Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
Shortness of breath; Redness; Swelling; Joint aches/pain; Fatigue or tiredness; Headache; Local reactions: Redness, Swelling; Muscle/body aches; Case reference number AU-BN-2025-000562 initially downloaded from regulatory authority is a spontaneous case received from consumer via Health Authority (ID: 764131) on 07-Apr-2025 and concerns 43-year-old, male patient. The patient's relevant medical history and concomitant medication details were not provided. On *19-Dec-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, an unknown amount of time after the vaccination with Jynneos, the patient developed *local reactions: redness, swelling headache, muscle/body aches, joint aches/pain fatigue or tiredness shortness of breath added from management of event unstructured, outcome is unknown but resolved*. *On an unspecified date, the patient was recovered from arthralgia, fatigue, headache, injection site reaction and myalgia.* *All of the symptoms from previous vaccine was resolved. Reaction details: Injection site reaction - minor/common/expected.* At the time of *follow-up* report, it was unknown if the patient recovered from event of dyspnoea. *The reporter assessed arthralgia, dyspnoea, fatigue, headache, injection site reaction and myalgia 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 other health professional via Health authority (ID: AU-TGA-0000764131) on 02-Jul-2025: New information included causality, seriousness, event details, vaccination details, patient's detail.; Reporter's Comments: A 43-year-old male patient experienced non-serious events arthralgia, dyspnoea, fatigue, headache, injection site reaction, erythema, swelling and myalgia on an unspecified date, an unknown amount of time after the patient was vaccinated with Jynneos for unknown indication. Fatigue, headache, injection site reaction and myalgia are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI, whilst dyspnoea, erythema and swelling are unlisted and unexpected. Arthralgia is listed and expected for Jynneos 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. Considering implied temporal relationship, lack of alternative explanation and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. This case is considered as non-serious.; Sender's Comments: A 43-year-old male patient experienced non-serious events arthralgia, dyspnoea, fatigue, headache, injection site reaction, erythema, swelling and myalgia on an unspecified date, an unknown amount of time after the patient was vaccinated with Jynneos for unknown indication. Fatigue, headache, injection site reaction and myalgia are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI, whilst dyspnoea, erythema and swelling are unlisted and unexpected. Arthralgia is listed and expected for Jynneos 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. Considering implied temporal relationship, lack of alternative explanation and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. This case is considered as non-serious.
Comments: None