Sex: M
Vaccine: SMALLMNK
Symptoms: CD4 lymphocytes, HIV test positive, Monkeypox, Orthopoxvirus test positive
Clinical narrative: The first dose of Jynneos was administered intradermal; Monkeypox; Case reference number US-BN-2022-004820 is a spontaneous case report initially received on 24-Nov-2022 from a physician via Bavarian Nordic and concerns a 28-year-old male patient.  The patient's medical history included human immunodeficiency virus (HIV) infection.  The patient's concomitant medication details were not provided.  On 10-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at an unknown dose, administered intradermally, at an unknown site of administration for an unknown indication (explicitly coded as 'intradermal injection').  On 07-Sep-2022, 28 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: unknown) at an unknown dose, administered subcutaneously, at an unknown site of administration for an unknown indication.  On 07-Nov-2022, 89 days after the first dose of Jynneos, PCR (Polymerase chain reaction) test was performed and confirmed the patient had monkeypox..  At the time of this report, the outcome for the event of 'monkeypox' was unknown.  The reporter did not provide seriousness assessment, however, the event of 'monkeypox' was assessed as serious due to medical significance. The reporter did not provide causality assessment.  Additional information received on 24-Nov-2022 from Bavarian Nordic included the patient's ID.  Additional information received on 01-Dec-2022 from Bavarian Nordic included confirmation of patient's ID.  This case is linked with US-BN-2022-004662, US-BN-2022-004663, US-BN-2022-004664, US-BN-2022-004665, US-BN-2022-004667 and US-BN-2022-004668.; Reporter's Comments: A 28-year-old male patient was vaccinated with the first dose of Jynneos at an unknown dose, administered intradermally, at an unknown site of administration for an unknown indication, which is considered as intradermal injection. On the day 28 after the first dose, the patient was vaccinated with the second dose of Jynneos, at an unknown dose, administered subcutaneously, at an unknown site of administration for an unknown indication. Reportedly, on the day 89 after the first dose, PCR (Polymerase chain reaction) test was performed and confirmed the patient had monkeypox (medical significance). Monkeypox is unlisted for Jynneos according to the CCDS v1 and USPI. However, vaccines are not necessarily protective in 100% of cases. Intradermal injection is considered as listed per company convention. The patient's medical history included human immunodeficiency virus (HIV) infection and concomitant medication details were not provided. The outcome for the event was unknown. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor.; Sender's Comments: A 28-year-old male patient was vaccinated with the first dose of Jynneos at an unknown dose, administered intradermally, at an unknown site of administration for an unknown indication, which is considered as intradermal injection. On the day 28 after the first dose, the patient was vaccinated with the second dose of Jynneos, at an unknown dose, administered subcutaneously, at an unknown site of administration for an unknown indication. Reportedly, on the day 89 after the first dose, PCR (Polymerase chain reaction) test was performed and confirmed the patient had monkeypox (medical significance). Monkeypox is unlisted for Jynneos according to the agency and other agency. However, vaccines are not necessarily protective in 100% of cases. Intradermal injection is considered as listed per company convention. The patient's medical history included human immunodeficiency virus (HIV) infection and concomitant medication details were not provided. The outcome for the event was unknown. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor.