Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | IM |
Jynneos was administered intramuscularly instead of subcutaneously to a patient; Case reference number US-BN-2024-002571 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV24-2557) on 30-Sep-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was vaccinated with a dose of Jynneos (batch number: unknown), at an unknown dose, or site, administered intramuscularly, for an unknown indication (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 the Jynneos vaccination. Non-significant case correction identified on 04-Nov-2024 included: new reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20240930-94bfa7 to US-BAVARIAN NORDIC A/S-US-BN-2024-002571, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A patient of unknown age and gender was vaccinated with a dose of Jynneos administered intramuscularly, for an unknown indication, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to the Jynneos vaccination. 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 patient of unknown age and gender was vaccinated with a dose of Jynneos administered intramuscularly, for an unknown indication, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to the Jynneos vaccination. 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