Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | ID |
Patient received Jynneos vaccine intradermally; Case reference number US-BN-2024-002131 is a spontaneous case initially received from a nurse via Communication (reference number: USBAV24-1563) on 03-Jul-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication were not provided. On an unspecified date, the patient was vaccinated with the dose of Jynneos (batch number: unknown) intradermally, at an unknown dose and site of administration for 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 Jynneos. Non-significant case correction performed for information received from VAERS on 05-Aug-2024 included additional reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20240703-49d803 to US-BAVARIAN NORDIC A/S-US-BN-2024-002131, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A patient of unknown age and gender was vaccinated with the dose of Jynneos intradermally, for unknown indication, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to Jynneos. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication 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 the dose of Jynneos intradermally, for unknown indication, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to Jynneos. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication 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.