Sex: M
Vaccine: SMALLMNK
Symptoms: Injection, Scar
Clinical narrative: Jynneos vaccine was administrated intradermally; Scarring on fingers; Case reference number US-BN-2022-004641 is a spontaneous case received from pharmacist on 08-Nov-2022 via agency (reference number: USBAV22-1903) and concerns 59-year-old male patient.  The patients' medical history and concomitant medication details were not provided.  On 15-Sep-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, lot number: unknown) at an unknown dose, administered intradermally (explicitly coded as 'Intradermal injection') in the left arm for an unknown indication.   On an unspecified date, the patient experienced scarring on thumb and fingers as a result of the vaccination. It was not at the injection site. For the second vaccination, the patient asked to change the route of administration.   On 21-Oct-2022, the patient was vaccinated with the second dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, lot number: unknown) at an unknown dose, administered subcutaneously in the left arm for an unknown indication.   At the time of this report, the outcome of the event of 'Scar' was unknown.  The reporter assessed reported event as non-serious and related to Jynneos vaccine.  Additional information received from Bavarian Nordic on 09-Nov-2022 included the information about suspect drug.  Additional information received from Bavarian Nordic on 09-Nov-2022 included the local BN case ID.; Reporter's Comments: A 59-year-old male patient experienced scarring on thumb and fingers as a result of the vaccination with the first dose of Jynneos (at unknown dose and for unknown indication), administered intradermally in the left arm (considered as intradermal injection) but it was not at the injection site. Approximately five weeks after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine, at an unknown dose, administered subcutaneously in the left arm for an unknown indication. Scar is unlisted and unexpected according to agency 1 and agency 2 for Jynneos while injection is considered listed per company convention. The outcome of event scar was unknown. The patients' medical history and concomitant medication details were not provided. Causality for scar is assessed as related due to somewhat compatible temporal relationship, lack of alternative explanation and since contributory role of the suspect product cannot be fully excluded at this point. Injection is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 59-year-old male patient experienced scarring on thumb and fingers as a result of the vaccination with the first dose of Jynneos (at unknown dose and for unknown indication), administered intradermally in the left arm (considered as intradermal injection) but it was not at the injection site. Approximately five weeks after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine, at an unknown dose, administered subcutaneously in the left arm for an unknown indication. Scar is unlisted and unexpected according to agency 1 and agency 2 for Jynneos while injection is considered listed per company convention. The outcome of event scar was unknown. The patients' medical history and concomitant medication details were not provided. Causality for scar is assessed as related due to somewhat compatible temporal relationship, lack of alternative explanation and since contributory role of the suspect product cannot be fully excluded at this point. Injection is assessed as not related to suspect product but to human factor. The case is non-serious.