Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
Lethargy; Itching; Fatigue or tirednes; Local reactions: Pain, Redness, Swelling extending past elbow/shoulder; Local reactions: Pain, Redness, Swelling extending past elbow/shoulder; Local reactions: Pain, Redness, Swelling extending past elbow/shoulder; Local reactions: Pain, Redness, Swelling extending past elbow/shoulder; Anaphylaxis; Local reactions: Pain, Redness, Swelling extending past elbow/shoulder; Case reference number AU-BN-2025-000652 initially downloaded from the health authority is a spontaneous case received from a consumer via the Health Authority (ID: 756894) on 07-Apr-2025 and concerns a *26-year-old*, male patient. The patient's relevant medical history and concomitant medication details were not provided. On *19-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 *also reported as in Oct-2022*, an unknown amount of time after the vaccination with Jynneos, the patient developed * possible anaphylaxis, local reactions: pain, redness, swelling extending past elbow/shoulder, fatigue or tiredness. * *On an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient experienced itching and lethargy. * At the time of *the follow-up* report, the patient *did not recover from events of anaphylaxis, 'extensive swelling of vaccinated limb', 'fatigue', 'injection site reaction', lethargy, itching, 'injection site pain', 'injection site redness' and 'injection site swelling'* The reporter assessed the events of 'extensive swelling of vaccinated limb', 'fatigue', 'injection site reaction', lethargy, itching, *'injection site pain', 'injection site redness' and 'injection site swelling' non-serious however, the event of anaphylaxis was considered serious due to medical significance. The reporter assessed the events of anaphylaxis, 'extensive swelling of vaccinated limb', 'fatigue', 'injection site reaction', lethargy, itching, *'injection site pain', 'injection site redness' and 'injection site swelling' 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 the TGA received from a consumer via the Health Authority (ID: AU-TGA-0000756894) on 17-Jul-2025: New information included patient details, dosing information, onset date of vaccination, seriousness and causality assessment, and outcome of the events.; Reporter's Comments: A 26-year-old male patient, had experienced a serious event of anaphylactic reaction (medical significance) and non-serious events of extensive swelling of vaccinated limb, lethargy, pruritus, fatigue, injection site reaction, injection site pain, injection site erythema, and injection site swelling, on an unspecified date, an unknown amount of time after the patient was vaccinated with Jynneos for unknown indication. Anaphylactic reaction, fatigue, injection site reaction, injection site pain, injection site erythema, and injection site swelling are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI, whilst extensive swelling of vaccinated limb, and lethargy are unlisted and unexpected. Pruritus 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 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 26-year-old male patient, had experienced a serious event of anaphylactic reaction (medical significance) and non-serious events of extensive swelling of vaccinated limb, lethargy, pruritus, fatigue, injection site reaction, injection site pain, injection site erythema, and injection site swelling, on an unspecified date, an unknown amount of time after the patient was vaccinated with Jynneos for unknown indication. Anaphylactic reaction, fatigue, injection site reaction, injection site pain, injection site erythema, and injection site swelling are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI, whilst extensive swelling of vaccinated limb, and lethargy are unlisted and unexpected. Pruritus 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 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