Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site swelling, Product administered at inappropriate site, Product administration error, Vaccination error
Clinical narrative: Patient returned to facility on November 10th, 2022, to receive Dose 2 of Jynneos series from an unexpired vial, per manufacturer recommendation.; Provider and patient were made aware of error with vaccination (dose from expired vial, punctured for more than eight hours); Provider and patient were made aware of error with vaccination (dose from expired vial, punctured for more than eight hours); Vaccine administered at left volar forearm; Jynneos vaccine administered intradermally; Area of induration measuring roughly half a centimeter, with erythema and swelling extending to the radius of roughly five centimeters.; Area of induration measuring roughly half a centimeter, with erythema and swelling extending to the radius of roughly five centimeters.; Area of induration measuring roughly half a centimeter, with erythema and swelling extending to the radius of roughly five centimeters.; Case reference number US-BN-2022-004532, is a spontaneous case report initially received from a consumer via Communication (reference number: USBAV22-1842) on 02-Nov-2022 and concerns a *30-year-old female patient.*  The patient's medical history and concomitant medications details were not reported. *It was stated that there were none relevant to vaccination error that occurred.*   On *04-Oct-2022*, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: *FDP00018*), at *dose of 0.1 mL*, intradermally (ID) (explicitly coded as 'Intradermal injection'), *into left volar forearm* (explicitly coded as 'Vaccine administered at inappropriate site') and for monkeypox/smallpox prophylaxis.  On 01-Nov-2022, the patient was vaccinated with the second dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: *FDP00018*), at dose 0.1 mL, administered intradermally (explicitly coded as 'Intradermal injection') into *left volar forearm* and for monkeypox/smallpox prophylaxis.  *On 02-Nov-2022, one day after vaccination, provider and patient were made aware of error with vaccination (dose from expired vial, punctured for >8 hours) (explicitly coded as 'Expired vaccine used' and 'Product administration error'). Examination of injection site occurred on 02-Nov-2022 and was noted to have an area of induration measuring roughly half a centimeter, with erythema and swelling extending to the radius of roughly five centimeters. No warmth, tenderness or drainage was noted.   As reported, patient and provider continued to monitor, and no additional documentation of adverse event progression or new adverse events related to the vaccination have been noted.   On 10-Nov-2022, the patient returned to the facility to receive dose two of Jynneos series from an unexpired vial (batch number: Unknown), per manufacturer recommendation (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of this report, the outcome of events was unknown.   The reporter assessed all reported events as non-serious and related to Jynneos vaccine. The reported explained that events were related as expected effect of vaccination and not related to vaccination error. *    Additional information received from on 03-Nov-2022 included the local case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a nurse on 16-Nov-2022 included patient's details: gender and age, vaccine details: batch number, date of vaccination and anatomical site location for first and second dose of Jynneos vaccine. New non-events 'Product administration error', 'Expired vaccine used', 'Vaccine administered at inappropriate site' and 'Inappropriate schedule of vaccine administered' were added. New events of 'Injection site induration', 'Injection site erythema' and 'Injection site swelling' were added.; Reporter's Comments: A 30-year-old female patient was vaccinated with the first dose of Jynneos, 0.1 mL applied intradermally in the left volar forearm (which is considered intradermal injection and vaccine administered at inappropriate site) for monkeypox prophylaxis. On day 28, the patient received the second dose of Jynneos, 0.1 mL administered intradermally in the left volar forearm (which is also considered intradermal injection and vaccine administered at inappropriate site). It was found that the second dose was given from a vial which had stayed punctured for over 8 hours and had thus expired (which is considered expired vaccine used and product administration error). On the day following the second dose, injection site reactions were observed (induration, swelling and erythema). It was reported that the patient returned on day 37 (9 days after the second dose) to receive Jynneos from an unexpired vial (which is considered inappropriate schedule of vaccine administered). Injection site erythema, injection site induration and injection site swelling are listed per the guidelines for Jynneos. Intradermal injection, vaccine administered at inappropriate site, expired vaccine used, product administration error and inappropriate schedule of vaccine administered are considered listed per company convention. Medical history and concomitant medications were unknown. Based on the short latency and the known safety profile of Jynneos, the injection site reactions are assessed as related. Intradermal injection, vaccine administered at inappropriate site, expired vaccine used, product administration error and inappropriate schedule of vaccine administered are considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A 30-year-old female patient was vaccinated with the first dose of Jynneos, 0.1 mL applied intradermally in the left volar forearm (which is considered intradermal injection and vaccine administered at inappropriate site) for monkeypox prophylaxis. On day 28, the patient received the second dose of Jynneos, 0.1 mL administered intradermally in the left volar forearm (which is also considered intradermal injection and vaccine administered at inappropriate site). It was found that the second dose was given from a vial which had stayed punctured for over 8 hours and had thus expired (which is considered expired vaccine used and product administration error). On the day following the second dose, injection site reactions were observed (induration, swelling and erythema). It was reported that the patient returned on day 37 (9 days after the second dose) to receive Jynneos from an unexpired vial (which is considered inappropriate schedule of vaccine administered). Injection site erythema, injection site induration and injection site swelling are listed per the guidelines for Jynneos. Intradermal injection, vaccine administered at inappropriate site, expired vaccine used, product administration error and inappropriate schedule of vaccine administered are considered listed per company convention. Medical history and concomitant medications were unknown. Based on the short latency and the known safety profile of Jynneos, the injection site reactions are assessed as related. Intradermal injection, vaccine administered at inappropriate site, expired vaccine used, product administration error and inappropriate schedule of vaccine administered are considered not related to Jynneos, but to human error. The case is non-serious.