Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Incorrect route of product administration
Clinical narrative: The second dose of Jynneos administered 23 days after the first dose; Jynneos vaccine administered intradermally; Case reference number US-BN-2022-003742 is a spontaneous case report initially received on 30-Sep-2022 from a nurse via Communications (reference number: USBAV22-1587) and concerns a male patient.  The patient's medical history and concomitant medication details were not reported.  On 07-Sep-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00019), at a dose reported as 0.1 ml, intradermally, for monkeypox prophylaxis (explicitly coded as 'intradermal injection').  On 30-Sep-2022, 23 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00019), at a dose reported as 0.1 ml, intradermally (explicitly coded as 'inappropriate schedule of vaccine administered' and 'intradermal injection').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 03-Oct-2022 included the local BN case ID.; Reporter's Comments: A male patient born in 1985 was vaccinated with the first dose of Jynneos, at a dose reported as 0.1 ml, intradermally, for monkeypox prophylaxis, which is considered as intradermal injection. Reportedly, on the day 23 after the first dose, the patient was vaccinated with the second dose of Jynneos, at a dose reported as 0.1 ml, intradermally, which is considered as inappropriate schedule of vaccine administered and intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Intradermal injection and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Intradermal injection and inappropriate schedule of product administration 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 male patient was vaccinated with the first dose of Jynneos, at a dose reported as 0.1 ml, intradermally, for monkeypox prophylaxis, which is considered as intradermal injection. Reportedly, on the day 23 after the first dose, the patient was vaccinated with the second dose of Jynneos, at a dose reported as 0.1 ml, intradermally, which is considered as inappropriate schedule of vaccine administered and intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Intradermal injection and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Intradermal injection and inappropriate schedule of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.