Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | Unknown | — |
The patient received the first dose of Jynneos in Feb-2023 and the second dose in Oct-2024; Case reference number US-BN-2024-002610 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV24-2622) on 07-Oct-2024 and concerns *59-year-old* male patient. The patient's medical history and concomitant medication details were not provided. On unspecified day in Feb-2023, the patient was vaccinated with the first dose of Jynneos (batch number: unknown), at an unknown dose, route and site of administration for an unknown indication. *On 05-Oct-2024, unknown amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: 96867, expiration date: 01-Apr-2026), at a dose of 0.5 ml, subcutaneously in the left arm* (explicitly coded as Inappropriate schedule of product administration'). *As reported, the patient did not receive any additional doses of Jynneos*. At the time of the *follow-up report, the patient did not experience* any adverse event due to Jynneos. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a pharmacist on 16-Oct-2024: New information included patient demographics, Jynneos dosing details and confirmation that patient did not experience any adverse event. 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-20241007-620905 to US-BAVARIAN NORDIC A/S-US-BN-2024-002610, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 59-year-old male patient was vaccinated with the first dose of Jynneos for an unknown indication in Feb-2023 and with the second dose in Oct-2024 (at a dose of 0.5 ml, subcutaneously in the left arm), which is considered as inappropriate schedule of product administration. The patient did not experience any adverse event due to Jynneos. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule 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 59-year-old male patient was vaccinated with the first dose of Jynneos for an unknown indication in Feb-2023 and with the second dose in Oct-2024 (at a dose of 0.5 ml, subcutaneously in the left arm), which is considered as inappropriate schedule of product administration. The patient did not experience any adverse event due to Jynneos. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None