Sex: U
Vaccine: SMALLMNK
Symptoms: Erythema, Extra dose administered
Clinical narrative: Large area of redness intradermally; Patient received Jynneos vaccine intradermally; Patient received Jynneos vaccine intradermally at dose of 0.5 ml; Case reference number US-BN-2023-001539 is a spontaneous case report received from a nurse on 19-Sep-2023 and concerns a patient of unknown age and gender.    The patient's relevant medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos (batch number: unknown), at an unknown dose, route or site of administration for unknown indication.  On an unspecified date, an unknown amount of time after receiving the first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at a dose of 0.5 milliliter, intradermally, at unknown site of administration (explicitly coded as 'intradermal injection' and *'overdose'*).   On an unspecified date, an unknown amount of time after vaccination with Jynneos, the patient experienced large area of redness intradermally. It was reported that the patient had no adverse effects additionally.   At the time of the initial report, it was unknown if the patient recovered from the event of redness.  The reporter assessed the event of redness as non-serious. The reporter assessed the event of redness as related to Jynneos.  Additional information received on 20-Sep-2023 from Bavarian Nordic included local BN case ID.  All updated information is blended into the case narrative above, with the corrected information presented between asterisks (*)  Need for significant correction identified on 13-Oct-2023 for the information received on 19-Sep-2023. Correction included adding the new event overdose, since the patient received Jynneos vaccine intradermally at dose of 0.5 ml.; Reporter's Comments: A patient of unknown age and gender was vaccinated with the second dose of Jynneos (unknown time after the first dose), at a dose of 0.5 milliliter, intradermally (at unknown site of administration) which is considered as intradermal injection and overdose. Unknown amount of time after vaccination with Jynneos, the patient experienced large area of redness intradermally. Erythema is unlisted according to Regulatory Authority and unexpected according to regulations while intradermal injection and overdose are considered listed per company convention. The outcome of erythema was unknown. The patient's relevant medical history and concomitant medication details were not provided. Erythema is conservatively assessed as related to suspect product due to lack of alternative explanation and since contributory role of suspect product cannot be excluded at this point. Intradermal injection and overdose are assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender was vaccinated with the second dose of Jynneos (unknown time after the first dose), at a dose of 0.5 milliliter, intradermally (at unknown site of administration) which is considered as intradermal injection and overdose. Unknown amount of time after vaccination with Jynneos, the patient experienced large area of redness intradermally. Erythema is unlisted according to regulations and unexpected according to Regulatory Authority while intradermal injection and overdose are considered listed per company convention. The outcome of erythema was unknown. The patient's relevant medical history and concomitant medication details were not provided. Erythema is conservatively assessed as related to suspect product due to lack of alternative explanation and since contributory role of suspect product cannot be excluded at this point. Intradermal injection and overdose are assessed as not related to suspect product but to human factor. The case is non-serious.