Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pruritus, Injection site swelling, Vaccination site erythema
Clinical narrative: Itching at the site; Slight erythema and swelling at the site of the wheal to about the size of a quarter in diameter and 1/4 cm in height; Slight erythema and swelling at the site of the wheal to about the size of a quarter in diameter and 1/4 cm in height; Jynneos was administered intradermally; Case reference number US-BN-2022-002029 is a spontaneous case report initially received from a physician via Bavarian Nordic on 19-Aug-2022 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, also reported as yesterday, the patient was vaccinated with Jynneos (smallpox and monkeypox vaccine, live, nonreplicating, batch number not provided) at an unknown dose, administered intradermally at unknown site, for an unknown indication (explicitly coded as inappropriate route of vaccination').   On an unspecified date, reported as 15 minutes after vaccination, the patient experienced itching at the site of vaccination, slight erythema and swelling at the site of the wheal to about the size of a quarter in diameter and quarter in height.  On an unspecified date, the outcome of the event injection site erythema was resolved.  The outcome of the event injection site itching was not reported.  At the time of this report, the patient did not recover from the event of injection site swelling.   The reporter did not provide seriousness and causality assessment for the events.  No further information was provided.; Reporter's Comments: A male patient of unknown age was vaccinated with Jynneos at an unknown dose, administered intradermally at unknown site, for an unknown indication which is considered as inappropriate route of vaccination. 15 minutes after vaccination, the patient experienced itching at the site of vaccination with slight erythema and swelling of the wheal to about the size of a quarter in diameter and in height. Injection site pruritus, injection site erythema and injection site swelling are all listed and expected according to RA v1 and RA. Incorrect route of product administration is considered listed per company convention. The outcome of the event injection site erythema was resolved and the outcome for injection site itching was not reported while injection site swelling was not resolved. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related for injection site pruritus, injection site erythema and injection swelling due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Incorrect route of product administration is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with Jynneos at an unknown dose, administered intradermally at unknown site, for an unknown indication which is considered as inappropriate route of vaccination. 15 minutes after vaccination, the patient experienced itching at the site of vaccination with slight erythema and swelling of the wheal to about the size of a quarter in diameter and in height. Injection site pruritus, injection site erythema and injection site swelling are all listed and expected according to RA v1 and RA. Incorrect route of product administration is considered listed per company convention. The outcome of the event injection site erythema was resolved.and the outcome for injection site itching was not reported while injection site swelling was not resolved. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related for injection site pruritus, injection site erythema and injection swelling due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Incorrect route of product administration is assessed as not related to suspect product but to human factor. The case is non-serious.