Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event, Product administration error
Clinical narrative: an expired dose of Jynneos was given to a patient; an expired dose of Jynneos was given to a patient; Jynneos vaccine administered intradermally; Jynneos vaccine administered in lower left arm; Case reference number US-BN-2022-004202 is a spontaneous case report initially received on 14-Oct-2022 from a nurse (reference number: USBAV22-1704) and concerns a *43-year-old male patient*.  The patient's medical history and concomitant medication details were not provided.  On *12-Oct-2022*, an expired *first* dose of Jynneos (Smallpox and monkeypox vaccine, live, nonreplicating; batch number: *FDP00020*) was administered, at an unknown dose, *intradermally in lower left arm*, for monkeypox prophylaxis (explicitly coded as 'Expired vaccine used', 'Product administration error', *'Intradermal injection' and 'Vaccine administered at inappropriate site'*).   At the time of this report, * the patient did not experience any adverse event due to Jynneos*.  Additional information received from Bavarian Nordic on 14-Oct-2022 included the local case ID.  Non-significant case correction performed for information received from Bavarian Nordic on 19-Oct-2022 to include an additional reference number.  Non-significant case correction performed for information received from the reporter on 01-Nov-2022 to include additional contact details.  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 15-Nov-2022 included patient's details, date of vaccination, batch number, route of administration, anatomical location and confirmation that the patient did not experience any adverse event. Two non-events were added: 'Intradermal injection' and 'Vaccine administered at inappropriate site'.; Reporter's Comments: A patient of unknown demographics was vaccinated with an expired dose of Jynneos (batch number FDP00020), applied intradermally in the lower left arm, for monkeypox prophylaxis, which is considered expired vaccine used, product administration error, intradermal injection and vaccine administered at inappropriate site. The patient did not experience any associated adverse events. Expired vaccine used, product administration error, intradermal injection and vaccine administered at inappropriate site are considered listed per company. The patient's medical history and concomitant medications were unknown. The events are considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with an expired dose of Jynneos (batch number FDP00020), applied intradermally in the lower left arm, for monkeypox prophylaxis, which is considered expired vaccine used, product administration error, intradermal injection and vaccine administered at inappropriate site. The patient did not experience any associated adverse events. Expired vaccine used, product administration error, intradermal injection and vaccine administered at inappropriate site are considered listed per company. The patient's medical history and concomitant medications were unknown. The events are considered not related to Jynneos, but to human error. The case is non-serious.