Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | IM |
Jynneos vaccine was administered intramuscularly to a patient; Case reference number US-BN-2024-002770 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV24-2982) on 11-Nov-2024 and concerns a patient of unspecified age and gender. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient received the dose of Jynneos vaccine (batch number: unknown), at unknown dose, intramuscularly, at unknown site of administration, for unknown indication (explicitly codes as 'inappropriate route of vaccination'). At the time of the initial report, the patient did not experience any adverse events due to Jynneos. No further information was provided. Non-significant case correction performed for information received from VAERS on 06-Jan-2025 included additional reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20241111-ec895d to US-BAVARIAN NORDIC A/S-US-BN-2024-002770, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A patient of unspecified age and gender received the dose of Jynneos vaccine intramuscularly, for unknown indication, 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 unspecified age and gender received the dose of Jynneos vaccine intramuscularly, for unknown indication, 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