Sex: U
Vaccine: SMALLMNK
Symptoms: Intentional underdose, Wrong technique in product usage process
Clinical narrative: Jynneos administered intradermally; Patient received 0.08 mL of Jynneos; Dead space and air bubble in the drawn up content; Case reference number US-BN-2022-003927 is a spontaneous case received from other health care professional on 05-Oct-2022 via Communications (reference number: USBAV22-1635) and concerns a patient on unknown demographics.  The patient's relevant 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: unknown), at a dose 0.08 mL, administered intradermally, for monkeypox/smallpox prophylaxis. As reported, the correct dosage was drawn up for the administration, but dead space and air bubble were not accounted, therefore, only 0.08 mL were administered to the patient (explicitly coded as 'intradermal injection', 'wrong technique in product usage process' and 'intentional underdose').   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.   Additional information received from Bavarian Nordic on 06-Oct-2022 included the local BN case ID.; Reporter's Comments: A patient on unknown demographics was vaccinated with Jynneos, at a dose 0.08 mL, administered intradermally, for monkeypox/smallpox prophylaxis. As reported, the correct dosage was drawn up for the administration, but dead space and air bubble were not accounted, therefore, only 0.08 mL were administered to the patient, which is considered as intradermal injection, wrong technique in product usage process and intentional underdose. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. The events of intradermal injection, wrong technique in product usage process and intentional underdose are considered as listed per company conventions. The patient's relevant medical history and concomitant medication details were not provided. Intradermal injection, wrong technique in product usage process and intentional underdose 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 on unknown demographics was vaccinated with Jynneos, at a dose 0.08 mL, administered intradermally, for monkeypox/smallpox prophylaxis. As reported, the correct dosage was drawn up for the administration, but dead space and air bubble were not accounted, therefore, only 0.08 mL were administered to the patient, which is considered as intradermal injection, wrong technique in product usage process and intentional underdose. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. The events of intradermal injection, wrong technique in product usage process and intentional underdose are considered as listed per company conventions. The patient's relevant medical history and concomitant medication details were not provided. Intradermal injection, wrong technique in product usage process and intentional underdose have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.