Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | FDP00013 | SC / LA |
Patient received second dose of Jynneos on day 21; Patient received second dose of Jynneos intradermally; Case reference number US-BN-2024-002090 is a spontaneous case initially received from a pharmacist via Communication (reference number: USBAV24-1470) on 24-Jun-2024 and concerns a *60-year-old male patient*. The patient's medical history and concomitant medication were not provided. *On 20-Aug-2022*, the patient was vaccinated with the first dose of Jynneos (*batch number: FDP00013*) at an unknown dose, *subcutaneously in left arm for mpox pre-exposure prophylaxis.* *On 08-Sep-2022, 21 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00013) at an unknown dose, intradermally in left forearm (explicitly coded as 'inappropriate schedule of vaccine administered' and 'intradermal injection').* *At the time of 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 05-Jul-2024: New information included patient demographic details (initials, gender and age) and Jynneos dosage information. Non-significant case correction performed for information received from VAERS on 05-Aug-2024 included additional reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20240625-20d85e to US-BAVARIAN NORDIC A/S-US-BN-2024-002090, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 60-year-old male patient was vaccinated with the second dose of Jynneos, 21 days after the first dose, at an unknown dose, intradermally in left forearm which is considered as inappropriate schedule of vaccine administered and intradermal injection. It was unknown if the patient experienced any adverse event due to Jynneos. Inappropriate schedule of product administration and injection are both considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Causality is assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 60-year-old male patient was vaccinated with the second dose of Jynneos, 21 days after the first dose, at an unknown dose, intradermally in left forearm which is considered as inappropriate schedule of vaccine administered and intradermal injection. It was unknown if the patient experienced any adverse event due to Jynneos. Inappropriate schedule of product administration and injection are both considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Causality is assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.