Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product administration error, Product storage error
Clinical narrative: Jynneos vaccine experienced a temperature excursion and was administered afterwards; Jynneos vaccine experienced a temperature excursion and was administered afterwards; Case reference number US-BN-2022-003271 is a spontaneous case report initially received on 23-Sep-2022 from other health care professional via Communications (reference number: USBAV22-1511) and concerns a 63-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) had a temperature excursion as it was stored in the refrigerator which was too cold. The excursion lasted 15 minutes and the coldest temperature reached was 1.9 degrees Celsius. It was also reported that the vaccine had no prior temperature excursions (explicitly coded as 'product storage error').  On an unspecified date, reported also as after the excursion, the patient was vaccinated with the affected Jynneos vaccine (batch number: unknown), at unknown dose, route or site of administration, for unknown indication (explicitly coded as 'product administration error').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 23-Sep-2022 included the local case ID.; Reporter's Comments: A 63-year-old male patient was about to be vaccinated with Jynneos vaccine, and on an unspecified date, Jynneos vaccine had a temperature excursion as it was stored in the refrigerator which was too cold. The excursion lasted 15 minutes and the coldest temperature reached was 1.9 degrees Celsius. It was also reported that the vaccine had no prior temperature excursions, which is considered as product storage error. On an unspecified date, reported also as after the excursion, the patient was vaccinated with the affected Jynneos vaccine, at unknown dose, route or site of administration, for unknown indication, which is considered as product administration error. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 63-year-old male patient was about to be vaccinated with Jynneos vaccine, and on an unspecified date, Jynneos vaccine had a temperature excursion as it was stored in the refrigerator which was too cold. The excursion lasted 15 minutes and the coldest temperature reached was 1.9 degrees Celsius. It was also reported that the vaccine had no prior temperature excursions, which is considered as product storage error. On an unspecified date, reported also as after the excursion, the patient was vaccinated with the affected Jynneos vaccine, at unknown dose, route or site of administration, for unknown indication, which is considered as product administration error. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.