Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Jynneos vaccine was administered intradermally, past beyond use date; Jynneos vaccine was administered intradermally, past beyond use date; Second dose of Jynneos was administered 182 days after the first dose; Case reference number US-BN-2023-000321 is a spontaneous case report initially received on 21-Feb-2023 from other health care professional via Communications (reference: USBAV23-0301) and concerns an adult male patient.  The patient's medical history and concomitant medications details were not provided.  On 09-Aug-2022, the patient was vaccinated with the first dose of Jynneos vaccine (batch number: FDP00015; expiration date: 30-Sep-2024), at a dose of 0.1 mL, at unknown site of administration, intradermally (explicitly coded as 'intradermal injection'), for smallpox/monkeypox prophylaxis.  On 07-Feb-2023, 182 days after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (batch number: FDP00015; expiration date: 30-Sep-2024), (explicitly coded as Inappropriate schedule of vaccine administered'), at a dose of 0.1 mL, at unknown site of administration, intradermally (explicitly coded as 'intradermal injection') with beyond use date of 26-Jan-2023 (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 22-Feb-2023 from Bavarian Nordic included local BN case ID.  This case is linked to US-BN-2023-000316, US-BN-2023-000317, US-BN-2023-000318, US-BN-2023-000319, US-BN-2023-000320, US-BN-2023-000322, US-BN-2023-000323 and US-BN-2023-000324, concerning same reporter.; Reporter's Comments: An adult male patient was vaccinated with the first dose of Jynneos vaccine, at a dose of 0.1 mL, at unknown site of administration, intradermally, which is considered as intradermal injection, for smallpox/monkeypox prophylaxis. On 07-Feb-2023, on the day 182 after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine, which is considered as inappropriate schedule of vaccine administered, at a dose of 0.1 mL, at unknown site of administration, intradermally, which is considered as intradermal injection, with beyond use date of 26-Jan-2023, 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, inappropriate schedule of product administration and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Expired product administered, inappropriate schedule of product administration and intradermal injection 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: An adult male patient was vaccinated with the first dose of Jynneos vaccine, at a dose of 0.1 mL, at unknown site of administration, intradermally, which is considered as intradermal injection, for smallpox/monkeypox prophylaxis. On 07-Feb-2023, on the day 182 after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine, which is considered as inappropriate schedule of vaccine administered, at a dose of 0.1 mL, at unknown site of administration, intradermally, which is considered as intradermal injection, with beyond use date of 26-Jan-2023, 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, inappropriate schedule of product administration and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Expired product administered, inappropriate schedule of product administration and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.