Sex: U
Vaccine: SMALLMNK
Symptoms: Product storage error, Wrong technique in product usage process
Clinical narrative: Jynneos vaccine was administered intradermally; The nurse was used a vial of the Jynneos that was punctured and left in the refrigerator for more than eight hours (for 22 hours to be exact) and was administered to a patient; The nurse was used a vial of the Jynneos that was punctured and left in the refrigerator for more than eight hours (for 22 hours to be exact) and was administered to a patient; Case reference number US-BN-2022-004182 is a spontaneous case report initially received on 12-Oct-2022 from a pharmacist via Communications (reference number: USBAV22-1688) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the nurse used a vial of the Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number was not provided) that was punctured and left in the refrigerator for more than eight hours (for 22 hours to be exact) and was administered to the patient, at an unknown dose and site of administration, intradermally for unknown indication. (Explicitly coded as 'product storage error', 'product administration error' and 'intradermal injection).  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 12-Oct-2022 included local case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with the Jynneos vaccine on an unspecified date. Reportedly, the nurse used a vial of the Jynneos that was punctured and left in the refrigerator for more than eight hours, 22 hours to be exact, and was later administered to the patient at an unknown dose and site of administration, intradermally for unknown indication, which is considered as product storage error, product administration error and intradermal injection. All three 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 following vaccination. Product storage error, product administration error and intradermal injection are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the Jynneos vaccine on an unspecified date. Reportedly, the nurse used a vial of the Jynneos that was punctured and left in the refrigerator for more than eight hours, 22 hours to be exact, and was later administered to the patient at an unknown dose and site of administration, intradermally for unknown indication, which is considered as product storage error, product administration error and intradermal injection. All three 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 following vaccination. Product storage error, product administration error and intradermal injection are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.