Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product administered at inappropriate site
Clinical narrative: The patient vaccinated with an expired vial of the Jynneos vaccine; Jynneos vaccine administered in the left forearm; The second dose of Jynneos vaccine was repeated eight days after the patient was vaccinated with an expired vial; Jynneos vaccine was administered intradermally at 0.1 mL; Case reference number US-BN-2022-004189 is a spontaneous case initially received on 12-Oct-2022 from a health care professional (reference number: USBAV22-1695) and concerns a male patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown), at unknown dose, site and route of administration for monkeypox/smallpox prophylaxis.  On 12-Oct-2022 at 11:00 AM, an unspecified amount of time after the first Jynneos dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00019, expiration date 11-Oct-2022 at 5:30 PM) (explicitly coded as 'expired vaccine used'), intradermally, at 0.1 mL (explicitly coded as 'intradermal injection) in the left forearm (explicitly coded as 'vaccine administered at inappropriate site').  On 20-Oct-2022, at *2:45 PM*, an unspecified amount of time after the first Jynneos dose and eight days after the second Jynneos dose, the patient was re-vaccinated with Jynneos *(batch number: FDP00019, expiration date 31-Oct-2024, beyond use date 20-Oct-2022 at 5 PM)* (explicitly coded as 'inappropriate schedule of vaccine administered'), *at 0.1 mL*, *intradermally (explicitly coded as 'intradermal injection)*, in the *left forearm (explicitly coded as 'vaccine administered at inappropriate site') *.  As reported, the patient did not experience any adverse event due to Jynneos vaccination.  Additional information received from Bavarian Nordic on 12-Oct-2022 included local case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from the health care professional on 28-Oct-2022: New information included anatomical site for the second vaccine, the patient's age, change of expiration time for the second dose of Jynneos (from 17:17 to 17:30), information that the patient was revaccinated on 20-Oct-2022 and the confirmation that the patient had no medical history, concomitant medication nor adverse events due to Jynneos.  Follow-up information received from the health care professional on 10-Nov-2022: New information regarding re-vaccination with Jynneos included exact time of vaccination, batch number, dosage, route of administration, site of administration, expiration date, beyond use date and patient's initials.; Reporter's Comments: A 33-year-old male patient was vaccinated with the first dose of Jynneos vaccine on an unspecified date. Reportedly, on 12-Oct-22 at 11:00 o'clock the patient was vaccinated with the second dose of Jynneos vaccine. The vaccine expiration date was 11-Oct-22 at 17:30 o'clock which is considered expired vaccine used. The vaccine was also administered intradermally which is coded as intradermal injection, at a dose of 0.1 ml, at the left forearm, which is considered as vaccine administered at inappropriate site for monkeypox/smallpox prophylaxis. Reportedly, on the day 8 after the second vaccination, the patient was revaccinated with Jynneos, intradermally in the left forearm (also considered as intradermal injection, vaccine administered at inappropriate site and inappropriate schedule of vaccine administered). All the events are listed per the company convention. The patient had no medical history or concomitant medication. It was reported that the patient did not experience any adverse event due to Jynneos. Intradermal injection, expired vaccine used, vaccine administered at inappropriate site and inappropriate schedule of vaccine administered are assessed as not related to the suspect vaccine but related to a human factor. The case is non-serious.; Sender's Comments: A 33-year-old male patient was vaccinated with the first dose of Jynneos vaccine on an unspecified date. Reportedly, on 12-Oct-22 at 11:00 o'clock the patient was vaccinated with the second dose of Jynneos vaccine. The vaccine expiration date was 11-Oct-22 at 17:30 o'clock which is considered expired vaccine used. The vaccine was also administered intradermally which is coded as intradermal injection, at a dose of 0.1 ml, at the left forearm, which is considered as vaccine administered at inappropriate site for monkeypox/smallpox prophylaxis. Reportedly, on the day 8 after the second vaccination, the patient was revaccinated with Jynneos, intradermally in the left forearm (also considered as intradermal injection, vaccine administered at inappropriate site and inappropriate schedule of vaccine administered). All the events are listed per the company. The patient had no medical history or concomitant medication. It was reported that the patient did not experience any adverse event due to Jynneos. Intradermal injection, expired vaccine used, vaccine administered at inappropriate site and inappropriate schedule of vaccine administered are assessed as not related to the suspect vaccine but related to a human factor. The case is non-serious.