Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | Unknown | IM |
The patient received the Jynneos vaccine intramuscularly two months ago and then received a subcutaneous injection last month; The patient received the Jynneos vaccine intramuscularly two months ago and then received a subcutaneous injection last month; Case reference number US-BN-2025-000004 is a spontaneous case initially received from pharmacist via Communication (reference number: USBAV25-0006) on 02-Jan-2025 and concerns a male patient with unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date, reported as two months ago, the patient received first dose of Jynneos vaccine (batch number: unknown) intramuscularly, at unknown dose, site of administration for unknown indication (explicitly coded as 'Inappropriate route of vaccination'). On unspecified date, reported as last month, for unknown amount of time from the first dose, the patient received the second dose of Jynneos vaccine (batch number: unknown) subcutaneously, at unknown dose, site of administration (explicitly coded as 'Inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patient experienced any adverse events due Jynneos vaccine. No further information was provided. Non-significant case correction received from VAERS on 14-Feb-2025 included new reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20250102-a84dae to US-BAVARIAN NORDIC A/S-US-BN-2025-000004, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A male patient with unspecified age received the first dose of Jynneos vaccine, intramuscularly, for unknown indication, which is considered as inappropriate route of vaccination. On unspecified date, reported as last month, an unknown amount of time from the first dose, the patient received the second dose of Jynneos vaccine, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due Jynneos vaccine. Incorrect route of product administration and inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration 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 male patient with unspecified age received the first dose of Jynneos vaccine, intramuscularly, for unknown indication, which is considered as inappropriate route of vaccination. On unspecified date, reported as last month, an unknown amount of time from the first dose, the patient received the second dose of Jynneos vaccine, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due Jynneos vaccine. Incorrect route of product administration and inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration 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