Sex: U
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Incorrect route of product administration, Product administration error, Product colour issue, Underdose
Clinical narrative: Jynneos vaccine was clear; Jynneos vaccine was clear and affected vaccine was adminstered; Jynneos vaccine was administered on day 29; Jynneos vaccine was administered transdermally; Jynneos vaccine administered at dose 0.1 ml; Case reference number US-BN-2022-001877 is a spontaneous case report initially received on 12-Aug-2022 from a nurse via Communications (reference number: USBAV22-0983) and concerns an adult patient of unknown age and gender.  The patient's medical history and concomitant medication details were not provided.  On 15-Jul-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00002), at a dose 0.5 mL, administered subcutaneously, for an unknown indication. It was reported that the vaccine was clear, not milky, light yellow or pale white and there were no particulate matter seen (explicitly coded as 'product color issue' and 'product administration error').  On 13-Aug-2022 (as reported), 29 days after first dose, the patient was vaccinated with the second dose of Jynneos vaccine (FDP00004), (explicitly coded as 'inappropriate schedule of vaccine administered') at a dose 0.1 mL (explicitly coded as 'underdose'), administered transdermally (explicitly coded as 'inappropriate route of vaccination). It was reported that the vaccine was clear, not milky, light yellow or pale white and there were no particulate matter seen (explicitly coded as 'product color issue' and 'product administration error').  At the time of this report, it was unknown if the patient experienced any adverse event.  This case is linked to case US-BN-2022-001876 (same reporter).  Additional information received on 16-Aug-2022 included the local BN case ID.; Reporter's Comments: An adult patient of unknown age and gender was vaccinated with the first dose of Jynneos vaccine, at a dose 0.5 mL, administered subcutaneously, for an unknown indication. It was reported that the vaccine was clear, not milky, light yellow or pale white and there were no particulate matter seen which is considered as product color issue and product administration error. 29 days after first dose, the patient was vaccinated with the second dose of Jynneos vaccine which is considered as inappropriate schedule of vaccine administered, at a dose 0.1 mL which is considered as underdose, administered transdermally, considered as inappropriate route of vaccination. It was reported that the vaccine was clear, not milky, light yellow or pale white and there were no particulate matter seen which is again considered as product color issue and product administration error. Product color issue, product administration error, inappropriate schedule of product administration, incorrect route of product administration and underdose are all considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event. The patient's medical history and concomitant medication details were not provided. Causality for all reported events is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An adult patient of unknown age and gender was vaccinated with the first dose of Jynneos vaccine, at a dose 0.5 mL, administered subcutaneously, for an unknown indication. It was reported that the vaccine was clear, not milky, light yellow or pale white and there were no particulate matter seen which is considered as product color issue and product administration error. 29 days after first dose, the patient was vaccinated with the second dose of Jynneos vaccine which is considered as inappropriate schedule of vaccine administered, at a dose 0.1 mL which is considered as underdose, administered transdermally, considered as inappropriate route of vaccination. It was reported that the vaccine was clear, not milky, light yellow or pale white and there were no particulate matter seen which is again considered as product color issue and product administration error. Product color issue, product administration error, inappropriate schedule of product administration, incorrect route of product administration and underdose are all considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event. The patient's medical history and concomitant medication details were not provided. Causality for all reported events is assessed as not related to suspect product but to human factor. The case is non-serious.