Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 1 | 96867 | IM / LA |
Patient received the first dose of Jynneos intramuscularly instead of subcutaneously; Case reference number US-BN-2024-002544 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV24-2503) on 24-Sep-2024 and concerns a 27-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 20-Sep-2024, the patient was vaccinated with the first dose of Jynneos (batch number: 96867, expiry date: 20-Apr-2026) *0.5 milliliter*, intramuscularly in left deltoid for indication reported as vaccination (explicitly coded as 'inappropriate route of vaccination'). At the time of *follow up report, the patient did not experience* any adverse events due to Jynneos. 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 19-Oct-2024: New information included added Jynneos dosage information and confirmation that the patient did not experience any adverse event. 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-20240924-57e2f9 to US-BAVARIAN NORDIC A/S-US-BN-2024-002544, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 27-year-old male patient was vaccinated with the first dose of Jynneos (0.5 milliliter), administered intramuscularly in left deltoid for indication reported as vaccination, which is considered as inappropriate route of vaccination. The patient did not experience any adverse events due to Jynneos. Incorrect route 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 is not related to the suspect product, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 27-year-old male patient was vaccinated with the first dose of Jynneos (0.5 milliliter), administered intramuscularly in left deltoid for indication reported as vaccination, which is considered as inappropriate route of vaccination. The patient did not experience any adverse events due to Jynneos. Incorrect route 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 is not related to the suspect product, but to a human factor. This case is considered as non-serious.
Comments: None.