Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, Incorrect route of product administration, Product administration error, Product storage error, Underdose
Clinical narrative: Jynneos vaccine administered intradermally; Incomplete dose of Jynneos vaccine administered; Jynneos vaccine would have been expired at the time of vaccination; Opened Jynneos vaccine was left in the fridge and was administered; Opened Jynneos vaccine was left in the fridge and was administered; Case reference number US-BN-2022-001981 is a spontaneous case report initially received from other health care professional via Bavarian Nordic on 19-Aug-2022 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, also reported as yesterday, Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) was left opened in the fridge (explicitly coded as 'Product storage error').  On an unspecified date, also reported as this am, the patient was vaccinated with the affected and expired, as reported, Jynneos vial (batch number: unknown), at an incomplete dose (one vial was used for two patients), administered intradermally, for unknown indication (explicitly coded as 'Inappropriate route of vaccination', 'Underdose', ' Expired product administered' and 'Product administration error).    At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received from agency on 19-Aug-2022 included an additional reference number.  This case is linked to case US-BN-2022-001982 (same reporter).; Reporter's Comments: On an unspecified date, Jynneos vaccine was left opened in the fridge, which is considered as product storage error. On an unspecified date, the patient was vaccinated with the affected and expired Jynneos vial at an incomplete dose (one vial was used for two patients), administered intradermally, for unknown indication, which is considered as inappropriate route of vaccination, vaccine underdose, expired product administered and product administration error. No associated adverse events were reported. Product storage error, inappropriate route of vaccination, vaccine underdose, expired product administered and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, inappropriate route of vaccination, vaccine underdose, expired product administered and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: On an unspecified date, Jynneos vaccine was left opened in the fridge, which is considered as product storage error. On an unspecified date, the patient was vaccinated with the affected and expired Jynneos vial at an incomplete dose (one vial was used for two patients), administered intradermally, for unknown indication, which is considered as inappropriate route of vaccination, vaccine underdose, expired product administered and product administration error. No associated adverse events were reported. Product storage error, inappropriate route of vaccination, vaccine underdose, expired product administered and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, inappropriate route of vaccination, vaccine underdose, expired product administered and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.