Sex: M
Vaccine: SMALLMNK
Symptoms: Cytology, Incorrect route of product administration, Product storage error, Wrong technique in product usage process
Clinical narrative: The dose was opened and kept in the fridge; Jynneos was administered intradermally; Case reference number US-BN-2022-004034 is a spontaneous case report initially received from a nurse via agency (reference number: USBAV22-1682) on 11-Oct-2022 and concerns an adult male patient.  The patient's current medical condition included human immunodeficiency virus (HIV) and low grade squamous intraepith lesion on cytologic smear, as reported.  The patient's concomitant medication details were not provided.  On 06-Sep-2022, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00018) at a dose 0.1 mL, administered intradermally, for monkeypox/smallpox prophylaxis.  On 11-Oct-2022, at around 11:00 am, 35 days after the first dose, the patient was vaccinated with second dose of Jynneos (batch number: FDP00018, expiration date: 31-Aug-2022), at a dose 0.1 mL, administered intradermally (explicitly coded as 'intradermal injection'). As reported, this dose was opened the previous day (10-Oct-2022), around 01:00 pm, and stored in the fridge (explicitly coded as 'product storage error').  At the time of this report, it was unknown if the patient experienced any adverse events.   Additional information received from Bavarian Nordic on 11-Oct-2022 included the local BN case ID.; Reporter's Comments: An adult male patient was vaccinated with the first dose of Jynneos vaccine on 06-Sep-22. The vaccine was administered intradermally at a dose of 0.1mL for monkeypox/small prophylaxis, which is coded as intradermal injection. Approximately, 35 days after the first dose, the patient was vaccinated with the second dose of Jynneos. The vaccine was also administered intradermally at a dose of 0.1ml. Reportedly, this dose was opened the previous day and stored in the fridge which is considered product storage error. Both events are listed per the Company conventions. Patient's medical history included human immunodeficiency virus (HIV) and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection and product storage error are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: An adult male patient was vaccinated with the first dose of Jynneos vaccine on 06-Sep-22. The vaccine was administered intradermally at a dose of 0.1mL for monkeypox/small prophylaxis, which is coded as intradermal injection. Approximately, 35 days after the first dose, the patient was vaccinated with the second dose of Jynneos. The vaccine was also administered intradermally at a dose of 0.1ml. Reportedly, this dose was opened the previous day and stored in the fridge which is considered product storage error. Both events are listed per the Company conventions. Patient's medical history included human immunodeficiency virus (HIV) and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection and product storage error are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.