Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Incorrect route of product administration
Clinical narrative: Early vaccination on day 23 for second dose of Jynneos, instead of day 28; Jynneos vaccine administrated intramuscularly instead of subcutaneous; Case reference number US-BN-2022-002439 is a spontaneous case report initially received on 15-Sep-22 from other health professional via Agency (reference number: USBAV22-1409) and concerns an adult male patient.  The patient's medical history and concomitant medications details were not provided.  On 18-Aug-2022, the patient was vaccinated with a first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP0009) at unknown dose, administered intramuscularly, for unknown indication (explicitly coded as 'inappropriate route of vaccination').  On 10-Sep-2022, 23 days after the first dose, the patient was vaccinated with a second dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP0009), (explicitly coded as 'inappropriate schedule of vaccine administration') at unknown dose, administered intramuscularly, for unknown indication (explicitly coded as 'inappropriate route of vaccination').  It was reported that no treatment was given to the patient due to adverse event and no laboratory tests have been performed.  The Reporter assessed the events as non-serious and not related to Jynneos.  Additional information received on 16-Sep-2022 from Bavarian Nordic included local BN case ID.  This case is linked to case US-BN-2022-002518.; Reporter's Comments: An adult male patient was vaccinated with a first dose of Jynneos vaccine, at unknown dose, administered intramuscularly, for unknown indication, which is considered as inappropriate route of vaccination. On the day 23 after the first dose, the patient was vaccinated with a second dose of Jynneos vaccine, which is considered as inappropriate schedule of vaccine administration, at unknown dose, administered intramuscularly, for unknown indication, which is considered as inappropriate route of vaccination. Inappropriate schedule of product administration and incorrect route of product administration are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Inappropriate schedule of product administration and incorrect route of product administration 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: An adult male patient was vaccinated with a first dose of Jynneos vaccine, at unknown dose, administered intramuscularly, for unknown indication, which is considered as inappropriate route of vaccination. On the day 23 after the first dose, the patient was vaccinated with a second dose of Jynneos vaccine, which is considered as inappropriate schedule of vaccine administration, at unknown dose, administered intramuscularly, for unknown indication, which is considered as inappropriate route of vaccination. Inappropriate schedule of product administration and incorrect route of product administration are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Inappropriate schedule of product administration and incorrect route of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. US-BN-2022-002518: