Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: Three patients received Jynneos vaccine a couple of months past the beyound use date (BUD); Patients were vaccinated with the third dose of Jynneos vaccine; Case reference number US-BN-2023-001441 is a spontaneous case report initially received from nurse via agency (reference number: USBAV23-1308) on 23-Aug-2023 and concerns three patients of unknown demographics.  The patients' medical history and concomitant medication details were not provided.  On an unspecified date, reported as a couple of months, Jynneos vaccine expired.  On 22-May-2023, patients were vaccinated with the first dose of expired Jynneos vaccine (batch number: FDP00014), at unknown dose, route and site of administration, for indication reported as smallpox/monkeypox prophylaxis (explicitly coded as 'expired vaccine used').   On 19-Jun-2023, 28 days after the first dose of Jynneos, patients were vaccinated with the second dose of expired Jynneos vaccine (batch number: FDP00014), at unknown dose, route and site of administration (explicitly coded as 'expired vaccine used').   On 31-Jul-2023, 42 days after the second dose of Jynneos, patients were vaccinated with the third dose of expired Jynneos vaccine (batch number: FDP00014), at unknown dose, route and site of administration (explicitly coded as 'expired vaccine used' and 'extra dose administered').  As reported, someone from the pharmacy that was managing the vaccine called the reporter and got a verbal authorization for revaccination as soon as possible. The call must have been made around 31-Jul-2023 because that's when the extra dose went in, as early as the first week in July. The reporter wanted to know if Jynneos send out a medical stability report and to confirm that revaccinating after an expired dose is right with a stability report.  At the time of initial report, it was unknown if the patients experienced any adverse event due to Jynneos vaccination.  Additional information received from Bavarian Nordic on 24-Aug-2023 included local BN case ID number.; Reporter's Comments: This case concerns three patients of unknown demographics who were vaccinated with the first dose of expired Jynneos vaccine, at unknown dose, route and site of administration which is considered as expired vaccine used. 28 days after the first dose of Jynneos, patients were vaccinated with the second dose of expired Jynneos vaccine, at unknown dose, route and site of administration which is also considered as expired vaccine used. 42 days after the second dose of Jynneos, patients were vaccinated with the third dose of expired Jynneos vaccine, at unknown dose, route and site of administration which is considered as expired vaccine used and extra dose administered. Expired product administered and extra dose administered are both considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse event due to Jynneos vaccination. The patients' medical history and concomitant medication details were not provided. Expired product administered and extra dose administered are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case concerns three patients of unknown demographics who were vaccinated with the first dose of expired Jynneos vaccine, at unknown dose, route and site of administration which is considered as expired vaccine used. 28 days after the first dose of Jynneos, patients were vaccinated with the second dose of expired Jynneos vaccine, at unknown dose, route and site of administration which is also considered as expired vaccine used. 42 days after the second dose of Jynneos, patients were vaccinated with the third dose of expired Jynneos vaccine, at unknown dose, route and site of administration which is considered as expired vaccine used and extra dose administered. Expired product administered and extra dose administered are both considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse event due to Jynneos vaccination. The patients' medical history and concomitant medication details were not provided. Expired product administered and extra dose administered are both assessed as not related to suspect product but to human factor. The case is non-serious.