Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Intentional underdose
Clinical narrative: Jynneos vaccine administered intradermally; Jynneos vaccine administered at the dose of 0.1 mL; Second dose of Jynneos vaccine administered 29 days after the first dose; On vaccine injection site patient thought it was a mosquito bite; Case reference number US-BN-2022-002368 is a spontaneous case report initially received on 12-Sep-2022 from a pharmacist via Agency (reference numbers: USBAV22-1354 and USBAV22-1382) and concerns a 36-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 10-Aug-2022, the patient was vaccinated with the first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00003) at a dose of 0.5 milliliter, administered subcutaneously, at an unspecified site, for monkeypox prophylaxis.  On 08-Sep-2022, 29 days after the first dose, the patient was vaccinated with the second dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00004) at a dose of 0.1 milliliter administered intradermally (explicitly coded as 'Intradermal injection', 'Intentional underdose' and 'inappropriate schedule of product administration') at an unspecified site.  On 08-Sep-2022, 12 hours after administered of the vaccine, on the injection site the patient thought it was a mosquito bite. The patient applied a bug bite sting suction tool for treating the symptoms.   At the time of this report, the outcome of the event 'Immunisation reaction' was unknown.  The Reporter assessed the event as non-serious and possibly related to Jynneos.  Additional information received on 13-Sep-2022 from pharmacist included patient demographics, vaccination information and details regarding the event.  Additional information received from Bavarian Nordic on 14-Sep-2022 included the local BN case ID.  No further information was provided.; Reporter's Comments: A 36-year-old male patient developed non-serious event immunisation reaction on the same day, 12 hours after the second dose of Jynneos at a dose of 0.1 ml was administered intradermally, which is considered inappropriate schedule of vaccine administered and intentional underdose. Immunisation reaction is listed per CCDS v1 and the PI. Inappropriate schedule of vaccine administered, intentional underdose and intradermal injection are listed by convention. The patient's medical history and concomitant medications were not provided. Considering plausible temporal relationship, immunisation reaction has been considered as related to Jynneos. Inappropriate schedule of vaccine administration, intentional underdose and intradermal injection are not related to Jynneos, but to a human factor.; Sender's Comments: A 36-year-old male patient developed non-serious event immunisation reaction on the same day, 12 hours after the second dose of Jynneos at a dose of 0.1 ml was administered intradermally, which is considered inappropriate schedule of vaccine administered and intentional underdose. Immunisation reaction is listed per CCDS v1 and the PI. Inappropriate schedule of vaccine administered, intentional underdose and intradermal injection are listed by convention. The patient's medical history and concomitant medications were not provided. Considering plausible temporal relationship, immunisation reaction has been considered as related to Jynneos. Inappropriate schedule of vaccine administration, intentional underdose and intradermal injection are not related to Jynneos, but to a human factor.