Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
Shortness of breath; Joint aches/pain; Fatigue or tiredness; Headache; Local reactions: Pain, Redness, Swelling, Itching; Muscle/Body aches; Fever; Local reactions: Pain, Redness, Swelling, Itching; Local reactions: Pain, Redness, Swelling, Itching; Local reactions: Pain, Redness, Swelling, Itching; Local reactions: Pain, Redness, Swelling, Itching; Case reference number AU-BN-2025-000626 initially downloaded from the regulatory authority is a spontaneous case received from a consumer via the Health Authority (ID: 757652) on 07-Apr-2025 and concerns a *23-year-old* male patient. The patient's relevant medical history and concomitant medication details were not provided. On *28-Oct-2022*, the patient was vaccinated with Jynneos (batch number: unknown) at an unknown dose, route, or site of administration for an unknown indication. On an unspecified date *in Oct-2022*, an unknown of time after the vaccination with Jynneos, the patient developed local reactions: pain, redness swelling and itching, fever, headache, muscle/body aches, joint aches/pain, fatigue or tiredness and shortness of breath. At the time of the *follow-up* report, it was unknown if the patient had recovered from the events of *shortness of breath, 'arthralgia', 'tiredness', headache, 'injection site reaction', 'muscle pain', fever, 'injection site pain', 'injection site redness', 'injection site swelling' and 'injection site itching'. * The reporter assessed the events of *shortness of breath, 'arthralgia', 'tiredness', headache, 'injection site reaction', 'muscle pain', fever, 'injection site pain', 'injection site redness', 'injection site swelling' and 'injection site itching' 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 the regulatory authority received from a consumer via the Health Authority (ID: AU-TGA-0000757652) on 17-Jul-2025: New information included patient details, dosing information, onset date of vaccination, seriousness and causality assessment.; Reporter's Comments: A 23-year-old male patient experienced non-serious events of dyspnoea, dyspnoea, arthralgia, fatigue, headache, myalgia, pyrexia, injection site reaction, injection site erythema, injection site pain, injection site pruritus and injection site swelling on an unspecified date, after the patient was vaccinated with Jynneos for unknown indication. Fatigue, headache, myalgia, pyrexia, injection site reaction, injection site erythema, injection site pain, injection site pruritus and injection site swelling are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI, whilst dyspnoea is unlisted and unexpected. Arthralgia 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 23-year-old male patient experienced non-serious events of dyspnoea, dyspnoea, arthralgia, fatigue, headache, myalgia, pyrexia, injection site reaction, injection site erythema, injection site pain, injection site pruritus and injection site swelling on an unspecified date, after the patient was vaccinated with Jynneos for unknown indication. Fatigue, headache, myalgia, pyrexia, injection site reaction, injection site erythema, injection site pain, injection site pruritus and injection site swelling are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI, whilst dyspnoea is unlisted and unexpected. Arthralgia 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