Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 1 | FDP00020 | IM / LA |
The patient received first dose of Jynneos vaccine intramuscularly instead of subcutaneous; Case reference number US-BN-2024-002817 is a spontaneous case initially received from a nurse via agency (reference number: USBAV24-3130) on 26-Nov-2024 and concerns a 23-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 26-Nov-2024, the patient was vaccinated with a first dose of Jynneos (batch number: FDP00020 and expiration date: 31-Aug-2026), at a dose of 0.5 ml, intramuscularly (instead of subcutaneous), in the left deltoid region, for the indication reported as vaccination (explicitly coded as 'inappropriate route of vaccination'). *As reported, the patient did not receive any additional doses of Jynneos but had an appointment to receive second dose on 26-Dec-2024.* At the time of *this follow-up report*, the patient *did not experience* any adverse event due to the Jynneos vaccination. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a nurse on 09-Dec-2024: New information included patient demographics, confirmed that no adverse events occurred and no additional doses of Jynneos were administered. Non-significant case correction performed for information received from VAERS on 06-Jan-2025 included additional reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20241126-4a4e42 to US-BAVARIAN NORDIC A/S-US-BN-2024-002817, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 23-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly (instead of subcutaneous), in the left deltoid region, for the indication reported as vaccination, which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered as listed per company convention. The patient did not experience any adverse event due to the Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 23-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly (instead of subcutaneous), in the left deltoid region, for the indication reported as vaccination, which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered as listed per company convention. The patient did not experience any adverse event due to the Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None