Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Injection site discolouration, Injection site induration, Injection site mass, Peripheral swelling
Clinical narrative: The arm got swollen after both first and second dose of Jynneos; the injection site bump was large, hard, brown and 5 weeks later it is hard, brown and flatter; the injection site bump was large, hard, brown and 5 weeks later it is hard, brown and flatter; Jynneos administrated intradermally at a dose of 0.1 ml in the same arm for both first and secon dose; The patient was vaccinated with the second dose 30 days after the first dose of Jynneos; Case reference number US-BN-2022-004168 is a spontaneous case report initially received on 17-Oct-22 from the consumer via Communications (reference number: USBAV22-1720) and concerns a 25-year-old male patient.  The patient's medical history and concomitant medications details were not provided.  On 04-Sep-2022, the patient was vaccinated with a first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at a dose of 0.1 ml, administrated intradermally, (explicitly coded as 'intradermal injection'), at unknown anatomical location, for monkeypox prophylaxis.  On 04-Oct-2022, 30 days after the first dose, the patient was vaccinated with a second dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown), (explicitly coded as 'inappropriate schedule of vaccine administered'), at a dose of 0.1 ml, administrated intradermally, as reported in the same arm as the first time, for monkeypox prophylaxis.  On an unspecified date, the patient still had a bump from the first shot that was large, hard, and brown, a couple of weeks ago and now, as reported, five weeks later, it was hard, brown and flatter.  As reported, both injection site (from first and second dose) got a similar response the arm got swollen, and the patient was spraying arm with topical antihistamines, and it got better, but he stopped because he read on the leaflet that he was not supposed to use topical antihistamines.   At the time of this report, the outcome of the events was not recovered/not resolved.  The reporter assessed the events as non-serious and possibly related to Jynneos.  Additional information received on 25-Oct-2022 from Bavarian Nordic included local BN case ID.; Reporter's Comments: A 25-year-old male patient was vaccinated with a first dose of Jynneos vaccine, at a dose of 0.1 ml, administrated intradermally, which is considered as intradermal injection, at unknown anatomical location, for monkeypox prophylaxis. On the day 30 after the first dose, the patient was vaccinated with a second dose of Jynneos vaccine, which is considered as inappropriate schedule of vaccine administered, at a dose of 0.1 ml, administrated intradermally, which is considered as intradermal injection, as reported in the same arm as the first time, for monkeypox prophylaxis. Reportedly, on an unspecified date, the patient experienced non-serious events of peripheral swelling, injection site discolouration and injection site induration. The event of injection site induration is listed for Jynneos according to the RA v1 and RA, and peripheral swelling and injection site discolouration are listed per RA v1 and unlisted per RA. Intradermal injection and inappropriate schedule of vaccine administered are considered as listed per company convention. Time to onset was not provided, therefore chronology needs more clarification. The patient's medical history and concomitant medications details were not provided. The outcome of the events was not resolved. Considering the lack of alternative etiology and since the contributory role of the suspect vaccine cannot be excluded, all the events have been considered as related to Jynneos. Intradermal injection and inappropriate schedule of vaccine administered 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: A 25-year-old male patient was vaccinated with a first dose of Jynneos vaccine, at a dose of 0.1 ml, administrated intradermally, which is considered as intradermal injection, at unknown anatomical location, for monkeypox prophylaxis. On the day 30 after the first dose, the patient was vaccinated with a second dose of Jynneos vaccine, which is considered as inappropriate schedule of vaccine administered, at a dose of 0.1 ml, administrated intradermally, which is considered as intradermal injection, as reported in the same arm as the first time, for monkeypox prophylaxis. Reportedly, on an unspecified date, the patient experienced non-serious events of peripheral swelling, injection site discolouration and injection site induration. The event of injection site induration is listed for Jynneos according to the RA v1 and RA, and peripheral swelling and injection site discolouration are listed per RA v1 and unlisted per RA. Intradermal injection and inappropriate schedule of vaccine administered are considered as listed per company convention. Time to onset was not provided, therefore chronology needs more clarification. The patient's medical history and concomitant medications details were not provided. The outcome of the events was not resolved. Considering the lack of alternative etiology and since the contributory role of the suspect vaccine cannot be excluded, all the events have been considered as related to Jynneos. Intradermal injection and inappropriate schedule of vaccine administered have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.