Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | Unknown | IM |
The patient received first and second dose of Jynneos intramuscularly instead of subcutaneously; Case reference number US-BN-2024-002659 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV24-2749) on 17-Oct-2024 and concerns a 20-year-old patient of unspecified gender. The patient's medical history and concomitant medication details were not provided. On 11-Sep-2024, the patient was vaccinated with the first dose of Jynneos (batch number: unknown), at an unknown dose or site of administration, intramuscularly, for unknown indication (explicitly coded as 'inappropriate route of vaccination'). On 09-Oct-2024, 28 days after vaccination with first dose of Jynneos vaccine, the patient was vaccinated with the second dose of Jynneos (batch number: unknown at an unknown dose or site of administration, intramuscularly (explicitly coded as 'inappropriate route of vaccination'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. Non-significant case correction downloaded from VAERS on 09-Dec-2024 included additional reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20241017-a617e8 to US-BAVARIAN NORDIC A/S-US-BN-2024-002659, in accordance with guidance on WWID formatting.; Reporter's Comments: A 20-year-old patient of unspecified gender was vaccinated with the first and with the second dose of Jynneos, intramuscularly, for unknown indication, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to Jynneos vaccine. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 20-year-old patient of unspecified gender was vaccinated with the first and with the second dose of Jynneos, intramuscularly, for unknown indication, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to Jynneos vaccine. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None