Sex: U
Vaccine: SMALLMNK
Symptoms: Administration site reaction, Extra dose administered, Incorrect route of product administration, Local reaction
Clinical narrative: The patient had local reaction at each of three sites; Jynneos administered intradermally; Case reference number US-BN-2022-003582 is a spontaneous case received from health care professional on 28-Sep-2022 via Company (reference number: USBAV22-1560) and concerns a patient of unknown demographic.   The patient's relevant medical history was not provided.  The patient's concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown) at a dose reported as 0.1 ml, intradermally (explicitly coded as 'Intradermal injection'), at an unknown anatomical site and for an unknown indication. As reported, three attempts of intradermal Jynneos vaccine were obtained with no wheal, but the patient had local reactions in each of three sites of product administration.  The outcome of the event was unknown.  The reporter assessed the event of 'local reaction' as non-serious and possibly related to Jynneos.  Additional information received from Bavarian Nordic on 28-Sep-2022 included local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos at a dose reported as 0.1 ml, intradermally, which is considered as intradermal injection, at an unknown anatomical site and for an unknown indication. On the day 0 after the vaccination, the patient experienced a non-serious event of local reaction. The event of local reaction is considered as listed according to the CCDS v1 and Agency, whilst intradermal injection is considered as listed per company convention. The patient's relevant medical history was not provided, and concomitant medication details were not provided. The outcome of the event was unknown, as reported. Considering suggestive temporal relationship and known product safety profile, the event of local reaction has been considered as related to Jynneos. Intradermal injection has 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 patient of unknown demographics was vaccinated with a dose of Jynneos at a dose reported as 0.1 ml, intradermally, which is considered as intradermal injection, at an unknown anatomical site and for an unknown indication. On the day 0 after the vaccination, the patient experienced a non-serious event of local reaction. The event of local reaction is considered as listed according to the CCDS v1 and Agency, whilst intradermal injection is considered as listed per company convention. The patient's relevant medical history was not provided, and concomitant medication details were not provided. The outcome of the event was unknown, as reported. Considering suggestive temporal relationship and known product safety profile, the event of local reaction has been considered as related to Jynneos. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.