Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | 96867 | SC |
The patient received intramuscularly the second dose of Jynneos vaccine; Case reference number US-BN-2024-002538 is a spontaneous case initially received from pharmacist via agency (reference number USBAV24-2480) on 23-Sep-2024 and concerns a 32-years-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient received the first dose of Jynneos (batch number: 96867), at unknown dose or site of administration, subcutaneously, for prevention of smallpox and monkeypox disease. On an unspecified date, unknown amount of time after the first dose of Jynneos vaccine, the patient received the second dose of Jynneos (batch number: 96867), at unknown dose or site of administration, intramuscularly (explicitly coded as 'Inappropriate route of vaccination'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. 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 [incorrect WWID] to US-BAVARIAN NORDIC A/S-US-BN-2024-002538 , in accordance with guidance on WWID formatting.; Reporter's Comments: A 32-years-old male patient received the second dose of Jynneos, unknown amount of time after the first dose of Jynneos vaccine, at unknown dose or site of administration, intramuscularly which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 32-years-old male patient received the second dose of Jynneos, unknown amount of time after the first dose of Jynneos vaccine, at unknown dose or site of administration, intramuscularly which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None