Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Product administration error, Product storage error
Clinical narrative: The vial of Jynneos vaccine was drew up on 08-Feb, and the dose was given on 09-Feb; The vial of Jynneos vaccine was drew up on 08-Feb, and the dose was given on 09-Feb; Second dose of Jynneos was given 132 days after the first dose; Jynneos was administered intradermally; Case reference number US-BN-2023-000252 is a spontaneous case report initially received from a nurse via Communication (reference number: USBAV23-0235) on 10-Feb-2023 and concerns an adult male patient.  The patient's concurrent medical history included HIV (human immunodeficiency virus).  The patient's concomitant medication details were not provided.  On 30-Sep-2022, the patient was vaccinated with the first dose of Jynneos vaccine (batch number: FDP00009) administered intradermally (explicitly coded as 'intradermal injection') at a dose of 0.1 mL, at an unknown site of administration for smallpox, monkeypox prophylaxis.   On 09-Feb-2023, 132 days after the first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00009) (explicitly coded as 'inappropriate schedule of vaccine administered) administered intradermally (explicitly coded as 'intradermal injection') at a dose of 0.1 mL, at an unknown site of administration. As reported, the patient was vaccinated with the Jynneos vaccine whose vial was drew up on 08-Feb-2023 (explicitly coded as 'product storage error' and 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos.   Additional information received from Bavarian Nordic on 10-Feb-2023 included local BN case ID.; Reporter's Comments: An adult male patient was vaccinated with the second dose of Jynneos 132 days after the first dose, administered intradermally, which is considered as inappropriate schedule of vaccine administered. As reported, the patient was vaccinated with the Jynneos vaccine on 09-Feb-2023 with a vial that was drew up on 08-Feb-2023, which is considered as product storage error and product administration error. No associated adverse events were reported. Inappropriate schedule of vaccine administered, intradermal injection, product administration error and product storage error are listed per company convention. The patient's concurrent medical history included HIV and concomitant medication details were not provided. Inappropriate schedule of vaccine administered, intradermal injection, product administration error and product storage error are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: An adult male patient was vaccinated with the second dose of Jynneos 132 days after the first dose, administered intradermally, which is considered as inappropriate schedule of vaccine administered. As reported, the patient was vaccinated with the Jynneos vaccine on 09-Feb-2023 with a vial that was drew up on 08-Feb-2023, which is considered as product storage error and product administration error. No associated adverse events were reported. Inappropriate schedule of vaccine administered, intradermal injection, product administration error and product storage error are listed per company convention. The patient's concurrent medical history included HIV and concomitant medication details were not provided. Inappropriate schedule of vaccine administered, intradermal injection, product administration error and product storage error are not related to Jynneos, but to a human factor. The case is non-serious.