Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | Unknown | IM |
The patient was vaccinated with the second dose of Jynneos two years after the first dose; Case reference number US-BN-2024-002560 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV24-2529) on 26-Sep-2024, and concerns an adult male patient reported as 25-30 years old. The patient's medical history and concomitant medication details were not provided. On an unspecified date, reported as two years ago, the patient was vaccinated with the first dose of Jynneos (batch number: unknown), at an unknown dose, or site, administered intramuscularly, for vaccination. On 23-Sep-2024, two years after the first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at an unknown dose, or site, administered intramuscularly (explicitly coded as 'inappropriate schedule of vaccine administered'). 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 identified on 04-Nov-2024 included: new reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20240926-3a0603 to US-BAVARIAN NORDIC A/S-US-BN-2024-002560, in accordance with guidance on WWID formatting.; Reporter's Comments: An adult male patient reported as 25-30 years old was vaccinated with the second dose of Jynneos for vaccination, two years after the first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to the Jynneos vaccination. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule 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: An adult male patient reported as 25-30 years old was vaccinated with the second dose of Jynneos for vaccination, two years after the first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to the Jynneos vaccination. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE