Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 1 | 96867 | IM |
The patient received the first dose of Jynneos on 24-Nov-2024 and didn't receive the second dose still; Patient received Jynneos vaccine intramuscularly; Case reference number US-BN-2025-000353 is a spontaneous case initially received from pharmacist via agency (reference number: USBAV25-0565) on 12-Mar-2025 and concerns a 28-year-old, female patient. The patient's medical history and concomitant medication details were not provided. On 24-Nov-2024, the patient took the first dose of Jynneos (batch number: 96867; expiration date: 30-Apr-2026) intramuscularly, at unknown dose, site of administration for travel. (explicitly coded as 'Incorrect route of product administration') The patient hasn't received the second dose yet (explicitly coded as 'Incomplete course of vaccination'). At the time of the initial report, it was unknown if the patient experienced any of the adverse events due to Jynneos. No further information was provided.; Reporter's Comments: A 28-year-old, female patient took the first dose of Jynneos, intramuscularly, at unknown dose and site of administration for travel which is considered as incorrect route of product administration. The patient hasn't received the second dose yet which is considered as incomplete course of vaccination. Incorrect route of product administration and incomplete course of vaccination are both considered listed per company conventions. At this point, it was unknown if the patient experienced any of the adverse events due to Jynneos. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration and incomplete course of vaccination are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 28-year-old, female patient took the first dose of Jynneos, intramuscularly, at unknown dose and site of administration for travel which is considered as incorrect route of product administration. The patient hasn't received the second dose yet which is considered as incomplete course of vaccination. Incorrect route of product administration and incomplete course of vaccination are both considered listed per company conventions. At this point, it was unknown if the patient experienced any of the adverse events due to Jynneos. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration and incomplete course of vaccination are both assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: NONE