Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | IM |
The patient received Jynneos in the muscle instead of under the skin; Case reference number US-BN-2025-000157 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV25-0180) on 23-Jan-2025 and concerns a 57-year-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was vaccinated with a dose of Jynneos (batch number: unknown), at an unknown dose or site of administration in the muscle instead of under the skin for an unknown indication (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 the Jynneos vaccination. No further information was provided.; Reporter's Comments: A 57-year-old male patient was vaccinated with a dose of Jynneos, at an unknown dose or site of administration in the muscle instead of under the skin for an unknown indication 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 the Jynneos vaccination. 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 57-year-old male patient was vaccinated with a dose of Jynneos, at an unknown dose or site of administration in the muscle instead of under the skin for an unknown indication 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 the Jynneos vaccination. 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