Sex: U
Vaccine: SMALLMNK
Symptoms: Culture positive, Drug ineffective, Monkeypox, Orthopoxvirus test positive
Clinical narrative: Positive for monkeypox after second dose of Jynneos vaccine; the infection occurred after the full course of two vaccinations.; Case reference number US-BN-2022-004303 is a spontaneous case report initially received on 21-Oct-22 from other health care professional via Bavarian Nordic (reference: BN_2022_02602) and concerns patient of unknown age and gender.  The patient's medical history and concomitant medications details were not provided.  On unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at an unknown dose, through unknown route of administration, at unknown anatomical location, for unknown indication.  On unspecified date, the patient was vaccinated with the second dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at an unknown dose, through unknown route of administration, at unknown anatomical location, for unknown indication.  On unspecified date, the patient was tested positive for monkeypox, as reported after the second dose of Jynneos.  At the time of this report, it was unknown rather there was treatment given to the patient due to any adverse event.  The Reporter did not assess the event per seriousness criteria and did not provide causality assessment to Jynneos.  Additional information received on 27-Oct-2022 from Bavarian Nordic included confirmation of the date when the request was made.; Reporter's Comments: A patient of unknown demographics was vaccinated with two doses of Jynneos, applied on unknown dates, via unknown anatomical sites or routes of administration. On an unknown date after the second dose, the patient tested positive for monkeypox (serious, medically significant event), which is considered as drug ineffective. The outcome of the event was unknown. Monkeypox is unlisted per the CCDS V1 and USPI for Jynneos. Drug ineffective is considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Considering that Jynneos is a non-replicating vaccine which does not contain the monkeypox virus, the event is assessed as not related to Jynneos. Drug ineffective has been considered as related to the suspect vaccine.; Sender's Comments: A patient of unknown demographics was vaccinated with two doses of Jynneos, applied on unknown dates, via unknown anatomical sites or routes of administration. On an unknown date after the second dose, the patient tested positive for monkeypox (serious, medically significant event), which is considered as drug ineffective. The outcome of the event was unknown. Monkeypox is unlisted per the CCDS V1 and USPI for Jynneos. Drug ineffective is considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Considering that Jynneos is a non-replicating vaccine which does not contain the monkeypox virus, the event is assessed as not related to Jynneos. Drug ineffective has been considered as related to the suspect vaccine.