Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Product administration error, Product storage error
Clinical narrative: Plates for a vaccine transport were placed in the freezer instead of the fridge and it caused the temperature of the Jynneos vaccine to fall below 2 degrees; Affected Jynneos vaccines were administrated; Jynneos vaccine administered intradermally; Case reference number US-BN-2022-002309 is a spontaneous case report initially received on 06-Sep-2022 from other health care professional via company and concerns a patient of an unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, plates for a vaccine transport were placed inadvertently in the freezer instead of the fridge and it caused the temperature of the Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP0005) to fall below two degrees (explicitly coded as 'Product storage error'). Vaccines were held at this temperature for approximately four hours, as reported.  On an unspecified date, also reported as approximately one to three hours after temperatures were in the freezer range, the patient was vaccinated with Jynneos vaccine (batch number: FDP0005), at an unknown dose, intradermally, for monkeypox prophylaxis (explicitly coded as 'Product administration error' and 'Inappropriate route of vaccination').  At the time of this report, it was unknown which dose this was or if the patient experienced any adverse event.  Non-significant case correction performed for information received from Bavarian Nordic on 12-Sep-2022 to include the local BN case ID.  Case linked with cases no. US-BN-2022-002267, US-BN-2022-002302, US-BN-2022-002303, US-BN-2022-002304, US-BN-2022-002305, US-BN-2022-002306, US-BN-2022-002307, US-BN-2022-002308, US-BN-2022-002310, US-BN-2022-002311, US-BN-2022-002312 and US-BN-2022-002313; concerning the same reporter; Reporter's Comments: A patient of an unknown demographics was about to be vaccinated with Jynneos vaccine for monkeypox prophylaxis, and on an unspecified date, plates for a vaccine transport were placed inadvertently in the freezer instead of the fridge and it caused the temperature of the Jynneos vaccine to fall below two degrees, which is considered as product storage error. Vaccines were held at this temperature for approximately four hours, as reported. Approximately one to three hours after temperatures were in the freezer range, the patient was vaccinated with Jynneos vaccine, intradermally, which is considered as product administration error and inappropriate route of vaccination. No associated adverse events have been reported with the reported medication error. Product storage error, product administration error and incorrect route of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and incorrect route of product administration 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 patient of an unknown demographics was about to be vaccinated with Jynneos vaccine for monkeypox prophylaxis, and on an unspecified date, plates for a vaccine transport were placed inadvertently in the freezer instead of the fridge and it caused the temperature of the Jynneos vaccine to fall below two degrees, which is considered as product storage error. Vaccines were held at this temperature for approximately four hours, as reported. Approximately one to three hours after temperatures were in the freezer range, the patient was vaccinated with Jynneos vaccine, intradermally, which is considered as product administration error and inappropriate route of vaccination. No associated adverse events have been reported with the reported medication error. Product storage error, product administration error and incorrect route of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and incorrect route of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.