Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Inappropriate schedule of product administration, Product administered at inappropriate site
Clinical narrative: Jynneos administrated intradermally; No wheal observed with administration requiring secondary administration; Jynneos administrated in the left forearm; Case reference number US-BN-2022-003770 is a spontaneous case report initially received on 14-Sep-22 from other health care professional via Communications (reference number: USBAV22-1396) and concerns a 28-year-old male patient.  The patient's medical history and concomitant medications details were unknown.  *On 12-Aug-2022, the patient was vaccinated with a first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: Unknown) at a dose of 0.5 ml, administrated subcutaneously, at unknown anatomical location, for unknown indication.*  On 09-Sep-2022, the patient was vaccinated with a *second dose* of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00016; expiration date: 31-Oct-2024) at unknown dose, unknown route of administration, in the left forearm (explicitly coded as 'vaccine administered at inappropriate site'), for monkeypox prevention.   As reported, no wheal observed with administration requiring secondary administration.  On the same date, an unspecified amount of time after the vaccination, the patient was vaccinated with the additional dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00016; expiration date: 31-Oct-2024), (explicitly coded as 'inappropriate schedule of vaccine administration'), at a dose of 0.1 ml, administrated intradermally (ID), (explicitly coded as 'intradermal injection'), at left forearm, for monkeypox prevention.   At the time of this report, it was unknown whether the patient experienced any adverse event.  Additional information received on 15-Sep-2022 from Bavarian Nordic included local BN case ID and is blended in the case narrative above.   Additional information downloaded from VAERS received from healthcare professional on 26-Sep-2022 included VAERS ID (2442887-1) and second dose details and is blended in the case narrative above.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information was received from health care professional on 02-Nov-2022: New information included dosing details, expiration date, indication, anatomical location.  Follow up information was received from health care professional on 10-Nov-2022: New information included updated date when first dose of Jynneos was administered, dosage details and route of administration for the first dose and updated date when the second dose was administered.; Reporter's Comments: A 28-year-old male patient was vaccinated with the second dose of Jynneos, applied intradermally at an unknown dose, which is considered intradermal injection. The vaccine was administered in the left forearm, which is considered vaccine administered at inappropriate site. Reportedly, no wheal was observed with administration requiring secondary administration and the dose (0.1 mL) was repeated on the same day, which is considered inappropriate schedule of vaccine administered. This dose was also administered intradermally in the left forearm, which is also considered intradermal injection. No associated adverse events were reported. Injection (intradermal), inappropriate schedule of product administration and product administered at inappropriate site are all considered listed per the company conventions. The patient's medical history and concomitant medications were unknown. The events are assessed as not related to Jynneos, but to human factor. The case is non-serious.; Sender's Comments: A 28-year-old male patient was vaccinated with the second dose of Jynneos, applied intradermally at an unknown dose, which is considered intradermal injection. The vaccine was administered in the left forearm, which is considered vaccine administered at inappropriate site. Reportedly, no wheal was observed with administration requiring secondary administration and the dose (0.1 mL) was repeated on the same day, which is considered inappropriate schedule of vaccine administered. This dose was also administered intradermally in the left forearm, which is also considered intradermal injection. No associated adverse events were reported. Injection (intradermal), inappropriate schedule of product administration and product administered at inappropriate site are all considered listed per the company conventions. The patient's medical history and concomitant medications were unknown. The events are assessed as not related to Jynneos, but to human factor. The case is non-serious.