Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | 96868 | SC / LA |
The patient accidentally received second dose of Jynneos vaccine intramuscularly instead of subcutaneously; The patient received second dose of Jynneos vaccine 32 days after first dose; Nausea; Case reference number US-BN-2025-000221 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV25-0338) on 13-Feb-2025 and concerns a 55-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 12-Jan-2025, the patient was vaccinated with the first dose of Jynneos (batch number: 96868, expiration date: 30-Apr-2026), at a dose of 0.5 ml, subcutaneously, at left arm for monkeypox vaccination and travel. On 13-Feb-2025, 32 days after vaccination with first dose of Jynneos vaccine, the patient was vaccinated with the second dose of Jynneos (batch number: 96868, expiration date: 30-Apr-2026), at a dose of 0.5 ml, intramuscularly left deltoid (explicitly coded as 'inappropriate route of vaccination' and 'inappropriate schedule of vaccine administered'). On *20-Feb-2025, seven days after administration Jynneos vaccine,* reported as, one week after the vaccination, the patient experienced nausea. At the time of the *follow-up* report, it was *unknown* if the patient recovered from the event nausea. The reporter *assessed the event nausea as non-serious and not related 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 26-Mar-2025: New information included Jynneos dosing details, reporter and patient details, and confirmation that the patient experienced nausea. Follow up information received from a pharmacist on 19-Apr-2025: New information included seriousness criteria, causality assessment, dosing information for the first dose, onset date and outcome.; Reporter's Comments: A 55-year-old female patient was vaccinated with the second dose of Jynneos for monkeypox vaccination and travel, on the day 32 after the first dose, intramuscularly, left deltoid, which is considered as inappropriate route of vaccination and inappropriate schedule of vaccine administered. One week after the vaccination, the patient experienced a non-serious event of nausea. Nausea is listed and expected for Jynneos per CCDS v7 and USPI. Inappropriate schedule of product administration and incorrect route of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering plausible temporal relationship and known vaccine safety profile, the event of nausea is considered as related to Jynneos. Inappropriate schedule of product administration and incorrect route of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 55-year-old female patient was vaccinated with the second dose of Jynneos for monkeypox vaccination and travel, on the day 32 after the first dose, intramuscularly, left deltoid, which is considered as inappropriate route of vaccination and inappropriate schedule of vaccine administered. One week after the vaccination, the patient experienced a non-serious event of nausea. Nausea is listed and expected for Jynneos per CCDS v7 and USPI. Inappropriate schedule of product administration and incorrect route of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering plausible temporal relationship and known vaccine safety profile, the event of nausea is considered as related to Jynneos. Inappropriate schedule of product administration and incorrect route of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None