Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Jynneos was administered intramuscularly in error; Case reference number US-BN-2022-001534 is a spontaneous case report initially received on 12-Jul-2022 from other health professional via Communications (reference number: USBAV22-0535) and concerns *a 37-year-old male patient*.  *The patient had no relevant medical history.*  *The patient's concomitant medications included Truvada (emtricitabine, tenofovir disoproxil fumarate).*  On an unspecified date, the patient was vaccinated with a dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: not provided, expiration date: 31-Aug-2023) at *a dose of 0.5 ml, administered intramuscularly in the left deltoid, for monkeypox vaccination* (explicitly coded as 'inappropriate route of vaccination').  *It was confirmed that the patient didn't experience any adverse event due to Jynneos vaccination.*   Additional information received on 12-Jul-2022 from Bavarian Nordic 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 was received from other health professional on 01-Aug-2022: New information included patient's details (initials, age, date of birth and gender), concomitant medication information and details for Jynneos vaccine.  Non-significant case correction received on 17-Aug-2022 due to internal review included recoding of the suspect product due to listedness updated.; Reporter's Comments: On an unspecified date, a 37-year-old male patient was vaccinated with Jynneos vaccine, at a dose 0.5 ml was administered intramuscularly (instead of subcutaneously) at an unknown dose or site of administration, for monkeypox vaccination, which is considered as inappropriate route of vaccination. No associated adverse events were reported as it was confirmed that the patient didn't experience any adverse event due to Jynneos vaccination. The patient had no relevant medical history and concomitant medications included Truvada (emtricitabine, tenofovir disoproxil fumarate). Incorrect  route of product administration is considered listed per company convention. Inappropriate route of administration is not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: On an unspecified date, a 37-year-old male patient was vaccinated with Jynneos vaccine, at a dose 0.5 ml was administered intramuscularly (instead of subcutaneously) at an unknown dose or site of administration, for monkeypox vaccination, which is considered as inappropriate route of vaccination. No associated adverse events were reported as it was confirmed that the patient didn't experience any adverse event due to Jynneos vaccination. The patient had no relevant medical history and concomitant medications included Truvada (emtricitabine, tenofovir disoproxil fumarate). Incorrect  route of product administration is considered listed per company convention. Inappropriate route of administration is not related to Jynneos, but to a human factor. The case is non-serious.