Sex: M
Vaccine: SMALLMNK
Symptoms: Product administration error, Product leakage, Underdose
Clinical narrative: Concerned; The patient got little bit of a wheel; Not much swelling or redness; Not much swelling or redness/Little red spot on patient's arm; Jynneos was administered intradermally; Some of Jynneos vaccine came out while administering it; Some of Jynneos vaccine came out while administering it; Case reference number US-BN-2022-003583 is a spontaneous case report initially received from a consumer via Company (reference number: USBAV22-1545) on 27-Sep-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, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown), administered intradermally, at an unknown dose, for unknown indication.  On an unspecified date, an unknown amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (batch number: unknown) administered intradermally, at an unknown dose. During the administration, some of the vaccine content came out and the patient's developed a little bit of a wheel (explicitly coded as 'underdose' and 'product administration error').  On an unspecified date, an unknown time after the vaccination, the patient had not much swelling or redness.  On an unspecified date, reported also as three days later, the patient had a little red spot on the arm. The patient was concerned about the full effect of the second dose.  At the time of this report, outcome of the events was unknown.  The reporter assessed the events as non-serious and possibly related to the vaccine.  Additional information received from Bavarian Nordic on 06-Sep-2022 included the local BN case ID.; Reporter's Comments: A male patient of an unknown age received the second dose of the Jynneos vaccine, administered intradermally at an unspecified site on the arm (explicitly coded as intradermal injection). During the application, some of the vaccine content leaked out (which is considered vaccine underdose and product administration error). The patient developed an injection site wheel, injection site erythema and injection site swelling. At the time of this report, a little bit of erythema could be seen. Reportedly, the patient was anxious about their vaccine. Anxiety and injection site wheal are unlisted, whereas injection site erythema and injection site swelling are listed per the CCDS V1.0 and USPI for Jynneos. Intradermal injection, underdose and product administration error are considered listed per company convention. The patient's medical history and concomitant medication details were not provided. The patient's anxiety is considered not related to Jynneos, and is rather attributed to the scarce information available to the patient at that time. Injection site wheal, injection site erythema and injection site swelling are considered related to Jynneos. Intradermal injection, underdose and product administration error are considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A male patient of an unknown age received the second dose of the Jynneos vaccine, administered intradermally at an unspecified site on the arm (explicitly coded as intradermal injection). During the application, some of the vaccine content leaked out (which is considered vaccine underdose and product administration error). The patient developed an injection site wheel, injection site erythema and injection site swelling. At the time of this report, a little bit of erythema could be seen. Reportedly, the patient was anxious about their vaccine. Anxiety and injection site wheal are unlisted, whereas injection site erythema and injection site swelling are listed per the CCDS V1.0 and USPI for Jynneos. Intradermal injection, underdose and product administration error are considered listed per company convention. The patient's medical history and concomitant medication details were not provided. The patient's anxiety is considered not related to Jynneos, and is rather attributed to the scarce information available to the patient at that time. Injection site wheal, injection site erythema and injection site swelling are considered related to Jynneos. Intradermal injection, underdose and product administration error are considered not related to Jynneos, but to human error. The case is non-serious.