Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | Unknown | — |
The patient received second dose of Jynneos intramuscularly instead of subcutaneously; Case reference number US-BN-2024-002487 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV24-2357) on 12-Sep-2024 and concerns a patient of unknown demographics. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was vaccinated with the first dose of Jynneos (batch number: unknown), at an unknown dose, route, and site of administration for protection against monkeypox virus. On 12-Sep-2024, an unknown amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at an unknown dose, intramuscularly, at an unknown site of administration (explicitly coded as 'inappropriate route of vaccination'). As reported, the patient did not experience any adverse events due to Jynneos. 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-20240912-5de7dd to US-BAVARIAN NORDIC A/S-US-BN-2024-002487, in accordance with guidance on WWID formatting.; Reporter's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos for protection against monkeypox virus, intramuscularly, which is considered as inappropriate route of vaccination. The patient did not experience any adverse events due to Jynneos. 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 demographics was vaccinated with the second dose of Jynneos for protection against monkeypox virus, intramuscularly, which is considered as inappropriate route of vaccination. The patient did not experience any adverse events due to Jynneos. 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.