Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
possible anaphylaxis; Abdominal pain; influenza like illness; cough; Joint aches/pain; Local reactions: Pain; Rash on chest/back, arms, legs; Headache; Fatigue or tiredness; Case reference number AU-BN-2025-000724 initially downloaded from Regulatory Administration is a spontaneous case received from consumer via Health Authority (ID: 755374) on 07-Apr-2025 and concerns a *20-year-old* male patient. The patient's relevant medical history and concomitant medication details were not provided. On *01-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, an unknown amount of time after the vaccination with Jynneos, the patient developed *local reaction of pain and rash on chest/back arms, legs. It was reported that the rash occurred with a cough. The rash started seven to 72 hours after vaccination and lasted for more than twenty-four hours. The subject also experienced headache, joint aches/pain, abdominal pain, fatigue or tiredness and possible anaphylaxis.* At the time of *this follow-up report*, it was unknown if the patient recovered from events of *'anaphylaxis', influenza like illness, 'injection site pain', 'rash', cough, headache, 'joint pain', abdominal pain and 'fatigue'*. *The reporter assessed the events of 'anaphylaxis', influenza like illness, 'injection site pain', 'rash', cough, headache, 'joint pain', abdominal pain and 'fatigue' as non-serious however, the event of 'anaphylaxis' was assessed as serious due to seriousness criteria of medical significance. The reporter assessed the events of 'anaphylaxis', influenza like illness, 'injection site pain', 'rash', cough, headache, 'joint pain', abdominal pain and 'fatigue' as possibly related to the product of 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 a consumer via Health Authority (ID: AU-TGA-0000755374) on 17-Jul-2025: patient details, reporter details, causality and seriousness of the event, Jynneos vaccination details.; Reporter's Comments: This case concerned a 20-year-old male patient, who experienced serious (medically significant) event of anaphylaxis and non-serious events of abdominal pain, influenza like illness, cough, arthralgia, injection site pain, rash, headache and fatigue on unspecified date, after the dose of Jynneos vaccine for unknown indication. Anaphylaxis, injection site pain, rash, headache and fatigue are listed and expected per CCDS v7 and Product Monograph of [withheld] and [withheld]. Abdominal pain, influenza like illness, cough, arthralgia are listed and expected per CCDS v7 and Product Monograph of [withheld], whilst unexpected per [withheld]. 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 serious due to medically significant criteria.; Sender's Comments: This case concerned a 20-year-old male patient, who experienced serious (medically significant) event of anaphylaxis and non-serious events of abdominal pain, influenza like illness, cough, arthralgia, injection site pain, rash, headache and fatigue on unspecified date, after the dose of Jynneos vaccine for unknown indication. Anaphylaxis, injection site pain, rash, headache and fatigue are listed and expected per CCDS v7 and Product Monograph of [withheld] and [withheld]. Abdominal pain, influenza like illness, cough, arthralgia are listed and expected per CCDS v7 and Product Monograph of [withheld], whilst unexpected per [withheld]. 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 serious due to medically significant criteria.
Comments: None