Sex: U
Vaccine: SMALLMNK
Symptoms: Immunisation reaction, Off label use, Product administered to patient of inappropriate age
Clinical narrative: Mild local and systemic reactogenicity event; Patient aged between four months and 17 years received Jynneos; Case reference number US-BN-2022-004823 is a spontaneous case report initially received from other health care professional via Bavarian Nordic on 30-Nov-2022 and concerns a patient aged between four months and 17 years of unknown gender (one out of four).  The patient's relevant medical history and concomitant medication details were not provided.  On unspecified dates, the patient was vaccinated with the first and the second dose of Jynneos (smallpox and monkeypox vaccine, live modified vaccinia virus ankara; batch number not provided) at an unknown dose, route or site of administration for close contact exposure with monkeypox case (explicitly coded as 'off label use').  On an unspecified date, an unknown amount of time after the first dose, the patient experienced mild local and systemic reactogenicity event.   At the time of this report, the outcome of the event was unknown.  The reporter did not provide a seriousness or causality assessment.   Additional information received from Bavarian Nordic on 05-Dec-2022 included confirmation of the country of occurrence.  Non-significant case correction received on 15-Dec-2022 from Bavarian Nordic included local BN case ID.  The case is linked with US-BN-2022-004822, US-BN-2022-004824, US-BN-2022-004825, US-BN-2022-004826 and US-BN-2022-004827.; Reporter's Comments: A patient aged between four months and 17 years, of unknown gender experienced mild local and systemic reactogenicity event, unknown time after vaccination with the first and the second dose of Jynneos, at an unknown dose, route or site of administration for close contact exposure with monkeypox case (which is considered as off label use). Immunization reaction is considered listed and expected per RA v1 and RA while off label use is considered listed per company convention. The outcome was unknown. The patient's relevant medical history and concomitant medication details were not provided. Immunization reaction is assessed as related due to known product safety profile, lack of alternative explanation and since contributory role of the suspect product cannot be excluded. Off label use is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient aged between four months and 17 years, of unknown gender experienced mild local and systemic reactogenicity event, unknown time after vaccination with the first and the second dose of Jynneos, at an unknown dose, route or site of administration for close contact exposure with monkeypox case (which is considered as off label use). Immunization reaction is considered listed and expected per RA v1 and RA while off label use is considered listed per company convention. The outcome was unknown. The patient's relevant medical history and concomitant medication details were not provided. Immunization reaction is assessed as related due to known product safety profile, lack of alternative explanation and since contributory role of the suspect product cannot be excluded. Off label use is assessed as not related to suspect product but to human factor. The case is non-serious.