Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | Unknown | — |
Patient received second dose of Jynneos vaccine as reported two days after the eight weeks; Case reference number US-BN-2024-002592 is a spontaneous case initially received from pharmacist via agency (reference number: USBAV24-2617) on 04-Oct-2024 and concerns a patient of unknown age and gender. 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 unknown indication. On an unspecified date, *reported also as two days after the eight weeks*, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00015, BUD: 30-Sep-2024) at an unknown dose, route and site of administration (explicitly coded as 'inappropriate schedule of vaccine administered') At the time of *follow up* report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a pharmacist on 17-Oct-2024: New information included confirmation that patient received vaccine within BUD (event of expired vaccine used' deleted). 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-20241004-d34310 to US-BAVARIAN NORDIC A/S-US-BN-2024-002592, in accordance with guidance on WWID formatting.; Reporter's Comments: A patient of unknown age and gender was vaccinated with the second dose of Jynneos for unknown indication, 8 weeks and 2 days after the first dose, which is considered inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to Jynneos. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is non-serious.; Sender's Comments: A patient of unknown age and gender was vaccinated with the second dose of Jynneos for unknown indication, 8 weeks and 2 days after the first dose, which is considered inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to Jynneos. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is non-serious.
Comments: None.