Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | Unknown | — |
The second dose of Jynneos fully jabbed the patient, suspected intramuscularly; The patient received the second dose of Jynneos 27 days after the first dose; Case reference number US-BN-2024-002516 is a spontaneous case initially received from a consumer via Communications (reference number: USBAV24-2431) on 18-Sep-2024 and concerns a 41-year-old male patient. The patient's medical history and concomitant medication details were not provided. The patient's concomitant vaccination included Covid-19 vaccine (brand name unknown) and flu vaccine (brand name unknown). On 22-Aug-2024, the patient was vaccinated with the first dose of Jynneos (batch number: unknown), at an unknown dose, and site of administration, administered as reporter right under the skin, for indication reported as vaccination, also stated as no known exposure to disease. On 18-Sep-2024, 27 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at a dose reported as one, administered suspected intramuscularly, in right arm, reported as fully jabbed like Covid or flushot (explicitly coded as 'Inappropriate route of vaccination' and 'Inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to the Jynneos. 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-20240918-c57b22 to US-BAVARIAN NORDIC A/S-US-BN-2024-002516, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 41-year-old male patient was vaccinated with the second dose of Jynneos for indication reported as vaccination, also stated as no known exposure to disease, 27 days after the first dose, administered suspected intramuscularly, in right arm, reported as fully jabbed like Covid or flushot, which is considered as inappropriate route of vaccination and inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to the Jynneos. Incorrect route of product administration 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, and concomitant vaccination included Covid-19 vaccine and flu vaccine. 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 41-year-old male patient was vaccinated with the second dose of Jynneos for indication reported as vaccination, also stated as no known exposure to disease, 27 days after the first dose, administered suspected intramuscularly, in right arm, reported as fully jabbed like Covid or flushot, which is considered as inappropriate route of vaccination and inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to the Jynneos. Incorrect route of product administration 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, and concomitant vaccination included Covid-19 vaccine and flu vaccine. 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
COVID-19 VACCINE; INFLUENZA VACCINE