Age: 31.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Proctalgia, Rash, Rash macular, Rectal neoplasm
Clinical narrative: First and only dose of Jynneos was administered on the 13-Jul-2022; Monkeypox; developed spots; Patient's arm was sore the day after the injection; Rectal pain and it felt like there are some kind of growths there; Rectal pain and it feels like there are some kind of growths there; Case reference number US-BN-2022-001595 is a spontaneous case report initially received on 15-Jul-2022 from a consumer via Regulatory Authority (reference number: USBAV22-0574) and concerns a 31-year-old male patient.  The patient's medical history and concomitant medication details were not provided.   On 25-Jun-2022 *(also reported as 26-Jun-2022 and most likely 09-Jul-2022)*, the patient was exposed to monkeypox.  On 13-Jul-22, the patient was vaccinated with Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating); batch number: unknown) at an unknown dose or route of administration, administered in the arm, for monkeypox.  On 14-Jul-22, one day after vaccination, the patient developed symptoms reported as spots on penis and two spots near rectum. Additionally, the patient reported rectal pain and felt like there were some kind of growths there. The patient stated that it seemed to be getting worst each day.  On *16*-Jul-2022, also reported as yesterday, the patient was tested for monkeypox *and it was confirmed positive.*  It was confirmed that the patient did not receive further doses (explicitly coded as 'incomplete course of vaccination).  At the time of this report, the outcome for the events 'rectal neoplasm', 'rectal pain', 'spots' and 'injection site pain' was reported as not resolved/ongoing. *The outcome of the event 'monkeypox' was unknown.*  The reporter assessed the events *'rectal neoplasm', 'rectal pain', 'spots' and 'injection site pain'* as related to Jynneos vaccine, *but did not provide causality assessment for the event 'monkeypox'*. Seriousness assessment was not provided. *However, the event 'monkeypox' was assessed as serious due to the seriousness criteria of  medical significance.*  Additional information received on 19-Jul-2022 from Bavarian Nordic included local BN case ID.  Non-significant case correction received on 17-Aug-2022 due to internal review included recoding of the suspect product due to listedness update.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from the consumer on 06-Sep-2022 included confirmation of the date of first vaccination and of the symptoms, date of exposure and the results of the test for monkeypox. New event 'monkeypox' was added. Seriousness assessment changed from 'non serious' to 'serious', due to medical significance.; Reporter's Comments: A 31-year-old male patient experienced a serious (medically significant) event of Monkeypox 2 days after vaccination with Jynneos, and non-serious events of proctalgia, rectal neoplasm, rash macular and injection site pain on the day 1 after the vaccination with Jynneos vaccine for monkeypox, as reported, after the patient was exposed to monkeypox two weeks earlier. Monkeypox, proctalgia and rectal neoplasm are unlisted and unexpected for Jynneos while rash macular is considered listed and injection site pain is listed according to Agency. The patient was vaccinated with one and only dose of Jynneos vaccine and did not receive further doses which is considered as inclomplete course of vaccination. The patient's medical history and concomitant medication details were not provided. The patient was tested for monkeypox and the test was positive. The outcome for the events injection site pain, proctalgia, rectal neoplasm and macular rash was reported as not resolved while the outcome of the event monkeypox was unknown. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, at this point, the events of monkeypox, proctalgia, rectal neoplasm, rash macular and injection site pain have been considered as related to Jynneos. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. This case is considered serious due to medical significance.; Sender's Comments: A 31-year-old male patient experienced a serious (medically significant) event of Monkeypox 2 days after vaccination with Jynneos, and non-serious events of proctalgia, rectal neoplasm, rash macular and injection site pain on the day 1 after the vaccination with Jynneos vaccine for monkeypox, as reported, after the patient was exposed to monkeypox two weeks earlier. Monkeypox, proctalgia and rectal neoplasm are unlisted and unexpected for Jynneos while rash macular is considered listed and injection site pain is listed according to Agency. The patient was vaccinated with one and only dose of Jynneos vaccine and did not receive further doses which is considered as inclomplete course of vaccination. The patient's medical history and concomitant medication details were not provided. The patient was tested for monkeypox and the test was positive. The outcome for the events injection site pain, proctalgia, rectal neoplasm and macular rash was reported as not resolved while the outcome of the event monkeypox was unknown. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, at this point, the events of monkeypox, proctalgia, rectal neoplasm, rash macular and injection site pain have been considered as related to Jynneos. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. This case is considered serious due to medical significance.