Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
Chest pain, pressure or discomfort; Chest pain, pressure or discomfort; Local reactions: Redness, Swelling; Local reactions: Redness, Swelling; Local reactions: Redness, Swelling; Case reference number AU-BN-2025-000629 initially downloaded from regulatory authority is a spontaneous case received from consumer via Health Authority (ID: 757648) on 07-Apr-2025 and concerns a *44-years-old* male patient. The patient's relevant medical history and concomitant medication details were not provided. On *29-Oct-2022*, the patient was vaccinated with Jynneos (batch number: unknown) at an unknown dose, route or site of administration for unknown indication. On an unspecified date *in Oct-2022*, an unknown amount of time after the vaccination with Jynneos, the patient developed chest discomfort, chest pain *or pressure and injection site reaction, redness and swelling*. At the time of *follow-up* report, it was unknown if the patient recovered from events of 'chest pressure', 'chest pain', 'injection site reaction', 'injection site redness' and 'injection site reaction swelling'.* The reporter assessed the events of *'chest pressure', 'chest pain', 'injection site reaction', 'injection site redness' and 'injection site reaction swelling' as non-serious and possibly related to Jynneos.* All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up downloaded from regulatory authority received from consumer via Health authority (ID: AU-TGA-0000757648) on 17-Jul-2025: New information included additional events, updated patient and reporter details, updated event start date, seriousness, causality and added Jynneos dosing information.; Reporter's Comments: A 44-year-old male patient experienced non-serious events of chest discomfort, chest pain, injection site reaction, injection site erythema and injection site swelling on an unspecified date, after the patient was vaccinated with Jynneos for unknown indication. Injection site reaction, injection site erythema and injection site swelling are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI, whilst chest discomfort is unlisted and unexpected. Chest pain is listed and expected per CCDS v7 and Product Monograph, whilst unexpected per USPI. The patient's relevant medical history and concomitant medication details were not provided. The outcome was unknown. However, considering plausible temporal relationship and plausible biological mechanism the contributory role of the suspect vaccine cannot be excluded, and the reported events have been considered as related to Jynneos. This case is considered as non-serious.; Sender's Comments: A 44-year-old male patient experienced non-serious events of chest discomfort, chest pain, injection site reaction, injection site erythema and injection site swelling on an unspecified date, after the patient was vaccinated with Jynneos for unknown indication. Injection site reaction, injection site erythema and injection site swelling are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI, whilst chest discomfort is unlisted and unexpected. Chest pain is listed and expected per CCDS v7 and Product Monograph, whilst unexpected per USPI. The patient's relevant medical history and concomitant medication details were not provided. The outcome was unknown. However, considering plausible temporal relationship and plausible biological mechanism the contributory role of the suspect vaccine cannot be excluded, and the reported events have been considered as related to Jynneos. This case is considered as non-serious.
Comments: None