Sex: F
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Inappropriate schedule of product administration, Wrong technique in product usage process
Clinical narrative: Second dose attempt of Jynneos in left arm with a wheal formed.; First attempt of Jynneos vaccine given in left arm with no elevation of the skin or wheal present after administering. Second dose attempt of Jynneos in left arm with a wheal formed.; Jynneos was administered intradermally instead of subcutaneously; Case reference number US-BN-2022-002432 initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 12-Sep-2022, is a spontaneous case received from non-health care professional via Health Authority (VAERS ID: 2419420-1) and concerns a 54-year-old female patient.   The patient's medical history and concomitant medications details were not provided.   On 24-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00004) administered intradermally *(explicitly coded as 'Intradermal injection') * at an unknown dose or site of administration for unknown indication.   On an unspecified date, a first attempt of Jynneos vaccine was given in the left arm with no elevation of the skin or wheal present after administering. The second dose attempt of Jynneos in left arm with a wheal formed (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of this report, the outcome of the event was unknown.    The reporter assessed the event as non-serious. Causality assessment was not provided.  All updated information is blended into the case narrative above, with the corrected information presented between asterisks (*).  Need for significant correction identified on 07-Oct-2022 due to internal review, for the information received on 12-Sep-2022 from Health Authority; corrections included adding the event 'intradermal injection'.; Reporter's Comments: A 54-year-old female patient developed non-serious event injection site wheal on the same day when the first and the second dose of Jynneos were administered intradermally which is considered inappropriate schedule of vaccine administered. It was reported that no elevation of the skin or wheal was present after administering a first attempt of Jynneos vaccine. Therefore, the second dose attempt of Jynneos was administered and a wheal formed. Injection site wheal is unlisted per CCDS v1 and the Agency. Intradermal injection and inappropriate schedule of vaccine administered are listed by convention. Considering plausible temporal relationship, injection site wheal has been considered as related to Jynneos. Intradermal injection and inappropriate schedule of vaccine administered are not related to Jynneos, but to a human factor.; Sender's Comments: A 54-year-old female patient developed non-serious event injection site wheal on the same day when the first and the second dose of Jynneos were administered intradermally which is considered inappropriate schedule of vaccine administered. It was reported that no elevation of the skin or wheal was present after administering a first attempt of Jynneos vaccine. Therefore, the second dose attempt of Jynneos was administered and a wheal formed. Injection site wheal is unlisted per CCDS v1 and the Agency. Intradermal injection and inappropriate schedule of vaccine administered are listed by convention. Considering plausible temporal relationship, injection site wheal has been considered as related to Jynneos. Intradermal injection and inappropriate schedule of vaccine administered are not related to Jynneos, but to a human factor.