Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
Swelling extending past elbow/shoulder; Lethargy; Itching; Headache; Local reactions: Pain; Injection site pruritus; Fatigue or tiredness; Anaphylaxis; Case reference number AU-BN-2025-000735 initially downloaded from the Regulatory Administration is a spontaneous case received from a consumer via the Health Authority (ID: 754496) on 07-Apr-2025 and concerns a 27-year-old male patient. The patient's relevant medical history and concomitant medication details were not provided. On *24-Sep-2022*, the patient was vaccinated with Jynneos (batch number: unknown) at an unknown dose, route or site of administration for unknown indication. *On the same date, the patient experienced anaphylaxis.* On an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient developed swelling extending past elbow/shoulder, *itching*, headache, injection site pain, injection site pruritus, lethargy, *fatigue or tiredness.* At the time of *the follow-up report*, it was unknown if the patient recovered from the events of *itching and 'fatigue'*, *and the patient did not recover from the event of* anaphylaxis, 'extensive swelling of vaccinated limb', headache, injection site pain, injection site pruritus, and lethargy. The reporter *assessed the events of * anaphylaxis, 'extensive swelling of vaccinated limb', headache, injection site pain, injection site pruritus, lethargy, itching and 'fatigue' *as serious due to other medically important conditions, and anaphylaxis as serious due to the seriousness criteria of medically significance. The reporter assessed events of anaphylaxis, 'extensive swelling of vaccinated limb', headache, injection site pain, injection site pruritus, lethargy, itching and 'fatigue' as 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-0000754496) on 17-Jul-2025: New information included patient details, onset date of vaccination, seriousness and causality assessment, start date of anaphylaxis, and outcome of the events.; Reporter's Comments: A 27-year-old male patient experienced a serious event of anaphylactic reaction, extensive swelling of vaccinated limb, headache, pruritus, fatigue, injection site pain, injection site pruritus, and lethargy ,after the patient was vaccinated with Jynneos for unknown indication. Anaphylactic reaction, headache, pruritus, fatigue, injection site pain and injection site pruritus are listed and expected for Jynneos per CCDS v7, Product Monograph of [withheld] and [withheld], whilst extensive swelling of vaccinated limb and lethargy are unlisted and unexpected. The patient's relevant medical history and concomitant medication details were not provided. The outcome was not recovered. . 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 medical significance.; Sender's Comments: A 27-year-old male patient experienced a serious event of anaphylactic reaction, extensive swelling of vaccinated limb, headache, pruritus, fatigue, injection site pain, injection site pruritus, and lethargy ,after the patient was vaccinated with Jynneos for unknown indication. Anaphylactic reaction, headache, pruritus, fatigue, injection site pain and injection site pruritus are listed and expected for Jynneos per CCDS v7, Product Monograph of [withheld] and [withheld], whilst extensive swelling of vaccinated limb and lethargy are unlisted and unexpected. The patient's relevant medical history and concomitant medication details were not provided. The outcome was not recovered. 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 medical significance.
Comments: None