Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 1 | FDP00013 | SC / LA |
Patient was given the Jynneos vaccine at age of 17; Case reference number US-BN-2024-002543 is a spontaneous case initially received from a nurse via agency (reference number: USBAV24-2486) on 24-Sep-2024 and concerns a 17-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 30-Aug-2024, the patient was vaccinated with the first dose of Jynneos *(batch number: FDP00013, expiration date: 30-Sep-2024) at a dose of 0.5 ml, subcutaneously in the left upper arm, for indication reported as travel* (explicitly coded as 'product administered to patient of inappropriate age'). *The patient did not receive any additional doses of Jynneos.* As reported, the patient did not experience any adverse events due to Jynneos. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a nurse on 21-Oct-2024: New information included patient demographics (initials) added, Jynneos dosing details for the first dose, and confirmation regarding absence of additional doses. 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-20240924-ebe64e to US-BAVARIAN NORDIC A/S-US-BN-2024-002543, in accordance with guidance on WWID formatting.; Reporter's Comments: A 17-year-old male patient was vaccinated with the first dose of Jynneos for unknown indication, which is considered as product administered to patient of inappropriate age. The patient did not experience any adverse events due to Jynneos. Product administered to patient of inappropriate age is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered to patient of inappropriate age is not related to the suspect product, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 17-year-old male patient was vaccinated with the first dose of Jynneos for unknown indication, which is considered as product administered to patient of inappropriate age. The patient did not experience any adverse events due to Jynneos. Product administered to patient of inappropriate age is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered to patient of inappropriate age is not related to the suspect product, but to a human factor. This case is considered as non-serious.
Comments: None.