Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
lethargy; Myalgia; Palpitations; Chills (shivering and feeling cold); Headache; Local reactions: Redness, Swelling, Itching; Local reactions: Redness, Swelling, Itching; Local reactions: Redness, Swelling, Itching; Local reactions: Redness, Swelling, Itching; Fatigue/tiredness; Case reference number AU-BN-2025-000625 initially downloaded from regulatory authority is a spontaneous case received from consumer via Health Authority (ID: 757654) on 07-Apr-2025 and concerns a *58-years-old* male patient. The patient's relevant medical history and concomitant medication details were not provided. On *01-Nov-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 *in Nov-2022*, an unknown of time after the vaccination with Jynneos, the patient developed palpitations, *chills (shivering and feeling cold)*, headache, injection site reaction, lethargy, *muscle/body aches, local reactions: redness, swelling, itching, fatigue and tiredness.* At the time of *follow-up* report, it was unknown if the patient recovered from events *palpitations, 'chills', headache, 'injection site reaction', lethargy, 'myalgia', 'injection site redness', 'injection site swelling', 'injection site itching' and 'fatigue'.* The reporter assessed the events of *palpitations, 'chills', headache, 'injection site reaction', lethargy, 'myalgia', 'injection site redness', 'injection site swelling', 'injection site itching' and 'fatigue' 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 consumer via Health authority (ID: AU-TGA-0000757654) on 17-Jul-2025: New information included additional events, updated patient and reporter details, updated event start date, seriousness, causality and added Jynneos dosing information.; Reporter's Comments: A 58-year-old male patient experienced non-serious events lethargy, palpitations, chills, headache, injection site reaction, injection site erythema, injection site swelling, injection site pruritus, fatigue and myalgia on an unspecified date, within approximately one month after the patient was vaccinated with Jynneos for unknown indication. Lethargy is unlisted and unexpected per CCDS v7, Product Monograph and USPI. Palpitations, chills, headache, injection site reaction, injection site erythema, injection site swelling, injection site pruritus, fatigue and myalgia are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI. The outcome was unknown. All reported events are assessed as related due to suggestive temporal relationship, known product safety profile (for palpitations, chills, headache, injection site reaction, injection site erythema, injection site swelling, injection site pruritus, fatigue and myalgia), lack of alternative explanation at this point, and since contributory role of suspect product cannot be excluded. This case is considered as non-serious.; Sender's Comments: A 58-year-old male patient experienced non-serious events lethargy, palpitations, chills, headache, injection site reaction, injection site erythema, injection site swelling, injection site pruritus, fatigue and myalgia on an unspecified date, within approximately one month after the patient was vaccinated with Jynneos for unknown indication. Lethargy is unlisted and unexpected per CCDS v7, Product Monograph and USPI. Palpitations, chills, headache, injection site reaction, injection site erythema, injection site swelling, injection site pruritus, fatigue and myalgia are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI. The outcome was unknown. All reported events are assessed as related due to suggestive temporal relationship, known product safety profile (for palpitations, chills, headache, injection site reaction, injection site erythema, injection site swelling, injection site pruritus, fatigue and myalgia), lack of alternative explanation at this point, and since contributory role of suspect product cannot be excluded. This case is considered as non-serious.
Comments: None