Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Product storage error
Clinical narrative: The patient vaccinated twice in one day, and after second dose experienced not a big enough wheal; The patient vaccinated twice in one day, and after second dose experienced not a big enough wheal; Patient received two doses of Jynneos intradermally; The patient administered Jynneos vaccine that was stored at the wrong temperature of minus 22 degrees Fahrenheit in the freezer where the temperature of the vaccine was colder than intended; The patient administered Jynneos vaccine that was stored at the wrong temperature of minus 22 degrees Fahrenheit in the freezer where the temperature of the vaccine was colder than intended; Case reference number US-BN-2024-000126 is a spontaneous case report initially received from a nurse on 30-Jan-2024 and concerns a 34-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 31-Aug-2022, the patient received the first dose of the Jynneos vaccine (batch number: FDP00005, expiry date: 31-Aug-2023), at a dose of 0.1 milliliter via intradermal route and unknown site of administration, for an unknown indication (explicitly coded as 'intradermal injection').  On 28-Sep-2022, 28 days after the first dose of the Jynneos, the patient received the second dose of the Jynneos vaccine (batch number: FDP00013, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration (explicitly coded as 'intradermal injection').  On an unspecified date, the patient was vaccinated twice in one day, stated as not a big enough wheal (explicitly coded as 'inappropriate schedule of vaccine administered').   As reported, administered Jynneos doses twice in a day (explicitly coded as 'inappropriate schedule of vaccine administered').  As reported, administered Jynneos doses were stored at the wrong temperature of minus 22 degrees Fahrenheit in the freezer where the temperature of the vaccines was colder than intended (explicitly coded as 'product storage error' and 'product administration error').  At the time of the initial report, the outcome for the event of injection site wheal was unknown. As reported, patient who was vaccinated met the CDC criteria and not had a known exposure or symptoms.  The reporter did not provide seriousness or causality assessment for the event of injection site wheal.  This case is linked with US-BN-2024-000060 (same reporter).  No further information was provided.; Reporter's Comments: A 34-year-old male patient was vaccinated with two doses of the Jynneos vaccine, at a dose of 0.1 milliliter via intradermal route and unknown site of administration. As reported, administered Jynneos doses twice in a day, stated as not a big enough wheal, which is considered as inappropriate schedule of vaccine administered. As reported, administered Jynneos doses were stored at the wrong temperature of minus 22 degrees Fahrenheit in the freezer where the temperature of the vaccines was colder than intended, which is considered as product storage error and product administration error. Injection site urticaria is unlisted/unexpected for MVA-BN according to RA version 1.0 and PI, whilst intradermal injection, inappropriate schedule of vaccine administered, product storage error and product administration error. The patient's medical history and concomitant medication details were not provided. Duet to implied temporal relationship, localization of the event and lack of alternative etiology, the causality for reported injection site urticaria is assessed as related to Jynneos. Intradermal injection, inappropriate schedule of vaccine administered, product storage error and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A 34-year-old male patient was vaccinated with two doses of the Jynneos vaccine, at a dose of 0.1 milliliter via intradermal route and unknown site of administration. As reported, administered Jynneos doses twice in a day, stated as not a big enough wheal, which is considered as inappropriate schedule of vaccine administered. As reported, administered Jynneos doses were stored at the wrong temperature of minus 22 degrees Fahrenheit in the freezer where the temperature of the vaccines was colder than intended, which is considered as product storage error and product administration error. Injection site urticaria is unlisted/unexpected for MVA-BN according to RA version 1.0 and PI, whilst intradermal injection, inappropriate schedule of vaccine administered, product storage error and product administration error. The patient's medical history and concomitant medication details were not provided. Duet to implied temporal relationship, localization of the event and lack of alternative etiology, the causality for reported injection site urticaria is assessed as related to Jynneos. Intradermal injection, inappropriate schedule of vaccine administered, product storage error and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.