Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 1 | Unknown | ID |
Patient received Jynneos intradermally instead of subcutaneously, at a dose of 0.5 mL; Patient received Jynneos intradermally instead of subcutaneously, at a dose of 0.5 mL; Case reference number US-BN-2024-002564 is a spontaneous case initially received from a physician via agency (reference number: USBAV24-2539) on 27-Sep-2024 and concerns a 28-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 the first dose of Jynneos (batch number: unknown), at a dose of 0.5 milliliter, intradermally, in unknown site of administration for unknown indication (explicitly coded as 'intradermal injection' and 'vaccine overdose'). As reported, patient was planned to receive the second dose subcutaneously. At the time of the initial report, it was unknown if the patient experienced any adverse events due to 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-20240927-18018a to US-BAVARIAN NORDIC A/S-US-BN-2024-002564, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 28-year-old male patient was vaccinated with the first dose of Jynneos at a dose of 0.5 milliliter, intradermally, for unknown indication, which is considered as intradermal injection and vaccine overdose. It was unknown if the patient experienced any adverse events due to Jynneos. Intradermal injection and overdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and overdose are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 28-year-old male patient was vaccinated with the first dose of Jynneos at a dose of 0.5 milliliter, intradermally, for unknown indication, which is considered as intradermal injection and vaccine overdose. It was unknown if the patient experienced any adverse events due to Jynneos. Intradermal injection and overdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and overdose are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.