Sex: M
Vaccine: COVID19, FLUX, SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was vaccinated with 1st dose of Jynneos at 09-Aug-22 and 25 days after with 2nd dose of Jynneos; Case reference number US-BN-2022-002597 is a spontaneous case report initially received on 02-Sep-2022 from a consumer via Agency (reference number: USBAV22-1448) and concerns an elderly male patient of unknown age.  The patient's relevant medical history and concomitant medications were not provided.  On 09-Aug-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at a dose reported as 0.5 mL, administered subcutaneously, at an unknown site for monkeypox prophylaxis.  On 03-Sep-2022, 25 days after the first Jynneos vaccination dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00016) at a dose reported as 0.5 mL, administered subcutaneously, at an unknown site (explicitly coded as 'inappropriate schedule of product administration') and with co-suspects Moderna COVID-19 vaccine (elasomeran) and quadrivalent influenza vaccine (brand name unknown), both at an unknown dose, route or site of administration, and for unknown indication.  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received on 20-Sep-2022 from Bavarian Nordic included local BN case ID.; Reporter's Comments: An adult male patient, received the first dose of Jynneos, 0.5 ml subcutaneously at an unknown site. 25 days later (which is considered inappropriate schedule of vaccine administered), the patient received the second dose of Jynneos, 0.5 ml subcutaneously at an unknown site. On the same day, the patient received two co-suspect vaccines - COVID-19 Moderna Bivalent vaccine (mRNA vaccine) and a quadrivalent flu vaccine (unknown brand). Further administration details were not available at the time of this report. It was unknown if the patient experienced any associated adverse events. Inappropriate schedule of vaccine administered is considered listed per company conventions. The patient's medical history and concomitant medications were unknown. The event is assessed as not related to Jynneos, but to human factor. The case is non-serious.; Sender's Comments: An adult male patient, received the first dose of Jynneos, 0.5 ml subcutaneously at an unknown site. 25 days later (which is considered inappropriate schedule of vaccine administered), the patient received the second dose of Jynneos, 0.5 ml subcutaneously at an unknown site. On the same day, the patient received two co-suspect vaccines - COVID-19 Moderna Bivalent vaccine (mRNA vaccine) and a quadrivalent flu vaccine (unknown brand). Further administration details were not available at the time of this report. It was unknown if the patient experienced any associated adverse events. Inappropriate schedule of vaccine administered is considered listed per company conventions. The patient's medical history and concomitant medications were unknown. The event is assessed as not related to Jynneos, but to human factor. The case is non-serious.