Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 1 | 96868 | IM / LA |
The Jynneos vaccine was administered intramuscularly instead of subcutaneously; Patient received first dose (only one dose) of Jynneos vaccine on 08-Apr-2025; Case reference number US-BN-2025-000922 is a spontaneous case initially received from pharmacist via Manufacturer (reference number: BN_2025_00130) on 08-May-2025 and concerns a 27-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 08-Apr-2025, the patient received Jynneos vaccine (batch number: 96868; expiration date: 30-Apr-2026) at 0.5 dose, intramuscularly, in the left deltoid for smallpox (monkey pox) prevention (explicitly coded as 'Inappropriate route of vaccine administered' and 'Incomplete course of vaccination'). At the time of initial report, the patient had not experienced any adverse events due to Jynneos, reported as none reported. Follow-up information received from pharmacist on 21-May-2025 included: Jynneos vaccine administration information, patient information and confirmation that patient did not experience any adverse event.; Reporter's Comments: A 27-year-old male patient received only one dose of Jynneos vaccine intramuscularly instead of subcutaneously, for smallpox (monkey pox) prevention, which is considered as incorrect route of product administration and incomplete course of vaccination. The patient had not experienced any adverse events due to Jynneos. Incorrect route of product administration and incomplete course of vaccination are considered as listed as per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration and incomplete course of vaccination are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 27-year-old male patient received only one dose of Jynneos vaccine intramuscularly instead of subcutaneously, for smallpox (monkey pox) prevention, which is considered as incorrect route of product administration and incomplete course of vaccination. The patient had not experienced any adverse events due to Jynneos. Incorrect route of product administration and incomplete course of vaccination are considered as listed as per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration and incomplete course of vaccination are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE