Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | Unknown | IM |
The patient received first dose of Jynneos intramuscularly instead subcutaneously; Case reference number US-BN-2024-002635 is a spontaneous case initially received from pharmacist via agency (reference number: USBAV24-2676) on 10-Oct-2024 and concerns a patient of unspecified 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 first dose of Jynneos (batch number: unknown), at an unknown dose, intramuscularly, on the arm for unknown indication (explicitly coded as 'incorrect route of product administration'). On 09-Oct-2024, reported as yesterday, unknow amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), an unknown dose, subcutaneously at unknown site of administration. 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 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-20241010-63978a to US-BAVARIAN NORDIC A/S-US-BN-2024-002635, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A patient of unspecified age and gender was vaccinated with a first dose of Jynneos, at an unknown dose, intramuscularly, on the arm for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to the Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age and gender was vaccinated with a first dose of Jynneos, at an unknown dose, intramuscularly, on the arm for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to the Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None