Sex: M
Vaccine: SMALLMNK
Symptoms: Product dose omission issue, Wrong technique in product usage process
Clinical narrative: Patient canceled scheduled vaccination and did not reschedule it.; Jynneos vaccine administered intradermally.; Case reference number US-BN-2022-004220 is a spontaneous case report initially received on 21-Oct-2022 via Communications (reference number: USBAV22-1759) and concerns an adult patient born in 1997.  The patient's medical history and concomitant medication details were not provided.  On 23-Sep-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at a dose of 0.1 milliliter, intradermally, at unknown anatomical location and for monkeypox prophylaxis (explicitly coded as 'Intradermal injection').  As reported, the patient was scheduled for second dose of Jynneos on 21-Oct-2022, at 1:30 PM but, the patient cancelled the appointment. The patient did not reschedule for later in the day. Since this should have been patient's second dose, he will be late for it (explicitly coded as 'Product dose omission issue').  The reporter wanted to get information regarding the storage and handling for Jynneos. They have had the vial out of the refrigerator and allowed it to sit at room temperature before administration. It was an unpunctured vial. They wanted to know if they can put it back in the fridge and for how long it will be good for if it's been taken out of the fridge.  At the time of reporting, it was unknown if the patient experienced any adverse events..  Additional information received on 21-Oct-2022 via Communications (reference number: USBAV22-1759): new information included the local case ID which is BN_2022_02599.  No further information received.; Reporter's Comments: An adult patient born in 1997 was vaccinated with the Jynneos vaccine on 23-Sep-22. The vaccine was administered intradermally, at a dose of 0.1ml which is coded as intradermal injection. Reportedly, the patient was scheduled for second dose of Jynneos on 21-Oct-22 but cancelled it and did not reschedule for later, which is considered product dose omission issue. Both events are listed per the Company conventions. The patient's medical history and concomitant medication details were not provided. It was unknown if the patient experienced any adverse events. Intradermal injection and product dose omission issue 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 patient born in 1997 was vaccinated with the Jynneos vaccine on 23-Sep-22. The vaccine was administered intradermally, at a dose of 0.1ml which is coded as intradermal injection. Reportedly, the patient was scheduled for second dose of Jynneos on 21-Oct-22 but cancelled it and did not reschedule for later, which is considered product dose omission issue. Both events are listed per the Company conventions. The patient's medical history and concomitant medication details were not provided. It was unknown if the patient experienced any adverse events. Intradermal injection and product dose omission issue are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.