A patient of unknown age and gender received a dose of Jynneos at a dose of 0.1 milliliters intradermally for monkeypox prophylaxis, which is considered as inappropriate route of vaccination and vaccine underdose. A dose administrated to the patient was from the same vial of the Jynneos that was out of the fridge the day before and was punctured for administration, and then placed back in the fridge, which is considered as product storage error and product administration error. Inappropriate route of vaccination, vaccine underdose, product storage error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate route of vaccination, vaccine underdose, product storage error and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender received a dose of Jynneos at a dose of 0.1 milliliters intradermally for monkeypox prophylaxis, which is considered as inappropriate route of vaccination and vaccine underdose. A dose administrated to the patient was from the same vial of the Jynneos that was out of the fridge the day before and was punctured for administration, and then placed back in the fridge, which is considered as product storage error and product administration error. Inappropriate route of vaccination, vaccine underdose, product storage error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate route of vaccination, vaccine underdose, product storage error and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.