Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, Inappropriate schedule of product administration, Injection
Clinical narrative: Expiration date was before the date of injection; First and second dose of Jynneos administered intradermally; Second dose of Jynneos administered on day 83; Case reference number US-BN-2022-004841 is a spontaneous case report initially received on 05-Dec-2022 from a consumer via Communications (reference number: USBAV22-2060) and concerns a patient of unspecified age or gender.  The patient's medical history and concomitant medication details were not provided.  On 09-Sep-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at a dose of 0.1 ml, administered intradermally (explicitly coded as 'intradermal injection') at an unknown site of administration, for monkeypox prophylaxis.  On 01-Dec-2022, 83 days after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (batch number: FDP00018), at a dose of 0.1 ml, administered intradermally (explicitly coded as 'intradermal injection'), at an unknown site of administration (explicitly coded as 'inappropriate schedule of vaccine administered').  As reported, it was noticed on the record that the expiration date was before the date that the patient was injected with the second dose of Jynneos (explicitly coded as 'expired vaccine used').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 06-Dec-2022 from Bavarian Nordic included local BN case ID.; Reporter's Comments: A patient of unspecified age or gender was vaccinated with the first dose of Jynneos vaccine, at a dose of 0.1 ml, administered intradermally, which is considered as intradermal injection, at an unknown site of administration, for monkeypox prophylaxis. Reportedly, on the day 83 after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine, at a dose of 0.1 ml, administered intradermally, which is considered as intradermal injection and inappropriate schedule of vaccine administered. As reported, it was noticed on the record that the expiration date was before the date that the patient was injected with the second dose of Jynneos, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered, intradermal injection and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered, intradermal injection and inappropriate schedule of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified age or gender was vaccinated with the first dose of Jynneos vaccine, at a dose of 0.1 ml, administered intradermally, which is considered as intradermal injection, at an unknown site of administration, for monkeypox prophylaxis. Reportedly, on the day 83 after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine, at a dose of 0.1 ml, administered intradermally, which is considered as intradermal injection and inappropriate schedule of vaccine administered. As reported, it was noticed on the record that the expiration date was before the date that the patient was injected with the second dose of Jynneos, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered, intradermal injection and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered, intradermal injection and inappropriate schedule of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.