Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
Possible Anaphylaxis; Extensive swelling of vaccinated limb; Swelling in armpit area (lymphadenopathy); Local reactions: Redness; Case reference number AU-BN-2025-000723 initially downloaded from Regulatory Administration is a spontaneous case received from consumer via Health Authority (ID: 755375) on 07-Apr-2025 and concerns *67-years-old* male patient. The patient's relevant medical history and concomitant medication details were not provided. On *27-Sep-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 *redness, swelling extending past elbow/shoulder swelling in armpit area (lymphadenopathy) possible anaphylaxis*. At the time of *follow-up* report, it was unknown if the patient recovered from events of 'anaphylaxis', 'extensive swelling of vaccinated limb' and 'lymphadenopathy'. *The reporter assessed the events of 'anaphylaxis', 'extensive swelling of vaccinated limb' and 'lymphadenopathy' as non-serious, however the event anaphylactic reaction was assessed as serious due to medically significance. The reporter assessed the events of 'anaphylaxis', 'extensive swelling of vaccinated limb' and 'lymphadenopathy' 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-0000755375) on 17-Jul-2025: New information patient's detail, date of vaccination, seriousness and causality assessment.; Reporter's Comments: This case concerned a 67-year-old male patient, who experienced serious (medically significant) event of anaphylaxis and non-serious events of extensive swelling of vaccinated limb, lymphadenopathy and injection site erythema on unspecified date, after the dose of Jynneos vaccine for unknown indication. Anaphylaxis and injection site erythema are listed and expected per CCDS v7 and Product Monograph of [withheld] and [withheld], whilst extensive swelling of vaccinated limb is unlisted and unexpected. Lymphadenopathy is 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 67-year-old male patient, who experienced serious (medically significant) event of anaphylaxis and non-serious events of extensive swelling of vaccinated limb, lymphadenopathy and injection site erythema on unspecified date, after the dose of Jynneos vaccine for unknown indication. Anaphylaxis and injection site erythema are listed and expected per CCDS v7 and Product Monograph of [withheld] and [withheld], whilst extensive swelling of vaccinated limb is unlisted and unexpected. Lymphadenopathy is 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