Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | Unknown | — |
The patient received the Jynneos dose three weeks instead of four weeks apart; Case reference number US-BN-2025-000192 is a spontaneous case initially received from nurse via agency (reference number: USBAV25-0253) on 04-Feb-2025 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 first and second dose (to be confirmed) of Jynneos (batch number: unknown) at an unknown dose, route and site of administration for unknown indication. As reported, the patient received the Jynneos dose three weeks instead of four weeks apart (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Jynneos. No further information was provided.; Reporter's Comments: This case report concerns a patient of unknown age and gender. Reportedly, the patient was vaccinated with first and second dose (to be confirmed) of Jynneos, at an unknown dose, route and site of administration for unknown indication and the patient received Jynneos dose three weeks instead of four weeks apart, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Jynneos. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case report concerns a patient of unknown age and gender. Reportedly, the patient was vaccinated with first and second dose (to be confirmed) of Jynneos, at an unknown dose, route and site of administration for unknown indication and the patient received Jynneos dose three weeks instead of four weeks apart, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Jynneos. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None