Sex: U
Vaccine: SMALLMNK
Symptoms: Product administered to patient of inappropriate age, Product administration error, Product packaging difficult to open
Clinical narrative: Jynneos was administered to pediatric patient; On one vial the cap was difficult to came off and created a very sharp edge and on the other vial, the metal cap came completely off and then when the nurse went to withdraw from the stopper, it just "popped" out; Product packaging difficult to open potentially affected the integrity of the product, however the patient received full dose; Case reference number US-BN-2022-002266 is a spontaneous case report initially received on 02-Sep-2022 from a pharmacist via Agency (reference number: USBAV22-1265) and concerns a paediatric patient of an unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: L-JYN-2020.001 Expiry date: 31-Aug-2023) at a dose of 0.5 ml, administered subcutaneously at an unknown site of administration for monkeypox exposure (explicitly coded as 'product administered to patient of inappropriate age').  When the caps were removed for use, on one vial the cap was difficult to come off and created a very sharp edge where the nurse could have cut themselves. On the other vial, the metal cap came completely off and then when the nurse went to withdraw from the stopper, it just "popped" out (explicitly coded as 'product packaging difficult to open'). This potentially affected the integrity of the products, however, the patient received the full dose and experienced no harm (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. PQC number was not provided.  Additional information received from Bavarian Nordic on 02-Sep-2022 included local BN case ID and confirmed country of occurrence.  Additional information received from Bavarian Nordic on 06-Sep-2022 included confirmation that the report was assessed as containing relevant safety information as the product was used on a paediatric patient.; Reporter's Comments: A paediatric patient of an unknown age was vaccinated with Jynneos at a dose of 0.5 ml, administered subcutaneously at an unknown site of administration for monkeypox exposure, which is considered as product administered to patient of inappropriate age.  When the caps were removed for use, on one vial the cap was difficult to come off and created a very sharp edge where the nurse could have cut themselves. On the other vial, the metal cap came completely off and then when the nurse went to withdraw from the stopper, it just "popped" out, which is considered as product packaging difficult to open. This potentially affected the integrity of the products; however, the patient received the full dose and experienced no harm, which is considered as product administration error. The events of product administered to patient of inappropriate age, product packaging difficult to open and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered to patient of inappropriate age, product packaging difficult to open 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 paediatric patient of an unknown age was vaccinated with Jynneos at a dose of 0.5 ml, administered subcutaneously at an unknown site of administration for monkeypox exposure, which is considered as product administered to patient of inappropriate age.  When the caps were removed for use, on one vial the cap was difficult to come off and created a very sharp edge where the nurse could have cut themselves. On the other vial, the metal cap came completely off and then when the nurse went to withdraw from the stopper, it just "popped" out, which is considered as product packaging difficult to open. This potentially affected the integrity of the products; however, the patient received the full dose and experienced no harm, which is considered as product administration error. The events of product administered to patient of inappropriate age, product packaging difficult to open and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered to patient of inappropriate age, product packaging difficult to open 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.