Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Product dose omission issue
Clinical narrative: The second dose was put off; Jynneos vaccine administered intramuscularly; Case reference number US-BN-2022-002625 is a spontaneous case report initially received from a consumer via Agency (reference number: USBAV22-1437) on 19-Sep-2022 and concerns a male patient of unknown age.   The patient's current medical condition included human immunodeficiency virus (HIV). The patient had no acquired immunodeficiency syndrome (AIDS) or opportunistic infections. It was reported that the patient maybe had some level of compromised immunity.  The patient's concomitant vaccination included COVID vaccine.  On 31-Jul-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: not provided), administered intramuscularly (explicitly coded as 'inappropriate route of vaccination'), at a dose of 0.5 mL, at an unknown site of administration, for unknown indication.  It was confirmed that the patient's second dose was put off (explicitly coded as 'missed dose').  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 20-Sep-2022 included the local BN case ID.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos, administered intramuscularly, which is considered as inappropriate route of vaccination, at a dose of 0.5 mL, at an unknown site of administration, for unknown indication. It was confirmed that the patient's second dose was put off, which is considered as missed dose. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Product dose omission issue and incorrect route of product administration are considered as listed per company convention. The patient's current medical condition included human immunodeficiency virus (HIV). The patient had no acquired immunodeficiency syndrome (AIDS) or opportunistic infections. It was reported that the patient maybe had some level of compromised immunity and concomitant vaccination included COVID vaccine. Product dose omission issue 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 male patient of unknown age was vaccinated with the first dose of Jynneos, administered intramuscularly, which is considered as inappropriate route of vaccination, at a dose of 0.5 mL, at an unknown site of administration, for unknown indication. It was confirmed that the patient's second dose was put off, which is considered as missed dose. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Product dose omission issue and incorrect route of product administration are considered as listed per company convention. The patient's current medical condition included human immunodeficiency virus (HIV). The patient had no acquired immunodeficiency syndrome (AIDS) or opportunistic infections. It was reported that the patient maybe had some level of compromised immunity and concomitant vaccination included COVID vaccine. Product dose omission issue 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.