Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | ID |
possible anaphylaxis; Swelling extending past elbow/shoulder; itching; local reactions: redness; The patient received Jynneos intradermally; The patient received Jynneos intradermally; Case reference number AU-BN-2025-000737 initially downloaded from Regulatory Administration is a spontaneous case received from consumer via Health Authority (ID: 754494) 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 or site of administration, *intradermally* for unknown indication. *(explicitly coded as 'intradermal injection' and 'off label use').* On an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient developed *local reactions of redness, swelling extended past elbow/shoulder, itching and possible anaphylaxis*. At the time of *this follow-up report*, it was unknown if the patient recovered from events of *anaphylaxis*, 'extensive swelling of vaccinated limb', *'injection site redness' and itching*. *The reporter assessed the events of anaphylaxis, 'extensive swelling of vaccinated limb', 'injection site redness', 'itching' 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, 'extensive swelling of vaccinated limb', 'injection site redness', itching 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-0000754494) on 17-Jul-2025: patient details, reporter details, causality and seriousness of the event, Jynneos vaccination details.; Reporter's Comments: This case concerned a 27-year-old male patient, who was vaccinated with Jynneos vaccine, intradermally for unknown indication, which is considered as injection and off label use. Patient experienced serious (medically significant) event of anaphylaxis and non-serious events of extensive swelling of vaccinated limb, pruritus, injection site erythema, on unspecified date after the dose of Jynneos vaccine for unknown indication. Anaphylaxis, injection site erythema are listed and expected for Jynneos per CCDS v7, Product Monograph of [withheld] and [withheld] whilst extensive swelling of vaccinated limb is unlisted and unexpected. Pruritus is listed and expected per CCDS v7 and Product Monograph of [withheld], whilst unexpected per [withheld]. Intradermal injection and off label use are considered as listed as per company convention. 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. Injection and off label use are not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medically significant criteria.; Sender's Comments: This case concerned a 27-year-old male patient, who was vaccinated with Jynneos vaccine, intradermally for unknown indication, which is considered as injection and off label use. Patient experienced serious (medically significant) event of anaphylaxis and non-serious events of extensive swelling of vaccinated limb, pruritus, injection site erythema, on unspecified date after the dose of Jynneos vaccine for unknown indication. Anaphylaxis, injection site erythema are listed and expected for Jynneos per CCDS v7, Product Monograph of [withheld] and [withheld] whilst extensive swelling of vaccinated limb is unlisted and unexpected. Pruritus is listed and expected per CCDS v7 and Product Monograph of [withheld], whilst unexpected per [withheld]. Intradermal injection and off label use are considered as listed as per company convention. 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. Injection and off label use are not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medically significant criteria.
Comments: None