Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | unknown | IM |
The first dose of Jynneos was administered intramuscularly rather than subcutaneously; The patient received the second dose of Jynneos four months and 10 days after the first dose; Case reference number US-BN-2025-000311 is a spontaneous case initially received from pharmacist via agency (reference number: US-BN-2025-000311) on 04-Mar-2025 and concerns a 37-year-old, male patient. The patient's medical history and concomitant medication details were not provided. On 19-Oct-2024, the patient was vaccinated with first dose of Jynneos (batch number: unknown) intramuscularly, at unknown dose, site of administration, for unknown indication (explicitly coded as 'intradermal injection'). On 01-Mar-2025, after four months and 10 days from the first dose, the patient was vaccinated with second dose of Jynneos (batch number: unknown) subcutanously, at unknown dose and site of administration (explicitly coded as 'Inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any of adverse events due Jynneos. No further information was provided.; Reporter's Comments: A 37-year-old male patient was vaccinated with the first dose of Jynneos intramuscularly for unknown indication, which is considered as intradermal injection. Reportedly, after four months and 10 days from the first dose, the patient was vaccinated with the second dose of Jynneos, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any of adverse events due Jynneos. Intradermal injection and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 37-year-old male patient was vaccinated with the first dose of Jynneos intramuscularly for unknown indication, which is considered as intradermal injection. Reportedly, after four months and 10 days from the first dose, the patient was vaccinated with the second dose of Jynneos, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any of adverse events due Jynneos. Intradermal injection and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE