Received Jun 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
Atrial fibrillation; Case reference number AU-BN-2025-000487 initially downloaded from Department of Health and Aged Care, Regulatory Authority is a spontaneous case received from consumer via Health Authority (TGA ID: AU-TGA-0000775733) and concerns a *59-year-old*, male patient. The patient's relevant medical history and concomitant medication details were not provided. On *17-Sep-2022*, the patient was vaccinated with a dose of Jynneos (batch number: unknown) at an unknown dose, route or site of administration for unknown indication. On an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient developed atrial fibrillation. *The event management of atrial fibrillation was conducted through the hospital emergency department. * Patient had no previous vaccine reactions. At the time of initial report, it was unknown if the patient recovered from event atrial fibrillation. The reporter *assessed the event atrial fibrillation as non-serious and as possibly related to Jynneos*, however the event of atrial fibrillation was assessed serious due to seriousness criteria of medically significance. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up downloaded from RA received from consumer via Health authority (TGA ID: AU-TGA-0000775733) on 05-Jun-2025: New information included patient details, event management, onset date of vaccination, seriousness and causality assessment.; Reporter's Comments: A 59-year-old male patient experienced a serious event of atrial fibrillation (medical significance) on an unspecified date, an unknown amount of time after the patient was vaccinated with Jynneos for unknown indication. Atrial fibrillation is unlisted and unexpected for Jynneos per CCDS v7, Product Monograph and USPI. The patient's relevant medical history and concomitant medication details were not provided. The outcome was unknown. The report lacks critical information necessary for a meaningful causality assessment. Specifically, the timing of onset relative to vaccination, patient's relevant medical history, concomitant medications, and clinical course are not provided which renders the causality as not assessable. This case is considered as serious due to medical significance.; Sender's Comments: A 59-year-old male patient experienced a serious event of atrial fibrillation (medical significance) on an unspecified date, an unknown amount of time after the patient was vaccinated with Jynneos for unknown indication. Atrial fibrillation is unlisted and unexpected for Jynneos per CCDS v7, Product Monograph and USPI. The patient's relevant medical history and concomitant medication details were not provided. The outcome was unknown. The report lacks critical information necessary for a meaningful causality assessment. Specifically, the timing of onset relative to vaccination, patient's relevant medical history, concomitant medications, and clinical course are not provided which renders the causality as not assessable. This case is considered as serious due to medical significance.
Comments: None